[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5435 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 5435
To amend title XVIII of the Social Security Act to provide for the
coverage of home as a site of care for infusion therapy under the
Medicare Program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 10, 2014
Mr. Engel (for himself, Mr. Tiberi, Mr. Larson of Connecticut, Mr.
Harper, Mr. Meehan, Ms. Pingree of Maine, and Mr. Peterson) introduced
the following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on Ways and Means, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to provide for the
coverage of home as a site of care for infusion therapy under the
Medicare Program.
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 ``Medicare Home Infusion Site of Care
Act of 2014''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) The Medicare fee-for-service program covers infusion
therapy in the hospital, skilled nursing facility, physician
office, and hospital outpatient department, but does not cover
the full range of services for the provision of infusion
therapies in a patient's home.
(2) The Medicare program is presently the only major health
care payer in the United States that does not provide
comprehensive coverage of home infusion therapy.
(3) As a result of the Medicare program not providing for
comprehensive coverage of home infusion therapy, many Medicare
beneficiaries are unable to obtain infusion therapy in the most
cost-effective and convenient setting of their home, and
physicians are deprived of the ability to select the best site
of care for their patients.
(4) The Medicare program is paying for institutional care
for the provision of infusion therapy in many instances when
such institutional care could be avoided if the Medicare
program provided coverage for home infusion therapy.
(5) The Government Accountability Office found in a 2010
report that home infusion therapy is utilized widely by private
payers providing health insurance coverage for individuals
enrolled under such coverage and that such private payers
generally are satisfied with the quality of care and the
savings they achieve through avoided institutionalizations.
(6) A recent study has reported a potential savings for
Medicare if infusion therapies were covered in the home site of
care.
SEC. 3. MEDICARE COVERAGE OF HOME INFUSION THERAPY.
(a) In General.--Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended--
(1) in subsection (s)(2)--
(A) by striking ``and'' at the end of subparagraph
(EE);
(B) by inserting ``and'' at the end of subparagraph
(FF); and
(C) by inserting at the end the following new
subparagraph:
``(GG) home infusion therapy (as defined in subsection
(iii)(1));''; and
(2) by adding at the end the following new subsection:
``Home Infusion Therapy
``(iii)(1) The term `home infusion therapy' means the items and
services described in paragraph (2) furnished to an individual, who is
under the care of a physician, which are provided by a qualified home
infusion therapy supplier under a plan (for furnishing such items and
services to such individual) established and periodically reviewed by a
physician, which items and services are provided in an integrated
manner in the individual's home in conformance with uniform standards
of care established by the Secretary and in coordination with the
provision of covered infusion drugs under part D. The Secretary shall
establish such standards after taking into account the standards
commonly used for home infusion therapy by Medicare Advantage plans and
in the private sector and after consultation with all interested
stakeholders.
``(2) The items and services described in this paragraph are the
following:
``(A) Professional services, including nursing services
(other than nursing services covered as home health services),
provided in accordance with the plan (including administrative,
compounding, dispensing, distribution, clinical monitoring, and
care coordination services) and all necessary supplies and
equipment (including medical supplies such as sterile tubing
and infusion pumps).
``(B) Other items and services the Secretary determines
appropriate to administer infusion drug therapies to an
individual safely and effectively in the home.
``(3) For purposes of this subsection:
``(A) The term `home' means a place of residence used as an
individual's home and includes such other alternate settings as
the Secretary determines.
``(B) The term `qualified home infusion therapy supplier'
means any pharmacy, physician, or other provider licensed by
the State in which the pharmacy, physician, or provider resides
or provides services, whose State authorized scope of practice
includes dispensing authority and that--
``(i) has expertise in the preparation of
parenteral medications in compliance with enforceable
standards of the United States Pharmacopoeia and other
nationally recognized standards that regulate
preparation of parenteral medications as determined by
the Secretary and meets such standards;
``(ii) provides infusion therapy to patients with
acute or chronic conditions requiring parenteral
administration of drugs and biologicals administered
through catheters or needles, or both, in a home; and
``(iii) meets such other uniform requirements as
the Secretary determines are necessary to ensure the
safe and effective provision and administration of home
infusion therapy on a 7-day-a-week, 24-hour basis
(taking into account the standards of care for home
infusion therapy established by Medicare Advantage
plans and in the private sector), and the efficient
administration of the home infusion therapy benefit.
``(4) A qualified home infusion therapy supplier may subcontract
with a pharmacy, physician, provider, or supplier to meet the
requirements of paragraph (3)(B).''.
(b) Payment for Home Infusion Therapy.--Section 1834 of the Social
Security Act (42 U.S.C. 1395m) is amended by adding at the end the
following new subsection:
``(p) Payment for Home Infusion Therapy.--
``(1) In general.--The Secretary shall determine a per diem
schedule for payment for the professional services (including
nursing services), supplies, and equipment described in section
1861(iii)(2)(A) for each infusion therapy type that reflects
the reasonable costs which must be incurred by efficiently and
economically operated qualified home infusion therapy suppliers
to provide such services, supplies, and equipment in conformity
with applicable State and Federal laws, regulations, and the
uniform quality and safety standards developed under section
1861(iii)(1) and to assure that Medicare beneficiaries have
reasonable access to such therapy.
``(2) Considerations.--In developing the per diem schedule
under this subsection, the Secretary shall consider recent
credible studies about the costs of providing infusion therapy
in the home, consult with home infusion therapy suppliers,
consider payment amounts established by Medicare Advantage
plans and private payers for home infusion therapy, and, if
necessary, conduct a statistically valid national market
analysis involving the costs of administering infusion drugs
and of providing professional services necessary for the drugs'
administration.
``(3) Annual updates.--The Secretary shall update such
schedule from year to year by the percentage increase in the
Consumer Price Index for all urban consumers (United States
city average) for the 12-month period ending with June of the
preceding year. The Secretary may modify the per diem schedule
with respect to beneficiaries who qualify for home infusion
therapy services under section 1861(iii)(1) but who receive
nursing services as home health services.''.
(c) Conforming Amendments.--
(1) Payment reference.--Section 1833(a)(1) of the Social
Security Act (42 U.S.C. 13951(a)(1)) is amended--
(A) by striking ``and'' before ``(Z)''; and
(B) by inserting before the semicolon at the end
the following: ``, and (AA) with respect to home
infusion therapy, the amounts paid shall be determined
under section 1834(p)''.
(2) Direct payment.--The first sentence of section
1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6))
is amended--
(A) by striking ``and'' before ``(H)''; and
(B) by inserting before the period at the end the
following: ``, and (I) in the case of home infusion
therapy, payment shall be made to the qualified home
infusion therapy supplier''.
(3) Exclusion from durable medical equipment and home
health services.--Section 1861 of the Social Security Act (42
U.S.C. 1395x) is amended--
(A) in subsection (m)(5)--
(i) by striking ``and'' before ``durable
medical equipment'' and inserting a comma; and
(ii) by inserting before the semicolon at
the end the following: ``, and supplies used in
the provision of home infusion therapy after
excluding other drugs and biologicals''; and
(B) in subsection (n), by adding at the end the
following: ``Such term does not include home infusion
therapy, other than equipment and supplies used in the
provision of insulin.''.
(4) Application of accreditation provisions.--The
provisions of section 1865(a) of the Social Security Act (42
U.S.C. 1395bb(a)) apply to the accreditation of qualified home
infusion therapy suppliers in the same way as they apply to
other suppliers.
SEC. 4. MEDICARE COVERAGE OF HOME INFUSION DRUGS.
Section 1860D-2(e) of the Social Security Act (42 U.S.C. 1395w-
102(e)) is amended--
(1) in paragraph (1)--
(A) by striking ``or'' at the end of subparagraph
(A);
(B) by striking the comma at the end of
subparagraph (B) and inserting, ``; or''; and
(C) by inserting after subparagraph (B) the
following new subparagraph:
``(C) an infusion drug (as defined in paragraph
(5)),''; and
(2) by adding at the end the following new paragraph:
``(5) Infusion drug defined.--For purposes of this part,
the term `infusion drug' means a parenteral drug or biological
administered via an intravenous, intraspinal, intra-arterial,
intrathecal, epidural, subcutaneous, or intramuscular access
device or injection, and may include a drug used for catheter
maintenance and declotting, a drug contained in a device,
additives including but not limited to vitamins, minerals,
solutions, and diluents, and other components used in the
provision of home infusion therapy.''.
SEC. 5. ENSURING BENEFICIARY ACCESS TO HOME INFUSION THERAPY.
(a) Objectives in Implementation.--The Secretary of Health and
Human Services shall implement the Medicare home infusion therapy
benefit under the amendments made by this Act in a manner that ensures
that Medicare beneficiaries have timely and appropriate access to
infusion therapy in their homes and that there is rapid and seamless
coordination between drug coverage under part D of title XVIII of the
Social Security Act and coverage for home infusion therapy services
under part B of such title to avoid the filing of duplicative or
otherwise improper claims. Specifically, the Secretary shall ensure
that--
(1) the benefit is practical and workable with minimal
administrative burden for beneficiaries, qualified home
infusion therapy suppliers, physicians, prescription drug
plans, MA-PD plans, and Medicare Advantage plans, and the
Secretary shall consider the use of consolidated claims
encompassing covered part D drugs and part B services,
supplies, and equipment under such part B to ensure the
efficient operation of this benefit;
(2) any prior authorization or utilization review process
is expeditious, allowing Medicare beneficiaries meaningful
access to home infusion therapy;
(3) medical necessity determinations for home infusion
therapy will be made--
(A) except as provided in subparagraph (B), by
Medicare administrative contractors under such part B
and communicated to the appropriate prescription drug
plans; or
(B) in the case of an individual enrolled in a
Medicare Advantage plan, by the Medicare Advantage
organization offering the plan; and an individual may
be initially qualified for coverage for such benefit
for a 90-day period and subsequent 90-day periods
thereafter;
(4) except as otherwise provided in this section, the
benefit is modeled on current private sector coverage and
coding for home infusion therapy; and
(5) prescription drug plans and MA-PD plans structure their
formularies, utilization review protocols, and policies in a
manner that ensures that Medicare beneficiaries have timely and
appropriate access to infusion therapy in their homes.
(b) Report.--Not later than January 1, 2018, the Comptroller
General of the United States shall submit a report to Congress on
Medicare beneficiary access to home infusion therapy. Such report shall
specifically address whether the objectives specified in subsection (a)
have been met and shall make recommendations to Congress and the
Secretary of Health and Human Services on how to improve the benefit
and better ensure that Medicare beneficiaries have timely and
appropriate access to infusion therapy in their homes.
SEC. 6. EFFECTIVE DATE.
The amendments made by this Act shall apply to home infusion
therapy furnished on or after January 1, 2015.
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