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 Commu-
nities Act’’ or the ‘‘SUPPORT for Patients and Commu-
nities Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
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. Drug management program for at-risk beneficiaries. 
Sec. 1005. Medicaid drug review and utilization. 
Sec. 1006. 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. 1007. Medicaid health homes for opioid-use-disorder Medicaid enrollees. 
TITLE II—MEDICARE PROVISIONS TO ADDRESS THE OPIOID 
CRISIS 
Sec. 2001. Authority not to apply certain Medicare telehealth requirements in 
the case of certain treatment of a substance use disorder or co- 
occurring mental health disorder. 
Sec. 2002. Encouraging the use of non-opioid analgesics for the management 
of post-surgical pain. 
Sec. 2003. Requiring a review of current opioid prescriptions for chronic pain 
and screening for opioid use disorder to be included in the Wel-
come to Medicare initial preventive physical examination. 
Sec. 2004. Modification of payment for certain outpatient surgical services. 
Sec. 2005. Requiring e-prescribing for coverage of covered part D controlled 
substances. 
Sec. 2006. Requiring prescription drug plan sponsors under Medicare to estab-
lish drug management programs for at-risk beneficiaries. 
Sec. 2007. Medicare coverage of certain services furnished by opioid treatment 
programs. 
TITLE III—OTHER HEALTH PROVISIONS TO ADDRESS THE 
OPIOID CRISIS
Sec. 3001. Clarifying FDA regulation of non-addictive pain and addiction 
therapies. 
Sec. 3002. Surveillance and Testing of Opioids to Prevent Fentanyl Deaths. 
Sec. 3003. Allowing for more flexibility with respect to medication-assisted 
treatment for opioid use disorders. 
Sec. 3004. High-quality, evidence-based opioid analgesic prescribing guidelines 
and report. 
Sec. 3005. Report on opioids prescribing practices for pregnant women. 
Sec. 3006. Guidelines for prescribing naloxone. 
Sec. 3007. Requiring a survey of substance use disorder treatment providers re-
ceiving Federal funding. 
TITLE IV—OFFSETS 
Sec. 4001. Promoting value in Medicaid managed care. 
Sec. 4002. Extending period of application of Medicare secondary payer rules 
for individuals with end stage renal disease. 
Sec. 4003. Requiring reporting by group health plans of prescription drug cov-
erage information for purposes of identifying primary payer sit-
uations under the Medicare program. 
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 meas-
ures. 
Subtitle B—Medicaid IMD Additional Info 
Sec. 5011. Short title. 
Sec. 5012. MACPAC exploratory study and report on institutions for mental 
diseases requirements and practices under Medicaid. 
Subtitle C—CHIP Mental Health Parity 
Sec. 5021. Short title. 
Sec. 5022. Ensuring access to mental health and substance use disorder serv-
ices 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 sys-
tems to help in-need patients. 
TITLE VI—OTHER MEDICARE PROVISIONS 
Subtitle A—Testing of Incentive Payments for Behavioral Health Providers 
for Adoption and Use of Certified Electronic Health Record Technology
Sec. 6001. Testing of incentive payments for behavioral health providers for 
adoption and use of certified electronic health record tech-
nology. 
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. Short title. 
Sec. 6022. Provision of information regarding opioid use and pain management 
as part of Medicare & You handbook. 
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. Medicare notifications to outlier prescribers of opioids. 
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 treat-
ment 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. Pain management study. 
Subtitle J—Combating Opioid Abuse for Care in Hospitals 
Sec. 6091. Short title. 
Sec. 6092. Developing guidance on pain management and opioid use disorder 
prevention for hospitals receiving payment under part A of the 
Medicare program. 
Sec. 6093. Requiring the review of quality measures relating to opioids and 
opioid use disorder treatments furnished under the medicare 
program and other federal health care programs. 
Sec. 6094. Technical expert panel on reducing surgical setting opioid use; Data 
collection on perioperative opioid use. 
Sec. 6095. Requiring the posting and periodic update of opioid prescribing 
guidance for Medicare beneficiaries. 
Subtitle K—Stop Excessive Narcotics in Our Retirement Communities 
Protection 
Sec. 6101. Short title. 
Sec. 6102. Suspension of payments by Medicare prescription drug plans and 
MA–PD plans pending investigations of credible allegations of 
fraud by pharmacies. 
Subtitle L—Providing Reliable Options for Patients and Educational 
Resources 
Sec. 6111. Short title. 
Sec. 6112. 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. 6113. Requiring Medicare Advantage plans and prescription drug plans to 
provide information on the safe disposal of prescription drugs. 
Sec. 6114. Revising measures used under the Hospital Consumer Assessment 
of Healthcare Providers and Systems survey relating to pain 
management. 
TITLE VII—OTHER HEALTH PROVISIONS 
Subtitle A—Synthetic Drug Awareness 
Sec. 7001. Short title. 
Sec. 7002. Report on effects on public health of synthetic drug use. 
Subtitle B—Empowering Pharmacists in the Fight Against Opioid Abuse
Sec. 7011. Short title. 
Sec. 7012. Programs and materials for training on certain circumstances under 
which a pharmacist may decline to fill a prescription. 
Subtitle C—Indexing Narcotics, Fentanyl, and Opioids 
Sec. 7021. Short title. 
Sec. 7022. Establishment of substance use disorder information dashboard. 
Sec. 7023. Interagency Substance Use Disorder Coordinating Committee. 
Subtitle D—Ensuring Access to Quality Sober Living 
Sec. 7031. Short title. 
Sec. 7032. National recovery housing best practices. 
Subtitle E—Advancing Cutting Edge Research 
Sec. 7041. Short title. 
Sec. 7042. Unique research initiatives. 
Subtitle F—Jessie’s Law 
Sec. 7051. Short title. 
Sec. 7052. Inclusion of opioid addiction history in patient records. 
Sec. 7053. Communication with families during emergencies. 
Subtitle G—Safe Disposal of Unused Medication 
Sec. 7061. Short title. 
Sec. 7062. Disposal of controlled substances of a deceased hospice patient by 
employees of a qualified hospice program. 
Subtitle H—Substance Use Disorder Workforce Loan Repayment 
Sec. 7071. Short title. 
Sec. 7072. Loan repayment program for substance use disorder treatment em-
ployees. 
Subtitle I—Preventing Overdoses While in Emergency Rooms 
Sec. 7081. Short title. 
Sec. 7082. Program to support emergency room discharge and care coordina-
tion for drug overdose patients. 
Subtitle J—Alternatives to Opioids in the Emergency Department 
Sec. 7091. Short title. 
Sec. 7092. Emergency department alternatives to opioids demonstration pro-
gram. 
Subtitle K—Stop Counterfeit Drugs by Regulating and Enhancing 
Enforcement Now 
Sec. 7101. Short title. 
Sec. 7102. Detention, refusal, and destruction of drugs offered for importation. 
Sec. 7103. Notification, nondistribution, and recall of adulterated or mis-
branded drug products. 
Sec. 7104. Single source pattern of shipments of adulterated or misbranded 
drugs.
Sec. 7105. Fund to strengthen efforts of FDA to combat the opioid and sub-
stance use epidemic. 
Sec. 7106. Consideration of potential for misuse and abuse required for drug 
approval. 
Subtitle L—Treatment, Education, and Community Help to Combat 
Addiction 
Sec. 7111. Short title. 
Sec. 7112. Establishment of Regional Centers of Excellence in Substance Use 
Disorder Education. 
Subtitle M—Guidance From National Mental Health and Substance Use 
Policy Laboratory 
Sec. 7121. Guidance from National Mental Health and Substance Use Policy 
Laboratory. 
Subtitle N—Comprehensive Opioid Recovery Centers 
Sec. 7131. Short title. 
Sec. 7132. Comprehensive opioid recovery centers. 
Subtitle O—Poison Center Network Enhancement 
Sec. 7141. Short title. 
Sec. 7142. Reauthorization of poison control centers national toll-free number. 
Sec. 7143. Reauthorization of nationwide public awareness campaign to pro-
mote poison control center utilization. 
Sec. 7144. Reauthorization of the poison control center grant program. 
Subtitle P—Eliminating Opioid Related Infectious Diseases 
Sec. 7151. Short title. 
Sec. 7152. Reauthorization and expansion of program of surveillance and edu-
cation regarding infections associated with illicit drug use and 
other risk factors. 
Subtitle Q—Better Pain Management Through Better Data 
Sec. 7161. Short title. 
Sec. 7162. Guidance addressing alternative approaches to data collection and 
labeling claims for opioid sparing. 
Subtitle R—Special Registration for Telemedicine Clarification 
Sec. 7171. Short title. 
Sec. 7172. Deadline for interim final regulations for a special registration To 
engage in the practice of telemedicine. 
Subtitle S—Peer Support Communities of Recovery 
Sec. 7181. Short title. 
Sec. 7182. Building communities of recovery. 
Subtitle T—Stop Illicit Drug Importation 
Sec. 7191. Short title. 
Sec. 7192. Detention, refusal, and destruction of drugs offered for importation.
Sec. 7193. Seizure. 
Sec. 7194. Debarring violative individuals or companies. 
Subtitle U—Creating Opportunities That Necessitate New and Enhanced 
Connections That Improve Opioid Navigation Strategies 
Sec. 7201. Short title. 
Sec. 7202. Preventing overdoses of controlled substances. 
Sec. 7203. Prescription drug monitoring program. 
Subtitle V—Securing Opioids and Unused Narcotics With Deliberate Disposal 
and Packaging 
Sec. 7211. Short title. 
Sec. 7212. Improved technologies, controls, or measures with respect to the 
packaging or disposal of certain drugs. 
Subtitle W—Postapproval Study Requirements 
Sec. 7221. Postapproval study requirements. 
TITLE VIII—MISCELLANEOUS 
Subtitle A—Synthetics Trafficking and Overdose Prevention 
Sec. 8001. Short title; table of contents. 
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—Recognizing Early Childhood Trauma Related to Substance 
Abuse 
Sec. 8011. Short title. 
Sec. 8012. Recognizing Early Childhood Trauma Related to Substance Abuse. 
Subtitle C—Assisting States’ Implementation of Plans of Safe Care 
Sec. 8021. Short title. 
Sec. 8022. Assisting States with implementation of plans of safe care. 
Subtitle D—Improving the Federal Response to Families Impacted by 
Substance Use Disorder 
Sec. 8031. Short title. 
Sec. 8032. Interagency Task Force to Improve the Federal Response to Fami-
lies Impacted by Substance Use Disorders. 
Subtitle E—Establishment of an Advisory Committee on Opioids and the 
Workplace 
Sec. 8041. Establishment of an Advisory Committee on Opioids and the Work-
place.
Subtitle F—Veterans Treatment Court Improvement 
Sec. 8051. Short title. 
Sec. 8052. Hiring by Department of Veterans Affairs of additional Veterans 
Justice Outreach Specialists. 
Subtitle G—Peer Support Counseling Program for Women Veterans 
Sec. 8061. Peer support counseling program for women veterans. 
Subtitle H—Treating Barriers to Prosperity 
Sec. 8071. Short title. 
Sec. 8072. Drug abuse mitigation initiative. 
Subtitle I—Supporting Grandparents Raising Grandchildren 
Sec. 8081. Short title. 
Sec. 8082. Findings. 
Sec. 8083. Advisory Council To Support Grandparents Raising Grandchildren. 
Sec. 8084. Definitions. 
Subtitle J—Reauthorizing and Extending Grants for Recovery From Opioid 
Use Programs 
Sec. 8091. Short title. 
Sec. 8092. Reauthorization of the comprehensive opioid abuse grant program. 
TITLE IX—SITSA ACT 
Sec. 9001. Short title. 
Sec. 9002. Establishment of schedule A. 
Sec. 9003. Temporary and permanent scheduling of schedule A substances. 
Sec. 9004. Penalties. 
Sec. 9005. False labeling of schedule A controlled substances. 
Sec. 9006. Registration requirements for handlers of schedule A substances. 
Sec. 9007. Additional conforming amendments. 
Sec. 9008. Controlled substance analogues. 
Sec. 9009. Rules of construction. 
Sec. 9010. Study by Comptroller General. 
Sec. 9011. Report on controlled substance analogues sold by means of the 
Internet. 
Sec. 9012. Controlled substance analogues. 
TITLE X—THRIVE ACT 
Sec. 10001. Short title. 
Sec. 10002. Demonstration program to study the impact of using rental vouch-
ers for supportive housing for individuals recovering from 
opioid use disorders or other substance use disorders. 
Sec. 10003. Repeal of Rental Voucher Demonstration Program. 
Sec. 10004. Demonstration Close-Out. 
Sec. 10005. No additional funds authorized. 
TITLE XI—IMD CARE ACT 
Sec. 11001. Short title.
Sec. 11002. Medicaid State plan option to provide services for certain individ-
uals with targeted SUDs in institutions for mental diseases. 
Sec. 11003. Promoting value in Medicaid managed care. 
TITLE I—MEDICAID PROVISIONS 
TO ADDRESS THE OPIOID CRISIS 
SEC. 1001. AT-RISK YOUTH MEDICAID PROTECTION. 
(a) IN GENERAL.—Section 1902 of the Social Secu-
rity 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 eligi-
bility for medical assistance under the State 
plan for an individual who is an eligible juvenile 
(as defined in subsection (nn)(2)) because the 
juvenile is an inmate of a public institution (as 
defined in subsection (nn)(3)), but may suspend 
coverage during the period the juvenile is such 
an inmate; 
‘‘(B) in the case of an individual who is an 
eligible juvenile described in paragraph (2)(A) 
of subsection (nn), the State shall, prior to the
individual’s release from such a public institu-
tion, conduct a redetermination of eligibility for 
such individual with respect to such medical as-
sistance (without requiring a new application 
from the individual) and, if the State deter-
mines pursuant to such redetermination that 
the individual continues to meet the eligibility 
requirements for such medical assistance, the 
State shall restore coverage for such medical 
assistance to such an individual upon the indi-
vidual’s release from such public institution; 
and 
‘‘(C) in the case of an individual who is an 
eligible juvenile described in paragraph (2)(B) 
of subsection (nn), the State shall process any 
application for medical assistance submitted by, 
or on behalf of, such individual such that the 
State makes a determination of eligibility for 
such individual with respect to such medical as-
sistance 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 IN-
STITUTION.—For purposes of subsection (a)(84) and this 
subsection: 
‘‘(1) JUVENILE.—The term ‘juvenile’ means an 
individual who is— 
‘‘(A) under 21 years of age; or 
‘‘(B) 
described 
in 
subsection 
(a)(10)(A)(i)(IX). 
‘‘(2) ELIGIBLE JUVENILE.—The term ‘eligible 
juvenile’ means a juvenile who is an inmate of a 
public institution and who— 
‘‘(A) was determined eligible for medical 
assistance under the State plan immediately be-
fore becoming an inmate of such a public insti-
tution; or 
‘‘(B) is determined eligible for such med-
ical assistance while an inmate of a public insti-
tution. 
‘‘(3) INMATE OF A PUBLIC INSTITUTION.—The 
term ‘inmate of a public institution’ has the meaning 
given such term for purposes of applying the sub-
division (A) following paragraph (29) 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.— 
Nothing in this section shall be construed as changing the 
exclusion from medical assistance under the subdivision 
(A) following paragraph (29) of section 1905(a) of the So-
cial Security Act (42 U.S.C. 1396d(a)), including any ap-
plicable restrictions on a State submitting claims for Fed-
eral financial participation under title XIX of such Act 
for such assistance. 
(c) NO CHANGE IN CONTINUITY OF ELIGIBILITY BE-
FORE ADJUDICATION OR SENTENCING.—Nothing in this 
section shall be construed to mandate, encourage, or sug-
gest that a State suspend or terminate coverage for indi-
viduals 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 
LEGISLATION.—In the case of a State plan for med-
ical assistance under title XIX of the Social Security 
Act which the Secretary of Health and Human Serv-
ices determines requires State legislation (other than
legislation appropriating funds) in order for the plan 
to meet the additional requirements imposed by the 
amendments made by subsection (a), the State plan 
shall not be regarded as failing to comply with the 
requirements of such title solely on the basis of its 
failure to meet these additional requirements before 
the first day of the first calendar quarter beginning 
after the close of the first regular session of the 
State legislature that begins after the date of the en-
actment of this Act. For purposes of the previous 
sentence, in the case of a State that has a 2-year 
legislative session, each year of such session shall be 
deemed to be a separate regular session of the State 
legislature. 
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 
foster youth who attain 18 years of age on or after 
January 1, 2023. 
(b) GUIDANCE.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall issue guidance to States, with re-
spect to the State Medicaid programs of such States— 
(1) on best practices for— 
(A) 
removing 
barriers 
and 
ensuring 
streamlined, timely access to Medicaid coverage 
for former foster youth up to age 26; and 
(B) 
conducting 
outreach 
and 
raising 
awareness among such youth regarding Med-
icaid coverage options for such youth; and 
(2) which shall include examples of States that 
have successfully extended Medicaid coverage to 
former foster youth up to age 26.
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 section, the Secretary shall, in consultation, as 
appropriate, with the Director of the Agency for 
Healthcare Research and Quality and the Assistant 
Secretary for Mental Health and Substance Use, 
conduct a 54-month demonstration project for the 
purpose described in paragraph (2) under which the 
Secretary shall— 
‘‘(A) for the first 18-month period of such 
project, award planning grants described in 
paragraph (3); and 
‘‘(B) for the remaining 36-month period of 
such project, provide to each State selected 
under paragraph (4) payments in accordance 
with paragraph (5). 
‘‘(2) PURPOSE.—The purpose described in this 
paragraph is for each State selected under para-
graph (4) to increase the treatment capacity of pro-
viders participating under the State plan (or a waiv-
er of such plan) to provide substance use disorder 
treatment or recovery services under such plan (or 
waiver) through the following activities: 
‘‘(A) For the purpose described in para-
graph (3)(C)(i), activities that support an ongo-
ing assessment of the behavioral health treat-
ment needs of the State, taking into account 
the matters described in subclauses (I) through 
(IV) of such paragraph. 
‘‘(B) Activities that, taking into account 
the results of the assessment described in sub-
paragraph (A), support the recruitment, train-
ing, and provision of technical assistance for 
providers participating under the State plan (or 
a waiver of such plan) that offer substance use 
disorder treatment or recovery services. 
‘‘(C) Improved reimbursement for and 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— 
‘‘(i) are authorized to dispense drugs 
approved by the Food and Drug Adminis-
tration for individuals with a substance use 
disorder who need withdrawal management 
or maintenance treatment for such dis-
order; 
‘‘(ii) have in effect a registration or 
waiver under section 303(g) of the Con-
trolled Substances Act for purposes of dis-
pensing narcotic drugs to individuals for 
maintenance treatment or detoxification 
treatment and are in compliance with any 
regulation promulgated by the Assistant 
Secretary for Mental Health and Sub-
stance Use for purposes of carrying out 
the requirements of such section 303(g); 
and 
‘‘(iii) are qualified under applicable 
State law to provide substance use disorder 
treatment or recovery services. 
‘‘(D) Improved reimbursement for and 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 
American College of Obstetricians and 
Gynecologists relating to maternal care 
and infant care with respect to neonatal 
abstinence syndrome; 
‘‘(ii) pregnant women, postpartum 
women, and infants, particularly the con-
current treatment, as appropriate, and 
comprehensive case management of preg-
nant women, postpartum women and in-
fants, enrolled 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 subpara-
graph (B) for purposes of preparing an applica-
tion described in paragraph (4)(C) and carrying 
out the activities described in subparagraph 
(C). 
‘‘(B) SELECTION.—In selecting States for 
purposes of this paragraph, the Secretary 
shall— 
‘‘(i) select States that have a State 
plan (or waiver of the State plan) approved 
under this title; 
‘‘(ii) select States in a manner that 
ensures geographic diversity; and 
‘‘(iii) give preference to States with a 
prevalence of substance use disorders (in 
particular opioid use disorders) that is 
comparable to or higher than the national 
average prevalence, as measured by aggre-
gate per capita drug overdoses, or any 
other measure that the Secretary deems 
appropriate.
‘‘(C) ACTIVITIES
DESCRIBED.—Activities 
described in this subparagraph are, with respect 
to a State, each of the following: 
‘‘(i) Activities that support the devel-
opment of an initial assessment of the be-
havioral health treatment needs of the 
State to determine the extent to which pro-
viders are needed (including the types of 
such providers and geographic area of 
need) to improve the network of providers 
that treat substance use disorders under 
the State plan (or waiver), including the 
following: 
‘‘(I) An estimate of the number 
of individuals enrolled under the State 
plan (or a waiver of such plan) who 
have a substance use disorder. 
‘‘(II) Information on the capacity 
of providers to provide substance use 
disorder treatment or recovery serv-
ices to individuals enrolled under the 
State plan (or waiver), including in-
formation on providers who provide 
such services and their participation 
under the State plan (or waiver).
‘‘(III) Information on the gap in 
substance use disorder treatment or 
recovery services under the State plan 
(or waiver) based on the information 
described in subclauses (I) and (II). 
‘‘(IV) Projections regarding the 
extent to which the State partici-
pating 
under 
the 
demonstration 
project would increase the number of 
providers offering substance use dis-
order treatment or recovery services 
under the State plan (or waiver) dur-
ing the period of the demonstration 
project. 
‘‘(ii) Activities that, taking into ac-
count the results of the assessment de-
scribed in clause (i), support the develop-
ment of State infrastructure to, with re-
spect to the provision of substance use dis-
order treatment or recovery services under 
the State plan (or a waiver of such plan), 
recruit prospective providers and provide 
training and technical assistance to such 
providers.
‘‘(D) FUNDING.—For purposes of 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 
paragraph (1), select not more than 5 States in 
accordance 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 
comparable to or higher than the national 
average prevalence, as measured by aggre-
gate per capita drug overdoses, or any 
other measure that the Secretary deems 
appropriate. 
‘‘(C) APPLICATIONS.— 
‘‘(i) IN GENERAL.—A State seeking to 
be selected for purposes of this paragraph 
shall submit to the Secretary, at such time 
and in such form and manner as the Sec-
retary requires, an application that in-
cludes such information, provisions, and 
assurances, 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 re-
lated to substance use disorder treat-
ment or recovery services under the 
State plan (or waiver) that may create 
barriers to increasing the number of 
providers delivering such services. 
‘‘(III) The development of a plan, 
taking into account activities carried 
out under paragraph (3)(C)(ii), that 
will result in long-term and sustain-
able provider networks under the 
State plan (or waiver) that will offer 
a continuum of care for substance use 
disorders. Such plan shall include the 
following: 
‘‘(aa) Specific activities to 
increase the number of providers 
(including providers that spe-
cialize in providing substance use 
disorder treatment or recovery 
services, hospitals, health care 
systems, 
Federally 
qualified 
health centers, and, as applicable, 
certified community behavioral
health clinics) that offer sub-
stance use disorder treatment, re-
covery, or support services, in-
cluding 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 in-
formation to assess the effectiveness 
of the efforts of the State to expand 
the capacity of providers to deliver 
substance use disorder treatment or 
recovery services during the period of 
the demonstration project under this 
subsection. 
‘‘(V) The expected financial 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 in-
crease in the capacity of providers to 
deliver substance use disorder treat-
ment or recovery services resulting 
from the demonstration project under 
this subsection after the termination 
of such demonstration project.
‘‘(VIII) A description of how the 
State will coordinate the goals of the 
demonstration project with any waiver 
granted (or submitted by the State 
and pending) pursuant to section 
1115 for the delivery of substance use 
services under the State plan, as ap-
plicable. 
‘‘(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 oc-
curring during the period for which the dem-
onstration project is conducted (after the first 
18 months of such period), the Secretary shall 
pay under this subsection, subject to subpara-
graph (C), to each State selected under para-
graph (4) an amount equal to 80 percent of so 
much of the qualified sums expended during 
such quarter.
subsection, submit to the Secretary a quarterly 
report, with respect to expenditures for sub-
stance use treatment or recovery services for 
which payment is made to the State under this 
subsection, on the following: 
‘‘(i) The specific activities with re-
spect to which payment under this sub-
section 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 es-
timated number of providers that would 
have otherwise delivered such services in 
the absence 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 
Services shall, in consultation with the Di-
rector of the Agency for Healthcare Re-
search and Quality and the Assistant Sec-
retary for Mental Health and Substance
Use, submit to Congress an interim re-
port— 
‘‘(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 sub-
mitted in their applications under sub-
paragraph (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 
interim report; and 
‘‘(III) 
evaluating 
such 
dem-
onstration project. 
‘‘(C) AHRQ REPORT.—Not later than 3 
years after the date of the enactment of this 
subsection, the Director of the Agency for 
Healthcare Research and Quality, on consulta-
tion 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 para-
graph (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 collabo-
ration with States selected under paragraph (4), fa-
cilitate data sharing and the development of best
practices between such States and States that were 
not so selected. 
‘‘(8) CMS FUNDING.—There is appropriated, 
out of any funds in the Treasury not otherwise ap-
propriated, $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. DRUG MANAGEMENT PROGRAM FOR AT-RISK 
BENEFICIARIES. 
(a) IN GENERAL.—Title XIX of the Social Security 
Act is amended by inserting after section 1927 (42 U.S.C. 
1396r–8) the following new section: 
‘‘SEC. 1927A. DRUG MANAGEMENT PROGRAM FOR AT-RISK 
BENEFICIARIES. 
‘‘(a) IN GENERAL.—Beginning January 1, 2020, a 
State shall operate a qualified drug management program 
under which a State may enroll certain at-risk bene-
ficiaries identified by the State under the program. 
‘‘(b) QUALIFIED DRUG MANAGEMENT PROGRAM.— 
For purposes of this section, the term ‘qualified drug man-
agement program’ means, with respect to a State, a pro-
gram carried out by the State (including through a con-
tract with a pharmacy benefit manager) that provides at 
least for the following:
‘‘(1) IDENTIFICATION
OF
AT-RISK
INDIVID-
UALS.—Under the program, the State identifies, in 
accordance with subsection (c), individuals enrolled 
under the State plan (or waiver of the State plan) 
who are at-risk beneficiaries. 
‘‘(2) ELEMENTS OF PROGRAM.— 
‘‘(A) IN GENERAL.—Under the program, 
the State, with respect to each individual identi-
fied under paragraph (1) and enrolled under 
the program under paragraph (5)— 
‘‘(i) subject to subparagraphs (B) and 
(C), selects at least one, but not more than 
three, health care providers and at least 
one, but not more than three, pharmacies 
for each such individual for purposes of 
clause (ii), in accordance with a selection 
process that takes into account reasonable 
factors such as the individual’s previous 
utilization of items and services from 
health care providers and pharmacies, geo-
graphic proximity of the individual to such 
health care providers and pharmacies, ac-
cess of the individual to health care, rea-
sonable travel time, information regarding 
housing status, and any known preference
of the individual for a certain health care 
provider or pharmacy; and 
‘‘(ii) requires that any controlled sub-
stance furnished to such individual during 
the period for which such individual is en-
rolled under the program be prescribed by 
a health care provider selected under 
clause (i) for such individual and dispensed 
by a pharmacy selected under clause (i) for 
such individual in order for such controlled 
substance to be covered under the State 
plan (or waiver). 
‘‘(B) BENEFICIARY PREFERENCE.—In the 
case of an individual receiving a notice under 
paragraph (3)(A) of being identified as poten-
tially being an at-risk beneficiary described in 
such paragraph, such individual may submit, 
during the 30-day period following receipt of 
such notice, preferences for which health care 
providers and pharmacies the individual would 
prefer the State to select under subparagraph 
(A). The State shall select or change the selec-
tion of health care providers and pharmacies 
under subparagraph (A) for the individuals 
based on such preferences, except that in the
case that State determines that such selection 
(or change of selection) of a health care pro-
vider or pharmacy under subparagraph (A) is 
contributing or would contribute to prescription 
drug abuse or drug diversion by the individual, 
the State may select or change the selection of 
health care provider or pharmacy for the indi-
vidual without regard to the preferences of the 
individual described in this subparagraph. If the 
State selects or changes the selection pursuant 
to the preceding sentence without regard to the 
preferences of the individual, the State shall 
provide the individual with at least 30 days 
written notice of the selection or change of se-
lection and a rationale for the selection or 
change. 
‘‘(C) TREATMENT
OF
PHARMACY
WITH 
MULTIPLE LOCATIONS.—For purposes of sub-
paragraph (A)(i), in the case of a pharmacy 
that has multiple locations that share real-time 
electronic prescription data, all such locations 
of the pharmacy shall collectively be treated as 
one pharmacy. 
‘‘(D) TREATMENT OF EXISTING FFS DRUG 
MANAGEMENT PROGRAMS.—In the case of a pa-
tient review and restriction program (as identi-
fied in the annual report submitted to the Sec-
retary under section 1927(g)(3)(D)) operated 
by a State pursuant to section 1915(a)(2) be-
fore the date of the enactment of this section, 
such program shall be treated as a qualified 
drug management program. 
‘‘(E) REASONABLE ACCESS.—The program 
shall ensure, including through waiver of ele-
ments of the program (including under sub-
paragraph (A)(ii)), reasonable access to health 
care (including access to health care providers 
and pharmacies with respect to prescription 
drugs described in subparagraph (A)) in the 
case of individuals with multiple residences, in 
the case of natural disasters and similar situa-
tions, and in the case of the provision of emer-
gency services (as defined for purposes of sec-
tion 1860D–4(c)(5)(D)(ii)(II)). 
‘‘(3) NOTIFICATION
TO
IDENTIFIED
INDIVID-
UALS.—Under the program, the State provides each 
individual who is identified under paragraph (1), 
prior to enrolling such individual under the program, 
at least one notification of each of the following:
‘‘(A) Notice that the State has identified 
the individual as potentially being an at-risk 
beneficiary for abuse or misuse of a controlled 
substance. 
‘‘(B) The name, address, and contact in-
formation of each health care provider and 
pharmacy that may be selected for the indi-
vidual under paragraph (2)(A). 
‘‘(C) Information describing all State and 
Federal public health resources that are de-
signed to address such abuse or misuse to 
which the individual has access, including men-
tal health services, substance use disorder and 
recovery services, and other counseling services. 
‘‘(D) Notice of, and information about, the 
right of the individual to— 
‘‘(i) submit preferences of the indi-
vidual for health care providers and phar-
macies to be selected under paragraph 
(2)(A), including as described in paragraph 
(2)(B); 
‘‘(ii) appeal under paragraph (4)— 
‘‘(I) such identification described 
in subparagraph (A); and
‘‘(II) the selection of health care 
providers and pharmacies under para-
graph (2)(A). 
‘‘(E) An explanation of the meaning and 
consequences of the identification of the indi-
vidual as potentially being an at-risk beneficiary 
for abuse or misuse of a controlled substance, 
including an explanation of the program. 
‘‘(F) Information, including a contact list 
and clear instructions, that explain how the in-
dividual can contact the appropriate entities ad-
ministering the program in order to submit 
preferences described in paragraph (2)(B) and 
any other communications relating to the pro-
gram. 
‘‘(4) APPEALS PROCESS.—Under the program, 
the State provides for an appeals process under 
which, with respect to an individual identified under 
paragraph (1)— 
‘‘(A) such individual may appeal— 
‘‘(i) such identification; and 
‘‘(ii) the selection of a health care pro-
vider or pharmacy under paragraph (2)(A); 
‘‘(B) in the case of an appeal described in 
subparagraph (A)(ii), the State shall accommo-
date the health care provider or pharmacy pre-
ferred by the individual for selection for pur-
poses of paragraph (2)(A), unless the State de-
termines that a change to the selection of 
health care provider or pharmacy under such 
paragraph is contributing or would contribute 
to prescription drug abuse or drug diversion by 
the individual; 
‘‘(C) such individual is provided a period of 
not less than 30 days following the date of re-
ceipt of the notice described in paragraph (3) to 
submit such appeal; and 
‘‘(D) the State must make a determination 
with respect to an appeal described in subpara-
graph (A), and notify the individual of such de-
termination, prior to enrollment of such indi-
vidual in the program. 
‘‘(5) ENROLLMENT.—Under the program, the 
State initially enrolls individuals who are identified 
under paragraph (1) in the program for a 12-month 
period— 
‘‘(A) in the case of such an individual who 
does not submit an appeal under paragraph (4) 
within the period applied by the State pursuant 
to subparagraph (C) of such paragraph, begin-
ning on the day after the last day of such pe-
riod; and 
‘‘(B) in the case of such an individual who 
does submit an appeal under paragraph (4) 
within the period applied by the State pursuant 
to subparagraph (C) of such paragraph but 
such appeal is denied, beginning not later than 
30 days after the date of such denial. 
‘‘(6) NOTIFICATION
OF
HEALTH
CARE
PRO-
VIDERS AND PHARMACIES.—Under the program, the 
State provides to each health care provider and 
pharmacy selected for an individual under paragraph 
(2)— 
‘‘(A) notification that the individual is an 
at-risk beneficiary enrolled under the program 
and that the provider or pharmacy has been se-
lected for the individual under paragraph (2); 
‘‘(B) information on such program and the 
role of being so selected; and 
‘‘(C) a process through which the provider 
or pharmacy can submit a concern or complaint 
with respect to being so selected. 
‘‘(7) CONTINUATION OF ENROLLMENT.—Under 
the program, the State, with respect to an individual
enrolled under the program, provides for a process 
to— 
‘‘(A) not later than 30 days before the end 
of the 12-month period for which the individual 
is so enrolled pursuant to paragraph (5)— 
‘‘(i) assess, in accordance with pub-
licly available evidence-based guidelines, 
whether or not such individual should con-
tinue to be enrolled under the program; 
and 
‘‘(ii) notify such individual of the re-
sults of the assessment under clause (i); 
‘‘(B) continue, subject to subparagraph 
(C), enrollment of such individual if such as-
sessment recommends such continuation; and 
‘‘(C) appeal the continuation of enrollment 
in accordance with the appeals process de-
scribed in paragraph (4). 
‘‘(c) AT-RISK BENEFICIARY.— 
‘‘(1) IDENTIFICATION.—For purposes of this 
section, a State shall identify an individual enrolled 
under the State plan (or waiver of the State plan) 
as an at-risk beneficiary if the individual is not an 
exempted individual described in paragraph (2) 
and—
‘‘(A) is identified as such an at-risk bene-
ficiary through the use of publicly available evi-
dence-based guidelines that indicate misuse or 
abuse of a controlled substance; or 
‘‘(B) the State received notification from a 
PDP sponsor or Medicare Advantage organiza-
tion that such individual was identified as being 
an at-risk beneficiary for prescription drug 
abuse for enrollment in a drug management 
program established by the sponsor or organiza-
tion pursuant to section 1860D–4(c)(5) and 
such identification has not been terminated 
under subparagraph (F) of such section. 
‘‘(2) EXEMPTED INDIVIDUAL DESCRIBED.—For 
purposes of paragraph (1), an exempted individual 
described in this paragraph is an individual who— 
‘‘(A) is receiving— 
‘‘(i) hospice or palliative care; or 
‘‘(ii) treatment for cancer; 
‘‘(B) is a resident of a long-term care facil-
ity, of a facility described in section 1905(d), or 
of another facility for which frequently abused 
drugs are dispensed for residents through a 
contract with a single pharmacy; or
‘‘(C) the State elects to treat as an ex-
empted individual for purposes of paragraph 
(1). 
‘‘(d) APPLICATION OF PRIVACY RULES CLARIFICA-
TION.—The Secretary shall clarify privacy requirements, 
including requirements under the regulations promulgated 
pursuant to section 264(c) of the Health Insurance Port-
ability and Accountability Act of 1996 (42 U.S.C. 1320d– 
2 note), related to the sharing of data under subsection 
(b)(6) in the same manner as the Secretary is required 
under subparagraph (J) of section 1860D–4(c)(5) to clar-
ify privacy requirements related to the sharing of data de-
scribed in such subparagraph. 
‘‘(e) REPORTS.— 
‘‘(1) ANNUAL REPORTS.—A State operating a 
qualified drug management program shall include in 
the annual report submitted to the Secretary under 
section 1927(g)(3)(D), beginning with such reports 
submitted for 2021, the following information: 
‘‘(A) The number of individuals enrolled 
under the State plan (or waiver of the State 
plan) who are enrolled under the program and 
the percentage of individuals enrolled under the 
State plan (or waiver) who are enrolled under 
such program.
‘‘(2) MACPAC REPORTS
AND
REVIEW.—Not 
later than 2 years after the date of the enactment 
of this section, the Medicaid and CHIP Payment 
and Access Commission (in this section referred to 
as ‘MACPAC’), in consultation with the National 
Association of Medicaid Directors, pharmacy benefit 
managers, managed care organizations, health care 
providers (including pharmacists), beneficiary advo-
cates, and other stakeholders, shall publish a report 
that includes— 
‘‘(A) best practices for operating drug 
management programs, based on a review of a 
representative sample of States administering 
such a program; 
‘‘(B) a summary of the experience of the 
appeals process under drug management pro-
grams operated by several States, such as the 
frequency at which individuals appealed the 
identification of being an at-risk individual, the 
frequency at which individuals appealed the se-
lection of a health care provider or pharmacy 
under such a program, the timeframes for such 
appeals, a summary of the reasons for such ap-
peals, and the design of such appeals processes;
‘‘(C) a summary of trends and the effec-
tiveness of qualified drug management pro-
grams operated under this section; and 
‘‘(D) recommendations to States on how 
improvements can be made with respect to the 
operation of such programs. 
In reporting on State practices, the MACPAC shall 
consider how such programs have been implemented 
in rural areas, under fee-for-service as well as man-
aged care arrangements, and the extent to which 
such programs have resulted in increased efficiencies 
to such States or to the Federal Government under 
this title. 
‘‘(3) REPORT
ON
PLAN
FOR
COORDINATED 
CARE.—Not later than January 1, 2021, each State 
operating a qualified drug management program 
shall submit to the Administrator of the Centers for 
Medicare & Medicaid Services a report on how such 
State plans to provide coordinated care for individ-
uals enrolled under the State plan (or waiver of the 
State plan) and— 
‘‘(A) who are enrolled under the program; 
or
‘‘(B) who are enrolled with a managed care 
entity and enrolled under such a qualified drug 
management program operated by such entity. 
‘‘(f) APPLICABILITY
TO
MANAGED
CARE
ENTI-
TIES.— 
‘‘(1) IN GENERAL.—With respect to any con-
tract that a State enters into on or after January 
1, 2020, with a managed care entity (as defined in 
section 1932(a)(1)(B)) pursuant to section 1903(m), 
the State shall, as a condition of the contract, re-
quire the managed care entity— 
‘‘(A) to operate a qualified drug manage-
ment program (as defined in subsection (b)) for 
at-risk beneficiaries who are enrolled with such 
entity and identified by the managed care entity 
by means of application of paragraph (2); 
‘‘(B) to submit to the State an annual re-
port on the matters described in subparagraphs 
(A) through (E) of subsection (e)(1); and 
‘‘(C) to submit to the State a list (and as 
necessary update such list) of individuals en-
rolled with such entity under the qualified drug 
management program operated by such entity 
under subparagraph (A) for purposes of allow-
ing State plans for which medical assistance is
paid on a fee-for-service basis to have access to 
such information. 
‘‘(2) APPLICATION.—For purposes of applying, 
with respect to a managed care entity— 
‘‘(A) under paragraph (1)(A)— 
‘‘(i) the definition of the term ‘quali-
fied drug management program’ under 
subsection (b), other than paragraph 
(2)(D) of such subsection; and 
‘‘(ii) the provisions of paragraphs (1) 
and (2) of subsection (c); and 
‘‘(B) under paragraph (1)(B), the report 
requirements described in subparagraphs (A) 
through (E) of subsection (e)(1); 
each reference in such subsection (b) and para-
graphs of subsection (c) to ‘a State’ or ‘the State’ 
(other than to ‘a State plan’ or ‘the State plan’) 
shall be deemed a reference to the managed care en-
tity, each reference under such subsection, para-
graphs, or subparagraphs to individuals enrolled 
under the State plan (or waiver of the State plan) 
shall be deemed a reference to individuals enrolled 
with such entity, and each reference under such sub-
section, paragraphs, or subparagraphs to individuals 
enrolled under the qualified drug management pro-
gram operated by the State shall be deemed a ref-
erence to individuals enrolled under the qualified 
drug management program operated by the man-
aged care entity. 
‘‘(g) CONTROLLED SUBSTANCE DEFINED.—For pur-
poses of this section, the term ‘controlled substance’ 
means a drug that is included in schedule II, III, or IV 
of section 202(c) of the Controlled Substances Act, or any 
combination thereof, as specified by the State.’’. 
(b) 
GUIDANCE
ON
AT-RISK
POPULATION 
TRANSITIONING BETWEEN MEDICAID FFS AND MAN-
AGED CARE.—Not later than October 1, 2019, the Sec-
retary of Health and Human Services shall issue guidance 
for State Medicaid programs, with respect to individuals 
who are enrolled under a State plan (or waiver of such 
plan) under title XIX of the Social Security Act and under 
a drug management program, for purposes of providing 
best practices— 
(1) for transitioning, as applicable, such indi-
viduals from fee-for-service Medicaid (and such a 
program operated by the State) to receiving medical 
assistance under such title through a managed care 
entity (as defined in section 1932(a)(1)(B) of the 
Social Security Act) with a contract that with the
State pursuant to section 1903(m) of such Act (and 
such a program operated by such entity); and 
(2) for transitioning, as applicable, such indi-
viduals from receiving medical assistance under such 
title through a managed care entity (as defined in 
section 1932(a)(1)(B) of the Social Security Act) 
with a contract that with the State pursuant to sec-
tion 1903(m) of such Act (and such a program oper-
ated by such entity) to fee-for-service Medicaid (and 
such a program operated by the State). 
(c) 
GUIDANCE
ON
AT-RISK
POPULATION 
TRANSITIONING TO MEDICARE.— 
(1) IN GENERAL.—Not later than January 1, 
2020, the Secretary of Health and Human Services, 
after consultation with the Federal Coordinated 
Health Care Office established under section 2602 
of the Patient Protection and Affordable Care Act 
(42 U.S.C. 1315b), shall issue guidance for State 
Medicaid programs, with respect to transitioning in-
dividuals, providing for— 
(A) notification to be submitted by the 
State to the Centers for Medicare & Medicaid 
Services and such individuals of the status of 
such individuals as transitioning individuals;
(B) notification to such individuals about 
enrollment under a prescription drug plan 
under part D of such title or under a MA–PD 
plan under part C of such title; 
(C) best practices for transitioning such in-
dividuals to such a plan; and 
(D) best practices for coordination between 
the qualified drug management program (as de-
scribed in section 1927A(b) of the Social Secu-
rity Act, as added by subsection (a)) carried out 
by the State and a drug management program 
carried out under such a plan pursuant to sec-
tion 1860D–4(c)(5) of the Social Security Act 
(42 U.S.C. 1395w–10(c)(5)). 
(2) TRANSITIONING
INDIVIDUALS.—For pur-
poses of paragraph (1), a transitioning individual is 
an individual who, with respect to a month— 
(A) is enrolled under the State plan (or 
waiver of the State plan) and under the quali-
fied drug management program (as described in 
section 1927A(b) of the Social Security Act, as 
added by subsection (a)) carried out by the 
State; and
(B) is expected to become eligible for the 
Medicare program under title XVIII of such 
Act during the subsequent 12-month period. 
SEC. 1005. 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 101, is further 
amended— 
(A) in paragraph (83), at the end, by 
striking ‘‘and’’; 
(B) in paragraph (84), at the end, by 
striking the period and inserting ‘‘; and’’; and 
(C) by inserting after paragraph (84) the 
following new paragraph: 
‘‘(85) provide that the State is in compliance 
with the drug review and utilization requirements 
under subsection (oo)(1).’’. 
(2) DRUG REVIEW AND UTILIZATION REQUIRE-
MENTS.—Section 1902 of the Social Security Act 
(42 U.S.C. 1396a), as amended by section 101, is 
further amended by adding at the end the following 
new subsection: 
‘‘(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 pre-
scribed 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 auto-
mated process (as designed and imple-
mented by the State) that indicates 
when an individual enrolled under the 
plan (or waiver) is prescribed the mor-
phine equivalent for such treatment in 
excess of any limitation that may be 
identified by the State; and 
‘‘(III) a claims review automated 
process (as designed and implemented 
by the State) that monitors when an 
individual enrolled under the State 
plan (or under a waiver of the State 
plan) 
is 
concurrently 
prescribed 
opioids and— 
‘‘(aa) benzodiazepines; or 
‘‘(bb) antipsychotics. 
‘‘(ii) MANAGED CARE ENTITIES.—The 
State requires each managed care entity 
(as defined in section 1932(a)(1)(B)) with 
respect to which the State has a contract 
under section 1903(m) or under section 
1905(t)(3) to have in place, subject to 
paragraph (3), with respect to individuals 
who are eligible for medical assistance 
under the State plan (or under a waiver of 
the State plan) and who are enrolled with
the entity, the limitations described in sub-
clauses (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 en-
rolled as a participating provider in a 
State plan (or waiver of the State plan) or 
contracting with a managed care entity re-
garding the best items and services for an 
individual enrolled under such State plan 
(or waiver). 
‘‘(B) 
PROGRAM
TO
MONITOR 
ANTIPSYCHOTIC MEDICATIONS BY CHILDREN.— 
The State has in place a program (as designed 
and implemented by the State) to monitor and 
manage the appropriate use of antipsychotic
‘‘(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 
subparagraph 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 
Secretary shall submit to Congress a report on the 
most recent information submitted by States under 
paragraph (1)(D). 
‘‘(3) EXCEPTIONS.— 
‘‘(A) CERTAIN INDIVIDUALS EXEMPTED.— 
The drug review and utilization requirements 
under this subsection shall not apply with 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 
frequently abused drugs are dispensed for 
residents through a contract with a single 
pharmacy; 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 
subsection: 
‘‘(i) DRUG UTILIZATION REVIEW ACTIVITIES AND 
REQUIREMENTS.—Beginning not later than October 1, 
2019, each contract under a State plan with a managed
care entity (other than a primary care case manager) 
under section 1903(m) shall provide that the entity is in 
compliance with the applicable provisions of section 
438.3(s)(2) of title 42 of the 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 So-
cial Security Act (42 U.S.C. 1396r–8(g)) is amend-
ed— 
(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 over-
use,’’ 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 utiliza-
tion’’; 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 utiliza-
tion’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall take effect with respect to 
retrospective drug use reviews conducted on or after 
October 1, 2020. 
SEC. 1006. 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) the types of services, including post-dis-
charge services and parenting supports, for families 
of babies with neonatal abstinence syndrome that 
States may cover under the Medicaid program under 
title XIX of the Social Security Act; 
(2) best practices from States with respect to 
innovative or evidenced-based payment models that 
focus on prevention, screening, treatment, plans of 
safe care, and post-discharge services for mothers 
and fathers with substance use disorders and babies 
with neonatal abstinence syndrome that improve 
care and clinical outcomes; 
(3) 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 disorders, infants with neonatal absti-
nence syndrome, and home visiting services; and 
(4) guidance and technical assistance to State 
Medicaid agencies regarding additional flexibilities 
and incentives related to screening, prevention, and
post-discharge services, including parenting sup-
ports. 
(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 sub-
stance use disorder who had coverage during their preg-
nancy under the Medicaid program under such title. 
SEC. 1007. MEDICAID HEALTH HOMES FOR OPIOID-USE-DIS-
ORDER MEDICAID ENROLLEES. 
(a) EXTENSION OF ENHANCED FMAP FOR CERTAIN 
HEALTH HOMES FOR INDIVIDUALS WITH SUBSTANCE 
USE DISORDERS.—Section 1945 of the Social Security 
Act (42 U.S.C. 1396w–4) is amended— 
(1) in subsection (c)— 
(A) in paragraph (1), by inserting ‘‘subject 
to paragraph (4),’’ after ‘‘except that,’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(4) SPECIAL RULE RELATING TO SUBSTANCE 
USE DISORDER HEALTH HOMES.—
‘‘(A) IN GENERAL.—In the case of a State 
with an SUD-focused State plan amendment 
approved by the Secretary on or after October 
1, 2018, the Secretary may, at the request of 
the State, extend the application of the Federal 
medical assistance percentage described in 
paragraph (1) to payments for the provision of 
health home services to SUD-eligible individuals 
under such State plan amendment, in addition 
to the first 8 fiscal year quarters the State plan 
amendment is in effect, for the subsequent 2 
fiscal year quarters that the State plan amend-
ment is in effect. Nothing in this section shall 
be construed as prohibiting a State with a State 
plan amendment that is approved under this 
section and that is not an SUD-focused State 
plan amendment from additionally having ap-
proved on or after such date an SUD-focused 
State plan amendment under this section, in-
cluding for purposes of application of this para-
graph. 
‘‘(B) REPORT
REQUIREMENTS.—In the 
case of a State with an SUD-focused State plan 
amendment for which the application of the 
Federal medical assistance percentage has been
extended under subparagraph (A), such State 
shall, at the end of the period of such State 
plan amendment, submit to the Secretary a re-
port on the following, with respect to SUD-eli-
gible individuals provided health home services 
under such State plan amendment: 
‘‘(i) The quality of health care pro-
vided to such individuals, with a focus on 
outcomes relevant to the recovery of each 
such individual. 
‘‘(ii) The access of such individuals to 
health care. 
‘‘(iii) The total expenditures of such 
individuals for health care. 
For purposes of this subparagraph, the Sec-
retary shall specify all applicable measures for 
determining quality, access, and expenditures. 
‘‘(C) BEST
PRACTICES.—Not later than 
October 1, 2020, the Secretary shall make pub-
licly available on the Internet website of the 
Centers for Medicare & Medicaid Services best 
practices for designing and implementing an 
SUD-focused State plan amendment, based on 
the experiences of States that have State plan
amendments approved under this section that 
include SUD-eligible individuals. 
‘‘(D) DEFINITIONS.—For purposes of this 
paragraph: 
‘‘(i) SUD-ELIGIBLE
INDIVIDUALS.— 
The term ‘SUD-eligible individual’ means, 
with respect to a State, an individual who 
satisfies all of the following: 
‘‘(I) The individual is an eligible 
individual with chronic conditions. 
‘‘(II) The individual is an 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 
TREATMENT
AS
MEDICAL
ASSISTANCE.—Section 
1905(a) of the Social Security Act (42 U.S.C. 
1396d(a)) is amended— 
(A) in paragraph (28), by striking ‘‘and’’ 
at the end; 
(B) by redesignating paragraph (29) as 
paragraph (30); and 
(C) by inserting after paragraph (28) the 
following new paragraph: 
‘‘(29) subject to paragraph (2) of subsection 
(ee), for the period beginning October 1, 2020, and 
ending September 30, 2025, medication-assisted 
treatment (as defined in paragraph (1) of such sub-
section); 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 metha-
done, 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, coun-
seling 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 cer-
tifies to the satisfaction of the Secretary that imple-
menting such provisions statewide for all individuals 
eligible to enroll in the State plan (or waiver of the 
State plan) would not be feasible by reason of a
shortage of qualified providers of medication-assisted 
treatment, or facilities providing such treatment, 
that will contract with the State or a managed care 
entity with which the State has a contract under 
section 1903(m) or under section 1905(t)(3).’’. 
(4) EFFECTIVE DATE.— 
(A) IN
GENERAL.—Subject to subpara-
graph (B), the amendments made by this sub-
section shall apply with respect to medical as-
sistance provided on or after October 1, 2020, 
and before October 1, 2025. 
(B) EXCEPTION
FOR
STATE
LEGISLA-
TION.—In the case of a State plan under title 
XIX of the Social Security Act (42 U.S.C. 1396 
et seq.) that the Secretary of Health and 
Human Services determines requires State leg-
islation in order for the respective plan to meet 
any requirement imposed by the amendments 
made by this subsection, the respective plan 
shall not be regarded as failing to comply with 
the requirements of such title solely on the 
basis of its failure to meet such an additional 
requirement before the first day of the first cal-
endar quarter beginning after the close of the 
first regular session of the State legislature that
begins after the date of the enactment of this 
Act. For purposes of the previous sentence, in 
the case of a State that has a 2-year legislative 
session, each year of the session shall be consid-
ered to be a separate regular session of the 
State legislature. 
TITLE 
II—MEDICARE 
PROVI-
SIONS 
TO 
ADDRESS 
THE 
OPIOID CRISIS 
SEC. 2001. AUTHORITY NOT TO APPLY CERTAIN MEDICARE 
TELEHEALTH REQUIREMENTS IN THE CASE 
OF CERTAIN TREATMENT OF A SUBSTANCE 
USE DISORDER OR CO-OCCURRING MENTAL 
HEALTH DISORDER. 
Section 1834(m) of the Social Security Act (42 
U.S.C. 1395m(m)) is amended— 
(1) in paragraph (2)(B)(i), by inserting ‘‘and 
paragraph (7)(E)’’ after ‘‘Subject to clause (ii)’’; 
and 
(2) by adding at the end the following new 
paragraphs: 
‘‘(7) AUTHORITY NOT TO APPLY CERTAIN RE-
QUIREMENTS IN THE CASE OF CERTAIN TREATMENT 
OF SUBSTANCE USE DISORDER OR CO-OCCURRING 
MENTAL HEALTH DISORDER.—
‘‘(A) IN GENERAL.—For purposes of pay-
ment under this subsection, in the case of tele-
health services described in subparagraph (C) 
furnished on or after January 1, 2020, to an el-
igible beneficiary (as defined in subparagraph 
(F)) for the treatment of a substance use dis-
order or a mental health disorder that is co-oc-
curring with a substance use disorder, the Sec-
retary is authorized to, through rulemaking, not 
apply any of the requirements described in sub-
paragraph (B). 
‘‘(B) REQUIREMENTS
DESCRIBED.—For 
purposes of this paragraph, the requirements 
described in this subparagraph are any of the 
following: 
‘‘(i) Qualifications for an originating 
site under paragraph (4)(C)(ii). 
‘‘(ii) Geographic limitations under 
paragraph (4)(C)(i). 
‘‘(C) 
TELEHEALTH
SERVICES
DE-
SCRIBED.—For purposes of this paragraph, the 
telehealth services described in this subpara-
graph are services that are both telehealth serv-
ices (as described in paragraph (4)(F)) and 
identified by the Secretary, through rulemaking,
as services that are the most commonly fur-
nished (as defined by the Secretary) under this 
part to individuals diagnosed with a substance 
use disorder or a mental health disorder that is 
co-occurring with a substance use disorder. 
‘‘(D) CLARIFICATION.—Nothing in this 
paragraph shall be construed as limiting or oth-
erwise affecting the authority of the Secretary 
to limit or eliminate the non-application pursu-
ant to this paragraph of any of the require-
ments under subparagraph (B). 
‘‘(E) TREATMENT
OF
ORIGINATING
SITE 
FACILITY FEE.—No facility fee shall be paid 
under paragraph (2)(B) to an originating site 
with respect to a telehealth service described in 
subparagraph (B) for which payment is made 
under this subsection by reason of the non-ap-
plication of a requirement described in subpara-
graph (B) pursuant to this paragraph if pay-
ment for such service would not otherwise be 
permitted under this subsection if such require-
ment were applied. 
‘‘(F) ELIGIBLE BENEFICIARY DEFINED.— 
For purposes of this paragraph, the term ‘eligi-
ble beneficiary’ means an individual who—
‘‘(i) is entitled to, or enrolled for, ben-
efits under part A and enrolled for benefits 
under this part; 
‘‘(ii) has a diagnosis for a substance 
use disorder; and 
‘‘(iii) meets such other criteria as the 
Secretary determines appropriate. 
‘‘(G) REPORT.—Not later than 5 years 
after the date of the enactment of this para-
graph, the Secretary shall submit to Congress a 
report on the impact of any non-application 
under this paragraph of any of the require-
ments described in subparagraph (B) on 
‘‘(i) the utilization of health care serv-
ices related to substance use disorder, such 
as behavioral health services and emer-
gency department visits; and 
‘‘(ii) health outcomes related to sub-
stance use disorder, such as substance use 
overdose deaths. 
‘‘(H) FUNDING.—For purposes of carrying 
out this paragraph, in addition to funds other-
wise available, the Secretary shall provide for 
the transfer, from the Federal Supplementary 
Medical Insurance Trust Fund under section
1841, of $3,000,000 to the Centers for Medi-
care & Medicaid Services Program Management 
Account to remain available until expended. 
‘‘(8) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection may be construed as waiving require-
ments under this title to comply with applicable 
State law, including State licensure requirements.’’. 
SEC. 2002. ENCOURAGING THE USE OF NON-OPIOID ANAL-
GESICS FOR THE MANAGEMENT OF POST- 
SURGICAL PAIN. 
Section 1833(t)(6) of the Social Security Act (42 
U.S.C. 1395l(t)(6)) is amended— 
(1) in subparagraph (C)(i), by inserting ‘‘or, in 
the case of an eligible non-opioid analgesic (as de-
fined in subparagraph (J)), during a period of 5 
years,’’ after ‘‘3 years,’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(J) ELIGIBLE
NON-OPIOID
ANALGESIC 
DEFINED.—In this paragraph, the term ‘eligible 
non-opioid analgesic’ means a drug or biologi-
cal— 
‘‘(i) that is an analgesic that is not an 
opioid;
‘‘(ii) that demonstrated substantial 
clinical improvement, as determined by the 
Secretary; and 
‘‘(iii) for which payment— 
‘‘(I) as an outpatient hospital 
service under this part was not being 
made as of the date of the enactment 
of this subparagraph; or 
‘‘(II) was being made under this 
paragraph as of such date.’’. 
SEC. 2003. REQUIRING A REVIEW OF CURRENT OPIOID PRE-
SCRIPTIONS 
FOR 
CHRONIC 
PAIN 
AND 
SCREENING FOR OPIOID USE DISORDER TO 
BE INCLUDED IN THE WELCOME TO MEDI-
CARE INITIAL PREVENTIVE PHYSICAL EXAM-
INATION. 
(a) IN GENERAL.—Section 1861(ww) of the Social 
Security Act (42 U.S.C. 1395x(ww)) is amended— 
(1) in paragraph (1), by inserting ‘‘and a re-
view of current opioid prescriptions and screening 
for opioid use disorder (as defined in paragraph 
(4)),’’ before ‘‘but does not include’’; and 
(2) by adding at the end the following new 
paragraph:
physician or practitioner for additional treat-
ment. 
‘‘(B) For purposes of this paragraph, the term ‘quali-
fied non-physician practitioner’ means a physician assist-
ant, nurse practitioner, or clinical nurse specialist.’’. 
(b) CLARIFICATION.—Nothing in the amendments 
made by subsection (a) shall be construed to prohibit sepa-
rate payment for structured assessment and intervention 
services for substance abuse furnished to an individual on 
the same day as an initial preventive physical examination. 
(c) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply with respect to initial preventive 
physical examinations furnished on or after January 1, 
2020. 
SEC. 2004. MODIFICATION OF PAYMENT FOR CERTAIN OUT-
PATIENT SURGICAL SERVICES. 
(a) FREEZE OF PAYMENT FOR CERTAIN SERVICES 
FURNISHED IN AMBULATORY SURGICAL CENTERS.—Sec-
tion 1833(i)(2) of the Social Security Act (42 U.S.C. 
1395l(i)(2)) is amended by adding at the end the following 
new subparagraph: 
‘‘(F)(i) With respect to a targeted procedure 
(as defined in clause (ii)) furnished during 2020 or 
a subsequent year (before 2024) to an individual in 
an ambulatory surgical center, the payment amount
for such procedure that would otherwise be deter-
mined under the revised payment system under sub-
paragraph (D), without application of this subpara-
graph, shall be equal to the payment amount for 
such procedure furnished in 2016. 
‘‘(ii) For purposes of clause (i), the term ‘tar-
geted procedure’ means a procedure to which 
Healthcare Common Procedure Coding System code 
62310 (or, for years beginning after 2016, 62321), 
62311 (or, for years beginning after 2016, 62323), 
62264, 64490, 64493, or G0260, or any successor 
code, apply. 
‘‘(iii) This subparagraph shall not be applied in 
a budget-neutral manner.’’. 
(b) DATA COLLECTION.— 
(1) IN
GENERAL.—The Comptroller General 
shall collect data relating to the cost differential be-
tween targeted procedures (as defined in section 
1833(i)(2)(F)(ii) of the Social Security Act, as 
added by subsection (a)) that are performed in a 
hospital operating room and such procedures that 
are performed in an office setting within a hospital 
in order to determine whether such procedures are 
being properly coded for claims, based on setting, for 
payment under section 1833(i)(2)(D) of the Social
Security Act (42 U.S.C. 1395l(i)(2)(D)) and to de-
termine if further changes are needed in the classi-
fication system for covered outpatient department 
services (as described in section 1833(t)(2)(A) of the 
Social Security Act (42 U.S.C. 1395l(t)(2)(A)). 
(2) REPORT.—Not later than 4 years after the 
date of the enactment of this Act, the Comptroller 
General shall submit a report to the Committee on 
Energy and Commerce and the Committee on Ways 
and Means of the House of Representatives and the 
Committee on Finance of the Senate containing— 
(A) a determination of whether procedures 
described in paragraph (1) are being properly 
coded for claims, based on setting, for payment 
under section 1833(i)(2)(D) of the Social Secu-
rity Act (42 U.S.C. 1395l(i)(2)(D)); and 
(B) recommendations on any changes the 
Comptroller General determines are needed in 
the classification system for covered outpatient 
department services (as described in section 
1833(t)(2)(A) of the Social Security Act (42 
U.S.C. 1395l(t)(2)(A)). 
(c) STUDY.—Not later than 3 years after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall conduct a study and submit to Con-
gress a report on the extent to which procedures described 
in section 1833(i)(2)(F)(ii) of the Social Security Act, as 
added by subsection (a), are effective at preventing the 
need for opioids for individuals furnished such procedures. 
SEC. 2005. REQUIRING E-PRESCRIBING FOR COVERAGE OF 
COVERED 
PART 
D 
CONTROLLED 
SUB-
STANCES. 
(a) IN GENERAL.—Section 1860D–4(e) of the Social 
Security Act (42 U.S.C. 1395w–104(e)) is amended by 
adding at the end the following: 
‘‘(7) REQUIREMENT
OF
E-PRESCRIBING
FOR 
CONTROLLED SUBSTANCES.— 
‘‘(A) IN
GENERAL.—Subject to 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 ac-
cordance with an electronic prescription drug 
program that meets the requirements of para-
graph (2). 
‘‘(B) 
EXCEPTION
FOR
CERTAIN
CIR-
CUMSTANCES.—The Secretary shall, pursuant 
to rulemaking, specify circumstances with re-
spect to which the Secretary may waive the re-
quirement under subparagraph (A), with re-
spect to a covered part D drug, including in the 
case of— 
‘‘(i) a prescription issued when the 
practitioner and dispenser are the same 
entity; 
‘‘(ii) a prescription issued that cannot 
be transmitted electronically under the 
most recently implemented version of the 
National Council for Prescription Drug 
Programs SCRIPT Standard; 
‘‘(iii) a prescription issued by a practi-
tioner who has received a waiver or a re-
newal thereof for a specified period deter-
mined by the Secretary, not to exceed 1 
year, from the requirement to use elec-
tronic prescribing, pursuant to a process 
established by regulation by the Secretary, 
due to demonstrated economic hardship, 
technological limitations that are not rea-
sonably within the control of the practi-
tioner, or other exceptional circumstance 
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 
prescription 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 allowing for the dispensing of a non- 
patient specific prescription pursuant to a 
standing order, approved protocol for drug 
therapy, collaborative drug management, 
or comprehensive medication management, 
in response to a public health emergency, 
or other circumstances where the practi-
tioner may issue a non-patient specific pre-
scription; 
‘‘(vi) a prescription issued by a practi-
tioner prescribing a drug under a research 
protocol; 
‘‘(vii) a prescription issued by a prac-
titioner 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 
mitigation strategies that include elements 
to assure safe use; and 
‘‘(viii) a prescription issued by a prac-
titioner for an individual who— 
‘‘(I) receives hospice care under 
this title; or 
‘‘(II) is a resident of a skilled 
nursing facility (as defined in section 
1819(a)), or a medical institution or 
nursing facility for which payment is 
made for an institutionalized indi-
vidual under section 1902(q)(1)(B), 
for which frequently abused drugs are 
dispensed for residents through a con-
tract with a single pharmacy, as de-
termined by the Secretary in accord-
ance with this paragraph. 
‘‘(C) DISPENSING.—Nothing in this para-
graph 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 practi-
SEC. 2006. 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 sub-
paragraph (E) the following new subparagraph: 
‘‘(F) With respect to plan years beginning 
on or after January 1, 2021, 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, 2021, 
a PDP sponsor shall)’’ after ‘‘A PDP sponsor may’’. 
SEC. 2007. MEDICARE COVERAGE OF CERTAIN SERVICES 
FURNISHED BY OPIOID TREATMENT PRO-
GRAMS. 
(a) COVERAGE.—Section 1861(s)(2) of the Social Se-
curity 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:
‘‘(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 
opioid treatment program (as defined in section 8.2 
of title 42 of the Code of Federal Regulations, or 
any successor regulation) that— 
‘‘(A) is enrolled under section 1866(j); 
‘‘(B) has in effect a certification by the 
Substance Abuse and Mental Health Services 
Administration for such a program; 
‘‘(C) is accredited by an accrediting body 
approved by the Substance Abuse and Mental 
Health Services Administration; and 
‘‘(D) meets such additional conditions as 
the Secretary may find necessary to ensure— 
‘‘(i) the health and safety of 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 
Social Security Act (42 U.S.C. 1395l(a)(1)) is 
amended— 
(A) by striking ‘‘and (BB)’’ and inserting 
‘‘(BB)’’; and 
(B) by inserting before the semicolon at 
the end the following ‘‘, and (CC) with respect 
to opioid use disorder treatment services fur-
nished during an episode of care, the amount 
paid shall be equal to the amount payable under 
section 1834(w) less any copayment required as 
specified by the Secretary’’. 
(2) PAYMENT DETERMINATION.—Section 1834 
of the Social Security Act (42 U.S.C. 1395m) is 
amended by adding at the end the following new 
subsection: 
‘‘(w) OPIOID USE DISORDER TREATMENT 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 defined in paragraph (1) of such section) that 
are furnished by such program to an individual dur-
ing an episode of care (as defined by the Secretary) 
beginning on or after January 1, 2020. The Sec-
retary shall ensure, as determined appropriate by 
the Secretary, that no duplicative payments are 
made under this part or part D for items and serv-
ices furnished by an opioid treatment program. 
‘‘(2) CONSIDERATIONS.—The Secretary may 
implement this subsection through one or more bun-
dles based on the type of medication provided (such 
as buprenorphine, methadone, naltrexone, or a new 
innovative drug), the frequency of services, the scope 
of services furnished, characteristics of the individ-
uals furnished such services, or other factors as the 
Secretary determine appropriate. In developing such 
bundles, the Secretary may consider payment rates 
paid to opioid treatment programs for comparable 
services under State plans under title XIX or under 
the TRICARE program under chapter 55 of title 10 
of the United States Code. 
‘‘(3) ANNUAL UPDATES.—The Secretary shall 
provide an update each year to the bundled payment 
amounts under this subsection.’’.
(d) INCLUDING OPIOID TREATMENT PROGRAMS AS 
MEDICARE PROVIDERS.—Section 1866(e) of the Social 
Security Act (42 U.S.C. 1395cc(e)) is amended— 
(1) in paragraph (1), by striking at the end 
‘‘and’’; 
(2) in paragraph (2), by striking the period at 
the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following new 
paragraph: 
‘‘(3) opioid treatment programs (as defined in 
paragraph (2) of section 1861(jjj)), but only with re-
spect to the furnishing of opioid use disorder treat-
ment services (as defined in paragraph (1) of such 
section).’’. 
TITLE III—OTHER HEALTH PRO-
VISIONS TO ADDRESS THE 
OPIOID CRISIS 
SEC. 3001. CLARIFYING FDA REGULATION OF NON-ADDICT-
IVE PAIN AND ADDICTION THERAPIES. 
(a) PUBLIC MEETINGS.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall hold not less than one public meet-
ing to address the challenges and barriers of developing
non-addictive medical products intended to treat pain or 
addiction, which may include— 
(1) 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 Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355g)), and use of patient experience data (con-
sistent 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; and 
(2) 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 later than 1 year after the pub-
lic meetings are conducted under subsection (a) the Sec-
retary 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 in-
clude information regarding—
(1) how the Food and Drug Administration 
may apply sections 506 and 515B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356, 
360e–3) to non-addictive medical products intended 
to treat pain or addiction, including the cir-
cumstances under which the Secretary— 
(A) may apply the eligibility criteria under 
such sections 506 and 515B to non-opioid or 
non-addictive medical products intended to 
treat pain or addiction; 
(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; and 
(2) the methods by which sponsors may evalu-
ate acute and chronic pain, endpoints for non-addict-
ive medical products intended to treat pain, the 
manner in which endpoints and evaluations of effi-
cacy will be applied across and within review divi-
sions, taking into consideration the etiology of the 
underlying disease, and the manner in which spon-
sors may use surrogate endpoints, intermediate 
endpoints, and real world evidence. 
(c) MEDICAL PRODUCT DEFINED.—In this section, 
the term ‘‘medical product’’ means a drug (as defined in 
section 201(g)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(g)(1))), biological product (as 
defined in section 351(i) of the Public Health Service Act 
(42 U.S.C. 262(i))), or device (as defined in section 
201(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(h))). 
SEC. 3002. SURVEILLANCE AND TESTING OF OPIOIDS TO 
PREVENT FENTANYL DEATHS. 
(a) PUBLIC HEALTH LABORATORIES
TO DETECT 
FENTANYL.—Part F of title III of the Public Health Serv-
ice Act (42 U.S.C. 262 et seq.) is amended— 
(1) in the heading of part F, by striking ‘‘AND 
CLINICAL LABORATORIES’’ and inserting ‘‘, CLIN-
ICAL LABORATORIES, AND PUBLIC HEALTH LAB-
ORATORIES’’; and 
(2) by adding at the end the following new sub-
part:
‘‘Subpart 4—Public Health Laboratories 
‘‘SEC. 355. PUBLIC HEALTH LABORATORIES TO DETECT 
FENTANYL. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
program to award grants to Federal, State, and local 
agencies to support the establishment or operation of pub-
lic health laboratories to detect fentanyl, its analogues, 
and other synthetic opioids, as described in subsection (b). 
‘‘(b) STANDARDS.—The Secretary, in consultation 
with the Director of the National Institute of Standards 
and Technology, shall— 
‘‘(1) develop standards for safely and effectively 
handling and testing fentanyl, its analogues, and 
other synthetic opioids; 
‘‘(2) develop fentanyl and fentanyl analog ref-
erence materials and quality control standards and 
protocols to calibrate instrumentation for clinical 
diagnostics and postmortem surveillance; and 
‘‘(3) include in the standards developed pursu-
ant to paragraph (1) procedures for encountering 
new and emerging synthetic opioid formulations and 
reporting those findings to other Federal, State, and 
local public health laboratories. 
‘‘(c) LABORATORIES.—The Secretary shall require 
grantees under subsection (a) to—
‘‘(1) follow the standards established under 
subsection (b) and be capable of providing system-
atic and routine laboratory testing of drugs for the 
purposes of obtaining and disseminating public 
health information to Federal, State, and local pub-
lic health officials, laboratories, and other entities 
the Secretary deems appropriate; 
‘‘(2) work with law enforcement agencies and 
public health authorities, as feasible, to develop real- 
time information on the purity and movement of 
fentanyl, its analogues, and other synthetic opioids; 
‘‘(3) assist State and local law enforcement 
agencies in testing seized drugs when State and local 
forensic laboratories request additional assistance; 
‘‘(4) provide early warning information and ad-
vice to Federal, State, and local law enforcement 
agencies and public health authorities regarding po-
tential significant changes in the supply of fentanyl, 
its analogues, and other synthetic opioids; 
‘‘(5) provide biosurveillance for non-fatal expo-
sures; and 
‘‘(6) provide diagnostic testing for non-fatal ex-
posures of emergency personnel. 
‘‘(d) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $15,000,000 for each of fiscal years 2019 through 
2023.’’. 
(b) ENHANCED FENTANYL SURVEILLANCE.—Title 
III of the Public Health Service Act is amended by insert-
ing after section 317T of such Act (42 U.S.C. 247b–22) 
the following new section: 
‘‘SEC. 317U. ENHANCED FENTANYL SURVEILLANCE. 
‘‘(a) IN GENERAL.—The Director of the Centers for 
Disease Control and Prevention shall enhance its drug 
surveillance program by— 
‘‘(1) expanding its surveillance program to in-
clude all 50 States and the territories of the United 
States; 
‘‘(2) increasing and accelerating the collection 
of data on fentanyl, its analogues, and other syn-
thetic opioids and new emerging drugs of abuse, in-
cluding related overdose data from medical exam-
iners and drug treatment admissions; and 
‘‘(3) utilizing available and emerging informa-
tion on fentanyl, its analogues, and other synthetic 
opioids and new emerging drugs of abuse, including 
information from— 
‘‘(A) the National Drug Early Warning 
System;
‘‘(B) State and local public health authori-
ties; and 
‘‘(C) Federal, State, and local public 
health laboratories. 
‘‘(b) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $10,000,000 for each of fiscal years 2019 through 
2023.’’. 
(c) PILOT PROGRAM FOR POINT-OF-USE TESTING OF 
ILLICIT DRUGS FOR DANGEROUS CONTAMINANTS.—Part 
P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the fol-
lowing new section: 
‘‘SEC. 399V–7. PILOT PROGRAM FOR POINT-OF-USE TESTING 
OF ILLICIT DRUGS FOR DANGEROUS CON-
TAMINANTS. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) establish a pilot program through which 5 
State or local agencies conduct, in 5 States, point- 
of-use testing of illicit drugs for dangerous contami-
nants; 
‘‘(2) establish metrics to evaluate the success of 
the pilot program in reducing drug overdose rates; 
and
‘‘(3) based on such metrics, conduct an annual 
evaluation of the pilot program and submit an an-
nual report to the Congress containing the results of 
such evaluation. 
‘‘(b) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $5,000,000 for each of fiscal years 2019 through 
2023.’’. 
SEC. 3003. 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 Sub-
stances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to 
read as follows: 
‘‘(II) The applicable number is— 
‘‘(aa) 100 if, not sooner than 1 year after 
the date on which the practitioner submitted 
the initial notification, the practitioner submits 
a second notification to the Secretary of the 
need and intent of the practitioner to treat up 
to 100 patients; 
‘‘(bb) 100 if the practitioner holds addi-
tional credentialing, as defined in section 8.2 of
100 
title 42, Code of Federal Regulations (or suc-
cessor regulations); or 
‘‘(cc) 100 if the practitioner provides medi-
cation-assisted treatment (MAT) using covered 
medications (as such terms are defined in sec-
tion 8.2 of title 42, Code of Federal Regula-
tions (or successor regulations)) in a qualified 
practice setting (as described in section 8.615 
of title 42, Code of Federal Regulations (or suc-
cessor regulations)).’’. 
(b) ELIMINATING ANY TIME LIMITATION FOR NURSE 
PRACTITIONERS
AND PHYSICIAN ASSISTANTS TO BE-
COME QUALIFYING PRACTITIONERS.—Clause (iii) of sec-
tion 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: 
‘‘(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 
ANESTHETISTS, AND CERTIFIED NURSE MIDWIFES TO
101 
BECOME QUALIFYING PRACTITIONERS.—Clause (iii) of 
section 303(g)(2)(G) of the Controlled Substances Act (21 
U.S.C. 823(g)(2)(G)), as amended by subsection (b), is 
further amended by adding at the end the following: 
‘‘(III) for the period beginning on October 
1, 2018, and ending on October 1, 2023, a 
qualifying other practitioner, as defined in 
clause (iv), who is a clinical nurse specialist, 
certified registered nurse anesthetist, or cer-
tified 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 
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 quali-
fying 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 physi-
102 
cians, more than 100 patients, and in the case of quali-
fying practitioners who are not physicians, more than 30 
patients. Such report shall include recommendations on 
future applicable patient number levels and limits. In pre-
paring such report, the Secretary shall study, with respect 
to opioid use disorder treatment— 
(1) the average frequency with which qualifying 
practitioners see their patients; 
(2) the average frequency with which patients 
receive counseling, including the rates by which such 
counseling is provided by such a qualifying practi-
tioner directly, or by referral; 
(3) the frequency of toxicology testing, includ-
ing the average frequency with which random toxi-
cology testing is administered; 
(4) the average monthly patient caseload for 
each type of qualifying practitioner; 
(5) the treatment retention rates for patients; 
(6) overdose and mortality rates; and 
(7) any available information regarding the di-
version of drugs by patients receiving such treat-
ment from such a qualifying practitioner.
103 
SEC. 3004. HIGH-QUALITY, EVIDENCE-BASED OPIOID AN-
ALGESIC PRESCRIBING GUIDELINES AND RE-
PORT. 
(a) GUIDELINES.—The Commissioner of Food and 
Drugs shall develop high-quality, evidence-based opioid 
analgesic prescribing guidelines for the indication-specific 
treatment of acute pain in 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) conduct a public workshop, open to rep-
resentatives of State medical societies and medical 
boards, various medical specialties including pain 
medicine specialty societies, patient groups, phar-
macists, universities, and others; and 
(2) provide a period for the submission of com-
ments by the public. 
(c) REPORT.—Not later than the date that is 2 years 
after the date of enactment of this Act, 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 Pen-
sions of the Senate, and post on the public website of the 
Food and Drug Administration, a report on how the
104 
guidelines under subsection (a) will be utilized to protect 
the public health. 
(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 subsection (c). 
(e) STATEMENT TO ACCOMPANY GUIDELINES AND 
RECOMMENDATIONS.—The Commissioner of Food and 
Drugs shall ensure that any opioid analgesic prescribing 
guidelines and other recommendations developed under 
this section are accompanied by a clear statement that 
such guidelines or recommendations, as applicable— 
(1) are intended to help inform clinical decision-
making by prescribers and patients; and 
(2) should not be used by other parties, includ-
ing pharmacy benefit management companies, retail 
or community pharmacies, or public and private 
payors, for the purposes of restricting, limiting, de-
laying, or denying coverage for or access to a pre-
scription issued for a legitimate medical purpose by
105 
an individual practitioner acting in the usual course 
of professional practice. 
(f) DEFINITION.—In this section, the term ‘‘evidence- 
based’’ means informed by a robust and systemic review 
of treatment efficacy and clinical evidence. 
SEC. 3005. REPORT ON OPIOIDS PRESCRIBING PRACTICES 
FOR PREGNANT WOMEN. 
(a) IN GENERAL.—Not later than 180 days after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services, in coordination with the Centers for 
Disease Control and Prevention, the National Institutes 
of Health, and the Substance Abuse and Mental Health 
Services Administration shall develop and submit to the 
Congress a report— 
(1) on opioids prescribing practices for preg-
nant women and recommendations for such prac-
tices; 
(2) that provides recommendations for identi-
fying and reducing opioids misuse during pregnancy; 
(3) on prescription opioid misuse during preg-
nancy in urban and rural areas; 
(4) on prescription opioid use during pregnancy 
for the purpose of medication-assisted treatment in 
urban and rural areas;
106 
(5) evaluating current utilization of non-opiate 
pain management practices in place of prescription 
opioids during pregnancy; 
(6) providing guidelines encouraging the use of 
non-opioid pain management practices during preg-
nancy when safe and effective; and 
(7) that provides recommendations for increas-
ing public awareness and education of opioid use dis-
order in pregnancy, including available treatment re-
sources in urban and rural areas. 
(b) NO ADDITIONAL FUNDS.—No additional funds 
are authorized to be appropriated for purposes of carrying 
out subsection (a). 
SEC. 3006. GUIDELINES FOR PRESCRIBING NALOXONE. 
(a) IN GENERAL.—Not later than 180 days after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall issue guidelines for prescribing 
an opioid overdose reversal drug. 
(b) CONTENTS.—In issuing guidelines under sub-
section (a), the Secretary shall address the following: 
(1) Co-prescribing an opioid overdose reversal 
drug in conjunction with any prescribed opioid. 
(2) Dosage safety. 
(3) Prescribing an opioid overdose reversal drug 
to an individual other than a patient.