1.This Act may be cited as the
Medicare Home Infusion Therapy
Coverage Act of 2009
.
2.Medicare coverage
of home infusion therapy
(a)Section 1861 of the Social Security Act (42 U.S.C.
1395x), as amended by section 152(b) of the Medicare Improvements for Patients
and Providers Act of 2008 (Public Law 110–275), is amended—
(1)in subsection
(s)(2)—
(A)by striking
and
at the end of subparagraph (DD);
(B)by adding
and
at the end of subparagraph (EE); and
(C)by adding at the
end the following new subparagraph:
(FF)home infusion
therapy (as defined in subsection
(hhh)(1));
;
and
(2)by adding at the
end the following new subsection:
(hhh)(1)The term home
infusion therapy means the following items and services furnished to an
individual, who is under the care of a physician, which are provided by a
qualified home infusion therapy provider 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 (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) and in coordination with
the provision of covered infusion drugs under part D:
(A)Professional services other than
nursing 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, and other items and
services the Secretary determines appropriate) to administer infusion drug
therapies to an individual safely and effectively in the home.
(B)Nursing services provided in
accordance with the plan, directly by a qualified home infusion therapy
provider or under arrangements with an accredited homecare organization, in
connection with such infusion, except that such term does not include nursing
services to the extent they are covered as home health services.
(2)For purposes of paragraph (1):
(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 provider 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 U.S.
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.
A
qualified home infusion therapy provider may subcontract with a pharmacy,
physician, provider, or supplier to meet the requirements of this
subsection..
(b)Payment for home
infusion therapySection 1834 of the Social Security Act (42
U.S.C. 1395m) is amended by adding at the end the following new
subsection:
(n)Payment for home
infusion therapyThe payment amount under this part for home
infusion therapy is determined as follows:
(1)The Secretary shall determine a per diem schedule for
payment for the professional services, supplies, and equipment described in
section 1861(hhh)(1)(A) that reflects the reasonable costs which must be
incurred by efficiently and economically operated qualified home infusion
therapy providers 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(hhh)(1) and to assure
that Medicare beneficiaries have reasonable access to such therapy. 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.
(2)The Secretary shall develop a methodology for the
separate payment for nursing services described in section 1861(hhh)(1)(B)
provided in accordance with the plan under such section which reflects the
reasonable costs incurred in the provision of nursing services in connection
with infusion therapy in conformity with State and Federal laws, regulations,
and the uniform quality and safety standards developed pursuant to this Act and
to assure that Medicare beneficiaries have reasonable access to nursing
services for infusion therapy. 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.
.
(c)
(1)Section 1833(a)(1) of the Social Security Act (42
U.S.C. 13951(a)(1)), as amended by section 101(a)(2) of the Medicare
Improvements for Patients and Providers Act of 2008 (Public Law 110–275), is
amended—
(A)by striking
and
before (W)
; and
(B)by inserting
before the semicolon at the end the following: , and (X) with respect to
home infusion therapy, the amounts paid shall be determined under section
1834(n)
.
(2)The first sentence of section 1842(b)(6) of such 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 provider
.
(3)Exclusion from
durable medical equipment and home health servicesSection 1861
of such Act (42 U.S.C. 1395x) is amended—
(A)in subsection (m)(5), by inserting
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 provisionsThe provisions of section 1865(b) of the
Social Security Act (42 U.S.C. 1395bb(b)) apply to the accreditation of
qualified home infusion therapy providers in the manner they apply to other
suppliers.
3.Medicare coverage
of home infusion drugs
(a)Section 1860D–2(e)(1) of the Social Security Act (42
U.S.C. 1395w–102(e)(1)), as amended by section 182 of the Medicare Improvements
for Patients and Providers Act of 2008 (Public Law 110–275), 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
before the flush matter following 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)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 inserted into the body,
and includes a drug used for catheter maintenance and declotting, a drug
contained in a device, vitamins, intravenous solutions, diluents and minerals,
and other components used in the provision of home infusion
therapy.
.
(b)Infusion drug
formulariesFor the first 2 years after the effective date of
this Act, notwithstanding any other provision of law, prescription drug plans
and MA–PD plans under title XVIII of the Social Security Act shall maintain
open formularies for infusion drugs (as defined in section 1860D–2(e)(5) of
such Act, as added by subsection (a)). The Secretary of Health and Human
Services shall request the United States Pharmacopeia to develop, in
consultation with representatives of qualified home infusion therapy providers
and other interested stakeholders, a model formulary approach for home infusion
drugs for use by such plans after such 2-year period.
(c)Section 1860D–2(d)(1)(B) of the Social Security Act (42
U.S.C. 1395w–102(d)(1)(B)) is amended by inserting after any dispensing
fees for such drugs
the following: , other than for an infusion
drug
.
4.Ensuring
beneficiary access to home infusion therapy
(a)Objectives in
implementationThe 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. Specifically, the Secretary shall ensure
that—
(1)the benefit is
practical and workable with minimal administrative burden for beneficiaries,
qualified home infusion therapy providers, 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)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)Home infusion
therapy advisory panelIn implementing such home infusion therapy
benefit and meeting the objectives specified in subsection (a), the Secretary
shall establish an advisory panel to provide advice and recommendations. Such
panel shall—
(1)be comprised
primarily of qualified home infusion therapy providers and their representative
organizations;
(2)also include
representatives of the following:
(1)Patient
organizations.
(2)Hospital discharge
planners, care coordinators, or social workers.
(3)Prescription drug
plan sponsors and Medicare Advantage organizations.
(c)Not
later than January 1, 2012, and every 2 years thereafter, the Comptroller
General of the United States shall submit a report to Congress on Medicare
beneficiary access to home infusion therapy. Each such report shall
specifically address whether the objectives specified in subsection (a) have
been met and shall make recommendations to Congress and the Secretary on how to
improve the benefit and better ensure that Medicare beneficiaries have timely
and appropriate access to infusion therapy in their homes.
5.The amendments made by
this Act shall apply to home infusion therapy furnished on or after January 1,
2010.