[Congressional Record Volume 162, Number 34 (Wednesday, March 2, 2016)]
[Senate]
[Pages S1229-S1231]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 3389. Mr. WYDEN submitted an amendment intended to be proposed by
him to the bill S. 524, to authorize the Attorney General to award
grants to address the national epidemics of prescription opioid abuse
and heroin use; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER
THE MEDICARE PROGRAM.
(a) Drug Management Program for At-Risk Beneficiaries.--
(1) In general.--Section 1860D-4(c) of the Social Security
Act (42 U.S.C. 1395w-104(c)) is amended by adding at the end
the following:
``(5) Drug management program for at-risk beneficiaries.--
``(A) Authority to establish.--A PDP sponsor may establish
a drug management program for at-risk beneficiaries under
which, subject to subparagraph (B), the PDP sponsor may, in
the case of an at-risk beneficiary for prescription drug
abuse who is an enrollee in a prescription drug plan of such
PDP sponsor, limit such beneficiary's access to coverage for
frequently abused drugs under such plan to frequently abused
drugs that are prescribed for such beneficiary by a
prescriber (or prescribers) selected under subparagraph (D),
and dispensed for such beneficiary by a pharmacy (or
pharmacies) selected under such subparagraph.
``(B) Requirement for notices.--
``(i) In general.--A PDP sponsor may not limit the access
of an at-risk beneficiary for prescription drug abuse to
coverage for frequently abused drugs under a prescription
drug plan until such sponsor--
``(I) provides to the beneficiary an initial notice
described in clause (ii) and a second notice described in
clause (iii); and
``(II) verifies with the providers of the beneficiary that
the beneficiary is an at-risk beneficiary for prescription
drug abuse, as described in subparagraph (C)(iv).
``(ii) Initial notice.--An initial written notice described
in this clause is a notice that provides to the beneficiary--
``(I) notice that the PDP sponsor has identified the
beneficiary as potentially being an at-risk beneficiary for
prescription drug abuse;
``(II) information, when possible, describing State and
Federal public health resources that are designed to address
prescription drug abuse to which the beneficiary may have
access, including substance use disorder treatment services,
addiction treatment services, mental health services, and
other counseling services;
``(III) a request for the beneficiary to submit to the PDP
sponsor preferences for which prescribers and pharmacies the
beneficiary would prefer the PDP sponsor to select under
subparagraph (D) in the case that the beneficiary is
identified as an at-risk beneficiary for prescription drug
abuse as described in clause (iii)(I);
``(IV) an explanation of the meaning and consequences of
the identification of the beneficiary as potentially being an
at-risk beneficiary for prescription drug abuse, including an
explanation of the drug management program established by the
PDP sponsor pursuant to subparagraph (A);
``(V) clear instructions that explain how the beneficiary
can contact the PDP sponsor in order to submit to the PDP
sponsor the preferences described in subclause (IV) and any
other communications relating to the drug management program
for at-risk beneficiaries established by the PDP sponsor;
``(VI) contact information for other organizations that can
provide the beneficiary with information regarding drug
management program for at-risk beneficiaries (similar to the
information provided by the Secretary in other standardized
notices to part D eligible individuals enrolled in
prescription drug plans under this part); and
``(VII) notice that the beneficiary has a right to an
appeal pursuant to subparagraph (E).
``(iii) Second notice.--A second written notice described
in this clause is a notice that provides to the beneficiary
notice--
``(I) that the PDP sponsor has identified the beneficiary
as an at-risk beneficiary for prescription drug abuse;
``(II) that such beneficiary has been sent, or informed of,
such identification in the initial notice and is now subject
to the requirements of the drug management program for at-
risk beneficiaries established by such PDP sponsor for such
plan;
``(III) of the prescriber and pharmacy selected for such
individual under subparagraph (D);
``(IV) of, and information about, the right of the
beneficiary to a reconsideration and an appeal under
subsection (h) of such identification and the prescribers and
pharmacies selected;
``(V) that the beneficiary can, in the case that the
beneficiary has not previously submitted to the PDP sponsor
preferences for which prescribers and pharmacies the
beneficiary would prefer the PDP sponsor select under
subparagraph (D), submit such preferences to the PDP sponsor;
and
``(VI) that includes clear instructions that explain how
the beneficiary can contact the PDP sponsor in order to
submit to the PDP sponsor the preferences described in
subclause (V).
``(iv) Timing of notices.--
``(I) In general.--Subject to subclause (II), a second
written notice described in clause (iii) shall be provided to
the beneficiary on a date that is not less than 30 days after
an initial notice described in clause (ii) is provided to the
beneficiary.
``(II) Exception.--In the case that the PDP sponsor, in
conjunction with the Secretary, determines that concerns
identified through rulemaking by the Secretary regarding the
health or safety of the beneficiary or regarding significant
drug diversion activities require the PDP sponsor to provide
a second notice described in clause (iii) to the beneficiary
on a date that is earlier than the date described in
subclause (II), the PDP sponsor may provide such second
notice on such earlier date.
``(III) Form of notice.--The written notices under clauses
(ii) and (iii) shall be in a format determined appropriate by
the Secretary, taking into account beneficiary preferences.
``(C) At-risk beneficiary for prescription drug abuse.--
``(i) In general.--For purposes of this paragraph, the term
`at-risk beneficiary for prescription drug abuse' means a
part D eligible individual who is not an exempted individual
described in clause (ii) and--
``(I) who is identified through criteria developed by the
Secretary in consultation with PDP sponsors and other
stakeholders described in subsection section __(g)(2)(A) of
the Comprehensive Addiction and Recovery Act of 2016 based on
clinical factors indicating misuse or abuse of prescription
drugs described in subparagraph (G), including dosage,
quantity, duration of use, number of and reasonable access to
prescribers, and number of and reasonable access to
pharmacies used to obtain such drug; or
``(II) with respect to whom the PDP sponsor of a
prescription drug plan, upon enrolling such individual in
such plan, received notice from the Secretary that such
individual was identified under this paragraph to be an at-
risk beneficiary for prescription drug abuse under a
prescription drug plan in which such individual was
previously enrolled and such identification has not been
terminated under subparagraph (F).
``(ii) Exempted individual described.--An exempted
individual described in this clause is an individual who--
``(I) receives hospice care under this title;
``(II) resides in a long-term care facility, a facility
described in section 1905(d), or other facility under
contract with a single pharmacy; or
``(III) the Secretary elects to treat as an exempted
individual for purposes of clause (i).
``(iii) Program size.--The Secretary shall establish
policies, including the criteria developed under clause
(i)(I) and the exemptions under clause (ii)(III), to ensure
that the population of enrollees in a drug management program
for at-risk beneficiaries operated by a prescription drug
plan can be effectively managed by such plans.
``(iv) Clinical contact.--With respect to each at-risk
beneficiary for prescription drug abuse enrolled in a
prescription drug plan offered by a PDP sponsor, the PDP
sponsor shall contact the beneficiary's providers who have
prescribed frequently abused drugs regarding whether
prescribed medications are appropriate for such beneficiary's
medical conditions.
``(D) Selection of prescribers.--
``(i) In general.--With respect to each at-risk beneficiary
for prescription drug abuse enrolled in a prescription drug
plan offered by such sponsor, a PDP sponsor shall, based on
the preferences submitted to the PDP sponsor by the
beneficiary pursuant to clauses (ii)(III) and (iii)(V) of
subparagraph (B) if applicable, select--
``(I) one, or, if the PDP sponsor reasonably determines it
necessary to provide the beneficiary with reasonable access
under clause (ii), more than one, individual who is
authorized to prescribe frequently abused drugs (referred to
in this paragraph as a `prescriber') who may write
prescriptions for such drugs for such beneficiary; and
``(II) one, or, if the PDP sponsor reasonably determines it
necessary to provide the beneficiary with reasonable access
under clause (ii), more than one, pharmacy that may dispense
such drugs to such beneficiary.
``(ii) Reasonable access.--In making the selection under
this subparagraph, a PDP sponsor shall ensure, taking into
account geographic location, beneficiary preference, impact
on cost-sharing, and reasonable travel time, that the
beneficiary continues to have reasonable access to drugs
described in subparagraph (G), including--
``(I) for individuals with multiple residences; and
``(II) in the case of natural disasters and similar
emergency situations.
``(iii) Beneficiary preferences.--
``(I) In general.--If an at-risk beneficiary for
prescription drug abuse submits preferences for which in-
network prescribers and pharmacies the beneficiary would
prefer the PDP sponsor select in response to a notice under
subparagraph (B), the PDP sponsor shall--
``(aa) review such preferences;
``(bb) select or change the selection of a prescriber or
pharmacy for the beneficiary based on such preferences; and
``(cc) inform the beneficiary of such selection or change
of selection.
[[Page S1230]]
``(II) Exception.--In the case that the PDP sponsor
determines that a change to the selection of a prescriber or
pharmacy under item (bb) by the PDP sponsor is contributing
or would contribute to prescription drug abuse or drug
diversion by the beneficiary, the PDP sponsor may change the
selection of a prescriber or pharmacy for the beneficiary. If
the PDP sponsor changes the selection pursuant to the
preceding sentence, the PDP sponsor shall provide the
beneficiary with--
``(aa) at least 30 days written notice of the change of
selection; and
``(bb) a rationale for the change.
``(III) Timing.--An at-risk beneficiary for prescription
drug abuse may choose to express their prescriber and
pharmacy preference and communicate such preference to their
PDP sponsor at any date while enrolled in the program,
including after a second notice under subparagraph (B)(iii)
has been provided.
``(iv) Confirmation.--Before selecting a prescriber or
pharmacy under this subparagraph, a PDP sponsor must notify
the prescriber and pharmacy that the beneficiary involved has
been identified for inclusion in the drug management program
for at-risk beneficiaries and that the prescriber and
pharmacy has been selected as the beneficiary's designated
prescriber and pharmacy.
``(E) Appeals.--The identification of an individual as an
at-risk beneficiary for prescription drug abuse under this
paragraph, a coverage determination made under a drug
management program for at-risk beneficiaries, and the
selection of a prescriber or pharmacy under subparagraph (D)
with respect to such individual shall be subject to an
expedited reconsideration and appeal pursuant to subsection
(h).
``(F) Termination of identification.--
``(i) In general.--The Secretary shall develop standards
for the termination of identification of an individual as an
at-risk beneficiary for prescription drug abuse under this
paragraph. Under such standards such identification shall
terminate as of the earlier of--
``(I) the date the individual demonstrates that the
individual is no longer likely, in the absence of the
restrictions under this paragraph, to be an at-risk
beneficiary for prescription drug abuse described in
subparagraph (C)(i); or
``(II) the end of such maximum period of identification as
the Secretary may specify.
``(ii) Rule of construction.--Nothing in clause (i) shall
be construed as preventing a plan from identifying an
individual as an at-risk beneficiary for prescription drug
abuse under subparagraph (C)(i) after such termination on the
basis of additional information on drug use occurring after
the date of notice of such termination.
``(G) Frequently abused drug.--For purposes of this
subsection, the term `frequently abused drug' means a drug
that is determined by the Secretary to be frequently abused
or diverted and that is--
``(i) a Controlled Drug Substance in Schedule CII; or
``(ii) within the same class or category of drugs as a
Controlled Drug Substance in Schedule CII, as determined
through notice and comment rulemaking.
``(H) Data disclosure.--
``(i) Data on decision to impose limitation.--In the case
of an at-risk beneficiary for prescription drug abuse (or an
individual who is a potentially at-risk beneficiary for
prescription drug abuse) whose access to coverage for
frequently abused drugs under a prescription drug plan has
been limited by a PDP sponsor under this paragraph, the
Secretary shall establish rules and procedures to require
such PDP sponsor to disclose data, including necessary
individually identifiable health information, about the
decision to impose such limitations and the limitations
imposed by the PDP sponsor under this part.
``(ii) Data to reduce fraud, abuse, and waste.--The
Secretary shall establish rules and procedures to require PDP
sponsors operating a drug management program for at-risk
beneficiaries under this paragraph to provide the Secretary
with such data as the Secretary determines appropriate for
purposes of identifying patterns of prescription drug
utilization for plan enrollees that are outside normal
patterns and that may indicate fraudulent, medically
unnecessary, or unsafe use.
``(I) Sharing of information for subsequent plan
enrollments.--The Secretary shall establish procedures under
which PDP sponsors who offer prescription drug plans shall
share information with respect to individuals who are at-risk
beneficiaries for prescription drug abuse (or individuals who
are potentially at-risk beneficiaries for prescription drug
abuse) and enrolled in a prescription drug plan and who
subsequently disenroll from such plan and enroll in another
prescription drug plan offered by another PDP sponsor.
``(J) Privacy issues.--Prior to the implementation of the
rules and procedures under this paragraph, the Secretary
shall clarify privacy requirements, including requirements
under the regulations promulgated pursuant to section 264(c)
of the Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note), related to the sharing of data
under subparagraphs (H) and (I) by PDP sponsors. Such
clarification shall provide that the sharing of such data
shall be considered to be protected health information in
accordance with the requirements of the regulations
promulgated pursuant to such section 264(c).
``(K) Education.--The Secretary shall provide education to
enrollees in prescription drug plans of PDP sponsors and
providers regarding the drug management program for at-risk
beneficiaries described in this paragraph, including
education--
``(i) provided through the improper payment outreach and
education program described in section 1874A(h); and
``(ii) through current education efforts (such as State
health insurance assistance programs described in subsection
(a)(1)(A) of section 119 of the Medicare Improvements for
Patients and Providers Act of 2008 (42 U.S.C. 1395b-3 note))
and materials directed toward such enrollees.
``(L) CMS compliance review.--The Secretary shall ensure
that existing plan sponsor compliance reviews and audit
processes include the drug management programs for at-risk
beneficiaries under this paragraph, including appeals
processes under such programs.''.
(2) Information for consumers.--Section 1860D-4(a)(1)(B) of
the Social Security Act (42 U.S.C. 1395w-104(a)(1)(B)) is
amended by adding at the end the following:
``(v) The drug management program for at-risk beneficiaries
under subsection (c)(5).''.
(3) Dual eligibles.--Section 1860D-1(b)(3)(D) of the Social
Security Act (42 U.S.C. 1395w-101(b)(3)(D)) is amended by
inserting ``, subject to such limits as the Secretary may
establish for individuals identified pursuant to section
1860D-4(c)(5)'' after ``the Secretary''.
(b) Utilization Management Programs.--Section 1860D-4(c) of
the Social Security Act (42 U.S.C. 1395w-104(c)), as amended
by subsection (a)(1), is amended--
(1) in paragraph (1), by inserting after subparagraph (D)
the following new subparagraph:
``(E) A utilization management tool to prevent drug abuse
(as described in paragraph (5)(A)).''; and
(2) by adding at the end the following new paragraph:
``(6) Utilization management tool to prevent drug abuse.--
``(A) In general.--A tool described in this paragraph is
any of the following:
``(i) A utilization tool designed to prevent the abuse of
frequently abused drugs by individuals and to prevent the
diversion of such drugs at pharmacies.
``(ii) Retrospective utilization review to identify--
``(I) individuals that receive frequently abused drugs at a
frequency or in amounts that are not clinically appropriate;
and
``(II) providers of services or suppliers that may
facilitate the abuse or diversion of frequently abused drugs
by beneficiaries.
``(iii) Consultation with the contractor described in
subparagraph (B) to verify if an individual enrolling in a
prescription drug plan offered by a PDP sponsor has been
previously identified by another PDP sponsor as an individual
described in clause (ii)(I).
``(B) Reporting.--A PDP sponsor offering a prescription
drug plan in a State shall submit to the Secretary and the
Medicare drug integrity contractor with which the Secretary
has entered into a contract under section 1893 with respect
to such State a report, on a monthly basis, containing
information on--
``(i) any provider of services or supplier described in
subparagraph (A)(ii)(II) that is identified by such plan
sponsor during the 30-day period before such report is
submitted; and
``(ii) the name and prescription records of individuals
described in paragraph (5)(C).
``(C) CMS compliance review.--The Secretary shall ensure
that plan sponsor annual compliance reviews and program
audits include a certification that utilization management
tools under this paragraph are in compliance with the
requirements for such tools.''.
(c) Treatment of Certain Complaints for Purposes of Quality
or Performance Assessment.--Section 1860D-42 of the Social
Security Act (42 U.S.C. 1395w-152) is amended by adding at
the end the following new subsection:
``(d) Treatment of Certain Complaints for Purposes of
Quality or Performance Assessment.--In conducting a quality
or performance assessment of a PDP sponsor, the Secretary
shall develop or utilize existing screening methods for
reviewing and considering complaints that are received from
enrollees in a prescription drug plan offered by such PDP
sponsor and that are complaints regarding the lack of access
by the individual to prescription drugs due to a drug
management program for at-risk beneficiaries.''.
(d) Sense of Congress Regarding Use of Technology Tools To
Combat Fraud.--It is the sense of Congress that MA
organizations and PDP sponsors should consider using e-
prescribing and other health information technology tools to
support combating fraud under MA-PD plans and prescription
drug plans under parts C and D of the Medicare Program.
(e) GAO Study and Report.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the implementation of the amendments
made by this section, including the effectiveness of the at-
risk beneficiaries for prescription drug abuse drug
management programs authorized by section 1860D-4(c)(5) of
the Social Security Act (42 U.S.C. 1395w-10(c)(5)), as added
by subsection (a)(1). Such study shall include an analysis
of--
[[Page S1231]]
(A) the impediments, if any, that impair the ability of
individuals described in subparagraph (C) of such section
1860D-4(c)(5) to access clinically appropriate levels of
prescription drugs;
(B) the effectiveness of the reasonable access protections
under subparagraph (D)(ii) of such section 1860D-4(c)(5),
including the impact on beneficiary access and health;
(C) how best to define the term ``designated pharmacy'',
including whether the definition of such term should include
an entity that is comprised of a number of locations that are
under common ownership and that electronically share a real-
time, online database and whether such a definition would
help to protect and improve beneficiary access;
(D) the types of--
(i) individuals who, in the implementation of such section,
are determined to be individuals described in such
subparagraph; and
(ii) prescribers and pharmacies that are selected under
subparagraph (D) of such section;
(E) the extent of prescription drug abuse beyond Controlled
Drug Substances in Schedule CII in parts C and D of the
Medicare program; and
(F) other areas determined appropriate by the Comptroller
General.
(2) Report.--Not later than July 1, 2019, the Comptroller
General of the United States shall submit to the appropriate
committees of jurisdiction of Congress a report on the study
conducted under paragraph (1), together with recommendations
for such legislation and administrative action as the
Comptroller General determines to be appropriate.
(f) Report by Secretary.--
(1) In general.--Not later than 12 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall submit to the appropriate committees of
jurisdiction of Congress a report on ways to improve upon the
appeals process for Medicare beneficiaries with respect to
prescription drug coverage under part D of title XVIII of the
Social Security Act. Such report shall include an analysis
comparing appeals processes under parts C and D of such title
XVIII.
(2) Feedback.--In development of the report described in
paragraph (1), the Secretary of Health and Human Services
shall solicit feedback on the current appeals process from
stakeholders, such as beneficiaries, consumer advocates, plan
sponsors, pharmacy benefit managers, pharmacists, providers,
independent review entity evaluators, and pharmaceutical
manufacturers.
(g) Effective Date.--
(1) In general.--Except as provided in subsection (d)(2),
the amendments made by this section shall apply to
prescription drug plans for plan years beginning on or after
January 1, 2018.
(2) Stakeholder meetings prior to effective date.--
(A) In general.--Not later than January 1, 2017, the
Secretary of Health and Human Services shall convene
stakeholders, including individuals entitled to benefits
under part A of title XVIII of the Social Security Act or
enrolled under part B of such title of such Act, advocacy
groups representing such individuals, clinicians, plan
sponsors, pharmacists, retail pharmacies, entities delegated
by plan sponsors, and biopharmaceutical manufacturers for
input regarding the topics described in subparagraph (B). The
input described in the preceding sentence shall be provided
to the Secretary in sufficient time in order for the
Secretary to take such input into account in promulgating the
regulations pursuant to subparagraph (C).
(B) Topics described.--The topics described in this
subparagraph are the topics of--
(i) the impact on cost-sharing and ensuring accessibility
to prescription drugs for enrollees in prescription drug
plans of PDP sponsors who are at-risk beneficiaries for
prescription drug abuse (as defined in paragraph (5)(C) of
section 1860D-4(c) of the Social Security Act (42 U.S.C.
1395w-10(c)));
(ii) the use of an expedited appeals process under which
such an enrollee may appeal an identification of such
enrollee as an at-risk beneficiary for prescription drug
abuse under such paragraph (similar to the processes
established under the Medicare Advantage program under part C
of title XVIII of the Social Security Act);
(iii) the types of enrollees that should be treated as
exempted individuals, as described in clause (ii) of such
paragraph;
(iv) the manner in which terms and definitions in paragraph
(5) of such section 1860D-4(c) should be applied, such as the
use of clinical appropriateness in determining whether an
enrollee is an at-risk beneficiary for prescription drug
abuse as defined in subparagraph (C) of such paragraph (5);
(v) the information to be included in the notices described
in subparagraph (B) of such section and the standardization
of such notices;
(vi) with respect to a PDP sponsor that establishes a drug
management program for at-risk beneficiaries under such
paragraph (5), the responsibilities of such PDP sponsor with
respect to the implementation of such program;
(vii) notices for plan enrollees at the point of sale that
would explain why an at-risk beneficiary has been prohibited
from receiving a prescription at a location outside of the
designated pharmacy;
(viii) evidence-based prescribing guidelines for opiates;
and
(ix) the sharing of claims data under parts A and B with
PDP sponsors.
(C) Rulemaking.--The Secretary of Health and Human Services
shall, taking into account the input gathered pursuant to
subparagraph (A) and after providing notice and an
opportunity to comment, promulgate regulations to carry out
the provisions of, and amendments made by subsections (a) and
(b).
SEC. __. INCREASED ANTI-KICKBACKS PENALTIES.
Paragraphs (1) and (2) of section 1128B(b) of the Social
Security Act (42 U.S.C. 1320a-7b(b)) are each amended by
inserting ``(or, beginning January 1, 2017, $50,000)'' after
``$25,000''.
SEC. __. CENTER FOR MEDICARE AND MEDICAID INNOVATION TESTING
OF OPIOID ABUSE TREATMENT PROGRAM MODEL FOR
PART D PRESCRIPTION DRUG PLAN ENROLLEES.
Section 1115A of the Social Security Act (42 U.S.C. 1315a)
is amended--
(1) in subsection (b)(2)(A), by adding at the end the
following new sentence: ``The models selected under this
subparagraph shall include the model described in subsection
(h).''; and
(2) by adding at the end the following new subsection:
``(h) Opioid Abuse Treatment Program Model.--
``(1) In general.--The Secretary shall test a model
requiring prescription drug plans under part D of title XVIII
to have in place, directly or through appropriate
arrangements, an opioid abuse treatment program for
applicable enrollees in lieu of the medication therapy
management program under section 1860D-4(c)(2) with respect
to such applicable enrollees.
``(2) Start date.--The model under this subsection shall
start in plan year 2018.
``(3) Selection.--The Secretary shall select a limited
number of Medicare part D regions in which to the model,
giving priority to regions based on the number of total
opioid prescriptions in the region.
``(4) Requirements for program.--Under an opioid abuse
treatment program, the PDP sponsor offering the plan shall--
``(A) establish a care team that includes at least--
``(i) a pharmacist;
``(ii) a physician; and
``(iii) an individual licenced in a State with expertise in
behavioral health (as determined by the Secretary), which may
be the physician described in clause (ii); and
``(B) develop, in consultation with the applicable enrollee
and with input from the prescriber to the extent necessary
and practicable, a care plan for the applicable enrollee that
is intended to treat the applicable enrollee's pain and limit
any unnecessary opioid prescriptions when possible.
``(5) Payment.--
``(A) In general.--Under the model under this subsection,
the Secretary shall make a monthly payment to the PDP sponsor
offering the prescription drug plan for each applicable
enrollee who receives services under the opioid abuse
treatment program.
``(B) Shared savings.--Under the model under this
subsection, the Secretary shall (using a methodology
determined appropriate by the Secretary) make payments (in
addition to the payments under subparagraph (A)) to the PDP
sponsor offering the prescription drug plan if the Secretary
determines that total spending under parts A, B, and D of
title XVIII (and including the payments under subparagraph
(A)) for applicable enrollees who receive services under the
opioid abuse treatment program is less than a historical
benchmark of total spending under such parts A, B, and D for
such enrollees or similar enrollees. Such benchmark shall be
adjusted at the Secretary's discretion for changes in law or
regulation, unforeseen circumstances, or advances in medical
practice.
``(6) Quality.--Under the model under this subsection, the
Secretary shall measure the quality of care furnished by
opioid abuse treatment programs, including elements related
to access to care, the unnecessary use of opioids, pain
management, and the delivery of behavioral health services.
``(7) Applicable enrollee.--In this subsection, the term
`applicable enrollee' means an individual who is, with
respect to a prescription drug plan--
``(A) enrolled with the plan; and
``(B) an at-risk beneficiary for prescription drug abuse
(as defined in section 1860D-4(c)(5)(C)).
``(8) Model not applicable to ma-pd plans.--The model under
this subsection shall not apply to MA-PD plans or enrollees
of such plans.
``(9) Clarification of application.--For purposes of the
preceding provisions of this section (including paragraphs
(3) and (4) of subsection (b) and subsections (d) and (f)),
the model under this subsection shall be deemed to be a model
under subsection (b).''.
______