[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1913 Introduced in Senate (IS)]
114th CONGRESS
1st Session
S. 1913
To amend title XVIII of the Social Security Act to establish programs
to prevent prescription drug abuse under the Medicare program, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 30, 2015
Mr. Toomey (for himself, Mr. Brown, Mr. Portman, and Mr. Kaine)
introduced the following bill; which was read twice and referred to the
Committee on Finance
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to establish programs
to prevent prescription drug abuse under the Medicare 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 ``Stopping Medication Abuse and
Protecting Seniors Act of 2015''.
SEC. 2. 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 2(g)(2)(A) of the
Stopping Medication Abuse and
Protecting Seniors Act of 2015 based on
clinical factors indicating misuse or
abuse of prescription drugs described
in subparagraph (G), including dosage,
quantity, duration of use, number of
prescribers, and number of 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 physicians 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.
``(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 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--
(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 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;
(C) the extent of prescription drug abuse beyond
Controlled Drug Substances in Schedule CII in parts C
and D of the Medicare program; and
(D) 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).
(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; and
(viii) evidence-based prescribing
guidelines for opiates.
(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).
<all>