[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5808 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 5808
To amend title XIX of the Social Security Act to require States to
operate drug management programs for at-risk beneficiaries, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 15, 2018
Mr. Bilirakis (for himself and Mr. Ben Ray Lujan of New Mexico)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To amend title XIX of the Social Security Act to require States to
operate drug management programs for at-risk beneficiaries, 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 ``Medicaid Pharmaceutical Home Act of
2018''.
SEC. 2. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.
(a) In General.--Title XIX of the Social Security Act is amended by
inserting after section 1927 (42 U.S.C. 1396r-8) the following new
section:
``SEC. 1927A. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.
``(a) In General.--Beginning January 1, 2020, a State shall operate
a qualified drug management program under which a State may enroll
certain at-risk beneficiaries identified by the State under the
program.
``(b) Qualified Drug Management Program.--For purposes of this
section, the term `qualified drug management program' means, with
respect to a State, a program carried out by the State (including
through a contract with a pharmacy benefit manager) that provides at
least for the following:
``(1) Identification of at-risk individuals.--Under the
program, the State identifies, in accordance with subsection
(c), individuals enrolled under the State plan (or waiver of
the State plan) who are at-risk beneficiaries.
``(2) Elements of program.--
``(A) In general.--Under the program, the State,
with respect to each individual identified under
paragraph (1) and enrolled under the program under
paragraph (5)--
``(i) subject to subparagraphs (B) and (C),
selects at least one, but not more than three,
health care providers and at least one, but not
more than three, pharmacies for each such
individual for purposes of clause (ii), in
accordance with a selection process that takes
into account reasonable factors such as the
individual's previous utilization of items and
services from health care providers and
pharmacies, geographic proximity of the
individual to such health care providers and
pharmacies, access of the individual to health
care, reasonable travel time, information
regarding housing status, and any known
preference of the individual for a certain
health care provider or pharmacy; and
``(ii) requires that any controlled
substance furnished to such individual during
the period for which such individual is
enrolled under the program be prescribed by a
health care provider selected under clause (i)
for such individual and dispensed by a pharmacy
selected under clause (i) for such individual
in order for such controlled substance to be
covered under the State plan (or waiver).
``(B) Beneficiary preference.--In the case of an
individual receiving a notice under paragraph (3)(A) of
being identified as potentially being an at-risk
beneficiary described in such paragraph, such
individual may submit, during the 30-day period
following receipt of such notice, preferences for which
health care providers and pharmacies the individual
would prefer the State to select under subparagraph
(A). The State shall select or change the selection of
health care providers and pharmacies under subparagraph
(A) for the individuals based on such preferences,
except that in the case that State determines that such
selection (or change of selection) of a health care
provider or pharmacy under subparagraph (A) is
contributing or would contribute to prescription drug
abuse or drug diversion by the individual, the State
may select or change the selection of health care
provider or pharmacy for the individual without regard
to the preferences of the individual described in this
subparagraph. If the State selects or changes the
selection pursuant to the preceding sentence without
regard to the preferences of the individual, the State
shall provide the individual with at least 30 days
written notice of the selection or change of selection
and a rationale for the selection or change.
``(C) Treatment of pharmacy with multiple
locations.--For purposes of subparagraph (A)(i), in the
case of a pharmacy that has multiple locations that
share real-time electronic prescription data and the
same chain identification number, all such locations of
the pharmacy shall collectively be treated as one
pharmacy.
``(D) Treatment of existing ffs drug management
programs.--In the case of a patient review and
restriction program (as identified in the annual report
submitted to the Secretary under section 1927(g)(3)(D))
operated by a State pursuant to section 1915(a)(2)
before the date of the enactment of this section, such
program shall be treated as a qualified drug management
program.
``(E) Reasonable access.--The program shall ensure,
including through waiver of elements of the program
(including under subparagraph (A)(ii)), reasonable
access to health care (including access to health care
providers and pharmacies with respect to prescription
drugs described in subparagraph (A)) in the case of
individuals with multiple residences, in the case of
natural disasters and similar situations, and in the
case of the provision of emergency services (as defined
for purposes of section 1860D-4(c)(5)(D)(ii)(II)).
``(3) Notification to identified individuals.--Under the
program, the State provides each individual who is identified
under paragraph (1), prior to enrolling such individual under
the program, at least one notification of each of the
following:
``(A) Notice that the State has identified the
individual as potentially being an at-risk beneficiary
for abuse or misuse of a controlled substance.
``(B) The name, address, and contact information of
each health care provider and pharmacy that may be
selected for the individual under paragraph (2)(A).
``(C) Information describing all State and Federal
public health resources that are designed to address
such abuse or misuse to which the individual has
access, including mental health services and other
counseling services.
``(D) Notice of, and information about, the right
of the individual to--
``(i) submit preferences of the individual
for health care providers and pharmacies to be
selected under paragraph (2)(A), including as
described in paragraph (2)(B);
``(ii) appeal under paragraph (4)--
``(I) such identification described
in subparagraph (A); and
``(II) the selection of health care
providers and pharmacies under
paragraph (2)(A).
``(E) An explanation of the meaning and
consequences of the identification of the individual as
potentially being an at-risk beneficiary for abuse or
misuse of a controlled substance, including an
explanation of the program.
``(F) Information, including a contact list and
clear instructions, that explain how the individual can
contact the appropriate entities administering the
program in order to submit preferences described in
paragraph (2)(B) and any other communications relating
to the program.
``(4) Appeals process.--Under the program, the State
provides for an appeals process under which, with respect to an
individual identified under paragraph (1)--
``(A) such individual may appeal--
``(i) such identification; and
``(ii) the selection of a health care
provider or pharmacy under paragraph (2)(A);
``(B) in the case of an appeal described in
subparagraph (A)(ii), the State shall accommodate the
health care provider or pharmacy preferred by the
individual for selection for purposes of paragraph
(2)(A), unless the State determines that a change to
the selection of health care provider or pharmacy under
such paragraph is contributing or would contribute to
prescription drug abuse or drug diversion by the
individual;
``(C) such individual is provided a period of not
less than 30 days following the date of receipt of the
notice described in paragraph (3) to submit such
appeal; and
``(D) the State must make a determination with
respect to an appeal described in subparagraph (A), and
notify the individual of such determination, prior to
enrollment of such individual in the program.
``(5) Enrollment.--Under the program, the State initially
enrolls individuals who are identified under paragraph (1) in
the program for a 12-month period--
``(A) in the case of such an individual who does
not submit an appeal under paragraph (4) within the
period applied by the State pursuant to subparagraph
(C) of such paragraph, beginning on the day after the
last day of such period; and
``(B) in the case of such an individual who does
submit an appeal under paragraph (4) within the period
applied by the State pursuant to subparagraph (C) of
such paragraph but such appeal is denied, beginning not
later than 30 days after the date of such denial.
``(6) Notification of health care providers and
pharmacies.--Under the program, the State provides to each
health care provider and pharmacy selected for an individual
under paragraph (2)--
``(A) notification that the individual is an at-
risk beneficiary enrolled under the program and that
the provider or pharmacy has been selected for the
individual under paragraph (2);
``(B) information on such program and the role of
being so selected; and
``(C) a process through which the provider or
pharmacy can submit a concern or complaint with respect
to being so selected and refuse to be a provider or
pharmacy so selected.
``(7) Continuation of enrollment.--Under the program, the
State, with respect to an individual enrolled under the
program, provides for a process to--
``(A) not later than 30 days before the end of the
12-month period for which the individual is so enrolled
pursuant to paragraph (5)--
``(i) assess, in accordance with publicly
available evidence-based guidelines, whether or
not such individual should continue to be
enrolled under the program; and
``(ii) notify such individual of the
results of the assessment under clause (i);
``(B) continue, subject to subparagraph (C),
enrollment of such individual if such assessment
recommends such continuation; and
``(C) appeal the continuation of enrollment in
accordance with the appeals process described in
paragraph (4).
``(c) At-Risk Beneficiary.--
``(1) Identification.--For purposes of this section, a
State shall identify an individual enrolled under the State
plan (or waiver of the State plan) as an at-risk beneficiary if
the individual is not an exempted individual described in
paragraph (2) and--
``(A) is identified as such an at-risk beneficiary
through the use of publicly available evidence-based
guidelines that indicate misuse or abuse of a
controlled substance; or
``(B) the State received notification from a PDP
sponsor or Medicare Advantage organization that such
individual was identified as being an at-risk
beneficiary for prescription drug abuse for enrollment
in a drug management program established by the sponsor
or organization pursuant to section 1860D-4(c)(5) and
such identification has not been terminated under
subparagraph (F) of such section.
``(2) Exempted individual described.--For purposes of
paragraph (1), an exempted individual described in this
paragraph is an individual who--
``(A) is receiving--
``(i) hospice or palliative care; or
``(ii) treatment for cancer;
``(B) is a resident of a long-term care facility,
of a facility described in section 1905(d), or of
another facility for which frequently abused drugs are
dispensed for residents through a contract with a
single pharmacy; or
``(C) the State elects to treat as an exempted
individual for purposes of paragraph (1).
``(d) Application of Privacy Rules Clarification.--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 subsection (b)(6) in the
same manner as the Secretary is required under subparagraph (J) of
section 1860D-4(c)(5) to clarify privacy requirements related to the
sharing of data described in such subparagraph.
``(e) Reports.--
``(1) Annual reports.--A State operating a qualified drug
management program shall include in the annual report submitted
to the Secretary under section 1927(g)(3)(D), beginning with
such reports submitted for 2021, the following information:
``(A) The number of individuals enrolled under the
State plan (or waiver of the State plan) who are
enrolled under the program and the percentage of
individuals enrolled under the State plan (or waiver)
who are enrolled under such program.
``(B) The number of prescriptions for controlled
substances that were dispensed per month during each
such year per individual enrolled under the program,
including the dosage and pill count for each such
prescription.
``(C) The number of pharmacies filling
prescriptions for controlled substances for individuals
enrolled under such program.
``(D) The number of health care providers writing
prescriptions for controlled substances (other than
prescriptions for a refill) for individuals enrolled
under such program.
``(E) Any other data that the Secretary may
require.
``(F) Any report submitted by a managed care entity
under subsection (e)(2) with respect to years.
For each such report for a year after 2021, the information
described in this paragraph shall be provided in a manner that
compares such information with respect to the prior calendar
year to such information with respect to the second prior
calendar year.
``(2) MACPAC reports and review.--Not later than two years
after the date of the enactment of this section, the Medicaid
and CHIP Payment and Access Commission (in this section
referred to as `MACPAC'), in consultation with the National
Association of Medicaid Directors, pharmacy benefit managers,
managed care organizations, health care providers (including
pharmacists), beneficiary advocates, and other stakeholders,
shall publish a report that includes--
``(A) best practices for operating drug management
programs, based on a review of a representative sample
of States administering such a program;
``(B) a summary of the experience of the appeals
process under drug management programs operated by
several States, such as the frequency at which
individuals appealed the identification of being an at-
risk individual, the frequency at which individuals
appealed the selection of a health care provider or
pharmacy under such a program, the timeframes for such
appeals, a summary of the reasons for such appeals, and
the design of such appeals processes;
``(C) a summary of trends and the effectiveness of
qualified drug management programs operated under this
section; and
``(D) recommendations to States on how improvements
can be made with respect to the operation of such
programs.
In reporting on State practices, the MACPAC shall consider how
such programs have been implemented in rural areas, under fee-
for-service as well as managed care arrangements, and the
extent to which such programs have resulted in increased
efficiencies to such States or to the Federal Government under
this title.
``(3) Report on plan for coordinated care.--Not later than
January 1, 2021, each State operating a qualified drug
management program shall submit to the Administrator of the
Centers for Medicare & Medicaid Services a report on how such
State plans to provide coordinated care for individuals
enrolled under the State plan (or waiver of the State plan)
and--
``(A) who are enrolled under the program; or
``(B) who are enrolled with a managed care entity
and enrolled under such a qualified drug management
program operated by such entity.
``(f) Applicability to Managed Care Entities.--
``(1) In general.--With respect to any contract that a
State enters into on or after January 1, 2020, with a managed
care entity (as defined in section 1932(a)(1)(B)) pursuant to
section 1903(m), the State shall, as a condition of the
contract, require the managed care entity--
``(A) to operate a qualified drug management
program (as defined in subsection (b)) for at-risk
beneficiaries who are enrolled with such entity and
identified by the managed care entity by means of
application of paragraph (2);
``(B) to submit to the State an annual report on
the matters described in subparagraphs (A) through (E)
of subsection (e)(1); and
``(C) to submit to the State a list (and as
necessary update such list) of individuals enrolled
with such entity under the qualified drug management
program operated by such entity under subparagraph (A)
for purposes of allowing State plans for which medical
assistance is paid on a fee-for-service basis to have
access to such information.
``(2) Application.--For purposes of applying, with respect
to a managed care entity--
``(A) under paragraph (1)(A)--
``(i) the definition of the term `qualified
drug management program' under subsection (b),
other than paragraph (2)(D) of such subsection;
and
``(ii) the provisions of paragraphs (1) and
(2) of subsection (c); and
``(B) under paragraph (1)(B), the report
requirements described in subparagraphs (A) through (E)
of subsection (e)(1);
each reference in such subsection (b) and paragraphs of
subsection (c) to `a State' or `the State' (other than to `a
State plan' or `the State plan') shall be deemed a reference to
the managed care entity, each reference under such subsection,
paragraphs, or subparagraphs to individuals enrolled under the
State plan (or waiver of the State plan) shall be deemed a
reference to individuals enrolled with such entity, and each
reference under such subsection, paragraphs, or subparagraphs
to individuals enrolled under the qualified drug management
program operated by the State shall be deemed a reference to
individuals enrolled under the qualified drug management
program operated by the managed care entity.
``(g) Controlled Substance Defined.--For purposes of this section,
the term `controlled substance' means a drug that is included in
schedule II, III, or IV of section 202(c) of the Controlled Substances
Act, or any combination thereof, as specified by the State.''.
(b) Guidance on At-Risk Population Transitioning Between Medicaid
FFS and Managed Care.--Not later than October 1, 2019, the Secretary of
Health and Human Services shall issue guidance for State Medicaid
programs, with respect to individuals who are enrolled under a State
plan (or waiver of such plan) under title XIX of the Social Security
Act and under a drug management program, for purposes of providing best
practices--
(1) for transitioning, as applicable, such individuals from
fee-for-service Medicaid (and such a program operated by the
State) to receiving medical assistance under such title through
a managed care entity (as defined in section 1932(a)(1)(B) of
the Social Security Act) with a contract that with the State
pursuant to section 1903(m) of such Act (and such a program
operated by such entity); and
(2) for transitioning, as applicable, such individuals from
receiving medical assistance under such title through a managed
care entity (as defined in section 1932(a)(1)(B) of the Social
Security Act) with a contract that with the State pursuant to
section 1903(m) of such Act (and such a program operated by
such entity) to fee-for-service Medicaid (and such a program
operated by the State).
(c) Guidance on At-Risk Population Transitioning to Medicare.--
(1) In general.--Not later than January 1, 2020, the
Secretary of Health and Human Services, after consultation with
the Federal Coordinated Health Care Office established under
section 2602 of the Patient Protection and Affordable Care Act
(42 U.S.C. 1315b), shall issue guidance for State Medicaid
programs, with respect to transitioning individuals, providing
for--
(A) notification to be submitted by the State to
the Centers for Medicare & Medicaid Services and such
individuals of the status of such individuals as
transitioning individuals;
(B) notification to such individuals about
enrollment under a prescription drug plan under part D
of such title or under a MA-PD plan under part C of
such title;
(C) best practices for transitioning such
individuals to such a plan; and
(D) best practices for coordination between the
qualified drug management program (as described in
section 1927A(b) of the Social Security Act, as added
by subsection (a)) carried out by the State and a drug
management program carried out under such a plan
pursuant to section 1860D-4(c)(5) of the Social
Security Act (42 U.S.C. 1395w-10(c)(5)).
(2) Transitioning individuals.--For purposes of paragraph
(1), a transitioning individual is an individual who, with
respect to a month--
(A) is enrolled under the State plan (or waiver of
the State plan) and under the qualified drug management
program (as described in section 1927A(b) of the Social
Security Act, as added by subsection (a)) carried out
by the State; and
(B) is expected to become eligible for the Medicare
program under title XVIII of such Act during the
subsequent 12-month period.
<all>