•HRES 1099 EH 
‘‘(D) FUNDING.—For purposes of subpara-
graph (A), there is appropriated, out of any funds 
in the Treasury not otherwise appropriated, 
$50,000,000, to remain available until expended. 
‘‘(4) POST-PLANNING STATES.— 
‘‘(A) IN GENERAL.—The Secretary shall, with 
respect to the remaining 36-month period of the 
demonstration project conducted under paragraph 
(1), select not more than 5 States in accordance 
with subparagraph (B) for purposes of carrying out 
the activities described in paragraph (2) and receiv-
ing payments in accordance with paragraph (5). 
‘‘(B) SELECTION.—In selecting States for pur-
poses of this paragraph, the Secretary shall— 
‘‘(i) select States that received a planning 
grant under paragraph (3); 
‘‘(ii) select States that submit to the Sec-
retary an application in accordance with the 
requirements in subparagraph (C), taking into 
consideration the quality of each such applica-
tion; 
‘‘(iii) select States in a manner that en-
sures geographic diversity; and 
‘‘(iv) give preference to States with a 
prevalence of substance use disorders (in par-
•HRES 1099 EH 
ticular opioid use disorders) that is comparable 
to or higher than the national average preva-
lence, as measured by aggregate per capita 
drug overdoses, or any other measure that the 
Secretary deems appropriate. 
‘‘(C) APPLICATIONS.— 
‘‘(i) IN GENERAL.—A State seeking to be 
selected for purposes of this paragraph shall 
submit to the Secretary, at such time and in 
such form and manner as the Secretary re-
quires, an application that includes such infor-
mation, provisions, and assurances, as the Sec-
retary may require, in addition to the fol-
lowing: 
‘‘(I) A proposed process for carrying 
out the ongoing assessment described in 
paragraph (2)(A), taking into account the 
results of the initial assessment described 
in paragraph (3)(C)(i). 
‘‘(II) A review of reimbursement 
methodologies and other policies related to 
substance use disorder treatment or recov-
ery services under the State plan (or waiv-
er) that may create barriers to increasing
•HRES 1099 EH 
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 re-
sult in long-term and sustainable provider 
networks under the State plan (or waiver) 
that will offer a continuum of care for 
substance use disorders. Such plan shall 
include the following: 
‘‘(aa) Specific activities to in-
crease the number of providers (in-
cluding providers that specialize in 
providing 
substance 
use 
disorder 
treatment or recovery services, hos-
pitals, health care systems, Federally 
qualified health centers, and, as ap-
plicable, certified community behav-
ioral health clinics) that offer sub-
stance use disorder treatment, recov-
ery, or support services, including 
short-term 
detoxification 
services, 
outpatient substance use disorder 
services, and evidence-based peer re-
covery services.
•HRES 1099 EH 
‘‘(bb) 
Strategies 
that 
will 
incentivize providers described in sub-
paragraphs (C) and (D) of paragraph 
(2) to obtain the necessary training, 
education, and support to deliver sub-
stance use disorder treatment or re-
covery services in the State. 
‘‘(cc) Milestones and timeliness 
for implementing activities set forth 
in the plan. 
‘‘(dd) Specific measurable tar-
gets for increasing the substance use 
disorder treatment and recovery pro-
vider network under the State plan 
(or a waiver of such plan). 
‘‘(IV) A proposed process for report-
ing the information required under para-
graph (6)(A), including information to as-
sess the effectiveness of the efforts of the 
State to expand the capacity of providers 
to deliver substance use disorder treat-
ment or recovery services during the pe-
riod of the demonstration project under 
this subsection.
•HRES 1099 EH 
‘‘(V) The expected financial impact of 
the demonstration project under this sub-
section on the State. 
‘‘(VI) A description of all funding 
sources available to the State to provide 
substance use disorder treatment or recov-
ery services in the State. 
‘‘(VII) A preliminary plan for how 
the State will sustain any increase in the 
capacity of providers to deliver substance 
use disorder treatment or recovery serv-
ices resulting from the demonstration 
project under this subsection after the ter-
mination of such demonstration project. 
‘‘(VIII) A description of how the 
State will coordinate the goals of the dem-
onstration project with any waiver granted 
(or submitted by the State and pending) 
pursuant to section 1115 for the delivery 
of substance use services under the State 
plan, as applicable. 
‘‘(ii) CONSULTATION.—In completing an 
application under clause (i), a State shall con-
sult with relevant stakeholders, including Med-
icaid managed care plans, health care pro-
•HRES 1099 EH 
with respect to expenditures for substance use dis-
order treatment or recovery services furnished by 
providers participating under the State plan (or a 
waiver of such plan), payment may not also be 
made under subsection (a) with respect to expendi-
tures for the same services so furnished. 
‘‘(6) REPORTS.— 
‘‘(A) STATE REPORTS.—A State receiving pay-
ments under paragraph (5) shall, for the period of 
the demonstration project under this subsection, 
submit to the Secretary a quarterly report, with re-
spect to expenditures for substance use disorder 
treatment or recovery services for which payment is 
made to the State under this subsection, on the fol-
lowing: 
‘‘(i) The specific activities with respect to 
which payment under this subsection was pro-
vided. 
‘‘(ii) The number of providers that deliv-
ered substance use disorder treatment or recov-
ery services in the State under the demonstra-
tion project compared to the estimated number 
of providers that would have otherwise deliv-
ered such services in the absence of such dem-
onstration project.
•HRES 1099 EH 
‘‘(iii) The number of individuals enrolled 
under the State plan (or a waiver of such plan) 
who received substance use disorder treatment 
or recovery services under the demonstration 
project compared to the estimated number of 
such individuals who would have otherwise re-
ceived 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 Oc-
tober 1, 2020, the Administrator of the Cen-
ters 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 selec-
tion; and 
‘‘(III) the activities carried out by 
such States under such planning grants.
•HRES 1099 EH 
‘‘(ii) INTERIM
REPORT.—Not later than 
October 1, 2022, the Administrator of the Cen-
ters for Medicare & Medicaid Services shall, in 
consultation with the Director of the Agency 
for Healthcare Research and Quality and the 
Assistant Secretary for Mental Health and 
Substance Use, submit to Congress an interim 
report— 
‘‘(I) on activities carried out under 
the demonstration project under this sub-
section; 
‘‘(II) on the extent to which States 
selected 
under 
paragraph 
(4) 
have 
achieved the stated goals submitted in 
their applications under subparagraph (C) 
of such paragraph; 
‘‘(III) with a description of the 
strengths and limitations of such dem-
onstration project; and 
‘‘(IV) with a plan for the sustain-
ability of such project. 
‘‘(iii) FINAL REPORT.—Not later than Oc-
tober 1, 2024, the Administrator of the Cen-
ters for Medicare & Medicaid Services shall, in 
consultation with the Director of the Agency
•HRES 1099 EH 
for Healthcare Research and Quality and the 
Assistant Secretary for Mental Health and 
Substance Use, submit to Congress a final re-
port— 
‘‘(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 dem-
onstration project under this subsection 
after the submission of such interim re-
port; and 
‘‘(III) evaluating such demonstration 
project. 
‘‘(C) AHRQ REPORT.—Not later than 3 years 
after the date of the enactment of this subsection, 
the Director of the Agency for Healthcare Research 
and Quality, in consultation with the Administrator 
of the Centers for Medicare & Medicaid Services, 
shall submit to Congress a summary on the experi-
ences of States awarded planning grants under 
paragraph (3) and States selected under paragraph 
(4). 
‘‘(7) DATA SHARING AND BEST PRACTICES.—Dur-
ing the period of the demonstration project under this
•HRES 1099 EH 
subsection, the Secretary shall, in collaboration with 
States selected under paragraph (4), facilitate data shar-
ing and the development of best practices between such 
States and States that were not so selected. 
‘‘(8) CMS FUNDING.—There is appropriated, out of 
any funds in the Treasury not otherwise appropriated, 
$5,000,000 to the Centers for Medicare & Medicaid 
Services for purposes of implementing this subsection. 
Such amount shall remain available until expended.’’. 
SEC. 1004. MEDICAID DRUG REVIEW AND UTILIZATION. 
(a) MEDICAID DRUG UTILIZATION REVIEW.— 
(1) STATE PLAN REQUIREMENT.—Section 1902(a) 
of the Social Security Act (42 U.S.C. 1396a(a)), as 
amended by section 1001, is further amended— 
(A) in paragraph (83), at the end, by striking 
‘‘and’’; 
(B) in paragraph (84), at the end, by striking 
the period and inserting ‘‘; and’’; and 
(C) by inserting after paragraph (84) the fol-
lowing new paragraph: 
‘‘(85) provide that the State is in compliance with 
the drug review and utilization requirements under sub-
section (oo)(1).’’. 
(2) DRUG
REVIEW
AND
UTILIZATION
REQUIRE-
MENTS.—Section 1902 of the Social Security Act (42
•HRES 1099 EH 
U.S.C. 1396a), as amended by section 1001, is further 
amended by adding at the end the following new sub-
section: 
‘‘(oo) DRUG
REVIEW
AND
UTILIZATION
REQUIRE-
MENTS.— 
‘‘(1) IN
GENERAL.—For purposes of subsection 
(a)(85), the drug review and utilization requirements 
under this subsection are, subject to paragraph (3) and 
beginning October 1, 2019, the following: 
‘‘(A) CLAIMS REVIEW LIMITATIONS.— 
‘‘(i) IN
GENERAL.—The State has in 
place— 
‘‘(I) safety edits (as specified by the 
State) for subsequent fills for opioids and 
a claims review automated process (as de-
signed 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 subse-
quent fill of opioids in excess of any limi-
tation that may be identified by the State; 
‘‘(II) safety edits (as specified by the 
State) on the maximum daily morphine 
equivalent that can be prescribed to an in-
dividual enrolled under the State plan (or
•HRES 1099 EH 
under a waiver of the State plan) for 
treatment of chronic pain and a claims re-
view automated process (as designed and 
implemented by the State) that indicates 
when an individual enrolled under the 
plan (or waiver) is prescribed the mor-
phine equivalent for such treatment in ex-
cess of any limitation that may be identi-
fied by the State; and 
‘‘(III) a claims review automated 
process (as designed and implemented by 
the State) that monitors when an indi-
vidual enrolled under the State plan (or 
under a waiver of the State plan) is con-
currently 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 assist-
ance under the State plan (or under a waiver
•HRES 1099 EH 
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 sub-
clause (III) of such clause. 
‘‘(iii) RULES OF CONSTRUCTION.—Noth-
ing in this subparagraph may be construed as 
prohibiting a State or managed care entity 
from designing and implementing a claims re-
view automated process under this subpara-
graph that provides for prospective or retro-
spective reviews of claims. Nothing in this sub-
paragraph shall be understood as prohibiting 
the exercise of clinical judgment from a pro-
vider enrolled as a participating provider in a 
State plan (or waiver of the State plan) or con-
tracting with a managed care entity regarding 
the best items and services for an individual 
enrolled under such State plan (or waiver). 
‘‘(B) PROGRAM TO MONITOR ANTIPSYCHOTIC 
MEDICATIONS
BY
CHILDREN.—The State has in 
place a program (as designed and implemented by 
the State) to monitor and manage the appropriate 
use of antipsychotic medications by children en-
rolled under the State plan (or under a waiver of
•HRES 1099 EH 
mated process described in such subparagraph 
that was in place before October 1, 2019; 
‘‘(ii) described in subparagraph (B) by 
having a program described in such subpara-
graph that was in place before such date; or 
‘‘(iii) described in subparagraph (C) by 
having a process described in such subpara-
graph 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 in-
formation submitted by States under paragraph (1)(D). 
‘‘(3) EXCEPTIONS.— 
‘‘(A) CERTAIN INDIVIDUALS EXEMPTED.—The 
drug review and utilization requirements under this 
subsection shall not apply with respect to an indi-
vidual who— 
‘‘(i) is receiving— 
‘‘(I) hospice or palliative care; or 
‘‘(II) treatment for cancer; 
‘‘(ii) is a resident of a long-term care fa-
cility, 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
•HRES 1099 EH 
‘‘(iii) the State elects to treat as exempted 
from such requirements. 
‘‘(B) EXCEPTION RELATING TO ENSURING AC-
CESS.—In order to ensure reasonable access to 
health care, the Secretary shall waive the drug re-
view and utilization requirements under this sub-
section, with respect to a State, in the case of nat-
ural disasters and similar situations, and in the 
case of the provision of emergency services (as de-
fined 
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 RE-
QUIREMENTS.—Beginning not later than October 1, 2019, 
each contract under a State plan with a managed care entity 
(other than a primary care case manager) under section 
1903(m) shall provide that the entity is in compliance with 
the applicable provisions of section 438.3(s)(2) of title 42, 
Code of Federal Regulations, section 483.3(s)(4)) of such 
title, and section 483.3(s)(5) of such title, as such provisions 
were in effect on March 31, 2018.’’. 
(b) IDENTIFYING
AND
ADDRESSING
INAPPROPRIATE 
PRESCRIBING AND BILLING PRACTICES UNDER MEDICAID.—
•HRES 1099 EH 
(1) IN GENERAL.—Section 1927(g) of the Social 
Security Act (42 U.S.C. 1396r–8(g)) is amended— 
(A) in paragraph (1)(A)— 
(i) by striking ‘‘of section 1903(i)(10)(B)’’ 
and inserting ‘‘of section 1902(a)(54)’’; 
(ii) by striking ‘‘, by not later than Janu-
ary 1, 1993,’’; 
(iii) by inserting after ‘‘gross overuse,’’ 
the following: ‘‘excessive utilization,’’; and 
(iv) by striking ‘‘or inappropriate or medi-
cally unnecessary care’’ and inserting ‘‘inap-
propriate or medically unnecessary care, or 
prescribing or billing practices that indicate 
abuse or excessive utilization’’; and 
(B) in paragraph (2)(B)— 
(i) by inserting after ‘‘gross overuse,’’ the 
following: ‘‘excessive utilization,’’; and 
(ii) by striking ‘‘or inappropriate or medi-
cally unnecessary care’’ and inserting ‘‘inap-
propriate or medically unnecessary care, or 
prescribing or billing practices that indicate 
abuse or excessive utilization’’. 
(2) EFFECTIVE DATE.—The amendments made by 
paragraph (1) shall take effect with respect to retrospec-
•HRES 1099 EH 
tive drug use reviews conducted on or after October 1, 
2020. 
SEC. 1005. GUIDANCE TO IMPROVE CARE FOR INFANTS WITH 
NEONATAL ABSTINENCE SYNDROME AND THEIR 
MOTHERS; GAO STUDY ON GAPS IN MEDICAID 
COVERAGE FOR PREGNANT AND POSTPARTUM 
WOMEN WITH SUBSTANCE USE DISORDER. 
(a) GUIDANCE.—Not later than 1 year after the date of 
the enactment of this Act, the Secretary of Health and 
Human Services shall issue guidance to improve care for in-
fants with neonatal abstinence syndrome and their families. 
Such guidance shall include— 
(1) best practices from States with respect to inno-
vative or evidenced-based payment models that focus on 
prevention, screening, treatment, plans of safe care, and 
postdischarge services for mothers and fathers with sub-
stance use disorders and babies with neonatal abstinence 
syndrome that improve care and clinical outcomes; 
(2) recommendations for States on available financ-
ing 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
•HRES 1099 EH 
with neonatal abstinence syndrome, and home-visiting 
services; 
(3) guidance and technical assistance to State Med-
icaid agencies regarding additional flexibilities and incen-
tives related to screening, prevention, and postdischarge 
services, including parenting supports, and infant-care-
giver bonding, including breastfeeding when it is appro-
priate; and 
(4) guidance regarding suggested terminology and 
ICD codes to identify infants with neonatal abstinence 
syndrome and neonatal opioid withdrawal syndrome, 
which could include opioid-exposure, opioid withdrawal 
not requiring pharmacotherapy, and opioid withdrawal 
requiring pharmacotherapy. 
(b) GAO STUDY.—Not later than 1 year after the date 
of the enactment of this Act, the Comptroller General of the 
United States shall conduct a study, and submit to Congress 
a report, addressing gaps in coverage for pregnant women 
with substance use disorder under the Medicaid program 
under title XIX of the Social Security Act, and gaps in cov-
erage for postpartum women with substance use disorder who 
had coverage during their pregnancy under the Medicaid pro-
gram under such title.
•HRES 1099 EH 
section and that is not an SUD-focused State plan 
amendment from additionally having approved on or 
after such date an SUD-focused State plan amend-
ment under this section, including for purposes of 
application of this paragraph. 
‘‘(B) REPORT REQUIREMENTS.—In the case of 
a State with an SUD-focused State plan amend-
ment for which the application of the Federal med-
ical assistance percentage has been extended under 
subparagraph (A), such State shall, at the end of 
the period of such State plan amendment, submit to 
the Secretary a report on the following, with respect 
to SUD-eligible individuals provided health home 
services under such State plan amendment: 
‘‘(i) The quality of health care provided to 
such individuals, with a focus on outcomes rel-
evant to the recovery of each such individual. 
‘‘(ii) The access of such individuals to 
health care. 
‘‘(iii) The total expenditures of such indi-
viduals for health care. 
For purposes of this subparagraph, the Secretary 
shall specify all applicable measures for determining 
quality, access, and expenditures.
•HRES 1099 EH 
‘‘(C) BEST PRACTICES.—Not later than Octo-
ber 1, 2020, the Secretary shall make publicly avail-
able on the internet website of the Centers for 
Medicare & Medicaid Services best practices for de-
signing 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 re-
spect to a State, an individual who satisfies all 
of the following: 
‘‘(I) The individual is an eligible indi-
vidual with chronic conditions. 
‘‘(II) The individual is an individual 
with a substance use disorder. 
‘‘(III) The individual has not pre-
viously received health home services 
under any other State plan amendment 
approved for the State under this section 
by the Secretary. 
‘‘(ii) SUD-FOCUSED STATE PLAN AMEND-
MENT.—The term ‘SUD-focused State plan
•HRES 1099 EH 
amendment’ means a State plan amendment 
under this section that is designed to provide 
health home services primarily to SUD-eligible 
individuals.’’. 
(b) REQUIREMENT
FOR STATE MEDICAID PLANS TO 
PROVIDE COVERAGE
FOR MEDICATION-ASSISTED TREAT-
MENT.— 
(1) REQUIREMENT FOR STATE MEDICAID PLANS TO 
PROVIDE COVERAGE FOR MEDICATION-ASSISTED TREAT-
MENT.—Section 1902(a)(10)(A) of the Social Security 
Act (42 U.S.C. 1396a(a)(10)(A)) is amended, in the 
matter preceding clause (i), by striking ‘‘and (28)’’ and 
inserting ‘‘(28), and (29)’’. 
(2) INCLUSION OF MEDICATION-ASSISTED TREAT-
MENT AS MEDICAL ASSISTANCE.—Section 1905(a) of the 
Social Security Act (42 U.S.C. 1396d(a)) is amended— 
(A) in paragraph (28), by striking ‘‘and’’ at 
the end; 
(B) by redesignating paragraph (29) as para-
graph (30); and 
(C) by inserting after paragraph (28) the fol-
lowing new paragraph: 
‘‘(29) subject to paragraph (2) of subsection (ee), 
for the period beginning October 1, 2020, and ending
•HRES 1099 EH 
September 30, 2025, medication-assisted treatment (as 
defined in paragraph (1) of such subsection); and’’. 
(3) MEDICATION-ASSISTED
TREATMENT
DEFINED; 
WAIVERS.—Section 1905 of the Social Security Act (42 
U.S.C. 1396d) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(ee) MEDICATION-ASSISTED TREATMENT.— 
‘‘(1) DEFINITION.—For purposes of subsection 
(a)(29), the term ‘medication-assisted treatment’— 
‘‘(A) means all drugs approved under section 
505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355), including methadone, and all bio-
logical products licensed under section 351 of the 
Public Health Service Act (42 U.S.C. 262) to treat 
opioid use disorders; and 
‘‘(B) includes, with respect to the provision of 
such drugs and biological products, counseling serv-
ices 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 be-
fore the beginning of such period the State certifies to 
the satisfaction of the Secretary that implementing such 
provisions statewide for all individuals eligible to enroll 
in the State plan (or waiver of the State plan) would not
•HRES 1099 EH 
be feasible by reason of a shortage of qualified providers 
of medication-assisted treatment, or facilities providing 
such treatment, that will contract with the State or a 
managed care entity with which the State has a contract 
under section 1903(m) or under section 1905(t)(3).’’. 
(4) EFFECTIVE DATE.— 
(A) IN
GENERAL.—Subject to subparagraph 
(B), the amendments made by this subsection shall 
apply with respect to medical assistance provided on 
or after October 1, 2020, and before October 1, 
2025. 
(B) EXCEPTION FOR STATE LEGISLATION.—In 
the case of a State plan under title XIX of the So-
cial Security Act (42 U.S.C. 1396 et seq.) that the 
Secretary of Health and Human Services deter-
mines requires State legislation in order for the re-
spective plan to meet any requirement imposed by 
the amendments made by this subsection, the re-
spective 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
•HRES 1099 EH 
purposes of the previous sentence, in the case of a 
State that has a 2-year legislative session, each year 
of the session shall be considered to be a separate 
regular session of the State legislature. 
SEC. 1007. CARING RECOVERY FOR INFANTS AND BABIES. 
(a) STATE PLAN AMENDMENT.—Section 1902(a) of the 
Social Security Act (42 U.S.C. 1396a(a)), as amended by sec-
tions 1001 and 1004, is further amended— 
(1) in paragraph (84)(C), by striking ‘‘and’’ after 
the semicolon; 
(2) in paragraph (85), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (85), the following 
new paragraph: 
‘‘(86) provide, at the option of the State, for mak-
ing medical assistance available on an inpatient or out-
patient basis at a residential pediatric recovery center 
(as defined in subsection (pp)) to infants with neonatal 
abstinence syndrome.’’. 
(b) RESIDENTIAL PEDIATRIC RECOVERY CENTER DE-
FINED.—Section 1902 of such Act (42 U.S.C. 1396a), as 
amended by sections 1001 and 1004, is further amended by 
adding at the end the following new subsection: 
‘‘(pp) RESIDENTIAL PEDIATRIC RECOVERY CENTER DE-
FINED.—
•HRES 1099 EH 
‘‘(1) IN
GENERAL.—For purposes of section 
1902(a)(86), the term ‘residential pediatric recovery cen-
ter’ means a center or facility that furnishes items and 
services for which medical assistance is available under 
the State plan to infants with the diagnosis of neonatal 
abstinence syndrome without any other significant med-
ical risk factors. 
‘‘(2) COUNSELING
AND
SERVICES.—A residential 
pediatric recovery center may offer counseling and other 
services to mothers (and other appropriate family mem-
bers and caretakers) of infants receiving treatment at 
such centers if such services are otherwise covered under 
the State plan under this title or under a waiver of such 
plan. Such other services may include the following: 
‘‘(A) Counseling or referrals for services. 
‘‘(B) Activities to encourage caregiver-infant 
bonding. 
‘‘(C) Training on caring for such infants.’’. 
(c) EFFECTIVE DATE.—The amendments made by this 
section take effect on the date of enactment of this Act and 
shall apply to medical assistance furnished on or after that 
date, without regard to final regulations to carry out such 
amendments being promulgated as of such date.
•HRES 1099 EH 
SEC. 1008. PEER SUPPORT ENHANCEMENT AND EVALUATION 
REVIEW. 
(a) IN GENERAL.—Not later than 2 years after the date 
of the enactment of this Act, the Comptroller General of the 
United States shall submit to the Committee on Energy and 
Commerce of the House of Representatives, the Committee 
on Finance of the Senate, and the Committee on Health, 
Education, Labor and Pensions of the Senate a report on the 
provision of peer support services under the Medicaid pro-
gram. 
(b) CONTENT OF REPORT.— 
(1) IN GENERAL.—The report required under sub-
section (a) shall include the following information: 
(A) Information on State coverage of peer sup-
port services under Medicaid, including— 
(i) the mechanisms through which States 
may provide such coverage, including through 
existing statutory authority or through waivers; 
(ii) the populations to which States have 
provided such coverage; 
(iii) the payment models, including any al-
ternative payment models, used by States to 
pay providers of such services; and 
(iv) where available, information on Fed-
eral and State spending under Medicaid for 
peer support services.
•HRES 1099 EH 
(B) Information on selected State experiences 
in providing medical assistance for peer support 
services under State Medicaid plans and whether 
States measure the effects of providing such assist-
ance with respect to— 
(i) improving access to behavioral health 
services; 
(ii) improving early detection, and pre-
venting worsening, of behavioral health dis-
orders; 
(iii) reducing chronic and comorbid condi-
tions; and 
(iv) reducing overall health costs. 
(2) 
RECOMMENDATIONS.—The 
report 
required 
under subsection (a) shall include recommendations, in-
cluding recommendations for such legislative and admin-
istrative actions related to improving services, including 
peer support services, and access to peer support serv-
ices under Medicaid as the Comptroller General of the 
United States determines appropriate. 
SEC. 1009. MEDICAID SUBSTANCE USE DISORDER TREATMENT 
VIA TELEHEALTH. 
(a) DEFINITIONS.—In this section:
•HRES 1099 EH 
(1) COMPTROLLER GENERAL.—The term ‘‘Comp-
troller General’’ means the Comptroller General of the 
United States. 
(2) SCHOOL-BASED
HEALTH
CENTER.—The term 
‘‘school-based health center’’ has the meaning given that 
term in section 2110(c)(9) of the Social Security Act (42 
U.S.C. 1397jj(c)(9)). 
(3) SECRETARY.—The term ‘‘Secretary’’ means the 
Secretary of Health and Human Services. 
(4) UNDERSERVED AREA.—The term ‘‘underserved 
area’’ means a health professional shortage area (as de-
fined in section 332(a)(1)(A) of the Public Health Serv-
ice Act (42 U.S.C. 254e(a)(1)(A))) and a medically un-
derserved area (according to a designation under section 
330(b)(3)(A) of the Public Health Service Act (42 
U.S.C. 254b(b)(3)(A))). 
(b) GUIDANCE TO STATES REGARDING FEDERAL REIM-
BURSEMENT FOR FURNISHING SERVICES AND TREATMENT 
FOR SUBSTANCE USE DISORDERS UNDER MEDICAID USING 
SERVICES DELIVERED VIA TELEHEALTH, INCLUDING
IN 
SCHOOL-BASED HEALTH CENTERS.—Not later than 1 year 
after the date of enactment of this Act, the Secretary, acting 
through the Administrator of the Centers for Medicare & 
Medicaid Services, shall issue guidance to States on the fol-
lowing:
•HRES 1099 EH 
(1) State options for Federal reimbursement of ex-
penditures under Medicaid for furnishing services and 
treatment for substance use disorders, including assess-
ment, medication-assisted treatment, counseling, medica-
tion management, and medication adherence with pre-
scribed medication regimes, using services delivered via 
telehealth. Such guidance shall also include guidance on 
furnishing services and treatments that address the 
needs of high-risk individuals, including at least the fol-
lowing groups: 
(A) American Indians and Alaska Natives. 
(B) Adults under the age of 40. 
(C) Individuals with a history of non-fatal 
overdose. 
(D) Individuals with a co-occurring serious 
mental illness and substance use disorder. 
(2) State options for Federal reimbursement of ex-
penditures under Medicaid for education directed to pro-
viders serving Medicaid beneficiaries with substance use 
disorders using the hub and spoke model, through con-
tracts with managed care entities, through administra-
tive claiming for disease management activities, and 
under Delivery System Reform Incentive Payment 
(‘‘DSRIP’’) programs.
•HRES 1099 EH 
(3) State options for Federal reimbursement of ex-
penditures under Medicaid for furnishing services and 
treatment for substance use disorders for individuals en-
rolled in Medicaid in a school-based health center using 
services delivered via telehealth. 
(c) GAO EVALUATION
OF CHILDREN’S ACCESS
TO 
SERVICES
AND TREATMENT
FOR SUBSTANCE USE DIS-
ORDERS UNDER MEDICAID.— 
(1) STUDY.—The Comptroller General shall evalu-
ate children’s access to services and treatment for sub-
stance use disorders under Medicaid. The evaluation 
shall include an analysis of State options for improving 
children’s access to such services and treatment and for 
improving outcomes, including by increasing the number 
of Medicaid providers who offer services or treatment for 
substance use disorders in a school-based health center 
using services delivered via telehealth, particularly in 
rural and underserved areas. The evaluation shall in-
clude an analysis of Medicaid provider reimbursement 
rates for services and treatment for substance use dis-
orders. 
(2) REPORT.—Not later than 1 year after the date 
of enactment of this Act, the Comptroller General shall 
submit to Congress a report containing the results of the 
evaluation conducted under paragraph (1), together with
•HRES 1099 EH 
recommendations for such legislation and administrative 
action as the Comptroller General determines appro-
priate. 
(d) REPORT ON REDUCING BARRIERS TO USING SERV-
ICES DELIVERED VIA TELEHEALTH AND REMOTE PATIENT 
MONITORING FOR PEDIATRIC POPULATIONS UNDER MED-
ICAID.— 
(1) IN GENERAL.—Not later than 1 year after the 
date of enactment of this Act, the Secretary, acting 
through the Administrator of the Centers for Medicare 
& Medicaid Services, shall issue a report to the Com-
mittee on Finance of the Senate and the Committee on 
Energy and Commerce of the House of Representatives 
identifying best practices and potential solutions for re-
ducing barriers to using services delivered via telehealth 
to furnish services and treatment for substance use dis-
orders among pediatric populations under Medicaid. The 
report shall include— 
(A) analyses of the best practices, barriers, and 
potential solutions for using services delivered via 
telehealth to diagnose and provide services and 
treatment for children with substance use disorders, 
including opioid use disorder; and 
(B) identification and analysis of the dif-
ferences, if any, in furnishing services and treat-
•HRES 1099 EH 
ment for children with substance use disorders 
using services delivered via telehealth and using 
services delivered in person, such as, and to the ex-
tent feasible, with respect to— 
(i) utilization rates; 
(ii) costs; 
(iii) avoidable inpatient admissions and re-
admissions; 
(iv) quality of care; and 
(v) patient, family, and provider satisfac-
tion. 
(2) PUBLICATION.—The Secretary shall publish the 
report required under paragraph (1) on a public internet 
website of the Department of Health and Human Serv-
ices. 
SEC. 1010. ENHANCING PATIENT ACCESS TO NON-OPIOID 
TREATMENT OPTIONS. 
Not later than January 1, 2019, the Secretary of Health 
and Human Services, acting through the Administrator of the 
Centers for Medicare & Medicaid Services, shall issue 1 or 
more final guidance documents, or update existing guidance 
documents, to States regarding mandatory and optional items 
and services that may be provided under a State plan under 
title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), 
or under a waiver of such a plan, for non-opioid treatment
•HRES 1099 EH 
and management of pain, including, but not limited to, evi-
dence-based, non-opioid pharmacological therapies and non- 
pharmacological therapies. 
SEC. 1011. ASSESSING BARRIERS TO OPIOID USE DISORDER 
TREATMENT. 
(a) STUDY.— 
(1) IN GENERAL.—The Comptroller General of the 
United States (in this section referred to as the ‘‘Comp-
troller General’’) shall conduct a study regarding the 
barriers to providing medication used in the treatment of 
substance use disorders under Medicaid distribution 
models such as the ‘‘buy-and-bill’’ model, and options for 
State Medicaid programs to remove or reduce such bar-
riers. The study shall include analyses of each of the fol-
lowing models of distribution of substance use disorder 
treatment 
medications, 
particularly 
buprenorphine, 
naltrexone, and buprenorphine-naloxone combinations: 
(A) The purchasing, storage, and administra-
tion of substance use disorder treatment medica-
tions by providers. 
(B) The dispensing of substance use disorder 
treatment medications by pharmacists. 
(C) The ordering, prescribing, and obtaining 
substance use disorder treatment medications on 
demand from specialty pharmacies by providers.
•HRES 1099 EH 
(2) REQUIREMENTS.—For each model of distribu-
tion specified in paragraph (1), the Comptroller General 
shall evaluate how each model presents barriers or could 
be used by selected State Medicaid programs to reduce 
the barriers related to the provision of substance use dis-
order treatment by examining what is known about the 
effects of the model of distribution on— 
(A) Medicaid beneficiaries’ access to substance 
use disorder treatment medications; 
(B) the differential cost to the program be-
tween each distribution model for medication-as-
sisted treatment; and 
(C) provider willingness to provide or prescribe 
substance use disorder treatment medications. 
(b) REPORT.—Not later than 15 months after the date 
of the enactment of this Act, the Comptroller General shall 
submit to Congress a report containing the results of the 
study conducted under subsection (a), together with rec-
ommendations for such legislation and administrative action 
as the Comptroller General determines appropriate. 
SEC. 1012. HELP FOR MOMS AND BABIES. 
(a) MEDICAID STATE PLAN.—Section 1905(a) of the So-
cial Security Act (42 U.S.C. 1396d(a)), as amended by sec-
tion 1006, is further amended by adding at the end the fol-
lowing new sentence: ‘‘In the case of a woman who is eligible
•HRES 1099 EH 
for medical assistance on the basis of being pregnant (includ-
ing through the end of the month in which the 60-day period 
beginning on the last day of her pregnancy ends), who is a 
patient in an institution for mental diseases for purposes of 
receiving treatment for a substance use disorder, and who 
was enrolled for medical assistance under the State plan im-
mediately before becoming a patient in an institution for 
mental diseases or who becomes eligible to enroll for such 
medical assistance while such a patient, the exclusion from 
the definition of ‘medical assistance’ set forth in the subdivi-
sion (B) following paragraph (30) of the first sentence of this 
subsection shall not be construed as prohibiting Federal fi-
nancial participation for medical assistance for items or serv-
ices that are provided to the woman outside of the institu-
tion.’’. 
(b) EFFECTIVE DATE.— 
(1) IN GENERAL.—Except as provided in paragraph 
(2), the amendment made by subsection (a) shall take 
effect on the date of enactment of this Act. 
(2) RULE FOR CHANGES REQUIRING STATE LEGIS-
LATION.—In the case of a State plan under title XIX of 
the Social Security Act which the Secretary of Health 
and Human Services determines requires State legisla-
tion (other than legislation appropriating funds) in order 
for the plan to meet the additional requirements imposed
•HRES 1099 EH 
by the amendment made by subsection (a), the State 
plan shall not be regarded as failing to comply with the 
requirements of such title solely on the basis of its fail-
ure to meet these additional requirements before the 
first day of the first calendar quarter beginning after the 
close of the first regular session of the State legislature 
that begins after the date of the enactment of this Act. 
For purposes of the previous sentence, in the case of a 
State that has a 2-year legislative session, each year of 
such session shall be deemed to be a separate regular 
session of the State legislature. 
SEC. 1013. SECURING FLEXIBILITY TO TREAT SUBSTANCE USE 
DISORDERS. 
Section 1903(m) of the Social Security Act (42 U.S.C. 
1396b(m)) is amended by adding at the end the following 
new paragraph: 
‘‘(7) Payment shall be made under this title to a State 
for expenditures for capitation payments described in section 
438.6(e) of title 42, Code of Federal Regulations (or any suc-
cessor regulation).’’. 
SEC. 1014. MACPAC STUDY AND REPORT ON MAT UTILIZATION 
CONTROLS UNDER STATE MEDICAID PROGRAMS. 
(a) STUDY.—The Medicaid and CHIP Payment and Ac-
cess Commission shall conduct a study and analysis of utiliza-
tion control policies applied to medication-assisted treatment
•HRES 1099 EH 
for substance use disorders under State Medicaid programs, 
including policies and procedures applied both in fee-for-serv-
ice Medicaid and in risk-based managed care Medicaid, which 
shall— 
(1) include an inventory of such utilization control 
policies and related protocols for ensuring access to 
medically necessary treatment; 
(2) determine whether managed care utilization 
control policies and procedures for medication-assisted 
treatment for substance use disorders are consistent 
with section 438.210(a)(4)(ii) of title 42, Code of Fed-
eral Regulations; and 
(3) identify policies that— 
(A) limit an individual’s access to medication- 
assisted treatment for a substance use disorder by 
limiting the quantity of medication-assisted treat-
ment prescriptions, or the number of refills for such 
prescriptions, available to the individual as part of 
a prior authorization process or similar utilization 
protocols; and 
(B) apply without evaluating individual in-
stances of fraud, waste, or abuse. 
(b) REPORT.—Not later than 1 year after the date of 
the enactment of this Act, the Medicaid and CHIP Payment 
and Access Commission shall make publicly available a report
•HRES 1099 EH 
containing the results of the study conducted under sub-
section (a). 
SEC. 1015. OPIOID ADDICTION TREATMENT PROGRAMS EN-
HANCEMENT. 
(a) 
T–MSIS 
SUBSTANCE
USE
DISORDER
DATA 
BOOK.— 
(1) IN GENERAL.—Not later than the date that is 
12 months after the date of enactment of this Act, the 
Secretary of Health and Human Services (in this section 
referred to as the ‘‘Secretary’’) shall publish on the pub-
lic website of the Centers for Medicare & Medicaid Serv-
ices a report with comprehensive data on the prevalence 
of substance use disorders in the Medicaid beneficiary 
population and services provided for the treatment of 
substance use disorders under Medicaid. 
(2) CONTENT
OF
REPORT.—The report required 
under paragraph (1) shall include, at a minimum, the 
following data for each State (including, to the extent 
available, for the District of Columbia, Puerto Rico, the 
United States Virgin Islands, Guam, the Northern Mar-
iana Islands, and American Samoa): 
(A) The number and percentage of individuals 
enrolled in the State Medicaid plan or waiver of 
such plan in each of the major enrollment cat-
egories (as defined in a public letter from the Med-
•HRES 1099 EH 
icaid and CHIP Payment and Access Commission 
to the Secretary) who have been diagnosed with a 
substance use disorder and whether such individuals 
are enrolled under the State Medicaid plan or a 
waiver of such plan, including the specific waiver 
authority under which they are enrolled, to the ex-
tent available. 
(B) A list of the substance use disorder treat-
ment services by each major type of service, such as 
counseling, medication-assisted treatment, peer sup-
port, residential treatment, and inpatient care, for 
which beneficiaries in each State received at least 1 
service under the State Medicaid plan or a waiver 
of such plan. 
(C) The number and percentage of individuals 
with a substance use disorder diagnosis enrolled in 
the State Medicaid plan or waiver of such plan who 
received substance use disorder treatment services 
under such plan or waiver by each major type of 
service under subparagraph (B) within each major 
setting type, such as outpatient, inpatient, residen-
tial, and other home-based and community-based 
settings. 
(D) The number of services provided under the 
State Medicaid plan or waiver of such plan per indi-
•HRES 1099 EH 
vidual with a substance use disorder diagnosis en-
rolled in such plan or waiver for each major type of 
service under subparagraph (B). 
(E) The number and percentage of individuals 
enrolled in the State Medicaid plan or waiver, by 
major enrollment category, who received substance 
use disorder treatment through— 
(i) a medicaid managed care entity (as de-
fined in section 1932(a)(1)(B) of the Social Se-
curity Act (42 U.S.C. 1396u–2(a)(1)(B))), in-
cluding the number of such individuals who re-
ceived such assistance through a prepaid inpa-
tient health plan or a prepaid ambulatory 
health plan; 
(ii) a fee-for-service payment model; or 
(iii) an alternative payment model, to the 
extent available. 
(F) The number and percentage of individuals 
with a substance use disorder who receive substance 
use disorder treatment services in an outpatient or 
home-based and community-based setting after re-
ceiving treatment in an inpatient or residential set-
ting, and the number of services received by such 
individuals in the outpatient or home-based and 
community-based setting.
•HRES 1099 EH 
(3) ANNUAL UPDATES.—The Secretary shall issue 
an updated version of the report required under para-
graph (1) not later than January 1 of each calendar 
year through 2024. 
(4) USE
OF
T–MSIS
DATA.—The report required 
under paragraph (1) and updates required under para-
graph (3) shall— 
(A) use data and definitions from the Trans-
formed Medicaid Statistical Information System 
(‘‘T–MSIS’’) data set that is no more than 12 
months old on the date that the report or update 
is published; and 
(B) as appropriate, include a description with 
respect to each State of the quality and complete-
ness of the data and caveats describing the limita-
tions of the data reported to the Secretary by the 
State that is sufficient to communicate the appro-
priate uses for the information. 
(b) MAKING T–MSIS DATA ON SUBSTANCE USE DIS-
ORDERS AVAILABLE TO RESEARCHERS.— 
(1) IN GENERAL.—The Secretary shall publish in 
the Federal Register a system of records notice for the 
data specified in paragraph (2) for the Transformed 
Medicaid Statistical Information System, in accordance 
with section 552a(e)(4) of title 5, United States Code.
•HRES 1099 EH 
The notice shall outline policies that protect the security 
and privacy of the data that, at a minimum, meet the 
security and privacy policies of SORN 09–70–0541 for 
the Medicaid Statistical Information System. 
(2) REQUIRED DATA.—The data covered by the sys-
tems of records notice required under paragraph (1) 
shall be sufficient for researchers and States to analyze 
the prevalence of substance use disorders in the Med-
icaid beneficiary population and the treatment of sub-
stance use disorders under Medicaid across all States 
(including the District of Columbia, Puerto Rico, the 
United States Virgin Islands, Guam, the Northern Mar-
iana Islands, and American Samoa), forms of treatment, 
and treatment settings. 
(3) INITIATION
OF
DATA-SHARING
ACTIVITIES.— 
Not later than January 1, 2019, the Secretary shall ini-
tiate the data-sharing activities outlined in the notice re-
quired under paragraph (1). 
SEC. 1016. BETTER DATA SHARING TO COMBAT THE OPIOID 
CRISIS. 
(a) IN GENERAL.—Section 1903(m) of the Social Secu-
rity Act (42 U.S.C. 1396b(m)), as amended by section 1013, 
is further amended by adding at the end the following new 
paragraph:
•HRES 1099 EH 
‘‘(8)(A) The State agency administering the State plan 
under this title may have reasonable access, as determined by 
the State, to 1 or more prescription drug monitoring program 
databases administered or accessed by the State to the extent 
the State agency is permitted to access such databases under 
State law. 
‘‘(B) Such State agency may facilitate reasonable access, 
as determined by the State, to 1 or more prescription drug 
monitoring program databases administered or accessed by 
the State, to same extent that the State agency is permitted 
under State law to access such databases, for— 
‘‘(i) any provider enrolled under the State plan to 
provide services to Medicaid beneficiaries; and 
‘‘(ii) any managed care entity (as defined under sec-
tion 1932(a)(1)(B)) that has a contract with the State 
under this subsection or under section 1905(t)(3). 
‘‘(C) Such State agency may share information in such 
databases, to the same extent that the State agency is per-
mitted under State law to share information in such data-
bases, with— 
‘‘(i) any provider enrolled under the State plan to 
provide services to Medicaid beneficiaries; and 
‘‘(ii) any managed care entity (as defined under sec-
tion 1932(a)(1)(B)) that has a contract with the State 
under this subsection or under section 1905(t)(3).’’.
•HRES 1099 EH 
(b) SECURITY AND PRIVACY.—All applicable State and 
Federal security and privacy protections and laws shall apply 
to any State agency, individual, or entity accessing 1 or more 
prescription drug monitoring program databases or obtaining 
information in such databases in accordance with section 
1903(m)(8) of the Social Security Act (as added by sub-
section (a)). 
(c) EFFECTIVE DATE.—The amendment made by sub-
section (a) shall take effect on the date of enactment of this 
Act. 
SEC. 1017. REPORT ON INNOVATIVE STATE INITIATIVES AND 
STRATEGIES 
TO 
PROVIDE 
HOUSING-RELATED 
SERVICES 
AND 
SUPPORTS 
TO 
INDIVIDUALS 
STRUGGLING WITH SUBSTANCE USE DISORDERS 
UNDER MEDICAID. 
(a) IN GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and Human 
Services shall issue a report to Congress describing innovative 
State initiatives and strategies for providing housing-related 
services and supports under a State Medicaid program to in-
dividuals with substance use disorders who are experiencing 
or at risk of experiencing homelessness. 
(b) CONTENT OF REPORT.—The report required under 
subsection (a) shall describe the following:
•HRES 1099 EH 
(1) Existing methods and innovative strategies de-
veloped and adopted by State Medicaid programs that 
have achieved positive outcomes in increasing housing 
stability among Medicaid beneficiaries with substance 
use disorders who are experiencing or at risk of experi-
encing homelessness, including Medicaid beneficiaries 
with substance use disorders who are— 
(A) receiving treatment for substance use dis-
orders in inpatient, residential, outpatient, or home- 
based and community-based settings; 
(B) transitioning between substance use dis-
order treatment settings; or 
(C) living in supportive housing or another 
model of affordable housing. 
(2) Strategies employed by Medicaid managed care 
organizations, primary care case managers, hospitals, ac-
countable care organizations, and other care coordina-
tion providers to deliver housing-related services and 
supports and to coordinate services provided under State 
Medicaid programs across different treatment settings. 
(3) Innovative strategies and lessons learned by 
States with Medicaid waivers approved under section 
1115 or 1915 of the Social Security Act (42 U.S.C. 
1315, 1396n), including—
•HRES 1099 EH 
(A) challenges experienced by States in design-
ing, securing, and implementing such waivers or 
plan amendments; 
(B) how States developed partnerships with 
other organizations such as behavioral health agen-
cies, State housing agencies, housing providers, 
health care services agencies and providers, commu-
nity-based organizations, and health insurance 
plans to implement waivers or State plan amend-
ments; and 
(C) how and whether States plan to provide 
Medicaid coverage for housing-related services and 
supports in the future, including by covering such 
services and supports under State Medicaid plans or 
waivers. 
(4) Existing opportunities for States to provide 
housing-related services and supports through a Med-
icaid waiver under sections 1115 or 1915 of the Social 
Security Act (42 U.S.C. 1315, 1396n) or through a 
State Medicaid plan amendment, such as the Assistance 
in Community Integration Service pilot program, which 
promotes supportive housing and other housing-related 
supports under Medicaid for individuals with substance 
use disorders and for which Maryland has a waiver ap-
proved under such section 1115 to conduct the program.
•HRES 1099 EH 
(5) Innovative strategies and partnerships developed 
and implemented by State Medicaid programs or other 
entities to identify and enroll eligible individuals with 
substance use disorders who are experiencing or at risk 
of experiencing homelessness in State Medicaid pro-
grams. 
SEC. 1018. TECHNICAL ASSISTANCE AND SUPPORT FOR INNO-
VATIVE STATE STRATEGIES TO PROVIDE HOUS-
ING-RELATED SUPPORTS UNDER MEDICAID. 
(a) IN GENERAL.—The Secretary of Health and Human 
Services shall provide technical assistance and support to 
States regarding the development and expansion of innovative 
State strategies (including through State Medicaid dem-
onstration projects) to provide housing-related supports and 
services and care coordination services under Medicaid to in-
dividuals with substance use disorders. 
(b) REPORT.—Not later than 180 days after the date of 
enactment of this Act, the Secretary shall issue a report to 
Congress detailing a plan of action to carry out the require-
ments of subsection (a).
•HRES 1099 EH 
TITLE II—MEDICARE PROVISIONS 
TO ADDRESS THE OPIOID CRISIS 
SEC. 2001. EXPANDING THE USE OF TELEHEALTH SERVICES 
FOR THE TREATMENT OF OPIOID USE DISORDER 
AND OTHER SUBSTANCE USE DISORDERS. 
(a) IN GENERAL.—Section 1834(m) of the Social Secu-
rity Act (42 U.S.C. 1395m(m)) is amended— 
(1) in paragraph (2)(B)— 
(A) in clause (i), in the matter preceding sub-
clause (I), by striking ‘‘clause (ii)’’ and inserting 
‘‘clause (ii) and paragraph (6)(C)’’; and 
(B) in clause (ii), in the heading, by striking 
‘‘FOR HOME DIALYSIS THERAPY’’; 
(2) in paragraph (4)(C)— 
(A) in clause (i), by striking ‘‘paragraph (6)’’ 
and inserting ‘‘paragraphs (5), (6), and (7)’’; and 
(B) in clause (ii)(X), by inserting ‘‘or tele-
health services described in paragraph (7)’’ before 
the period at the end; and 
(3) by adding at the end the following new para-
graph: 
‘‘(7) TREATMENT OF SUBSTANCE USE DISORDER 
SERVICES
FURNISHED
THROUGH
TELEHEALTH.—The 
geographic 
requirements 
described 
in 
paragraph 
(4)(C)(i) shall not apply with respect to telehealth serv-
•HRES 1099 EH 
ices furnished on or after July 1, 2019, to an eligible 
telehealth individual with a substance use disorder diag-
nosis for purposes of treatment of such disorder or co- 
occurring mental health disorder, as determined by the 
Secretary, at an originating site described in paragraph 
(4)(C)(ii) (other than an originating site described in 
subclause (IX) of such paragraph).’’. 
(b) IMPLEMENTATION.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) may implement the amendments made by this sec-
tion by interim final rule. 
(c) REPORT.— 
(1) IN GENERAL.—Not later than 5 years after the 
date of the enactment of this Act, the Secretary shall 
submit to Congress a report on the impact of the imple-
mentation of the amendments made by this section with 
respect to telehealth services under section 1834(m) of 
the Social Security Act (42 U.S.C. 1395m(m)) on— 
(A) the utilization of health care items and 
services under title XVIII of such Act (42 U.S.C. 
1395 et seq.) related to substance use disorders, in-
cluding emergency department visits; and 
(B) health outcomes related to substance use 
disorders, such as opioid overdose deaths.
•HRES 1099 EH 
(2) FUNDING.—For purposes of carrying out para-
graph (1), in addition to funds otherwise available, the 
Secretary shall provide for the transfer, from the Fed-
eral Supplementary Medical Insurance Trust Fund 
under section 1841, of $3,000,000 to the Centers for 
Medicare & Medicaid Services Program Management Ac-
count to remain available until expended. 
SEC. 2002. COMPREHENSIVE SCREENINGS FOR SENIORS. 
(a) INITIAL PREVENTIVE PHYSICAL EXAMINATION.— 
Section 1861(ww) of the Social Security Act (42 U.S.C. 
1395x(ww)) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘paragraph (2) and’’ and in-
serting ‘‘paragraph (2),’’; and 
(B) by inserting ‘‘and the furnishing of a re-
view of any current opioid prescriptions (as defined 
in paragraph (4)),’’ after ‘‘upon the agreement with 
the individual,’’; and 
(2) in paragraph (2)— 
(A) by redesignating subparagraph (N) as sub-
paragraph (O); and 
(B) by inserting after subparagraph (M) the 
following new subparagraph: 
‘‘(N) Screening for potential substance use dis-
orders.’’; and
•HRES 1099 EH 
(3) by adding at the end the following new para-
graph: 
‘‘(4) For purposes of paragraph (1), the term ‘a review 
of any current opioid prescriptions’ means, with respect to an 
individual determined to have a current prescription for 
opioids— 
‘‘(A) a review of the potential risk factors to the in-
dividual for opioid use disorder; 
‘‘(B) an evaluation of the individual’s severity of 
pain and current treatment plan; 
‘‘(C) the provision of information on non-opioid 
treatment options; and 
‘‘(D) a referral to a specialist, as appropriate.’’. 
(b) ANNUAL WELLNESS VISIT.—Section 1861(hhh)(2) 
of the Social Security Act (42 U.S.C. 1395x(hhh)(2)) is 
amended— 
(1) by redesignating subparagraph (G) as subpara-
graph (I); and 
(2) by inserting after subparagraph (F) the fol-
lowing new subparagraphs: 
‘‘(G) Screening for potential substance use dis-
orders and referral for treatment as appropriate. 
‘‘(H) The furnishing of a review of any current 
opioid prescriptions (as defined in subsection 
(ww)(4)).’’.
•HRES 1099 EH 
(c) RULE OF CONSTRUCTION.—Nothing in the amend-
ments made by subsection (a) or (b) shall be construed to 
prohibit separate payment for structured assessment and 
intervention services for substance abuse furnished to an indi-
vidual on the same day as an initial preventive physical exam-
ination or an annual wellness visit. 
(d) EFFECTIVE DATE.—The amendments made by this 
section shall apply to examinations and visits furnished on or 
after January 1, 2020. 
SEC. 2003. EVERY PRESCRIPTION CONVEYED SECURELY. 
(a) IN GENERAL.—Section 1860D–4(e) of the Social Se-
curity Act (42 U.S.C. 1395w–104(e)) is amended by adding 
at the end the following: 
‘‘(7) REQUIREMENT OF E-PRESCRIBING FOR CON-
TROLLED SUBSTANCES.— 
‘‘(A) IN GENERAL.—Subject to subparagraph 
(B), a prescription for a covered part D drug under 
a prescription drug plan (or under an MA–PD 
plan) for a schedule II, III, IV, or V controlled sub-
stance shall be transmitted by a health care practi-
tioner electronically in accordance with an electronic 
prescription drug program that meets the require-
ments of paragraph (2). 
‘‘(B) 
EXCEPTION
FOR
CERTAIN
CIR-
CUMSTANCES.—The Secretary shall, through rule-
•HRES 1099 EH 
making, specify circumstances and processes by 
which the Secretary may waive the requirement 
under subparagraph (A), with respect to a covered 
part D drug, including in the case of— 
‘‘(i) a prescription issued when the practi-
tioner and dispensing pharmacy are the same 
entity; 
‘‘(ii) a prescription issued that cannot be 
transmitted electronically under the most re-
cently implemented version of the National 
Council 
for 
Prescription 
Drug 
Programs 
SCRIPT Standard; 
‘‘(iii) a prescription issued by a practi-
tioner who received a waiver or a renewal 
thereof for a period of time as determined by 
the Secretary, not to exceed one year, from the 
requirement to use electronic prescribing due 
to demonstrated economic hardship, techno-
logical limitations that are not reasonably with-
in the control of the practitioner, or other ex-
ceptional circumstance demonstrated by the 
practitioner; 
‘‘(iv) a prescription issued by a practi-
tioner under circumstances in which, notwith-
standing the practitioner’s ability to submit a
•HRES 1099 EH 
prescription electronically as required by this 
subsection, such practitioner reasonably deter-
mines that it would be impractical for the indi-
vidual involved to obtain substances prescribed 
by electronic prescription in a timely manner, 
and such delay would adversely impact the in-
dividual’s medical condition involved; 
‘‘(v) a prescription issued by a practi-
tioner prescribing a drug under a research pro-
tocol; 
‘‘(vi) a prescription issued by a practi-
tioner for a drug for which the Food and Drug 
Administration requires a prescription to con-
tain elements that are not able to be included 
in electronic prescribing, such as a drug with 
risk evaluation and mitigation strategies that 
include elements to assure safe use; 
‘‘(vii) a prescription issued by a practi-
tioner— 
‘‘(I) for an individual who receives 
hospice care under this title; and 
‘‘(II) that is not covered under the 
hospice benefit under this title; and 
‘‘(viii) a prescription issued by a practi-
tioner for an individual who is—
•HRES 1099 EH 
‘‘(I) a resident of a nursing facility 
(as defined in section 1919(a)); and 
‘‘(II) dually eligible for benefits under 
this title and title XIX. 
‘‘(C) DISPENSING.—(i) Nothing in this para-
graph shall be construed as requiring a sponsor of 
a prescription drug plan under this part, MA orga-
nization offering an MA–PD plan under part C, or 
a pharmacist to verify that a practitioner, with re-
spect to a prescription for a covered part D drug, 
has a waiver (or is otherwise exempt) under sub-
paragraph (B) from the requirement under sub-
paragraph (A). 
‘‘(ii) Nothing in this paragraph shall be con-
strued as affecting the ability of the plan to cover 
or the pharmacists’ ability to continue to dispense 
covered part D drugs from otherwise valid written, 
oral, or fax prescriptions that are consistent with 
laws and regulations. 
‘‘(iii) Nothing in this paragraph shall be con-
strued as affecting the ability of an individual who 
is being prescribed a covered part D drug to des-
ignate a particular pharmacy to dispense the cov-
ered part D drug to the extent consistent with the
•HRES 1099 EH 
requirements under subsection (b)(1) and under 
this paragraph. 
‘‘(D) ENFORCEMENT.—The Secretary shall, 
through rulemaking, have authority to enforce and 
specify appropriate penalties for non-compliance 
with the requirement under subparagraph (A).’’. 
(b) EFFECTIVE DATE.—The amendment made by sub-
section (a) shall apply to coverage of drugs prescribed on or 
after January 1, 2021. 
(c) UPDATE
OF BIOMETRIC COMPONENT
OF MULTI-
FACTOR AUTHENTICATION.—Not later than 1 year after the 
date of enactment of this Act, the Attorney General shall up-
date the requirements for the biometric component of multi-
factor authentication with respect to electronic prescriptions 
of controlled substances. 
SEC. 2004. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS 
UNDER MEDICARE TO ESTABLISH DRUG MANAGE-
MENT PROGRAMS FOR AT-RISK BENEFICIARIES. 
Section 1860D–4(c) of the Social Security Act (42 
U.S.C. 1395w–104(c)) is amended— 
(1) in paragraph (1), by inserting after subpara-
graph (E) the following new subparagraph: 
‘‘(F) With respect to plan years beginning on 
or after January 1, 2022, a drug management pro-
•HRES 1099 EH 
gram for at-risk beneficiaries described in para-
graph (5).’’; and 
(2) in paragraph (5)(A), by inserting ‘‘(and for plan 
years beginning on or after January 1, 2022, a PDP 
sponsor shall)’’ after ‘‘A PDP sponsor may’’. 
SEC. 2005. MEDICARE COVERAGE OF CERTAIN SERVICES FUR-
NISHED BY OPIOID TREATMENT PROGRAMS. 
(a) COVERAGE.—Section 1861(s)(2) of the Social Secu-
rity Act (42 U.S.C. 1395x(s)(2)) is amended— 
(1) in subparagraph (FF), by striking at the end 
‘‘and’’; 
(2) in subparagraph (GG), by inserting at the end 
‘‘and’’; and 
(3) by adding at the end the following new subpara-
graph: 
‘‘(HH) opioid use disorder treatment services (as 
defined in subsection (jjj)).’’. 
(b) OPIOID USE DISORDER TREATMENT SERVICES AND 
OPIOID TREATMENT PROGRAM DEFINED.—Section 1861 of 
the Social Security Act (42 U.S.C. 1395x) is amended by 
adding at the end the following new subsection: 
‘‘(jjj) OPIOID USE DISORDER TREATMENT SERVICES; 
OPIOID TREATMENT PROGRAM.— 
‘‘(1) OPIOID
USE
DISORDER
TREATMENT
SERV-
ICES.—The term ‘opioid use disorder treatment services’
•HRES 1099 EH 
means items and services that are furnished by an opioid 
treatment program for the treatment of opioid use dis-
order, including— 
‘‘(A) opioid agonist and antagonist treatment 
medications (including oral, injected, or implanted 
versions) that are approved by the Food and Drug 
Administration under section 505 of the Federal 
Food, Drug, and Cosmetic Act for use in the treat-
ment of opioid use disorder; 
‘‘(B) dispensing and administration of such 
medications, if applicable; 
‘‘(C) substance use counseling by a profes-
sional to the extent authorized under State law to 
furnish such services; 
‘‘(D) individual and group therapy with a phy-
sician or psychologist (or other mental health pro-
fessional to the extent authorized under State law); 
‘‘(E) toxicology testing, and 
‘‘(F) other items and services that the Sec-
retary determines are appropriate (but in no event 
to include meals or transportation). 
‘‘(2) OPIOID
TREATMENT
PROGRAM.—The term 
‘opioid treatment program’ means an entity that is an 
opioid treatment program (as defined in section 8.2 of
•HRES 1099 EH 
title 42 of the Code of Federal Regulations, or any suc-
cessor regulation) that— 
‘‘(A) is enrolled under section 1866(j); 
‘‘(B) has in effect a certification by the Sub-
stance Abuse and Mental Health Services Adminis-
tration for such a program; 
‘‘(C) is accredited by an accrediting body ap-
proved by the Substance Abuse and Mental Health 
Services Administration; and 
‘‘(D) meets such additional conditions as the 
Secretary may find necessary to ensure— 
‘‘(i) the health and safety of individuals 
being furnished services under such program; 
and 
‘‘(ii) the effective and efficient furnishing 
of such services.’’. 
(c) PAYMENT.— 
(1) IN GENERAL.—Section 1833(a)(1) of the Social 
Security Act (42 U.S.C. 1395l(a)(1)) is amended— 
(A) by striking ‘‘and (BB)’’ and inserting 
‘‘(BB)’’; and 
(B) by inserting before the semicolon at the 
end the following ‘‘, and (CC) with respect to opioid 
use disorder treatment services furnished during an 
episode of care, the amount paid shall be equal to
•HRES 1099 EH 
the amount payable under section 1834(w) less any 
copayment required as specified by the Secretary’’. 
(2) PAYMENT DETERMINATION.—Section 1834 of 
the Social Security Act (42 U.S.C. 1395m) is amended 
by adding at the end the following new subsection: 
‘‘(w) OPIOID USE DISORDER TREATMENT SERVICES.— 
‘‘(1) IN GENERAL.—The Secretary shall pay to an 
opioid treatment program (as defined in paragraph (2) 
of section 1861(jjj)) an amount that is equal to 100 per-
cent of a bundled payment under this part for opioid use 
disorder treatment services (as defined in paragraph (1) 
of such section) that are furnished by such program to 
an individual during an episode of care (as defined by 
the Secretary) beginning on or after January 1, 2020. 
The Secretary shall ensure, as determined appropriate 
by the Secretary, that no duplicative payments are made 
under this part or part D for items and services fur-
nished by an opioid treatment program. 
‘‘(2) CONSIDERATIONS.—The Secretary may imple-
ment this subsection through one or more bundles based 
on 
the 
type 
of 
medication 
provided 
(such 
as 
buprenorphine, methadone, naltrexone, or a new innova-
tive drug), the frequency of services, the scope of serv-
ices furnished, characteristics of the individuals fur-
nished such services, or other factors as the Secretary
•HRES 1099 EH 
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 pro-
vide 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 Secu-
rity Act (42 U.S.C. 1395cc(e)) is amended— 
(1) in paragraph (1), by striking at the end ‘‘and’’; 
(2) in paragraph (2), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by adding at the end the following new para-
graph: 
‘‘(3) opioid treatment programs (as defined in para-
graph (2) of section 1861(jjj)), but only with respect to 
the furnishing of opioid use disorder treatment services 
(as defined in paragraph (1) of such section).’’. 
SEC. 2006. ENCOURAGING APPROPRIATE PRESCRIBING UNDER 
MEDICARE FOR VICTIMS OF OPIOID OVERDOSE. 
Section 1860D–4(c)(5)(C) of the Social Security Act (42 
U.S.C. 1395w–104(c)(5)(C)) is amended—
•HRES 1099 EH 
(1) in clause (i), in the matter preceding subclause 
(I), by striking ‘‘For purposes’’ and inserting ‘‘Except as 
provided in clause (v), for purposes’’; and 
(2) by adding at the end the following new clause: 
‘‘(v) TREATMENT OF ENROLLEES WITH A 
HISTORY OF OPIOID-RELATED OVERDOSE.— 
‘‘(I) IN
GENERAL.—For plan years 
beginning not later than January 1, 2021, 
a part D eligible individual who is not an 
exempted individual described in clause 
(ii) and who is identified under this clause 
as a part D eligible individual with a his-
tory of opioid-related overdose (as defined 
by the Secretary) shall be included as a 
potentially at-risk beneficiary for prescrip-
tion drug abuse under the drug manage-
ment program under this paragraph. 
‘‘(II) 
IDENTIFICATION
AND
NO-
TICE.—For purposes of this clause, the 
Secretary shall— 
‘‘(aa) identify part D eligible in-
dividuals with a history of opioid-re-
lated overdose (as so defined); and 
‘‘(bb) notify the PDP sponsor of 
the prescription drug plan in which
•HRES 1099 EH 
such an individual is enrolled of such 
identification.’’. 
SEC. 2007. AUTOMATIC ESCALATION TO EXTERNAL REVIEW 
UNDER A MEDICARE PART D DRUG MANAGEMENT 
PROGRAM FOR AT-RISK BENEFICIARIES. 
(a) IN GENERAL.—Section 1860D–4(c)(5) of the Social 
Security Act (42 U.S.C. 1395ww–10(c)(5)) is amended— 
(1) in subparagraph (B), in each of clauses (ii)(III) 
and (iii)(IV), by striking ‘‘and the option of an auto-
matic escalation to external review’’ and inserting ‘‘, in-
cluding notice that if on reconsideration a PDP sponsor 
affirms its denial, in whole or in part, the case shall be 
automatically forwarded to the independent, outside enti-
ty contracted with the Secretary for review and resolu-
tion’’; and 
(2) in subparagraph (E), by striking ‘‘and the op-
tion’’ and all that follows and inserting the following: 
‘‘and if on reconsideration a PDP sponsor affirms its de-
nial, in whole or in part, the case shall be automatically 
forwarded to the independent, outside entity contracted 
with the Secretary for review and resolution.’’. 
(b) EFFECTIVE DATE.—The amendments made by sub-
section (a) shall apply beginning not later January 1, 2021.
•HRES 1099 EH 
SEC. 2008. SUSPENSION OF PAYMENTS BY MEDICARE PRE-
SCRIPTION 
DRUG 
PLANS 
AND 
MA–PD 
PLANS 
PENDING INVESTIGATIONS OF CREDIBLE ALLEGA-
TIONS OF FRAUD BY PHARMACIES. 
(a) IN GENERAL.—Section 1860D–12(b) of the Social 
Security Act (42 U.S.C. 1395w–112(b)) is amended by add-
ing at the end the following new paragraph: 
‘‘(7) SUSPENSION OF PAYMENTS PENDING INVES-
TIGATION
OF
CREDIBLE
ALLEGATIONS
OF
FRAUD
BY 
PHARMACIES.— 
‘‘(A) IN GENERAL.—Section 1862(o)(1) shall 
apply with respect to a PDP sponsor with a con-
tract under this part, a pharmacy, and payments to 
such pharmacy under this part in the same manner 
as such section applies with respect to the Sec-
retary, a provider of services or supplier, and pay-
ments to such provider of services or supplier under 
this title. A PDP sponsor shall notify the Secretary 
regarding the imposition of any payment suspension 
pursuant to the previous sentence, such as through 
the secure internet website portal (or other suc-
cessor 
technology) 
established 
under 
section 
1859(i). 
‘‘(B) RULE
OF
CONSTRUCTION.—Nothing in 
this paragraph shall be construed as limiting the
•HRES 1099 EH 
authority of a PDP sponsor to conduct postpayment 
review.’’. 
(b) 
APPLICATION
TO
MA–PD 
PLANS.—Section 
1857(f)(3) of the Social Security Act (42 U.S.C. 1395w– 
27(f)(3)) is amended by adding at the end the following new 
subparagraph: 
‘‘(D) SUSPENSION OF PAYMENTS PENDING IN-
VESTIGATION
OF
CREDIBLE
ALLEGATIONS
OF 
FRAUD
BY
PHARMACIES.—Section 
1860D– 
12(b)(7).’’. 
(c) CONFORMING AMENDMENT.—Section 1862(o)(3) of 
the Social Security Act (42 U.S.C. 1395y(o)(3)) is amended 
by inserting ‘‘, section 1860D–12(b)(7) (including as applied 
pursuant to section 1857(f)(3)(D)),’’ after ‘‘this subsection’’. 
(d) CLARIFICATION RELATING TO CREDIBLE ALLEGA-
TION OF FRAUD.—Section 1862(o) of the Social Security Act 
(42 U.S.C. 1395y(o)) is amended by adding at the end the 
following new paragraph: 
‘‘(4) CREDIBLE ALLEGATION OF FRAUD.—In car-
rying out this subsection, section 1860D–12(b)(7) (in-
cluding as applied pursuant to section 1857(f)(3)(D)), 
and section 1903(i)(2)(C), a fraud hotline tip (as defined 
by the Secretary) without further evidence shall not be 
treated as sufficient evidence for a credible allegation of 
fraud.’’.
•HRES 1099 EH 
(e) EFFECTIVE DATE.—The amendments made by this 
section shall apply with respect to plan years beginning on or 
after January 1, 2020. 
TITLE III—FDA AND CONTROLLED 
SUBSTANCE PROVISIONS 
Subtitle A—FDA Provisions 
CHAPTER 1—IN GENERAL 
SEC. 3001. CLARIFYING FDA REGULATION OF NON-ADDICTIVE 
PAIN PRODUCTS. 
(a) PUBLIC MEETINGS.—Not later than one year after 
the date of enactment of this Act, the Secretary of Health 
and Human Services (referred to in this section as the ‘‘Sec-
retary’’), acting through the Commissioner of Food and 
Drugs, shall hold not less than one public meeting to address 
the challenges and barriers of developing non-addictive med-
ical products intended to treat acute or chronic pain or addic-
tion, which may include— 
(1) the manner by which the Secretary may incor-
porate the risks of misuse and abuse of a controlled sub-
stance (as defined in section 102 of the Controlled Sub-
stances Act (21 U.S.C. 802)) into the risk benefit as-
sessments under subsections (d) and (e) of section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), section 510(k) of such Act (21 U.S.C. 360(k)), or
•HRES 1099 EH 
section 515(c) of such Act (21 U.S.C. 360e(c)), as appli-
cable; 
(2) the application of novel clinical trial designs 
(consistent with section 3021 of the 21st Century Cures 
Act (Public Law 114–255)), use of real world evidence 
(consistent with section 505F of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of 
patient experience data (consistent with section 569C of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–8c)) for the development of non-addictive med-
ical products intended to treat pain or addiction; 
(3) the evidentiary standards and the development 
of opioid-sparing data for inclusion in the labeling of 
medical products intended to treat acute or chronic pain; 
and 
(4) the application of eligibility criteria under sec-
tions 506 and 515B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive 
medical products intended to treat pain or addiction. 
(b) GUIDANCE.—Not less than one year after the public 
meetings are conducted under subsection (a) the Secretary 
shall issue one or more final guidance documents, or update 
existing guidance documents, to help address challenges to 
developing non-addictive medical products to treat pain or ad-
•HRES 1099 EH 
diction. Such guidance documents shall include information 
regarding— 
(1) how the Food and Drug Administration may 
apply sections 506 and 515B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-ad-
dictive medical products intended to treat pain or addic-
tion, including the circumstances under which the Sec-
retary— 
(A) may apply the eligibility criteria under 
such sections 506 and 515B to non-addictive med-
ical products intended to treat pain or addiction; 
(B) considers the risk of addiction of controlled 
substances approved to treat pain when establishing 
unmet medical need; and 
(C) considers pain, pain control, or pain man-
agement in assessing whether a disease or condition 
is a serious or life-threatening disease or condition; 
(2) the methods by which sponsors may evaluate 
acute and chronic pain, endpoints for non-addictive med-
ical products intended to treat pain, the manner in 
which endpoints and evaluations of efficacy will be ap-
plied across and within review divisions, taking into con-
sideration the etiology of the underlying disease, and the 
manner in which sponsors may use surrogate endpoints, 
intermediate endpoints, and real world evidence;
•HRES 1099 EH 
(3) the manner in which the Food and Drug Ad-
ministration will assess evidence to support the inclusion 
of opioid-sparing data in the labeling of non-addictive 
medical products intended to treat acute or chronic pain, 
including— 
(A) alternative data collection methodologies, 
including the use of novel clinical trial designs (con-
sistent with section 3021 of the 21st Century Cures 
Act (Public Law 114–255)) and real world evidence 
(consistent with section 505F of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355g)), includ-
ing patient registries and patient reported out-
comes, as appropriate, to support product labeling; 
(B) ethical considerations of exposing subjects 
to controlled substances in clinical trials to develop 
opioid-sparing data and considerations on data col-
lection methods that reduce harm, which may in-
clude the reduction of opioid use as a clinical ben-
efit; 
(C) endpoints, including primary, secondary, 
and surrogate endpoints, to evaluate the reduction 
of opioid use; 
(D) best practices for communication between 
sponsors and the agency on the development of data
•HRES 1099 EH 
collection methods, including the initiation of data 
collection; and 
(E) the appropriate format in which to submit 
such data results to the Secretary; and 
(4) the circumstances under which the Food and 
Drug Administration considers misuse and abuse of a 
controlled substance (as defined in section 102 of the 
Controlled Substances Act (21 U.S.C. 802)) in making 
the risk benefit assessment under paragraphs (2) and 
(4) of subsection (d) of section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) and in finding 
that a drug is unsafe under paragraph (1) or (2) of sub-
section (e) of such section. 
(c) DEFINITIONS.—In this section— 
(1) the term ‘‘medical product’’ means a drug (as 
defined in section 201(g)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321(g)(1))), biological 
product (as defined in section 351(i) of the Public 
Health Service Act (42 U.S.C. 262(i))), or device (as de-
fined in section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(h))); and 
(2) the term ‘‘opioid-sparing’’ means reducing, re-
placing, or avoiding the use of opioids or other controlled 
substances intended to treat acute or chronic pain.
•HRES 1099 EH 
SEC. 3002. EVIDENCE-BASED OPIOID ANALGESIC PRESCRIBING 
GUIDELINES AND REPORT. 
(a) GUIDELINES.—The Commissioner of Food and 
Drugs shall develop evidence-based opioid analgesic pre-
scribing guidelines for the indication-specific treatment of 
acute pain only for the relevant therapeutic areas where such 
guidelines do not exist. 
(b) PUBLIC INPUT.—In developing the guidelines under 
subsection (a), the Commissioner of Food and Drugs shall— 
(1) consult with stakeholders, which may include 
conducting a public meeting of medical professional soci-
eties (including any State-based societies), health care 
providers, State medical boards, medical specialties in-
cluding pain medicine specialty societies, patient groups, 
pharmacists, academic or medical research entities, and 
other entities with experience in health care, as appro-
priate; 
(2) collaborate with the Director of the Centers for 
Disease Control and Prevention, as applicable and ap-
propriate, and other Federal agencies with relevant ex-
pertise as appropriate; and 
(3) provide for a notice and comment period con-
sistent with section 701(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 371(h)) for the submission 
of comments by the public.
•HRES 1099 EH 
(c) REPORT.—Not later than 1 year after the date of en-
actment of this Act, or, if earlier, at the time the guidelines 
under subsection (a) are finalized, the Commissioner of Food 
and Drugs shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate, and post on the public website of the Food and Drug 
Administration, a report on how the Food and Drug Adminis-
tration will utilize the guidelines under subsection (a) to pro-
tect the public health and a description of the public health 
need with respect to each such indication-specific treatment 
guideline. 
(d) UPDATES.—The Commissioner of Food and Drugs 
shall periodically— 
(1) update the guidelines under subsection (a), in-
formed by public input described in subsection (b); and 
(2) submit to the committees specified in subsection 
(c) and post on the public website of the Food and Drug 
Administration an updated report under such subsection. 
(e) STATEMENT TO ACCOMPANY GUIDELINES AND REC-
OMMENDATIONS.—The Commissioner of Food and Drugs 
shall ensure that opioid analgesic prescribing guidelines and 
other recommendations developed under this section are ac-
companied by a clear statement that such guidelines or rec-
ommendations, as applicable—
•HRES 1099 EH 
(1) are intended to help inform clinical decision-
making by prescribers and patients; and 
(2) are not intended to be used for the purposes of 
restricting, limiting, delaying, or denying coverage for, or 
access to, a prescription issued for a legitimate medical 
purpose by an individual practitioner acting in the usual 
course of professional practice. 
CHAPTER 2—STOP COUNTERFEIT DRUGS BY 
REGULATING 
AND 
ENHANCING 
EN-
FORCEMENT NOW 
SEC. 3011. SHORT TITLE. 
This chapter may be cited as the ‘‘Stop Counterfeit 
Drugs by Regulating and Enhancing Enforcement Now Act’’ 
or the ‘‘SCREEN Act’’. 
SEC. 3012. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF 
CONTROLLED SUBSTANCES. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended 
by adding at the end the following: 
‘‘(eee) The failure to comply with any order issued under 
section 569D.’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL OF 
CONTROLLED SUBSTANCES.—Subchapter E of chapter V of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
•HRES 1099 EH 
360bbb et seq.) is amended by adding at the end the fol-
lowing: 
‘‘SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF CONTROLLED SUBSTANCES. 
‘‘(a) ORDER TO CEASE DISTRIBUTION AND RECALL.— 
‘‘(1) IN
GENERAL.—If the Secretary determines 
there is a reasonable probability that a controlled sub-
stance would cause serious adverse health consequences 
or death, the Secretary may, after providing the appro-
priate person with an opportunity to consult with the 
agency, issue an order requiring manufacturers, import-
ers, distributors, or pharmacists, who distribute such 
controlled substance to immediately cease distribution of 
such controlled substance. 
‘‘(2) HEARING.—An order under paragraph (1) 
shall provide the person subject to the order with an op-
portunity for an informal hearing, to be held not later 
than 10 days after the date of issuance of the order, on 
whether adequate evidence exists to justify an amend-
ment to the order, and what actions are required by 
such amended order pursuant to subparagraph (3). 
‘‘(3) ORDER RESOLUTION.—After an order is issued 
according to the process under paragraphs (1) and (2), 
the Secretary shall, except as provided in paragraph 
(4)—
100 
•HRES 1099 EH 
‘‘(A) vacate the order, if the Secretary deter-
mines that inadequate grounds exist to support the 
actions required by the order; 
‘‘(B) continue the order ceasing distribution of 
the controlled substance until a date specified in 
such order; or 
‘‘(C) amend the order to require a recall of the 
controlled substance, including any requirements to 
notify appropriate persons, a timetable for the recall 
to occur, and a schedule for updates to be provided 
to the Secretary regarding such recall. 
‘‘(4) RISK ASSESSMENT.—If the Secretary deter-
mines that the risk of recalling a controlled substance 
presents a greater health risk than the health risk of not 
recalling such controlled substance from use, an amend-
ed order under subparagraph (B) or (C) of paragraph 
(3) shall not include either a recall order for, or an order 
to cease distribution of, such controlled substance, as ap-
plicable. 
‘‘(5) ACTION FOLLOWING ORDER.—Any person who 
is subject to an order pursuant to subparagraph (B) or 
(C) of paragraph (3) shall immediately cease distribution 
of or recall, as applicable, the controlled substance and 
provide notification as required by such order.
101 
•HRES 1099 EH 
‘‘(b) NOTICE TO PERSONS AFFECTED.—If the Secretary 
determines necessary, the Secretary may require the person 
subject to an order pursuant to paragraph (1) or an amended 
order pursuant to subparagraph (B) or (C) of paragraph (3) 
to provide either a notice of a recall order for, or an order 
to cease distribution of, such controlled substance, as applica-
ble, under this section to appropriate persons, including per-
sons who manufacture, distribute, import, or offer for sale 
such product that is the subject of an order and to the public. 
In providing such notice, the Secretary may use the assist-
ance of health professionals who prescribed or dispensed such 
controlled substances. 
‘‘(c) NONDELEGATION.—An order described in sub-
section (a)(3) shall be ordered by the Secretary or an official 
designated by the Secretary. An official may not be so des-
ignated under this section unless the official is the Director 
of the Center for Drug Evaluation and Research or an offi-
cial senior to such Director. 
‘‘(d) SAVINGS CLAUSE.—Nothing contained in this sec-
tion shall be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an order 
to cease distribution of, or to recall, any drug under any 
other provision of this Act or the Public Health Service 
Act; or
102 
•HRES 1099 EH 
‘‘(2) the ability of the Secretary to request any per-
son to perform a voluntary activity related to any drug 
subject to this Act or the Public Health Service Act.’’. 
(c) CONTROLLED
SUBSTANCES
SUBJECT
TO
RE-
FUSAL.—The third sentence of section 801(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amend-
ed by inserting ‘‘, or is a controlled substance subject to an 
order under section 569D’’ before ‘‘, or (4)’’. 
(d) EFFECTIVE DATE.—Sections 301(eee) and 569D of 
the Federal Food, Drug, and Cosmetic Act, as added by sub-
sections (a) and (b), shall be effective beginning on the date 
of enactment of this Act. 
SEC. 3013. SINGLE SOURCE PATTERN OF IMPORTED ILLEGAL 
DRUGS. 
Section 801 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381), as amended by section 3012, is further 
amended by adding at the end the following: 
‘‘(t) SINGLE SOURCE PATTERN OF IMPORTED ILLEGAL 
DRUGS.—If the Secretary determines that a person subject 
to debarment as a result of engaging in a pattern of import-
ing or offering for import controlled substances or drugs as 
described in section 306(b)(3)(D), and such pattern is identi-
fied by the Secretary as being offered for import from the 
same manufacturer, distributor, or importer, the Secretary 
may by order determine all drugs being offered for import
103 
•HRES 1099 EH 
from such person as adulterated or misbranded, unless such 
person can provide evidence otherwise.’’. 
SEC. 3014. STRENGTHENING FDA AND CBP COORDINATION AND 
CAPACITY. 
(a) IN GENERAL.—The Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), act-
ing through the Commissioner of Food and Drugs, shall co-
ordinate with the Secretary of Homeland Security to carry 
out activities related to customs and border protection and in 
response to illegal controlled substances and drug imports, in-
cluding at sites of import (such as international mail facili-
ties), that will provide improvements to such facilities, tech-
nologies, and inspection capacity. Such Secretaries may carry 
out such activities through a memorandum of understanding 
between the Food and Drug Administration and the U.S. 
Customs and Border Protection. 
(b) FDA IMPORT FACILITIES AND INSPECTION CAPAC-
ITY.— 
(1) IN GENERAL.—In carrying out this section, the 
Secretary shall, in collaboration with the Secretary of 
Homeland Security and the Postmaster General of the 
United States Postal Service, provide that import facili-
ties in which the Food and Drug Administration oper-
ates or carries out activities related to drug imports 
within the international mail facilities include—
104 
•HRES 1099 EH 
(A) facility upgrades and improved capacity in 
order to increase and improve inspection and detec-
tion capabilities, which may include, as the Sec-
retary determines appropriate— 
(i) improvements to facilities, such as up-
grades or renovations, and support for the 
maintenance of existing import facilities and 
sites to improve coordination between Federal 
agencies; 
(ii) improvements in equipment and infor-
mation technology enhancement to identify un-
approved, counterfeit, or other unlawful con-
trolled substances for destruction; 
(iii) the construction of, or upgrades to, 
laboratory capacity for purposes of detection 
and testing of imported goods; 
(iv) upgrades to the security of import fa-
cilities; and 
(v) innovative technology and equipment 
to facilitate improved and near-real-time infor-
mation sharing between the Food and Drug 
Administration, the Department of Homeland 
Security, and the United States Postal Service; 
and
105 
•HRES 1099 EH 
(B) innovative technology, including controlled 
substance detection and testing equipment and 
other applicable technology, in order to collaborate 
with the U.S. Customs and Border Protection to 
share near-real-time information, including informa-
tion about test results, as appropriate. 
(2) INNOVATIVE
TECHNOLOGY.—Any technology 
used in accordance with paragraph (1)(B) shall be inter-
operable with technology used by other relevant Federal 
agencies, including the U.S. Customs and Border Pro-
tection, as the Secretary determines appropriate and 
practicable. 
(c) REPORT.—Not later than 6 months after the date of 
enactment of this Act, the Secretary, in consultation with the 
Secretary of Homeland Security and the Postmaster General 
of the United States Postal Service, shall report to the Com-
mittee on Energy and Commerce and the Committee on 
Homeland Security of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions and 
the Committee on Homeland Security and Governmental Af-
fairs of the Senate on the implementation of this section, in-
cluding a summary of progress made toward near-real-time 
information sharing and the interoperability of such tech-
nologies.
106 
•HRES 1099 EH 
CHAPTER 3—STOP ILLICIT DRUG 
IMPORTATION 
SEC. 3021. SHORT TITLE. 
This chapter may be cited as the ‘‘Stop Illicit Drug Im-
portation Act of 2018’’. 
SEC. 3022. RESTRICTING ENTRANCE OF ILLICIT DRUGS. 
(a) FOOD AND DRUG ADMINISTRATION AND U.S. CUS-
TOMS AND BORDER PROTECTION COOPERATION.— 
(1) IN
GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’), acting through the Commissioner of Food and 
Drugs and in consultation with the U.S. Customs and 
Border Protection, shall develop and periodically update 
a mutually agreed upon list of the controlled substances 
that the Secretary will refer to U.S. Customs and Bor-
der Protection, unless the Secretary and U.S. Customs 
and Border Protection agree otherwise, when such sub-
stances are offered for import via international mail and 
appear to violate the Controlled Substances Act (21 
U.S.C. 801 et seq.), the Controlled Substances Import 
and Export Act (21 U.S.C. 951 et seq.), the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
or any other applicable law. The Secretary shall transfer 
controlled substances on such list to the U.S. Customs 
and Border Protection. If the Secretary identifies addi-
107 
•HRES 1099 EH 
tional packages that appear to be the same as such 
package containing a controlled substance, such addi-
tional packages may also be transferred to U.S. Customs 
and Border Protection. The U.S. Customs and Border 
Protection shall receive such packages consistent with 
the requirements of the Controlled Substances Act (21 
U.S.C. 801 et seq.). 
(2) REPORT.—Not later than 9 months after the 
date of enactment of this Act, the Secretary, acting 
through the Commissioner of Food and Drugs and in 
consultation with the Secretary of Homeland Security, 
shall report to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate 
on the implementation of this section. 
(b) DEBARMENT, TEMPORARY DENIAL OF APPROVAL, 
AND SUSPENSION.— 
(1) PROHIBITED ACT.—Section 301(cc) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) 
is amended— 
(A) by inserting ‘‘or a drug’’ after ‘‘food’’; and 
(B) by inserting ‘‘from such activity’’ after 
‘‘person debarred’’.
108 
•HRES 1099 EH 
(2) DEBARMENT.—Section 306(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 
amended— 
(A) in paragraph (1)— 
(i) in the matter preceding subparagraph 
(A), by inserting ‘‘or (3)’’ after ‘‘paragraph 
(2)’’; 
(ii) in subparagraph (A), by striking the 
comma at the end and inserting a semicolon; 
(iii) in subparagraph (B), by striking ‘‘, 
or’’ and inserting a semicolon; 
(iv) in subparagraph (C), by striking the 
period and inserting ‘‘; or’’; and 
(v) by adding at the end the following: 
‘‘(D) a person from importing or offering for 
import into the United States a drug.’’; 
(B) in paragraph (3)— 
(i) in the heading, by inserting ‘‘OR 
DRUG’’ after ‘‘FOOD’’; 
(ii) in subparagraph (A), by striking ‘‘; 
or’’ and inserting a semicolon; 
(iii) in subparagraph (B), by striking the 
period and inserting a semicolon; and 
(iv) by adding at the end the following:
109 
•HRES 1099 EH 
‘‘(C) the person has been convicted of a felony 
for conduct relating to the importation into the 
United States of any drug or controlled substance 
(as defined in section 102 of the Controlled Sub-
stances Act); 
‘‘(D) the person has engaged in a pattern of 
importing or offering for import— 
‘‘(i) controlled substances that are prohib-
ited from importation under section 401(m) of 
the Tariff Act of 1930 (19 U.S.C. 1401(m)); 
or 
‘‘(ii) adulterated or misbranded drugs that 
are— 
‘‘(I) not designated in an authorized 
electronic data interchange system as a 
product that is regulated by the Secretary; 
or 
‘‘(II) knowingly or intentionally false-
ly designated in an authorized electronic 
data interchange system as a product that 
is regulated by the Secretary.’’; and 
(C) by adding at the end the following: 
‘‘(5) DEFINITION.—For purposes of paragraph 
(3)(D), the term ‘pattern of importing or offering for 
import’ means importing or offering for import a drug
110 
•HRES 1099 EH 
described in clause (i) or (ii) of paragraph (3)(D) in an 
amount, frequency, or dosage that is inconsistent with 
personal or household use by the importer.’’. 
(c) IMPORTS AND EXPORTS.—Section 801(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as 
amended, is further amended— 
(1) by striking ‘‘, then such article shall be refused 
admission’’ inserting ‘‘or (5) such article is being im-
ported or offered for import in violation of section 
301(cc), then any such article described in any of clauses 
(1) through (5) shall be refused admission’’; 
(2) by inserting ‘‘If it appears from the examination 
of such samples or otherwise that the article is a coun-
terfeit drug, such article shall be refused admission.’’ be-
fore ‘‘With respect to an article of food, if importation’’; 
and 
(3) by striking ‘‘Clause (2) of the third sentence’’ 
and all that follows through the period at the end and 
inserting the following: ‘‘Neither clause (2) nor clause 
(5) of the third sentence of this subsection shall be con-
strued to prohibit the admission of narcotic drugs, the 
importation of which is permitted under the Controlled 
Substances Import and Export Act.’’.
111 
•HRES 1099 EH 
(d) CERTAIN ILLICIT ARTICLES.—Section 801 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as 
amended, is amended by adding at the end the following— 
‘‘(u) ILLICIT ARTICLES CONTAINING ACTIVE PHARMA-
CEUTICAL INGREDIENTS.— 
‘‘(1) IN GENERAL.—For purposes of this section, an 
article that is being imported or offered for import into 
the United States may be treated by the Secretary as a 
drug if the article— 
‘‘(A) is not— 
‘‘(i) accompanied by an electronic import 
entry for such article submitted using an au-
thorized electronic data interchange system; 
and 
‘‘(ii) designated in such a system as an ar-
ticle regulated by the Secretary (which may in-
clude regulation as a drug, a device, a dietary 
supplement, or other product that is regulated 
under this Act); and 
‘‘(B) is an ingredient that presents significant 
public health concern and is, or contains— 
‘‘(i) an active ingredient in a drug— 
‘‘(I) that is approved under section 
505 or licensed under section 351 of the 
Public Health Service Act; or
112 
•HRES 1099 EH 
‘‘(II) for which— 
‘‘(aa) an investigational use ex-
emption has been authorized under 
section 505(i) of this Act or section 
351(a) of the Public Health Service 
Act; and 
‘‘(bb) a substantial clinical inves-
tigation has been instituted, and such 
investigation has been made public; 
or 
‘‘(ii) a substance that has a chemical 
structure that is substantially similar to the 
chemical structure of an active ingredient in a 
drug or biological product described in sub-
clause (I) or (II) of clause (i). 
‘‘(2) EFFECT.—This subsection shall not be con-
strued to bear upon any determination of whether an ar-
ticle is a drug within the meaning of section 201(g), 
other than for the purposes described in paragraph 
(1).’’.
113 
•HRES 1099 EH 
CHAPTER 4—SECURING OPIOIDS AND UN-
USED NARCOTICS WITH DELIBERATE DIS-
POSAL AND PACKAGING 
SEC. 3031. SHORT TITLE. 
This chapter may be cited as the ‘‘Securing Opioids and 
Unused Narcotics with Deliberate Disposal and Packaging 
Act of 2018’’ or the ‘‘SOUND Disposal and Packaging Act’’. 
SEC. 3032. SAFETY-ENHANCING PACKAGING AND DISPOSAL 
FEATURES. 
(a) DELIBERATE DISPOSAL AND PACKAGING ELEMENTS 
OF STRATEGY.—Section 505–1(e) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355–1(e)) is amended by add-
ing at the end the following: 
‘‘(4) PACKAGING
AND
DISPOSAL.—The Secretary 
may require a risk evaluation mitigation strategy for a 
drug for which there is a serious risk of an adverse drug 
experience described in subparagraph (B) or (C) of sub-
section (b)(1), taking into consideration the factors de-
scribed in subparagraphs (C) and (D) of subsection 
(f)(2) and in consultation with other relevant Federal 
agencies with authorities over drug disposal packaging, 
which may include requiring that— 
‘‘(A) the drug be made available for dispensing 
to certain patients in unit dose packaging, pack-
aging that provides a set duration, or another pack-
114 
•HRES 1099 EH 
aging system that the Secretary determines may 
mitigate such serious risk; or 
‘‘(B) the drug be dispensed to certain patients 
with a safe disposal packaging or safe disposal sys-
tem for purposes of rendering drugs nonretrievable 
(as defined in section 1300.05 of title 21, Code of 
Federal Regulations (or any successor regulation)) 
if the Secretary determines that such safe disposal 
packaging or system may mitigate such serious risk 
and is sufficiently available.’’. 
(b) ASSURING ACCESS AND MINIMIZING BURDEN.—Sec-
tion 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355–1(f)(2)(C)) is amended— 
(1) in clause (i) by striking ‘‘and’’ at the end; and 
(2) by adding at the end the following: 
‘‘(iii) patients with functional limitations; 
and’’. 
(c) APPLICATION TO ABBREVIATED NEW DRUG APPLI-
CATIONS.—Section 505–1(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1(i)) is amended— 
(1) in paragraph (1)— 
(A) by redesignating subparagraph (B) as sub-
paragraph (C); and 
(B) inserting after subparagraph (A) the fol-
lowing:
115 
•HRES 1099 EH 
‘‘(B) A packaging or disposal requirement, if 
required under subsection (e)(4) for the applicable 
listed drug.’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘and’’ at 
the end; 
(B) by redesignating subparagraph (B) as sub-
paragraph (C); and 
(C) by inserting after subparagraph (A) the 
following: 
‘‘(B) shall permit packaging systems and safe 
disposal packaging or safe disposal systems that are 
different from those required for the applicable list-
ed drug under subsection (e)(4); and’’. 
(d) GAO REPORT.—Not later than 12 months after the 
date of enactment of this Act, the Comptroller General of the 
United States shall prepare and submit to Congress a report 
containing— 
(1) a description of available evidence, if any, on 
the effectiveness of site-of-use, in-home controlled sub-
stance disposal products and packaging technologies; 
(2) an evaluation of existing reference standards 
with respect to controlled substance disposal products 
and packaging technologies, including any such stand-
ards established by a standards development organiza-
116 
•HRES 1099 EH 
tion, and how such standards should be considered in en-
suring effectiveness of such products and technologies; 
(3) identification of ways in which such disposal 
products intended for use by patients, consumers, and 
other end users that are not registrants under the Con-
trolled Substances Act (21 U.S.C. 801 et seq.), are made 
available to the public and any barriers to the use of 
such disposal products; 
(4) identification of ways in which packaging tech-
nologies are made available to the public and any bar-
riers to the use of such technologies; 
(5) a description of current Federal oversight, if 
any, of site-of-use, in-home controlled substance disposal 
products, including— 
(A) identification of the Federal agencies that 
oversee such products; 
(B) identification of the methods of disposal of 
controlled substances recommended by such agen-
cies for site-of-use, in-home disposal; and 
(C) a description of the effectiveness of such 
recommendations at preventing the diversion of le-
gally prescribed controlled substances; 
(6) a description of current Federal oversight, if 
any, of controlled substance packaging technologies, in-
cluding—
117 
•HRES 1099 EH 
(A) identification of the Federal agencies that 
oversee such technologies; 
(B) identification of the technologies rec-
ommended by such agencies, including unit dose 
packaging, packaging that provides a set duration, 
and other packaging systems that may mitigate 
abuse or misuse; and 
(C) a description of the effectiveness of such 
recommendations at preventing the diversion of le-
gally prescribed controlled substances; and 
(7) recommendations, as appropriate, on— 
(A) whether site-of-use, in-home controlled sub-
stance disposal products and packaging technologies 
require Federal oversight and, if so, which agency 
or agencies should be responsible for such oversight 
and, as applicable, review of such products or tech-
nologies; and 
(B) whether there are applicable standards 
that should be considered to ensure the effective-
ness of such products. 
CHAPTER 5—POSTAPPROVAL STUDY 
REQUIREMENTS 
SEC. 3041. CLARIFYING FDA POSTMARKET AUTHORITIES. 
(a) DEFINITION
OF ADVERSE DRUG EXPERIENCE.— 
Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cos-
118 
•HRES 1099 EH 
metic Act (21 U.S.C. 355–1(b)(1)(E)) is amended by striking 
‘‘of the drug’’ and inserting ‘‘of the drug, which may include 
reduced effectiveness under the conditions of use prescribed 
in the labeling of such drug, but which may not include re-
duced effectiveness that is in accordance with such labeling’’. 
(b) SAFETY LABELING CHANGES.—Section 505(o)(4) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(o)(4)) is amended— 
(1) in subparagraph (A) by— 
(A) striking ‘‘SAFETY INFORMATION’’ and in-
serting ‘‘SAFETY OR NEW EFFECTIVENESS INFOR-
MATION’’; and 
(B) by striking ‘‘If the Secretary becomes’’ and 
all that follows through ‘‘in the labeling of the 
drug’’ and inserting ‘‘If the Secretary becomes 
aware of new information, including any new safety 
information or information related to reduced effec-
tiveness, that the Secretary determines should be 
included in the labeling of the drug’’; 
(2) in clause (i) of subparagraph (B), by inserting 
before the semicolon ‘‘, or new effectiveness informa-
tion’’; 
(3) in subparagraph (C) by striking ‘‘safety infor-
mation’’ and inserting ‘‘safety or new effectiveness infor-
mation’’; and
119 
•HRES 1099 EH 
(4) in subparagraph (E) by striking ‘‘safety infor-
mation’’ and inserting ‘‘safety or new effectiveness infor-
mation’’. 
(c) GUIDANCE.—Not less than one year after the date 
of enactment of this Act, the Secretary of Health and Human 
Services shall issue guidance regarding the circumstances 
under which the Food and Drug Administration may require 
postmarket studies or clinical trials to assess the potential re-
duction in effectiveness of a drug and how such reduction in 
effectiveness could result in a change to the benefits of the 
drug and the risks to the patient. Such guidance shall also 
address how the Food and Drug Administration may apply 
this section and the amendments made thereby with respect 
to circumstances under which the Food and Drug Adminis-
tration may require postmarket studies or clinical trials and 
safety labeling changes related to the use of controlled sub-
stances for acute or chronic pain.
120 
•HRES 1099 EH 
Subtitle B—Controlled Substance 
Provisions 
CHAPTER 1—MORE FLEXIBILITY WITH RE-
SPECT TO MEDICATION-ASSISTED TREAT-
MENT FOR OPIOID USE DISORDERS 
SEC. 3201. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT 
TO 
MEDICATION-ASSISTED 
TREATMENT 
FOR 
OPIOID USE DISORDERS. 
(a) CONFORMING
APPLICABLE
NUMBER.—Subclause 
(II) of section 303(g)(2)(B)(iii) of the Controlled Substances 
Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to read as fol-
lows: 
‘‘(II) The applicable number is— 
‘‘(aa) 100 if, not sooner than 1 year after the 
date on which the practitioner submitted the initial 
notification, the practitioner submits a second noti-
fication to the Secretary of the need and intent of 
the practitioner to treat up to 100 patients; 
‘‘(bb) 100 if the practitioner holds additional 
credentialing, as defined in section 8.2 of title 42, 
Code of Federal Regulations (or successor regula-
tions); 
‘‘(cc) 100 if the practitioner provides medica-
tion-assisted treatment (MAT) using covered medi-
cations (as such terms are defined in section 8.2 of
121 
•HRES 1099 EH 
title 42, Code of Federal Regulations (or successor 
regulations)) in a qualified practice setting (as de-
scribed in section 8.615 of title 42, Code of Federal 
Regulations (or successor regulations)); or 
‘‘(dd) 275 if the practitioner meets the require-
ments specified in sections 8.610 through 8.655 of 
title 42, Code of Federal Regulations (or successor 
regulations).’’. 
(b) ELIMINATING ANY TIME LIMITATION FOR NURSE 
PRACTITIONERS AND PHYSICIAN ASSISTANTS TO BECOME 
QUALIFYING
PRACTITIONERS.—Clause 
(iii) 
of 
section 
303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 
823(g)(2)(G)) is amended— 
(1) in subclause (I), by striking ‘‘or’’ at the end; 
and 
(2) by amending subclause (II) to read as follows: 
‘‘(II) a qualifying other practitioner, as defined 
in clause (iv), who is a nurse practitioner or physi-
cian assistant; or’’. 
(c) IMPOSING A TIME LIMITATION FOR CLINICAL NURSE 
SPECIALISTS, 
CERTIFIED
REGISTERED
NURSE
ANES-
THETISTS, AND CERTIFIED NURSE MIDWIFES TO BECOME 
QUALIFYING
PRACTITIONERS.—Clause 
(iii) 
of 
section 
303(g)(2)(G) of the Controlled Substances Act (21 U.S.C.
122 
•HRES 1099 EH 
823(g)(2)(G)), as amended by subsection (b), is further 
amended by adding at the end the following: 
‘‘(III) for the period beginning on October 1, 
2018, and ending on October 1, 2023, a qualifying 
other practitioner, as defined in clause (iv), who is 
a clinical nurse specialist, certified registered nurse 
anesthetist, or certified nurse midwife.’’. 
(d) DEFINITION
OF
QUALIFYING
OTHER
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 Congress a re-
port that assesses the care provided by qualifying practi-
tioners (as defined in section 303(g)(2)(G)(iii) of the Con-
trolled Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are 
treating, in the case of physicians, more than 100 patients, 
and in the case of qualifying practitioners who are not physi-
cians, more than 30 patients. Such report shall include rec-
ommendations on future applicable patient number levels and
123 
•HRES 1099 EH 
limits. In preparing such report, the Secretary shall study, 
with respect to opioid use disorder treatment— 
(1) the average frequency with which qualifying 
practitioners see their patients; 
(2) the average frequency with which patients re-
ceive counseling, including the rates by which such coun-
seling is provided by such a qualifying practitioner di-
rectly, or by referral; 
(3) the frequency of toxicology testing, including the 
average frequency with which random toxicology testing 
is administered; 
(4) the average monthly patient caseload for each 
type of qualifying practitioner; 
(5) the treatment retention rates for patients; 
(6) overdose and mortality rates; and 
(7) any available information regarding the diver-
sion of drugs by patients receiving such treatment from 
such a qualifying practitioner. 
SEC. 3202. MEDICATION-ASSISTED TREATMENT FOR RECOVERY 
FROM SUBSTANCE USE DISORDER. 
(a) WAIVERS FOR MAINTENANCE TREATMENT OR DE-
TOXIFICATION.—Section 303(g)(2)(G)(ii) of the Controlled 
Substances Act (21 U.S.C. 823(g)(2)(G)(ii)) is amended by 
adding at the end the following:
124 
•HRES 1099 EH 
‘‘(VIII) The physician graduated in good standing 
from an accredited school of allopathic medicine or os-
teopathic medicine in the United States during the 5- 
year period immediately preceding the date on which the 
physician submits to the Secretary a written notification 
under subparagraph (B) and successfully completed a 
comprehensive allopathic or osteopathic medicine cur-
riculum or accredited medical residency that— 
‘‘(aa) included not less than 8 hours of train-
ing on treating and managing opioid-dependent pa-
tients; and 
‘‘(bb) included, at a minimum— 
‘‘(AA) the training described in items (aa) 
through (gg) of subclause (IV); and 
‘‘(BB) training with respect to any other 
best practice the Secretary determines should 
be included in the curriculum, which may in-
clude training on pain management, including 
assessment and appropriate use of opioid and 
non-opioid alternatives.’’. 
(b) TREATMENT
FOR CHILDREN.—The Secretary of 
Health and Human Services shall consider ways to ensure 
that an adequate number of qualified practitioners, as defined 
in subparagraph (G)(ii) of section 303(g)(2) of the Controlled 
Substances Act (21 U.S.C. 823(g)(2)), who have a specialty
125 
•HRES 1099 EH 
in pediatrics or the treatment of children or adolescents, are 
granted a waiver under such section 303(g)(2) to treat chil-
dren and adolescents with substance use disorders. 
(c) TECHNICAL AMENDMENT.—Section 102(24) of the 
Controlled Substances Act (21 U.S.C. 802(24)) is amended 
by striking ‘‘Health, Education, and Welfare’’ and inserting 
‘‘Health and Human Services’’. 
SEC. 3203. GRANTS TO ENHANCE ACCESS TO SUBSTANCE USE 
DISORDER TREATMENT. 
(a) IN GENERAL.—The Secretary of Health and Human 
Services shall establish a grant program under which the Sec-
retary may make grants to accredited schools of allopathic 
medicine or osteopathic medicine and teaching hospitals lo-
cated in the United States to support the development of cur-
ricula that meet the requirements under subclause (VIII) of 
section 303(g)(2)(G)(ii) of the Controlled Substances Act, as 
added by section 3202(a) of this Act. 
(b) AUTHORIZATION OF APPROPRIATIONS.—There is au-
thorized to be appropriated, for grants under subsection (a), 
$4,000,000 for each of fiscal years 2019 through 2023.
126 
•HRES 1099 EH 
SEC. 3204. DELIVERY OF A CONTROLLED SUBSTANCE BY A 
PHARMACY TO BE ADMINISTERED BY INJECTION 
OR IMPLANTATION. 
(a) IN GENERAL.—The Controlled Substances Act is 
amended by inserting after section 309 (21 U.S.C. 829) the 
following: 
‘‘DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY 
TO AN ADMINISTERING PRACTITIONER 
‘‘SEC. 309A. (a) IN GENERAL.—Notwithstanding section 
102(10), a pharmacy may deliver a controlled substance to a 
practitioner in accordance with a prescription that meets the 
requirements of this title and the regulations issued by the 
Attorney General under this title, for the purpose of admin-
istering the controlled substance by the practitioner if— 
‘‘(1) the controlled substance is delivered by the 
pharmacy to the prescribing practitioner or the practi-
tioner administering the controlled substance, as applica-
ble, at the location listed on the practitioner’s certificate 
of registration issued under this title; 
‘‘(2) the controlled substance is to be administered 
for the purpose of maintenance or detoxification treat-
ment under section 303(g)(2) and— 
‘‘(A) the practitioner who issued the prescrip-
tion is a qualifying practitioner authorized under, 
and acting within the scope of that section; and
127 
•HRES 1099 EH 
‘‘(B) the controlled substance is to be adminis-
tered by injection or implantation; 
‘‘(3) the pharmacy and the practitioner are author-
ized to conduct the activities specified in this section 
under the law of the State in which such activities take 
place; 
‘‘(4) the prescription is not issued to supply any 
practitioner with a stock of controlled substances for the 
purpose of general dispensing to patients; 
‘‘(5) except as provided in subsection (b), the con-
trolled substance is to be administered only to the pa-
tient named on the prescription not later than 14 days 
after the date of receipt of the controlled substance by 
the practitioner; and 
‘‘(6) notwithstanding any exceptions under section 
307, the prescribing practitioner, and the practitioner 
administering the controlled substance, as applicable, 
maintain complete and accurate records of all controlled 
substances delivered, received, administered, or otherwise 
disposed of under this section, including the persons to 
whom controlled substances were delivered and such 
other information as may be required by regulations of 
the Attorney General.
128 
•HRES 1099 EH 
‘‘(b) MODIFICATION
OF NUMBER
OF DAYS BEFORE 
WHICH
CONTROLLED
SUBSTANCE
SHALL
BE
ADMINIS-
TERED.— 
‘‘(1) INITIAL 2-YEAR PERIOD.—During the 2-year 
period beginning on the date of enactment of this sec-
tion, the Attorney General, in coordination with the Sec-
retary, may reduce the number of days described in sub-
section (a)(5) if the Attorney General determines that 
such reduction will— 
‘‘(A) reduce the risk of diversion; or 
‘‘(B) protect the public health. 
‘‘(2) MODIFICATIONS
AFTER
SUBMISSION
OF
RE-
PORT.—After the date on which the report described in 
section 3204(b) of the SUPPORT for Patients and 
Communities Act is submitted, the Attorney General, in 
coordination with the Secretary, may modify the number 
of days described in subsection (a)(5). 
‘‘(3) MINIMUM NUMBER OF DAYS.—Any modifica-
tion under this subsection shall be for a period of not 
less than 7 days.’’. 
(b) STUDY AND REPORT.—Not later than 2 years after 
the date of enactment of this section, the Comptroller Gen-
eral of the United States shall conduct a study and submit 
to Congress a report on access to and potential diversion of
129 
•HRES 1099 EH 
controlled substances administered by injection or implanta-
tion. 
(c) TECHNICAL AND CONFORMING AMENDMENT.—The 
table of contents for the Comprehensive Drug Abuse Preven-
tion and Control Act of 1970 is amended by inserting after 
the item relating to section 309 the following: 
‘‘Sec. 309A. Delivery of a controlled substance by a pharmacy to an admin-
istering practitioner.’’. 
CHAPTER 2—EMPOWERING PHARMACISTS IN 
THE FIGHT AGAINST OPIOID ABUSE 
SEC. 3211. SHORT TITLE. 
This chapter may be cited as the ‘‘Empowering Phar-
macists in the Fight Against Opioid Abuse Act’’. 
SEC. 3212. PROGRAMS AND MATERIALS FOR TRAINING ON CER-
TAIN CIRCUMSTANCES UNDER WHICH A PHAR-
MACIST MAY DECLINE TO FILL A PRESCRIPTION. 
(a) IN GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and Human 
Services, in consultation with the Administrator of the Drug 
Enforcement Administration, Commissioner of Food and 
Drugs, Director of the Centers for Disease Control and Pre-
vention, and Assistant Secretary for Mental Health and Sub-
stance Use, shall develop and disseminate, as appropriate, 
materials for pharmacists, health care providers, and patients 
on—
130 
•HRES 1099 EH 
(1) circumstances under which a pharmacist may, 
consistent with section 309 of the Controlled Substances 
Act (21 U.S.C. 829) and regulations thereunder, includ-
ing section 1306.04 of title 21, Code of Federal Regula-
tions, decline to fill a prescription for a controlled sub-
stance because the pharmacist suspects the prescription 
is fraudulent, forged, or of doubtful, questionable, or 
suspicious origin; and 
(2) other Federal requirements pertaining to declin-
ing to fill a prescription under such circumstances, in-
cluding the partial fill of prescriptions for certain con-
trolled substances. 
(b) MATERIALS INCLUDED.—In developing materials 
under subsection (a), the Secretary of Health and Human 
Services shall include information for— 
(1) pharmacists on how to decline to fill a prescrip-
tion and actions to take after declining to fill a prescrip-
tion; and 
(2) other health care practitioners and the public on 
a pharmacist’s ability to decline to fill prescriptions in 
certain circumstances and a description of those cir-
cumstances (as described in the materials developed 
under subsection (a)(1)). 
(c) STAKEHOLDER INPUT.—In developing the programs 
and materials required under subsection (a), the Secretary of
131 
•HRES 1099 EH 
Health and Human Services shall seek input from relevant 
national, State, and local associations, boards of pharmacy, 
medical societies, licensing boards, health care practitioners, 
and patients, including individuals with chronic pain. 
CHAPTER 3—SAFE DISPOSAL OF UNUSED 
MEDICATION 
SEC. 3221. SHORT TITLE. 
This chapter may be cited as the ‘‘Safe Disposal of Un-
used Medication Act’’. 
SEC. 3222. DISPOSAL OF CONTROLLED SUBSTANCES OF A HOS-
PICE PATIENT BY EMPLOYEES OF A QUALIFIED 
HOSPICE PROGRAM. 
(a) IN GENERAL.—Subsection (g) of section 302 of the 
Controlled Substances Act (21 U.S.C. 822) is amended by 
adding at the end the following: 
‘‘(5)(A) In the case of a person receiving hospice care, 
an employee of a qualified hospice program, acting within the 
scope of employment, may handle, without being registered 
under this section, any controlled substance that was lawfully 
dispensed to the person receiving hospice care, for the pur-
pose of disposal of the controlled substance so long as such 
disposal occurs onsite in accordance with all applicable Fed-
eral, State, Tribal, and local law and— 
‘‘(i) the disposal occurs after the death of a person 
receiving hospice care;
132 
•HRES 1099 EH 
‘‘(ii) the controlled substance is expired; or 
‘‘(iii)(I) the employee is— 
‘‘(aa) the physician of the person receiving 
hospice care; and 
‘‘(bb) registered under section 303(f); and 
‘‘(II) the hospice patient no longer requires the 
controlled substance because the plan of care of the 
hospice patient has been modified. 
‘‘(B) For the purposes of this paragraph: 
‘‘(i) The terms ‘hospice care’ and ‘hospice program’ 
have the meanings given to those terms in section 
1861(dd) of the Social Security Act. 
‘‘(ii) The term ‘employee of a qualified hospice pro-
gram’ means a physician, physician assistant, nurse, or 
other person who— 
‘‘(I) is employed by, or pursuant to arrange-
ments made by, a qualified hospice program; 
‘‘(II)(aa) is licensed to perform medical or 
nursing services by the jurisdiction in which the 
person receiving hospice care was located; and 
‘‘(bb) is acting within the scope of such em-
ployment in accordance with applicable State law; 
and 
‘‘(III) has completed training through the 
qualified hospice program regarding the disposal of
133 
•HRES 1099 EH 
controlled substances in a secure and responsible 
manner so as to discourage abuse, misuse, or diver-
sion. 
‘‘(iii) The term ‘qualified hospice program’ means a 
hospice program that— 
‘‘(I) has written policies and procedures for as-
sisting in the disposal of the controlled substances 
of a person receiving hospice care after the person’s 
death; 
‘‘(II) at the time when the controlled sub-
stances are first ordered— 
‘‘(aa) provides a copy of the written poli-
cies and procedures to the patient or patient 
representative and family; 
‘‘(bb) discusses the policies and proce-
dures with the patient or representative and 
the family in a language and manner that they 
understand to ensure that these parties are 
educated regarding the safe disposal of con-
trolled substances; and 
‘‘(cc) documents in the patient’s clinical 
record that the written policies and procedures 
were provided and discussed; and 
‘‘(III) at the time following the disposal of the 
controlled substances—
134 
•HRES 1099 EH 
‘‘(aa) documents in the patient’s clinical 
record the type of controlled substance, dosage, 
route of administration, and quantity so dis-
posed; and 
‘‘(bb) the time, date, and manner in which 
that disposal occurred.’’. 
(b) GUIDANCE.—The Attorney General may issue guid-
ance to hospice programs (as defined in paragraph (5) of sec-
tion 302(g) of the Controlled Substances Act (21 U.S.C. 
822(g)), as added by subsection (a)) to assist the programs 
in satisfying the requirements under such paragraph (5). 
(c) RULE OF CONSTRUCTION RELATING TO STATE AND 
LOCAL LAW.—Nothing in this section or the amendments 
made by this section shall be construed to prevent a State or 
local government from imposing additional controls or restric-
tions relating to the regulation of the disposal of controlled 
substances in hospice care or hospice programs. 
SEC. 3223. GAO STUDY AND REPORT ON HOSPICE SAFE DRUG 
MANAGEMENT. 
(a) STUDY.— 
(1) IN GENERAL.—The Comptroller General of the 
United States (in this section referred to as the ‘‘Comp-
troller General’’) shall conduct a study on the require-
ments applicable to, and challenges of, hospice programs
135 
•HRES 1099 EH 
with regard to the management and disposal of con-
trolled substances in the home of an individual. 
(2) CONTENTS.—In conducting the study under 
paragraph (1), the Comptroller General shall include— 
(A) an overview of any challenges encountered 
by selected hospice programs regarding the disposal 
of controlled substances, such as opioids, in a home 
setting, including any key changes in policies, proce-
dures, or best practices for the disposal of con-
trolled substances over time; and 
(B) a description of Federal requirements, in-
cluding requirements under the Medicare program, 
for hospice programs regarding the disposal of con-
trolled substances in a home setting, and oversight 
of compliance with those requirements. 
(b) REPORT.—Not later than 18 months after the date 
of enactment of this Act, the Comptroller General shall sub-
mit to Congress a report containing the results of the study 
conducted under subsection (a), together with recommenda-
tions, if any, for such legislation and administrative action as 
the Comptroller General determines appropriate.
136 
•HRES 1099 EH 
CHAPTER 4—SPECIAL REGISTRATION FOR 
TELEMEDICINE CLARIFICATION 
SEC. 3231. SHORT TITLE. 
This chapter may be cited as the ‘‘Special Registration 
for Telemedicine Clarification Act of 2018’’. 
SEC. 3232. REGULATIONS RELATING TO A SPECIAL REGISTRA-
TION FOR TELEMEDICINE. 
Section 311(h)(2) of the Controlled Substances Act (21 
U.S.C. 831(h)(2)) is amended to read as follows: 
‘‘(2) REGULATIONS.—Not later than 1 year after 
the date of enactment of the SUPPORT for Patients 
and Communities Act, in consultation with the Sec-
retary, the Attorney General shall promulgate final regu-
lations specifying— 
‘‘(A) the limited circumstances in which a spe-
cial registration under this subsection may be 
issued; and 
‘‘(B) the procedure for obtaining a special reg-
istration under this subsection.’’. 
CHAPTER 5—SYNTHETIC ABUSE AND 
LABELING OF TOXIC SUBSTANCES 
SEC. 3241. CONTROLLED SUBSTANCE ANALOGUES. 
Section 203 of the Controlled Substances Act (21 U.S.C. 
813) is amended—
137 
•HRES 1099 EH 
(1) by striking ‘‘A controlled’’ and inserting ‘‘(a) IN 
GENERAL.—A controlled’’; and 
(2) by adding at the end the following: 
‘‘(b) DETERMINATION.—In determining whether a con-
trolled substance analogue was intended for human consump-
tion under subsection (a), the following factors may be con-
sidered, along with any other relevant factors: 
‘‘(1) The marketing, advertising, and labeling of the 
substance. 
‘‘(2) The known efficacy or usefulness of the sub-
stance for the marketed, advertised, or labeled purpose. 
‘‘(3) The difference between the price at which the 
substance is sold and the price at which the substance 
it is purported to be or advertised as is normally sold. 
‘‘(4) The diversion of the substance from legitimate 
channels and the clandestine importation, manufacture, 
or distribution of the substance. 
‘‘(5) Whether the defendant knew or should have 
known the substance was intended to be consumed by in-
jection, inhalation, ingestion, or any other immediate 
means. 
‘‘(6) Any controlled substance analogue that is 
manufactured, formulated, sold, distributed, or marketed 
with the intent to avoid the provisions of existing drug 
laws.
138 
•HRES 1099 EH 
‘‘(c) LIMITATION.—For purposes of this section, evi-
dence that a substance was not marketed, advertised, or la-
beled for human consumption, by itself, shall not be sufficient 
to establish that the substance was not intended for human 
consumption.’’. 
CHAPTER 6—ACCESS TO INCREASED DRUG 
DISPOSAL 
SEC. 3251. SHORT TITLE. 
This chapter may be cited as the ‘‘Access to Increased 
Drug Disposal Act of 2018’’. 
SEC. 3252. DEFINITIONS. 
In this chapter— 
(1) the term ‘‘Attorney General’’ means the Attor-
ney General, acting through the Assistant Attorney Gen-
eral for the Office of Justice Programs; 
(2) the term ‘‘authorized collector’’ means a nar-
cotic treatment program, a hospital or clinic with an on- 
site pharmacy, a retail pharmacy, or a reverse dis-
tributor, that is authorized as a collector under section 
1317.40 of title 21, Code of Federal Regulations (or any 
successor regulation); 
(3) the term ‘‘covered grant’’ means a grant award-
ed under section 3003; and 
(4) the term ‘‘eligible collector’’ means a person 
who is eligible to be an authorized collector.
139 
•HRES 1099 EH 
SEC. 3253. AUTHORITY TO MAKE GRANTS. 
The Attorney General shall award grants to States to 
enable the States to increase the participation of eligible col-
lectors as authorized collectors. 
SEC. 3254. APPLICATION. 
A State desiring a covered grant shall submit to the At-
torney General an application that, at a minimum— 
(1) identifies the single State agency that oversees 
pharmaceutical care and will be responsible for com-
plying with the requirements of the grant; 
(2) details a plan to increase participation rates of 
eligible collectors as authorized collectors; and 
(3) describes how the State will select eligible collec-
tors to be served under the grant. 
SEC. 3255. USE OF GRANT FUNDS. 
A State that receives a covered grant, and any sub-
recipient of the grant, may use the grant amounts only for 
the costs of installation, maintenance, training, purchasing, 
and disposal of controlled substances associated with the par-
ticipation of eligible collectors as authorized collectors. 
SEC. 3256. ELIGIBILITY FOR GRANT. 
The Attorney General shall award a covered grant to 5 
States, not less than 3 of which shall be States in the lowest 
quartile of States based on the participation rate of eligible 
collectors as authorized collectors, as determined by the At-
torney General.
140 
•HRES 1099 EH 
SEC. 3257. DURATION OF GRANTS. 
The Attorney General shall determine the period of 
years for which a covered grant is made to a State. 
SEC. 3258. ACCOUNTABILITY AND OVERSIGHT. 
A State that receives a covered grant shall submit to the 
Attorney General a report, at such time and in such manner 
as the Attorney General may reasonably require, that— 
(1) lists the ultimate recipients of the grant 
amounts; 
(2) describes the activities undertaken by the State 
using the grant amounts; and 
(3) contains performance measures relating to the 
effectiveness of the grant, including changes in the par-
ticipation rate of eligible collectors as authorized collec-
tors. 
SEC. 3259. DURATION OF PROGRAM. 
The Attorney General may award covered grants for 
each of the first 5 fiscal years beginning after the date of en-
actment of this Act. 
SEC. 3260. AUTHORIZATION OF APPROPRIATIONS. 
There is authorized to be appropriated to the Attorney 
General such sums as may be necessary to carry out this 
chapter.
141 
•HRES 1099 EH 
CHAPTER 7—USING DATA TO PREVENT 
OPIOID DIVERSION 
SEC. 3271. SHORT TITLE. 
This chapter may be cited as the ‘‘Using Data To Pre-
vent Opioid Diversion Act of 2018’’. 
SEC. 3272. PURPOSE. 
(a) IN GENERAL.—The purpose of this chapter is to pro-
vide drug manufacturers and distributors with access to 
anonymized information through the Automated Reports and 
Consolidated Orders System to help drug manufacturers and 
distributors identify, report, and stop suspicious orders of 
opioids and reduce diversion rates. 
(b) RULE OF CONSTRUCTION.—Nothing in this chapter 
should be construed to absolve a drug manufacturer, drug 
distributor, or other Drug Enforcement Administration reg-
istrant from the responsibility of the manufacturer, dis-
tributor, or other registrant to— 
(1) identify, stop, and report suspicious orders; or 
(2) maintain effective controls against diversion in 
accordance with section 303 of the Controlled Sub-
stances Act (21 U.S.C. 823) or any successor law or as-
sociated regulation.
142 
•HRES 1099 EH 
SEC. 3273. AMENDMENTS. 
(a) RECORDS AND REPORTS OF REGISTRANTS.—Section 
307 of the Controlled Substances Act (21 U.S.C. 827) is 
amended— 
(1) by redesignating subsections (f), (g), and (h) as 
subsections (g), (h), and (i), respectively; 
(2) by inserting after subsection (e) the following: 
‘‘(f)(1) The Attorney General shall, not less frequently 
than quarterly, make the following information available to 
manufacturer and distributor registrants through the Auto-
mated Reports and Consolidated Orders System, or any sub-
sequent automated system developed by the Drug Enforce-
ment Administration to monitor selected controlled sub-
stances: 
‘‘(A) The total number of distributor registrants 
that distribute controlled substances to a pharmacy or 
practitioner registrant, aggregated by the name and ad-
dress of each pharmacy and practitioner registrant. 
‘‘(B) The total quantity and type of opioids distrib-
uted, listed by Administration Controlled Substances 
Code Number, to each pharmacy and practitioner reg-
istrant described in subparagraph (A). 
‘‘(2) The information required to be made available 
under paragraph (1) shall be made available not later than 
the 30th day of the first month following the quarter to 
which the information relates.
438 
•HRES 1099 EH 
establish a program to support individuals in substance use 
disorder treatment and recovery to live independently and 
participate in the workforce. 
(b) GRANTS AUTHORIZED.—In carrying out the activi-
ties under this section, the Secretary shall, on a competitive 
basis, award grants for a period of not more than 5 years to 
entities to enable such entities to carry out evidence-based 
programs to help individuals in substance use disorder treat-
ment and recovery to live independently and participate in 
the workforce. Such entities shall coordinate, as applicable, 
with Indian tribes or tribal organizations (as applicable), 
State boards and local boards (as defined in section 3 of the 
Workforce Innovation and Opportunity Act (29 U.S.C. 3102), 
lead State agencies with responsibility for a workforce invest-
ment activity (as defined in such section 3), and State agen-
cies responsible for carrying out substance use disorder pre-
vention and treatment programs. 
(c) PRIORITY.— 
(1) IN GENERAL.—In awarding grants under this 
section, the Secretary shall give priority based on the 
State in which the entity is located. Priority shall be 
given among States according to a formula based on the 
rates described in paragraph (2) and weighted as de-
scribed in paragraph (3).