[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5605 Referred in Senate (RFS)]
<DOC>
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 program, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Advancing High Quality Treatment for
Opioid Use Disorders in Medicare Act''.
SEC. 2. OPIOID USE DISORDER TREATMENT DEMONSTRATION 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 DEMONSTRATION PROGRAM.
``(a) Implementation of 4-Year Demonstration Program.--
``(1) In general.--Not later than January 1, 2021, the
Secretary shall implement a 4-year demonstration program under
this title (in this section referred to as the `Program') to
increase access of applicable beneficiaries to opioid use
disorder treatment 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 disorder treatment services delivered
through opioid use disorder care teams, or arranging for such
service to be furnished, to applicable beneficiaries
participating in the Program.
``(2) Opioid use disorder treatment services.--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 utilize
drugs approved under section 505 of the Federal Food,
Drug, and Cosmetic Act for the treatment of opioid use
disorders in an outpatient 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
appropriate; and
``(v) care management and care coordination
services, including coordination with other
providers of services and suppliers not on an
opioid use disorder care team.
``(b) Program Design.--
``(1) In general.--The Secretary shall design the Program
in such a manner to allow for the evaluation of the extent to
which the Program accomplishes the following purposes:
``(A) Reduces hospitalizations and emergency
department visits.
``(B) Increases use of medication-assisted
treatment for opioid use disorders.
``(C) Improves health outcomes of individuals with
opioid use disorders, including by reducing 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 Program, including
the criteria under subsection (e)(2)(A), the Secretary shall,
not later than 3 months after the date of the enactment of this
section, consult with specialists in the field of addiction,
clinicians in the primary care community, and beneficiary
groups.
``(c) Participants; Opioid Use Disorder Care Teams.--
``(1) Participants.--
``(A) Definition.--In this section, the term
`participant' means an entity or individual--
``(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
department;
``(IV) a federally qualified health
center (as defined in section
1861(aa)(4));
``(V) a rural health clinic (as
defined 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
certified community behavioral health
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 established
by the Secretary; and
``(iii) that establishes an opioid use
disorder care team (as defined in paragraph
(2)) through employing or contracting with
health care practitioners described in
paragraph (2)(A), and uses such team to furnish
or arrange for opioid use disorder treatment
services in the outpatient setting under the
Program.
``(B) Preference.--In selecting participants 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 average prevalence.
``(2) Opioid use disorder care teams.--
``(A) In general.--For purposes of this section,
the term `opioid use disorder care team' means a team
of health care practitioners established by a
participant described in paragraph (1)(A) that--
``(i) shall include--
``(I) at least one physician (as
defined in section 1861(r)(1))
furnishing primary care services or
addiction treatment services to an
applicable beneficiary; and
``(II) at least one eligible
practitioner (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
psychiatric, psychological, counseling, and
social services to applicable beneficiaries.
``(B) Requirements for receipt of payment under
program.--In order to receive payments under subsection
(e), each participant in the Program shall--
``(i) furnish opioid use disorder treatment
services through opioid use disorder care teams
to applicable beneficiaries who agree to
receive the services;
``(ii) meet minimum criteria, as
established by the Secretary; and
``(iii) submit to the Secretary, in such
form, manner, and frequency as specified by the
Secretary, with respect to each applicable
beneficiary for whom opioid use disorder
treatment services are furnished by the opioid
use disorder care team, data and such other
information as the Secretary determines
appropriate to--
``(I) monitor and evaluate the
Program;
``(II) determine if minimum
criteria are met under clause (ii); and
``(III) determine the incentive
payment under subsection (e).
``(3) Eligible practitioners; other provider-related
definitions and application provisions.--
``(A) Eligible practitioners.--For purposes of this
section, the term `eligible practitioner' 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
dispense narcotic drugs to individuals for
maintenance treatment or detoxification
treatment; and
``(iii) has in effect a waiver in
accordance 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 purposes of
subsection (e)(1)(B)(iv), the term `addiction
specialist' means a physician that possesses expert
knowledge and skills in addiction medicine, as
evidenced by appropriate certification from a specialty
body, a certificate of advanced qualification in
addiction medicine, or completion of an accredited
residency or fellowship in addiction medicine or
addiction psychiatry, as determined by the Secretary.
``(d) Participation of Applicable Beneficiaries.--
``(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 Advantage plan
under part C;
``(C) has a current diagnosis for an opioid use
disorder; and
``(D) meets such other criteria as the Secretary
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 beneficiary may participate in the
Program on a voluntary basis and may terminate participation in
the Program at any time. Not more than 20,000 applicable
beneficiaries may participate in the Program at any time.
``(3) Services.--In order to participate in the Program, an
applicable beneficiary shall agree to receive 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
beneficiary.
``(4) Beneficiary access to services.--Nothing in this
section shall be construed as encouraging providers to limit
applicable beneficiary access to services covered under this
title and applicable beneficiaries shall not be required to
relinquish access 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 beneficiary 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
payable under this title to the health care
practitioners in the participant's opioid use disorder
care team or, if applicable, to the participant. A
participant may use such per applicable beneficiary per
month care management fee to deliver additional
services to applicable beneficiaries, including
services not otherwise eligible for payment under this
title.
``(B) Payment amounts.--In carrying out
subparagraph (A), the Secretary shall--
``(i) consider payments otherwise payable
under this title for opioid use disorder
treatment services and the needs of applicable
beneficiaries;
``(ii) pay a higher per applicable
beneficiary per month care management fee for
an applicable beneficiary who receives more
intensive treatment services from a participant
and for whom those services are appropriate
based on clinical guidelines for opioid use
disorder care;
``(iii) pay a higher per applicable
beneficiary per month care management fee for
the month in which the applicable beneficiary
begins treatment with a participant 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
beneficiary per month care management fees for
participants that have established opioid use
disorder care teams that include an addiction
specialist (as defined in subsection
(c)(3)(B)); and
``(v) take into account whether a
participant's opioid use disorder care team
refers applicable beneficiaries to other
suppliers or providers for any opioid use
disorder treatment services.
``(C) No duplicate payment.--The Secretary shall
make payments under this paragraph to only one
participant for services furnished to an applicable
beneficiary during a calendar 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 determined appropriate by the Secretary)
to participants based on the performance of
participants 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 consideration of
the following:
``(I) Patient engagement and
retention 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 Secretary
shall--
``(I) consult with stakeholders,
including clinicians in the primary
care community and in the field of
addiction medicine; and
``(II) consider existing clinical
guidelines for the treatment of opioid
use disorders.
``(C) No duplicate payment.--The Secretary 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 applied 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 conduct an
intermediate and final evaluation of the program. Each such
evaluation shall determine the extent to which each of the
purposes described in subsection (b) have been accomplished
under the Program.
``(2) Reports.--The Secretary shall submit to the Secretary
and Congress--
``(A) a report with respect to the intermediate
evaluation under paragraph (1) not later than 3 years
after the date of the implementation 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 purposes 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 incentives.--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 available until expended.
``(i) Waivers.--The Secretary may waive any provision of this title
as may be necessary to carry out the Program under this section.''.
SEC. 3. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED PART D
CONTROLLED SUBSTANCES.
(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 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 substance shall
be transmitted by a health care practitioner
electronically in accordance with an electronic
prescription drug program that meets the requirements
of paragraph (2).
``(B) Exception for certain circumstances.--The
Secretary shall, pursuant to rulemaking, specify
circumstances with respect to 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
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
practitioner who has received a waiver or a
renewal thereof for a specified period
determined by the Secretary, not to exceed 1
year, from the requirement to use electronic
prescribing, pursuant to a process established
by regulation by the Secretary, due to
demonstrated economic hardship, technological
limitations that are not reasonably within the
control of the practitioner, or other
exceptional circumstance demonstrated by the
practitioner;
``(iv) a prescription issued by a
practitioner under circumstances in which,
notwithstanding the practitioner's ability to
submit a prescription electronically as
required by this subsection, such practitioner
reasonably determines that it would be
impractical for the individual involved to
obtain substances prescribed by electronic
prescription in a timely manner, and such delay
would adversely impact the individual's medical
condition involved;
``(v) a prescription issued by a
practitioner 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 practitioner may issue
a non-patient specific prescription;
``(vi) a prescription issued by a
practitioner prescribing a drug under a
research protocol;
``(vii) a prescription issued by a
practitioner for a drug for which the Food and
Drug Administration requires a prescription to
contain elements that are not able to be
included in electronic prescribing, such as a
drug with risk evaluation and mitigation
strategies that include elements to assure safe
use; and
``(viii) a prescription issued by a
practitioner 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
individual under section 1902(q)(1)(B),
for which frequently abused drugs are
dispensed for residents through a
contract with a single pharmacy, as
determined by the Secretary in
accordance with this paragraph.
``(C) Dispensing.--Nothing in this paragraph shall
be construed as requiring a sponsor of a prescription
drug plan under this part, MA organization offering an
MA-PD plan under part C, or a pharmacist to verify that
a practitioner, with respect to a prescription for a
covered part D drug, has a waiver (or is otherwise
exempt) under subparagraph (B) from the requirement
under subparagraph (A). Nothing in this paragraph shall
be construed as affecting the ability of the plan to
cover or the pharmacists' ability to continue to
dispense covered part D drugs from otherwise valid
written, oral or fax prescriptions that are consistent
with laws and regulations. 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).''.
(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.