129 
‘‘(E) other subjects related to substance 
use disorder in the workplace as the Secretary 
determines. 
‘‘(2) DIRECT SERVICE PROVIDERS.—The Sec-
retary shall conduct (directly or through grants or 
contracts) research, experiments, and demonstra-
tions, and publish studies relating to the occupa-
tional health and safety, recruitment, and retention 
of behavioral health providers who, as part of their 
job responsibilities, provide direct services to individ-
uals who are at risk of experiencing substance use 
disorder or who are experiencing or recovering from 
substance use disorder, including— 
‘‘(A) identifying factors that the Secretary 
believes may endanger the health or safety of 
such workers, including factors that affect the 
risks such workers face of developing substance 
use disorder; 
‘‘(B) motivational and behavioral factors 
relating to the field of behavioral health pro-
viders; 
‘‘(C) strategies to support the recruitment 
and retention of behavioral health providers; 
and 
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‘‘(D) other subjects related to behavioral 
health providers engaged in direct provision of 
substance use disorder prevention and treat-
ment services as the Secretary determines ap-
propriate. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this subsection— 
‘‘(A) $10,000,000 for fiscal year 2022; 
‘‘(B) $10,000,000 for fiscal year 2023; 
‘‘(C) $10,000,000 for fiscal year 2024; 
‘‘(D) $10,000,000 for fiscal year 2025; 
‘‘(E) $10,000,000 for fiscal year 2026; 
‘‘(F) $10,000,000 for fiscal year 2027; 
‘‘(G) $10,000,000 for fiscal year 2028; 
‘‘(H) $10,000,000 for fiscal year 2029; 
‘‘(I) $10,000,000 for fiscal year 2030; and 
‘‘(J) $10,000,000 for fiscal year 2031. 
‘‘SEC. 3435. IMPROVING AND EXPANDING CARE. 
‘‘(a) LEVEL OF CARE STANDARDS FOR SUBSTANCE 
USE DISORDER TREATMENT SERVICES.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this title, the Secretary, in 
consultation with the American Society of Addiction 
Medicine, State and tribal officials selected by the 
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Secretary, and other stakeholders as the Secretary 
determines necessary, and after seeking public input, 
shall promulgate model standards for the regulation 
of substance use disorder treatment services. 
‘‘(2) SUBSTANCE USE DISORDER TREATMENT 
SERVICES.—The 
model 
standards 
promulgated 
under paragraph (1) shall, at a minimum— 
‘‘(A) identify the types of substance use 
disorder treatment services intended to be cov-
ered without regard to whether they participate 
in any Federal health care program (as defined 
in section 1128B(f) of the Social Security Act) 
and shall not include— 
‘‘(i) a private practitioner who is al-
ready licensed by a State licensing board 
and whose practice is limited to non-inten-
sive outpatient care; or 
‘‘(ii) any substance use disorder treat-
ment service provided on a non-intensive 
outpatient basis in the office of a private 
practitioner who is licensed by a State li-
censing board; 
‘‘(B) require the designation of a single 
State agency to serve as the primary regulator 
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in the State for substance use disorder treat-
ment services; 
‘‘(C) subject to paragraph (3), require that 
substance use disorder treatment services iden-
tified in accordance with subparagraph (A), be 
licensed by the respective States according to 
the standards for levels of care set forth by the 
American Society of Addiction Medicine in 
2013 or an equivalent set of standards; 
‘‘(D) require implementation of a process 
to ensure that substance use disorder treatment 
program qualifications are verified by means of 
an onsite inspection not less frequently than 
every 3 years by the State agency serving as 
the primary regulator in the State for substance 
use disorder treatment services or by an inde-
pendent third party that is approved by the 
State’s primary regulator; and 
‘‘(E) require that all patients leaving a res-
idential treatment program receive a written 
transition plan prior to discharge from that 
level of care. 
‘‘(3) ANNUAL
ASSESSMENT.—Beginning with 
respect to fiscal year 2022, the Secretary shall make 
a determination with respect to each State on 
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whether the State has adopted, for each of the sub-
stance use disorder treatment services identified in 
accordance with paragraph (2)(A), licensure stand-
ards that are in compliance in all material respects 
with the model standards promulgated in accordance 
with this subsection. In the event the American Soci-
ety of Addiction Medicine revises its criteria, the 
Secretary shall revise the national model level of 
care standards accordingly and disseminate any such 
update to the States, and the States may adopt any 
such updates to be in compliance with this sub-
section. 
‘‘(b) STANDARDS FOR OTHER SPECIFIED MATTERS 
RELATED TO SUBSTANCE USE DISORDER TREATMENT 
SERVICES AND RECOVERY RESIDENCES.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of this title, the Sec-
retary, in consultation with representatives of non-
profit service providers and State and tribal officials 
as the Secretary determines necessary, shall promul-
gate model standards for the regulation of— 
‘‘(A) other specified matters related to sub-
stance use disorder treatment services; and 
‘‘(B) recovery residences. 
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‘‘(2) OTHER SPECIFIED MATTERS RELATED TO 
SUBSTANCE
USE
DISORDER
TREATMENT
SERV-
ICES.—The model standards promulgated under 
paragraph (1)(A) shall, at a minimum— 
‘‘(A) identify the professional credentials 
needed by each type of substance use disorder 
treatment professional; 
‘‘(B) include standards for data reporting 
and require compilation of statewide reports; 
‘‘(C) require the establishment and mainte-
nance within each State of a toll-free telephone 
number to receive complaints from the public 
regarding substance use disorder treatment 
service providers; and 
‘‘(D) require the establishment and main-
tenance on a publicly accessible internet website 
of a list of all substance use disorder treatment 
services in the State that have a certification in 
effect in accordance with this section. 
‘‘(3) RECOVERY RESIDENCES.— 
‘‘(A) 
ECONOMIC
RELATIONSHIP.—The 
model standards promulgated under paragraph 
(1)(B) shall, at a minimum, be applied to recov-
ery residences that have an ongoing economic 
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relationship with any commercial substance use 
disorder treatment service. 
‘‘(B) 
MINIMUM
REQUIREMENTS.—The 
model standards promulgated under paragraph 
(1)(B), which may include any model laws de-
veloped under section 550(a) shall, at a min-
imum, identify requirements for— 
‘‘(i) the designation of a single State 
agency to certify recovery residences; 
‘‘(ii) the implementation of a process 
to ensure that the qualifications of recov-
ery residences in which not fewer than 10 
individuals may lawfully reside are verified 
by means of an onsite inspection not less 
frequently than every 3 years by the State 
agency serving as the primary regulator in 
the State or by an independent third party 
that is approved by the State’s primary 
regulator; 
‘‘(iii) fire, safety, and health stand-
ards; 
‘‘(iv) equipping residences with opioid 
overdose reversal drug products, such as 
naloxone and training residence owners, 
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operators, and employees in the adminis-
tration of naloxone; 
‘‘(v) recovery residence owners and 
operators; 
‘‘(vi) a written policy that prohibits 
the exclusion of individuals on the basis 
that such individuals receive drugs ap-
proved by the Food and Drug Administra-
tion for the treatment of substance use dis-
order; 
‘‘(vii) the establishment and mainte-
nance within each State of a toll-free tele-
phone number to receive complaints from 
the public regarding recovery residences; 
and 
‘‘(viii) the establishment and mainte-
nance on a publicly accessible internet 
website of a list of all recovery residences 
in the State that have a certification in ef-
fect in accordance with this section. 
‘‘(4) ANNUAL
ASSESSMENT.—Beginning with 
respect to fiscal year 2023, the Secretary shall make 
a determination with respect to each State on 
whether the State has adopted, for each of the other 
specified substance use disorder treatment services 
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identified in this section and for recovery residences, 
standards that are in compliance in all material re-
spects with the model standards promulgated in ac-
cordance with this subsection. 
‘‘(c) ENSURING ACCESS TO MEDICATION FOR ADDIC-
TION TREATMENT.— 
‘‘(1) MEDICATION
FOR
ADDICTION
TREAT-
MENT.—The Secretary may not make a grant under 
this section unless the applicant for the grant agrees 
to require all entities offering substance use disorder 
treatment services under the grant to offer all drugs 
approved by the Food and Drug Administration for 
the treatment of substance use disorder for which 
the applicant offers treatment. 
‘‘(2) WAIVER.—The Secretary may grant a 
waiver with respect to any requirement of this sec-
tion if the grant applicant involved— 
‘‘(A) submits to the Secretary a justifica-
tion for such waiver containing such informa-
tion as the Secretary shall require; and 
‘‘(B) agrees to require all entities offering 
substance use disorder treatment services under 
the grant to— 
‘‘(i) offer, on site, at least 2 drugs ap-
proved by the Food and Drug Administra-
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tion for the treatment of substance use dis-
order; 
‘‘(ii) provide counseling to patients on 
the benefits and risks of all drugs ap-
proved by the Food and Drug Administra-
tion for the treatment of substance use dis-
order; and 
‘‘(iii) maintain an affiliation agree-
ment with a provider that can prescribe or 
otherwise dispense all other forms of drugs 
approved by the Food and Drug Adminis-
tration for the treatment of substance use 
disorder. 
‘‘(3) GAO STUDY.—Not later than 1 year after 
the date of enactment of this title, the Comptroller 
General of the United States shall submit to Con-
gress a comprehensive report describing any rela-
tionship between substance use rates, pain manage-
ment practices of the Indian Health Service, and pa-
tient request denials through the purchased/referred 
care program of the Indian Health Service. 
‘‘(d) ENSURING
A FULL CONTINUUM
OF SERV-
ICES.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of the enactment of this title, the Ad-
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ministrator of the Centers for Medicare & Medicaid 
Services shall issue a State Medicaid Director letter 
and tribal leader letter explaining how States and 
tribes can ensure access to a continuum of services 
for adults with substance use disorders who are re-
ceiving medical assistance under title XIX of the So-
cial Security Act. Such letter shall describe how 
States can cover the continuum of community-based, 
residential, and inpatient substance use disorder 
services and care coordination between different lev-
els of care as medical assistance, as defined in sec-
tion 1905(a) of such Act, including through section 
1915 of such Act and through demonstration 
projects under section 1115 of such Act. 
‘‘(2) MACPAC ANALYSIS.—Not later than 1 
year after the date of the enactment of this title, the 
Medicaid and CHIP Payment and Access Commis-
sion shall conduct an analysis, and make publicly 
available a report containing the results of such 
analysis, of States’ coverage of substance use serv-
ices for Medicaid beneficiaries. Such report shall in-
clude examples of promising strategies States use to 
cover a continuum of community-based substance 
use services. 
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‘‘(3) ANNUAL
ASSESSMENT.—Beginning with 
respect to fiscal year 2022, the Secretary shall make 
a determination with respect to each State on 
whether the State has carried out the requirements 
to ensure a continuum of services as described in 
section 1915(l)(4)(C) of the Social Security Act. 
‘‘SEC. 3436. NALOXONE DISTRIBUTION PROGRAM. 
‘‘(a) ESTABLISHMENT OF PROGRAM.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
for the purchase and delivery of federally approved 
opioid overdose reversal drug products on behalf of 
each State (or Indian tribe as defined in section 4 
of the Indian Health Care Improvement Act) that 
receives a grant under subtitle B. This paragraph 
constitutes budget authority in advance of appro-
priations Acts, and represents the obligation of the 
Federal Government to provide for the purchase and 
delivery to States and Indian tribes of the opioid 
overdose reversal drug products in accordance with 
this paragraph. 
‘‘(2) SPECIAL RULES WHERE OPIOID OVERDOSE 
REVERSAL DRUG PRODUCTS ARE UNAVAILABLE.—To 
the extent that a sufficient quantity of opioid over-
dose reversal drug products are not available for 
purchase or delivery under paragraph (1), the Sec-
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under this subsection and may modify or extend 
such contracts. 
‘‘(3) CONTRACT PRICE.— 
‘‘(A) IN GENERAL.—The Secretary, in ne-
gotiating the prices at which opioid overdose re-
versal drug products will be purchased and de-
livered from a manufacturer under this sub-
section, shall take into account quantities of 
opioid overdose reversal drug products to be 
purchased by States under the option under 
paragraph (4)(B). 
‘‘(B) NEGOTIATION OF DISCOUNTED PRICE 
FOR OPIOID OVERDOSE REVERSAL DRUG PROD-
UCTS.—With respect to contracts entered into 
for the purchase of opioid overdose reversal 
drug products on behalf of States under this 
subsection, the price for the purchase of such 
drug product shall be a discounted price nego-
tiated by the Secretary. 
‘‘(4) PRODUCT
DOSAGE.—All opioid overdose 
reversal products purchased under this section shall 
contain— 
‘‘(A) for each dose, the maximum amount 
of active pharmaceutical ingredient that acts as 
an opioid receptor antagonist as recommended 
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by the Food and Drug Administration as an 
initial dose when administered by one of the ap-
proved, labeled routes of administration in 
adults; and 
‘‘(B) a minimum of two doses packaged to-
gether. 
‘‘(5) QUANTITIES AND TERMS OF DELIVERY.— 
Under contracts under this subsection— 
‘‘(A) the Secretary shall provide, consistent 
with paragraph (6), for the purchase and deliv-
ery on behalf of States and Indian tribes of 
quantities of opioid overdose reversal drug 
products; and 
‘‘(B) each State and Indian tribe, at the 
option of the State or tribe, shall be permitted 
to obtain additional quantities of opioid over-
dose reversal drug products (subject to amounts 
specified to the Secretary by the State or tribe 
in advance of negotiations) through purchasing 
the opioid overdose reversal drug products from 
the manufacturers at the applicable price nego-
tiated by the Secretary consistent with para-
graph (3), if the State or tribe provides to the 
Secretary such information (at a time and man-
ner specified by the Secretary, including in ad-
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vance of negotiations under paragraph (1)) as 
the Secretary determines to be necessary, to 
provide for quantities of opioid overdose rever-
sal drug products for the State or tribe to pur-
chase pursuant to this subsection and to deter-
mine annually the percentage of the opioid over-
dose reversal drug market that is purchased 
pursuant to this section and this subparagraph. 
The Secretary shall enter into the initial negotia-
tions not later than 180 days after the date of the 
enactment of this title. 
‘‘(6) CHARGES
FOR
SHIPPING
AND
HAN-
DLING.—The Secretary may enter into a contract 
referred to in paragraph (1) only if the manufac-
turer involved agrees to submit to the Secretary 
such reports as the Secretary determines to be ap-
propriate to assure compliance with the contract and 
if, with respect to a State program under this sec-
tion that does not provide for the direct delivery of 
qualified opioid overdose reversal drug products, the 
manufacturer involved agrees that the manufacturer 
will provide for the delivery of the opioid overdose 
reversal drug products on behalf of the State in ac-
cordance with such program and will not impose any 
charges for the costs of such delivery (except to the 
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extent such costs are provided for in the price estab-
lished under paragraph (3)). 
‘‘(7) MULTIPLE SUPPLIERS.—In the case of the 
opioid overdose reversal drug product involved, the 
Secretary may, as appropriate, enter into a contract 
referred to in paragraph (1) with each manufacturer 
of the opioid overdose reversal drug product that 
meets the terms and conditions of the Secretary for 
an award of such a contract (including terms and 
conditions regarding safety and quality). With re-
spect to multiple contracts entered into pursuant to 
this paragraph, the Secretary may have in effect dif-
ferent prices under each of such contracts and, with 
respect to a purchase by States pursuant to para-
graph (4)(B), each eligible State may choose which 
of such contracts will be applicable to the purchase. 
‘‘(c) USE OF OPIOID OVERDOSE REVERSAL DRUG 
PRODUCT LIST.—Beginning not later than one year after 
the first contract has been entered into under this section, 
the Secretary shall use, for the purpose of the purchase, 
delivery, and administration of opioid overdose reversal 
drug products under this section, the list established (and 
periodically reviewed and, as appropriate, revised) by an 
advisory committee, established by the Secretary and lo-
cated within the Centers for Disease Control and Preven-
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tion, which considers the cost effectiveness of each opioid 
overdose reversal drug product. 
‘‘(d) STATE DISTRIBUTION OF OPIOID OVERDOSE 
REVERSAL DRUG PRODUCTS.—States shall distribute 
opioid overdose reversal drug products received under this 
section to the following: 
‘‘(1) First responders and local emergency med-
ical services organizations, including volunteer emer-
gency medical services organizations. 
‘‘(2) Public entities with authority to administer 
local public health services, including all local health 
departments, for the purposes of making opioid over-
dose reversal drug products available to— 
‘‘(A) nonprofit entities, including— 
‘‘(i) community-based organizations 
that provide substance use disorder treat-
ments or harm reduction services; 
‘‘(ii) nonprofit entities that provide 
substance use disorder treatments or harm 
reduction services; and 
‘‘(iii) faith based organizations that 
provide substance use disorder treatments 
or harm reduction services; 
‘‘(B) other areas of high need; and 
‘‘(C) the general public. 
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‘‘(e) STATE REQUIREMENTS.—To be eligible to re-
ceive opioid overdose reversal drugs under this section, 
each State shall— 
‘‘(1) establish a program for distributing opioid 
overdose reversal drug products to first responders, 
the general public, and entities with authority to ad-
minister local public health services, including local 
health departments; 
‘‘(2) beginning in the second year of the pro-
gram, demonstrate a distribution rate of a minimum 
of 90 percent of the opioid overdose reversal drug 
products received under this program; 
‘‘(3) certify to the Secretary that the State has 
in place a Good Samaritan Law that ensures immu-
nity from arrest and prosecution, including from pa-
role and probation violations, except that the State 
may apply to the Secretary for a waiver of the re-
quirement of this paragraph, and such waiver if 
granted shall not be longer than 3 years in duration 
and may not be renewed unless the State can show 
progress being made towards instituting a Good Sa-
maritan Law; and 
‘‘(4) certify to the Secretary that the State has 
in place additional measures that enhance access to 
opioid overdose reversal drug products, such as laws 
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that provide civil or disciplinary immunity for med-
ical personnel who prescribe an opioid overdose re-
versal drug product, Third Party Prescription Laws, 
Collaborative Practice Agreements, and Standing 
Orders. 
‘‘(f) INDIAN TRIBE REQUIREMENTS.—The Indian 
Health Service, in consultation with Indian tribes, shall 
determine any requirements that shall apply to Indian 
tribes receiving opioid overdose reversal drug products 
made available under this section. 
‘‘(g) DEFINITIONS.—For purposes of this section: 
‘‘(1) COLLABORATIVE PRACTICE AGREEMENT.— 
The term ‘Collaborative Practice Agreement’ means 
an agreement under which a pharmacist operates 
under authority delegated by another licensed practi-
tioner with prescribing authority. 
‘‘(2) EMERGENCY
MEDICAL
SERVICE.—The 
term ‘emergency medical service’ means resources 
used by a public or private licensed entity to deliver 
medical care outside of a medical facility under 
emergency conditions that occur as a result of the 
condition of the patient and includes services deliv-
ered (either on a compensated or volunteer basis) by 
an emergency medical services provider or other pro-
vider that is licensed or certified by the State in-
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volved as an emergency medical technician, a para-
medic, or an equivalent professional (as determined 
by the State). 
‘‘(3) GOOD SAMARITAN LAW.—The term ‘Good 
Samaritan Law’ means a law that provides criminal 
immunity for a person who administers an opioid 
overdose reversal drug product, a person who, in 
good faith, seeks medical assistance for someone ex-
periencing a drug-related overdose, or a person who 
experiences a drug-related overdose and is in need of 
medical assistance and, in good faith, seeks such 
medical assistance, or is the subject of such a good 
faith request for medical assistance. 
‘‘(4) INDIANS.—The terms ‘Indian’, ‘Indian 
tribe’, ‘tribal organization’, and ‘urban Indian orga-
nization’ have the meanings given such terms in sec-
tion 4 of the Indian Health Care Improvement Act. 
‘‘(5) MANUFACTURER.—The term ‘manufac-
turer’ means any corporation, organization, or insti-
tution, whether public or private (including Federal, 
State, and local departments, agencies, and instru-
mentalities), which manufactures, imports, proc-
esses, or distributes under its label any opioid over-
dose reversal drug product. The term ‘manufacture’ 
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means to manufacture, import, process, or distribute 
an opioid overdose reversal drug. 
‘‘(6) OPIOID OVERDOSE REVERSAL DRUG PROD-
UCT.—The term ‘opioid overdose reversal drug prod-
uct’ means a finished dosage form that has been ap-
proved by the Food and Drug Administration and 
that contains an active pharmaceutical ingredient 
that acts as an opioid receptor antagonist. The term 
‘opioid overdose reversal drug product’ includes a 
combination product, as defined in section 3.2(e) of 
title 21, Code of Federal Regulations. 
‘‘(7) STANDING
ORDER.—The term ‘standing 
order’ means a non-patient-specific order covering 
administration of medication by others to a patient 
who may be unknown to the prescriber at the time 
of the order. 
‘‘(8) THIRD PARTY PRESCRIPTION.—The term 
‘third party prescription’ means an order written for 
medication dispensed to one person with the inten-
tion that it will be administered to another person. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this suc-
tion— 
‘‘(1) $1,000,000,000 for fiscal year 2022; 
‘‘(2) $1,000,000,000 for fiscal year 2023; 
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‘‘(3) $1,000,000,000 for fiscal year 2024; 
‘‘(4) $1,000,000,000 for fiscal year 2025; 
‘‘(5) $1,000,000,000 for fiscal year 2026; 
‘‘(6) $1,000,000,000 for fiscal year 2027; 
‘‘(7) $1,000,000,000 for fiscal year 2028; 
‘‘(8) $1,000,000,000 for fiscal year 2029; 
‘‘(9) $1,000,000,000 for fiscal year 2030; and 
‘‘(10) $1,000,000,000 for fiscal year 2031. 
‘‘SEC. 3437. ADDITIONAL FUNDING FOR THE NATIONAL IN-
STITUTES OF HEALTH. 
‘‘There is authorized to be appropriated to the Na-
tional Institutes of Health for the purpose of conducting 
research on addiction and pain, including research to de-
velop overdose reversal drug products, non-opioid drug 
products and non-pharmacological treatments for address-
ing pain and substance use disorder, and drug products 
used to treat substance use disorder— 
‘‘(1) $1,000,000,000 for fiscal year 2022; 
‘‘(2) $1,000,000,000 for fiscal year 2023; 
‘‘(3) $1,000,000,000 for fiscal year 2024; 
‘‘(4) $1,000,000,000 for fiscal year 2025; 
‘‘(5) $1,000,000,000 for fiscal year 2026; 
‘‘(6) $1,000,000,000 for fiscal year 2027; 
‘‘(7) $1,000,000,000 for fiscal year 2028; 
‘‘(8) $1,000,000,000 for fiscal year 2029; 
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‘‘(9) $1,000,000,000 for fiscal year 2030; and 
‘‘(10) $1,000,000,000 for fiscal year 2031. 
‘‘SEC. 3438. ADDITIONAL FUNDING FOR THE CENTERS FOR 
DISEASE CONTROL AND PREVENTION. 
‘‘(a) IMPROVED DATA COLLECTION AND PREVEN-
TION OF INFECTIOUS DISEASE TRANSMISSION.— 
‘‘(1) DATA COLLECTION.—The Centers for Dis-
ease Control and Prevention shall use a portion of 
the funding appropriated under this section to en-
sure that all States participate in the Enhanced 
State Opioid Overdose Surveillance program and to 
provide technical assistance to medical examiners 
and coroners to facilitate improved data collection on 
fatal overdoses through such program. 
‘‘(2) CENTERS
FOR
DISEASE
CONTROL
AND 
PREVENTION.—The Centers for Disease Control and 
Prevention shall use amounts appropriated under 
this section for the purpose of improving data on 
drug overdose deaths and non-fatal drug overdoses, 
surveillance related to addiction and substance use 
disorder, and the prevention of transmission of infec-
tious diseases related to substance use. 
‘‘(3) TRIBAL DATA.—Not later than 6 months 
after the date of enactment of this title, the Director 
of the Centers for Disease Control and Prevention 
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shall consult with Indian tribes and confer with 
urban Indian organizations to develop and imple-
ment strategies that improve surveillance and re-
porting of fatal overdose deaths among American In-
dians and Alaska Natives, including strategies that 
reduce the underestimation of fatal overdose deaths 
among American Indians and Alaska Natives due to 
undersampling or racial misclassification in State 
and Federal public health surveillance systems. 
‘‘(b) CHILDHOOD TRAUMA.—The Centers for Disease 
Control and Prevention shall use a portion of the funding 
appropriated under this section to fund the surveillance 
and data collection activities described in section 7131 of 
the SUPPORT for Patients and Communities Act, includ-
ing to encourage all States to participate in collecting and 
reporting data on adverse childhood experiences through 
the Behavioral Risk Factor Surveillance System, the 
Youth Risk Behavior Surveillance System, and other rel-
evant public health surveys or questionnaires. 
‘‘(c) WORKER HEALTH RISKS.—The Centers for Dis-
ease Control and Prevention shall use a portion of the 
funding appropriated under this section for data collection 
and surveillance activities on substance use, substance use 
disorders, drug overdose deaths, and non-fatal drug 
overdoses among workers, and the factors and practices 
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154 
that contribute to such use, disorders, and overdoses, in-
cluding occupational injuries and illness as well as occupa-
tional exposure to opioids and other illicit and licit drugs. 
‘‘(d) TRIBAL EPIDEMIOLOGY CENTERS.—There shall 
be made available to the Indian Health Service for the 
purpose of funding efforts by Indian tribes and tribal epi-
demiology centers to improve data on drug overdose 
deaths and non-fatal drug overdoses, surveillance related 
to addiction and substance use disorder, and prevention 
of childhood trauma, not less than 1.5 percent of the total 
amount appropriated under this section for each fiscal 
year. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section— 
‘‘(1) $500,000,000 for fiscal year 2022; 
‘‘(2) $500,000,000 for fiscal year 2023; 
‘‘(3) $500,000,000 for fiscal year 2024; 
‘‘(4) $500,000,000 for fiscal year 2025; 
‘‘(5) $500,000,000 for fiscal year 2026; 
‘‘(6) $500,000,000 for fiscal year 2027; 
‘‘(7) $500,000,000 for fiscal year 2028; 
‘‘(8) $500,000,000 for fiscal year 2029; 
‘‘(9) $500,000,000 for fiscal year 2030; and 
‘‘(10) $500,000,000 for fiscal year 2031. 
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‘‘SEC. 3439. DEFINITIONS. 
‘‘In this title: 
‘‘(1) PLANNING COUNCIL.—The term ‘planning 
council’ means the substance use planning council 
established under section 3402. 
‘‘(2) RECOVERY RESIDENCE.—The term ‘recov-
ery residence’ means a residential dwelling unit, or 
other form of group housing, that is offered or ad-
vertised through any means, including oral, written, 
electronic, or printed means, by any individual or en-
tity as a residence that provides an evidence-based, 
peer-supported living environment for individuals un-
dergoing any type of substance use disorder treat-
ment or who have received any type of substance use 
disorder treatment in the past 3 years, including 
medication for addiction treatment. 
‘‘(3) STATE.— 
‘‘(A) IN
GENERAL.—The term ‘State’ 
means each of the 50 States, the District of Co-
lumbia, and each of the territories. 
‘‘(B) TERRITORIES.—The term ‘territory’ 
means each of American Samoa, Guam, the 
Commonwealth of Puerto Rico, the Common-
wealth of the Northern Mariana Islands, the 
Virgin Islands, the Republic of the Marshall Is-
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lands, the Federated States of Micronesia, and 
Palau. 
‘‘(4) 
SUBSTANCE
USE
DISORDER
TREAT-
MENT.— 
‘‘(A) IN GENERAL.—The term ‘substance 
use disorder treatment’ means an evidence- 
based, professionally directed, deliberate, and 
planned regimen including evaluation, observa-
tion, medical monitoring, and rehabilitative 
services 
and 
interventions 
such 
as 
pharmacotherapy, mental health services, and 
individual and group counseling, on an inpa-
tient or outpatient basis, to help patients with 
substance use disorder reach remission and 
maintain recovery. 
‘‘(B) TYPES OF TREATMENT.—Substance 
use disorder treatments shall include the fol-
lowing: 
‘‘(i) Clinical stabilization services, 
which are evidence-based services provided 
in secure, acute care facilities (which may 
be referred to as ‘addictions receiving fa-
cilities’) that, at a minimum— 
‘‘(I) provide intoxication manage-
ment and stabilization services; 
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‘‘(II) are operated 24 hours per 
day, 7 days per week; and 
‘‘(III) 
that 
serve 
individuals 
found to be substance use impaired. 
These can also be referred to as ‘Ad-
dictions receiving facilities’. 
‘‘(ii) Withdrawal management and de-
toxification, which is a medical service that 
is provided on an inpatient or an out-
patient basis to assist an individual in 
managing the process of withdrawal from 
the physiological and psychological effects 
of substance use disorder. 
‘‘(iii) All outpatient, residential, and 
inpatient services described in section 
1915(l)(4)(c) of the Social Security Act. 
‘‘(C) LIMITATION.—Substance use disorder 
treatment providers shall not include— 
‘‘(i) prevention only providers; and 
‘‘(ii) a private practitioner who is li-
censed by a State licensing board and 
whose practice is limited to non-intensive 
outpatient care. 
‘‘(5) SUBSTANCE USE DISORDER TREATMENT 
SERVICES.—The term ‘substance use disorder treat-
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ment services’ means any prevention services, core 
medical services, recovery and support services, early 
intervention services, and harm reduction services 
authorized under this title.’’. 
SEC. 4. AMENDMENTS TO THE CONTROLLED SUBSTANCES 
ACT. 
(a) CERTIFICATIONS.—Part C of the Controlled Sub-
stances Act (21 U.S.C. 821 et seq.) is amended by adding 
at the end the following: 
‘‘CERTIFICATIONS RELATING TO DIVERSION CONTROLS 
AND MISBRANDING 
‘‘SEC. 313. (a) DEFINITIONS.—In this section— 
‘‘(1) the term ‘covered dispenser’— 
‘‘(A) means a dispenser— 
‘‘(i) that is required to register under 
section 302(a)(2); and 
‘‘(ii) dispenses a controlled substance 
in schedule II; and 
‘‘(B) does not include a dispenser that is— 
‘‘(i) registered to dispense opioid 
agonist treatment medication under section 
303(g)(1); and 
‘‘(ii) operating in that capacity; 
‘‘(2) the term ‘covered distributor’ means a dis-
tributor— 
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‘‘(A) that is required to register under sec-
tion 302(a)(1); and 
‘‘(B) distributes a controlled substance in 
schedule II; 
‘‘(3) the term ‘covered manufacturer’ means a 
manufacturer— 
‘‘(A) that is required to register under sec-
tion 302(a)(1); and 
‘‘(B) manufactures a controlled substance 
in schedule II; 
‘‘(4) the term ‘covered officer’, with respect to 
a covered person means— 
‘‘(A) in the case of a covered person that 
is not an individual— 
‘‘(i) the chief executive officer of the 
covered person; 
‘‘(ii) the president of the covered per-
son; 
‘‘(iii) the chief medical officer of the 
covered person; or 
‘‘(iv) the chief counsel of the covered 
person; and 
‘‘(B) in the case of a covered person that 
is an individual, that individual; and 
‘‘(5) the term ‘covered person’ means— 
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‘‘(A) a covered dispenser; 
‘‘(B) a covered distributor; or 
‘‘(C) a covered manufacturer. 
‘‘(b) CERTIFICATIONS
RELATING
TO
DIVERSION 
CONTROLS.—Not later than 180 days after the date of 
enactment of this section, and each year thereafter, each 
covered officer of a covered person shall submit to the At-
torney General, for each controlled substance in schedule 
II dispensed, distributed, or manufactured by the covered 
person, a certification— 
‘‘(1) signed by the covered officer; and 
‘‘(2) certifying that— 
‘‘(A) the covered person maintains effective 
controls against diversion of the controlled sub-
stance into channels other than legitimate med-
ical, scientific, research, or industrial channels; 
‘‘(B) all information contained in any 
record, inventory, or report required to be kept 
or submitted to the Attorney General by the 
covered person under section 307, or under any 
regulation issued under that section, is accu-
rate; and 
‘‘(C) the covered person is in compliance 
with all applicable requirements under Federal 
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law relating to reporting suspicious orders for 
controlled substances. 
‘‘(c) 
CERTIFICATIONS
RELATING
TO
MIS-
BRANDING.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of enactment of this section, and each 
year thereafter, each covered officer of a covered 
manufacturer shall submit to the Secretary, for each 
controlled substance in schedule II manufactured by 
the covered manufacturer, a certification— 
‘‘(A) signed by the covered officer; and 
‘‘(B) certifying that the controlled sub-
stance is not misbranded, as described in sec-
tion 502 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352). 
‘‘(2) NOTIFICATION TO THE ATTORNEY GEN-
ERAL.— 
‘‘(A) 
FAILURE
TO
SUBMIT
CERTIFI-
CATIONS.—Not later than 30 days after the 
date on which a covered officer of a covered 
manufacturer is required to submit a certifi-
cation under paragraph (1) and fails to do so, 
the Secretary shall notify the Attorney General 
of the failure by the covered officer to submit 
the certification. 
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‘‘(B) FALSE
CERTIFICATIONS
RELATING 
TO
MISBRANDING.—Not later than 30 days 
after the date on which the Secretary becomes 
aware that a certification submitted under 
paragraph (1) contains a materially false state-
ment or representation relating to the mis-
branding of a controlled substance with respect 
to the year for which the certification is sub-
mitted, the Secretary shall notify the Attorney 
General that the certification contains the ma-
terially false statement or representation.’’. 
(b) OFFENSES.—Part D of title II of the Controlled 
Substances Act (21 U.S.C. 841 et seq.) is amended by 
adding at the end the following: 
‘‘CERTIFICATIONS BY COVERED OFFICERS 
‘‘SEC. 424. (a) DEFINITIONS.—In this section, the 
terms ‘covered dispenser’, ‘covered distributor’, ‘covered 
manufacturer’, ‘covered officer’, and ‘covered person’ have 
the meanings given those terms in section 313. 
‘‘(b) OFFENSES.— 
‘‘(1) FAILURE TO SUBMIT CERTIFICATIONS.— 
‘‘(A) CERTIFICATIONS
RELATING
TO
DI-
VERSION CONTROLS.—It shall be unlawful for a 
covered officer of a covered person to fail to 
submit a certification required under section 
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313(b), without regard to the state of mind of 
the covered officer. 
‘‘(B) CERTIFICATIONS RELATING TO MIS-
BRANDING.—It shall be unlawful for a covered 
officer of a covered manufacturer to fail to sub-
mit a certification required under section 
313(c)(1), without regard to the state of mind 
of the covered officer. 
‘‘(2) SUBMISSION OF FALSE CERTIFICATIONS.— 
‘‘(A) FALSE CERTIFICATIONS RELATING TO 
DIVERSION CONTROLS.—It shall be unlawful for 
a covered officer of a covered person to submit 
a certification required under section 313(b), 
without regard to the state of mind of the cov-
ered officer, that contains a materially false 
statement or representation relating to the in-
formation required to be certified under that 
section for the year for which the certification 
is submitted. 
‘‘(B) FALSE
CERTIFICATIONS
RELATING 
TO MISBRANDING.—It shall be unlawful for a 
covered officer of a covered manufacturer to 
submit a certification required under section 
313(c)(1), without regard to the state of mind 
of the covered officer, that contains a materially 
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false statement or representation relating to the 
misbranding of a controlled substance with re-
spect to the year for which the certification is 
submitted. 
‘‘(c) PENALTIES.— 
‘‘(1) CIVIL PENALTIES.—Except as provided in 
paragraph (2), a covered officer who violates sub-
section (b) shall be subject to a civil penalty of not 
more than $25,000. 
‘‘(2) CRIMINAL PENALTIES.—A covered officer 
who knowingly violates subsection (b)(2) shall be 
subject to criminal penalties under section 403(d). 
‘‘(d) 
COMPREHENSIVE
ADDICTION
RESOURCES 
FUND.— 
‘‘(1) ESTABLISHMENT.—There is established in 
the Treasury a fund to be known as the ‘Com-
prehensive Addiction Resources Fund’. 
‘‘(2) TRANSFER OF AMOUNTS.—There shall be 
transferred to the Comprehensive Addiction Re-
sources Fund 100 percent of— 
‘‘(A) any civil penalty paid to the United 
States under this section; and 
‘‘(B) any fine paid to the United States 
under section 403(d) for a knowing violation of 
subsection (b)(2) of this section. 
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