IIB 
115TH CONGRESS 
2D SESSION 
H. R. 5605 
IN THE SENATE OF THE UNITED STATES 
JUNE 20, 2018 
Received; read twice and referred to the Committee on Finance 
AN ACT 
To amend title XVIII of the Social Security Act to provide 
for an opioid use disorder treatment demonstration pro-
gram, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Advancing High Qual-
ity Treatment for Opioid Use Disorders in Medicare Act’’. 
SEC. 2. OPIOID USE DISORDER TREATMENT DEMONSTRA-
TION PROGRAM. 
Title XVIII of the Social Security Act (42 U.S.C. 
1395 et seq.) is amended by inserting after section 1866E 
(42 U.S.C. 1395cc–5) the following new section: 
‘‘SEC. 1866F. OPIOID USE DISORDER TREATMENT DEM-
ONSTRATION PROGRAM. 
‘‘(a) IMPLEMENTATION OF 4-YEAR DEMONSTRATION 
PROGRAM.— 
‘‘(1) IN GENERAL.—Not later than January 1, 
2021, the Secretary shall implement a 4-year dem-
onstration program under this title (in this section 
referred to as the ‘Program’) to increase access of 
applicable beneficiaries to opioid use disorder treat-
ment services, improve physical and mental health 
outcomes for such beneficiaries, and to the extent 
possible, reduce expenditures under this title. Under 
the Program, the Secretary shall make payments 
under subsection (e) to participants (as defined in 
subsection (c)(1)(A)) for furnishing opioid use dis-
order treatment services delivered through opioid use 
disorder care teams, or arranging for such service to 
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be furnished, to applicable beneficiaries participating 
in the Program. 
‘‘(2) OPIOID USE DISORDER TREATMENT SERV-
ICES.—For purposes of this section, the term ‘opioid 
use disorder treatment services’— 
‘‘(A) means, with respect to an applicable 
beneficiary, services that are furnished for the 
treatment of opioid use disorders and that uti-
lize drugs approved under section 505 of the 
Federal Food, Drug, and Cosmetic Act for the 
treatment of opioid use disorders in an out-
patient setting; and 
‘‘(B) includes— 
‘‘(i) medication assisted treatment; 
‘‘(ii) treatment planning; 
‘‘(iii) psychiatric, psychological, or 
counseling services (or any combination of 
such services), as appropriate; 
‘‘(iv) social support services, as appro-
priate; and 
‘‘(v) care management and care co-
ordination services, including coordination 
with other providers of services and sup-
pliers not on an opioid use disorder care 
team. 
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‘‘(b) PROGRAM DESIGN.— 
‘‘(1) IN GENERAL.—The Secretary shall design 
the Program in such a manner to allow for the eval-
uation of the extent to which the Program accom-
plishes the following purposes: 
‘‘(A) Reduces hospitalizations and emer-
gency department visits. 
‘‘(B) Increases use of medication-assisted 
treatment for opioid use disorders. 
‘‘(C) Improves health outcomes of individ-
uals with opioid use disorders, including by re-
ducing the incidence of infectious diseases (such 
as hepatitis C and HIV). 
‘‘(D) Does not increase the total spending 
on items and services under this title. 
‘‘(E) Reduces deaths from opioid overdose. 
‘‘(F) Reduces the utilization of inpatient 
residential treatment. 
‘‘(2) CONSULTATION.—In designing the Pro-
gram, including the criteria under subsection 
(e)(2)(A), the Secretary shall, not later than 3 
months after the date of the enactment of this sec-
tion, consult with specialists in the field of addiction, 
clinicians in the primary care community, and bene-
ficiary groups. 
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‘‘(c) PARTICIPANTS; OPIOID USE DISORDER CARE 
TEAMS.— 
‘‘(1) PARTICIPANTS.— 
‘‘(A) DEFINITION.—In this section, the 
term ‘participant’ means an entity or indi-
vidual— 
‘‘(i) that is otherwise enrolled under 
this title and that is— 
‘‘(I) a physician (as defined in 
section 1861(r)(1)); 
‘‘(II) a group practice comprised 
of at least one physician described in 
subclause (I); 
‘‘(III) a hospital outpatient de-
partment; 
‘‘(IV) a federally qualified health 
center 
(as 
defined 
in 
section 
1861(aa)(4)); 
‘‘(V) a rural health clinic (as de-
fined in section 1861(aa)(2)); 
‘‘(VI) a community mental health 
center 
(as 
defined 
in 
section 
1861(ff)(3)(B)); 
‘‘(VII) a clinic certified as a cer-
tified community behavioral health 
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clinic pursuant to section 223 of the 
Protecting Access to Medicare Act of 
2014; or 
‘‘(VIII) any other individual or 
entity specified by the Secretary; 
‘‘(ii) that applied for and was selected 
to participate in the Program pursuant to 
an application and selection process estab-
lished by the Secretary; and 
‘‘(iii) that establishes an opioid use 
disorder care team (as defined in para-
graph (2)) through employing or con-
tracting with health care practitioners de-
scribed in paragraph (2)(A), and uses such 
team to furnish or arrange for opioid use 
disorder treatment services in the out-
patient setting under the Program. 
‘‘(B) PREFERENCE.—In selecting partici-
pants for the Program, the Secretary shall give 
preference to individuals and entities that are 
located in areas with a prevalence of opioid use 
disorders that is higher than the national aver-
age prevalence. 
‘‘(2) OPIOID USE DISORDER CARE TEAMS.— 
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‘‘(A) IN GENERAL.—For purposes of this 
section, the term ‘opioid use disorder care team’ 
means a team of health care practitioners es-
tablished by a participant described in para-
graph (1)(A) that— 
‘‘(i) shall include— 
‘‘(I) at least one physician (as 
defined in section 1861(r)(1)) fur-
nishing primary care services or ad-
diction treatment services to an appli-
cable beneficiary; and 
‘‘(II) at least one eligible practi-
tioner 
(as 
defined 
in 
paragraph 
(3)(A)), who may be a physician who 
meets the criterion in subclause (I); 
and 
‘‘(ii) may include other practitioners 
licensed under State law to furnish psy-
chiatric, psychological, counseling, and so-
cial services to applicable beneficiaries. 
‘‘(B) REQUIREMENTS
FOR
RECEIPT
OF 
PAYMENT UNDER PROGRAM.—In order to re-
ceive payments under subsection (e), each par-
ticipant in the Program shall— 
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‘‘(i) furnish opioid use disorder treat-
ment services through opioid use disorder 
care teams to applicable beneficiaries who 
agree to receive the services; 
‘‘(ii) meet minimum criteria, as estab-
lished by the Secretary; and 
‘‘(iii) submit to the Secretary, in such 
form, manner, and frequency as specified 
by the Secretary, with respect to each ap-
plicable beneficiary for whom opioid use 
disorder treatment services are furnished 
by the opioid use disorder care team, data 
and such other information as the Sec-
retary determines appropriate to— 
‘‘(I) monitor and evaluate the 
Program; 
‘‘(II) determine if minimum cri-
teria are met under clause (ii); and 
‘‘(III) determine the incentive 
payment under subsection (e). 
‘‘(3) ELIGIBLE
PRACTITIONERS; OTHER
PRO-
VIDER-RELATED
DEFINITIONS
AND
APPLICATION 
PROVISIONS.— 
‘‘(A) ELIGIBLE PRACTITIONERS.—For pur-
poses of this section, the term ‘eligible practi-
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tioner’ means a physician or other health care 
practitioner, such as a nurse practitioner, 
that— 
‘‘(i) 
is 
enrolled 
under 
section 
1866(j)(1); 
‘‘(ii) is authorized to prescribe or dis-
pense narcotic drugs to individuals for 
maintenance treatment or detoxification 
treatment; and 
‘‘(iii) has in effect a waiver in accord-
ance with section 303(g) of the Controlled 
Substances Act for such purpose and is 
otherwise in compliance with regulations 
promulgated by the Substance Abuse and 
Mental Health Services Administration to 
carry out such section. 
‘‘(B) ADDICTION SPECIALISTS.—For pur-
poses of subsection (e)(1)(B)(iv), the term ‘ad-
diction specialist’ means a physician that pos-
sesses expert knowledge and skills in addiction 
medicine, as evidenced by appropriate certifi-
cation from a specialty body, a certificate of ad-
vanced qualification in addiction medicine, or 
completion of an accredited residency or fellow-
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ship in addiction medicine or addiction psychi-
atry, as determined by the Secretary. 
‘‘(d) 
PARTICIPATION
OF
APPLICABLE
BENE-
FICIARIES.— 
‘‘(1) APPLICABLE BENEFICIARY DEFINED.—In 
this section, the term ‘applicable beneficiary’ means 
an individual who— 
‘‘(A) is entitled to, or enrolled for, benefits 
under part A and enrolled for benefits under 
part B; 
‘‘(B) is not enrolled in a Medicare Advan-
tage plan under part C; 
‘‘(C) has a current diagnosis for an opioid 
use disorder; and 
‘‘(D) meets such other criteria as the Sec-
retary determines appropriate. 
Such term shall include an individual who is dually 
eligible for benefits under this title and title XIX if 
such individual satisfies the criteria described in 
subparagraphs (A) through (D). 
‘‘(2) VOLUNTARY PARTICIPATION; LIMITATION 
ON NUMBER OF PARTICIPANTS.—An applicable bene-
ficiary may participate in the Program on a vol-
untary basis and may terminate participation in the 
Program at any time. Not more than 20,000 appli-
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cable beneficiaries may participate in the Program 
at any time. 
‘‘(3) SERVICES.—In order to participate in the 
Program, an applicable beneficiary shall agree to re-
ceive opioid use disorder treatment services from a 
participant. Participation under the Program shall 
not affect coverage of or payment for any other item 
or service under this title for the applicable bene-
ficiary. 
‘‘(4) BENEFICIARY
ACCESS
TO
SERVICES.— 
Nothing in this section shall be construed as encour-
aging providers to limit applicable beneficiary access 
to services covered under this title and applicable 
beneficiaries shall not be required to relinquish ac-
cess to any benefit under this title as a condition of 
receiving services from a participant in the Program. 
‘‘(e) PAYMENTS.— 
‘‘(1) 
PER
APPLICABLE
BENEFICIARY
PER 
MONTH CARE MANAGEMENT FEE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish a schedule of per applicable bene-
ficiary per month care management fees. Such 
a per applicable beneficiary per month care 
management fee shall be paid to a participant 
in addition to any other amount otherwise pay-
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able under this title to the health care practi-
tioners in the participant’s opioid use disorder 
care team or, if applicable, to the participant. 
A participant may use such per applicable bene-
ficiary per month care management fee to de-
liver additional services to applicable bene-
ficiaries, including services not otherwise eligi-
ble for payment under this title. 
‘‘(B) PAYMENT
AMOUNTS.—In carrying 
out subparagraph (A), the Secretary shall— 
‘‘(i) consider payments otherwise pay-
able under this title for opioid use disorder 
treatment services and the needs of appli-
cable beneficiaries; 
‘‘(ii) pay a higher per applicable bene-
ficiary per month care management fee for 
an applicable beneficiary who receives more 
intensive treatment services from a partici-
pant and for whom those services are ap-
propriate based on clinical guidelines for 
opioid use disorder care; 
‘‘(iii) pay a higher per applicable ben-
eficiary per month care management fee 
for the month in which the applicable ben-
eficiary begins treatment with a partici-
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pant than in subsequent months, to reflect 
the greater time and costs required for the 
planning and initiation of treatment, as 
compared to maintenance of treatment; 
‘‘(iv) pay higher per applicable bene-
ficiary per month care management fees 
for participants that have established 
opioid use disorder care teams that include 
an addiction specialist (as defined in sub-
section (c)(3)(B)); and 
‘‘(v) take into account whether a par-
ticipant’s opioid use disorder care team re-
fers applicable beneficiaries to other sup-
pliers or providers for any opioid use dis-
order treatment services. 
‘‘(C) NO DUPLICATE PAYMENT.—The Sec-
retary shall make payments under this para-
graph to only one participant for services fur-
nished to an applicable beneficiary during a cal-
endar month. 
‘‘(2) INCENTIVE PAYMENTS.— 
‘‘(A) IN GENERAL.—Under the Program, 
the Secretary shall establish a performance- 
based incentive payment, which shall be paid 
(using a methodology established and at a time 
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determined appropriate by the Secretary) to 
participants based on the performance of par-
ticipants with respect to criteria, as determined 
appropriate by the Secretary, in accordance 
with subparagraph (B). 
‘‘(B) CRITERIA.— 
‘‘(i) IN GENERAL.—Criteria described 
in subparagraph (A) may include consider-
ation of the following: 
‘‘(I) Patient engagement and re-
tention in treatment. 
‘‘(II) Evidence-based medication- 
assisted treatment. 
‘‘(III) Other criteria established 
by the Secretary. 
‘‘(ii) REQUIRED CONSULTATION AND 
CONSIDERATION.—In determining criteria 
described in subparagraph (A), the Sec-
retary shall— 
‘‘(I) consult with stakeholders, 
including clinicians in the primary 
care community and in the field of ad-
diction medicine; and 
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‘‘(II) consider existing clinical 
guidelines for the treatment of opioid 
use disorders. 
‘‘(C) NO DUPLICATE PAYMENT.—The Sec-
retary shall ensure that no duplicate payments 
under this paragraph are made with respect to 
an applicable beneficiary. 
‘‘(f) MULTIPAYER STRATEGY.—In carrying out the 
Program, the Secretary shall encourage other payers to 
provide similar payments and to use similar criteria as ap-
plied under the Program under subsection (e)(2)(C). The 
Secretary may enter into a memorandum of understanding 
with other payers to align the methodology for payment 
provided by such a payer related to opioid use disorder 
treatment services with such methodology for payment 
under the Program. 
‘‘(g) EVALUATION.— 
‘‘(1) IN GENERAL.—The Secretary shall con-
duct an intermediate and final evaluation of the pro-
gram. Each such evaluation shall determine the ex-
tent to which each of the purposes described in sub-
section (b) have been accomplished under the Pro-
gram. 
‘‘(2) REPORTS.—The Secretary shall submit to 
the Secretary and Congress— 
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‘‘(A) a report with respect to the inter-
mediate evaluation under paragraph (1) not 
later than 3 years after the date of the imple-
mentation of the Program; and 
‘‘(B) a report with respect to the final 
evaluation under paragraph (1) not later than 
6 years after such date. 
‘‘(h) FUNDING.— 
‘‘(1) ADMINISTRATIVE FUNDING.—For the pur-
poses of implementing, administering, and carrying 
out the Program (other than for purposes described 
in paragraph (2)), $5 million shall be available from 
the Federal Supplementary Medical Insurance Trust 
Fund under section 1841. 
‘‘(2) CARE
MANAGEMENT
FEES
AND
INCEN-
TIVES.—For the purposes of making payments 
under subsection (e), $10 million shall be available 
from the Federal Supplementary Medical Insurance 
Trust Fund under section 1841 for each of fiscal 
years 2021 through 2024. 
‘‘(3) 
AVAILABILITY.—Amounts 
transferred 
under this subsection for a fiscal year shall be avail-
able until expended. 
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‘‘(i) WAIVERS.—The Secretary may waive any provi-
sion of this title as may be necessary to carry out the Pro-
gram under this section.’’. 
SEC. 3. REQUIRING E-PRESCRIBING FOR COVERAGE OF 
COVERED 
PART 
D 
CONTROLLED 
SUB-
STANCES. 
(a) IN GENERAL.—Section 1860D–4(e) of the Social 
Security Act (42 U.S.C. 1395w–104(e)) is amended by 
adding at the end the following: 
‘‘(7) REQUIREMENT
OF
E-PRESCRIBING
FOR 
CONTROLLED SUBSTANCES.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), a prescription for a covered part D 
drug under a prescription drug plan (or under 
an MA–PD plan) for a schedule II, III, IV, or 
V controlled substance shall be transmitted by 
a health care practitioner electronically in ac-
cordance with an electronic prescription drug 
program that meets the requirements of para-
graph (2). 
‘‘(B) 
EXCEPTION
FOR
CERTAIN
CIR-
CUMSTANCES.—The Secretary shall, pursuant 
to rulemaking, specify circumstances with re-
spect to which the Secretary may waive the re-
quirement under subparagraph (A), with re-
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spect to a covered part D drug, including in the 
case of— 
‘‘(i) a prescription issued when the 
practitioner and dispenser are the same 
entity; 
‘‘(ii) a prescription issued that cannot 
be transmitted electronically under the 
most recently implemented version of the 
National Council for Prescription Drug 
Programs SCRIPT Standard; 
‘‘(iii) a prescription issued by a practi-
tioner who has received a waiver or a re-
newal thereof for a specified period deter-
mined by the Secretary, not to exceed 1 
year, from the requirement to use elec-
tronic prescribing, pursuant to a process 
established by regulation by the Secretary, 
due to demonstrated economic hardship, 
technological limitations that are not rea-
sonably within the control of the practi-
tioner, or other exceptional circumstance 
demonstrated by the practitioner; 
‘‘(iv) a prescription issued by a practi-
tioner under circumstances in which, not-
withstanding the practitioner’s ability to 
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submit a prescription electronically as re-
quired by this subsection, such practitioner 
reasonably determines that it would be im-
practical for the individual involved to ob-
tain substances prescribed by electronic 
prescription in a timely manner, and such 
delay would adversely impact the individ-
ual’s medical condition involved; 
‘‘(v) a prescription issued by a practi-
tioner allowing for the dispensing of a non- 
patient specific prescription pursuant to a 
standing order, approved protocol for drug 
therapy, collaborative drug management, 
or comprehensive medication management, 
in response to a public health emergency, 
or other circumstances where the practi-
tioner may issue a non-patient specific pre-
scription; 
‘‘(vi) a prescription issued by a practi-
tioner prescribing a drug under a research 
protocol; 
‘‘(vii) a prescription issued by a prac-
titioner for a drug for which the Food and 
Drug Administration requires a prescrip-
tion to contain elements that are not able 
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to be included in electronic prescribing, 
such as a drug with risk evaluation and 
mitigation strategies that include elements 
to assure safe use; and 
‘‘(viii) a prescription issued by a prac-
titioner for an individual who— 
‘‘(I) receives hospice care under 
this title; or 
‘‘(II) is a resident of a skilled 
nursing facility (as defined in section 
1819(a)), or a medical institution or 
nursing facility for which payment is 
made for an institutionalized indi-
vidual under section 1902(q)(1)(B), 
for which frequently abused drugs are 
dispensed for residents through a con-
tract with a single pharmacy, as de-
termined by the Secretary in accord-
ance with this paragraph. 
‘‘(C) DISPENSING.—Nothing in this para-
graph shall be construed as requiring a sponsor 
of a prescription drug plan under this part, MA 
organization offering an MA–PD plan under 
part C, or a pharmacist to verify that a practi-
tioner, with respect to a prescription for a cov-
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ered part D drug, has a waiver (or is otherwise 
exempt) under subparagraph (B) from the re-
quirement under subparagraph (A). Nothing in 
this paragraph shall be construed as affecting 
the ability of the plan to cover or the phar-
macists’ ability to continue to dispense covered 
part D drugs from otherwise valid written, oral 
or fax prescriptions that are consistent with 
laws and regulations. Nothing in this paragraph 
shall be construed as affecting the ability of the 
beneficiary involved to designate a particular 
pharmacy to dispense a prescribed drug to the 
extent consistent with the requirements under 
subsection (b)(1) and under this paragraph. 
‘‘(D) 
ENFORCEMENT.—The 
Secretary 
shall, pursuant to rulemaking, have authority to 
enforce and specify appropriate penalties for 
non-compliance with the requirement under 
subparagraph (A).’’. 
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(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to coverage of drugs prescribed 
on or after January 1, 2021. 
Passed the House of Representatives June 19, 2018. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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