Lymphedema Diagnosis and Treatment Cost Savings Act of 2010 - Amends title XVIII (Medicare) of the Social Security Act to extend coverage to lymphedema diagnosis and treatment services.
[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4662 Introduced in House (IH)]
111th CONGRESS
2d Session
H. R. 4662
To amend title XVIII of the Social Security Act to improve the
diagnosis and treatment of lymphedema under the Medicare Program and to
reduce costs under such program related to the treatment of
complications of lymphedema, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 23, 2010
Mr. Kissell 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 improve the
diagnosis and treatment of lymphedema under the Medicare Program and to
reduce costs under such program related to the treatment of
complications of lymphedema, 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 ``Lymphedema Diagnosis and Treatment
Cost Saving Act of 2010''.
SEC. 2. COVERAGE OF LYMPHEDEMA DIAGNOSIS AND TREATMENT SERVICES UNDER
MEDICARE.
(a) Coverage of Services.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x) is amended--
(1) in subsection (s)(2)--
(A) in subparagraph (DD), by striking ``and'' at
the end;
(B) in subparagraph (EE), by adding ``and'' at the
end; and
(C) by adding at the end the following new
subparagraph:
``(FF) lymphedema compression treatment items (as
described in subsection (iii)) and lymphedema diagnosis
and treatment services (as described in subsection
(hhh)) if such services are prescribed by and reviewed
by a treating physician and performed by such physician
or--
``(i) a physical therapist or an
occupational therapist who meets the quality
requirements of subsection (hhh)(2)(C);
``(ii) a qualified professional, such as a
physician, nurse practitioner, clinical nurse
specialist, chiropractor, or physician's
assistant who is licensed or certified by the
State in which the services are performed to
perform therapy services and who meets the
quality requirements of (hhh)(2)(C); or
``(iii) a qualified person, such as a
physical therapist assistant, occupational
therapy assistant, licensed massage therapist,
licensed practical nurse, or licensed home
health practitioner who meets the quality
requirements of (hhh)(2)(C) providing such
services are rendered under the direct
supervision of a physical therapist or
occupational therapist qualified in lymphedema
treatment and management who meets the quality
requirements of (hhh)(2)(C).''; and
(2) by adding at the end the following new subsections:
``(hhh) Lymphedema Diagnosis and Treatment Services.--(1) The term
`lymphedema diagnosis and treatment services' means, with respect to an
individual and consistent with paragraph (3), differential diagnosis
and treatment of lymphedema (regardless of cause) according to the
current standard of lymphedema diagnosis and treatment described in
paragraph (2)(A) by, or under the direction of, a health care
professional that is a certified provider as described in paragraph
(2)(B) in an outpatient setting and that meets the quality standards
described in paragraph (2)(C), but only if the physician who is
managing the individual's lymphedema certifies that such services are
needed under a comprehensive plan of care related to the individual's
diagnosed lymphedema.
``(2) For purposes of paragraph (1):
``(A) The current standard of lymphedema diagnosis and
treatment described in this subparagraph is such standard as
defined by the American Cancer Society and the International
Society of Lymphology and called `complex decongestive
therapy', a multi-modal therapy comprising manual lymph
drainage, compression therapy, exercise, and skin care. Such
standard consists of the initial phase of treatment which is
performed by qualified health care professionals on an
outpatient basis (Phase 1 treatment) and the continuing
maintenance phase (Phase 2 treatment) which is performed in a
home setting by the patient, patient's family, or patient's
aide after receiving instruction described in paragraph (5).
``(B) A qualified provider is a physician or lymphedema
therapist knowledgeable of the diagnosis and current medical
standard of treatment of lymphedema, or any other individual or
entity designated by the Secretary, that, in addition to
providing lymphedema outpatient self-management training
services (as defined in paragraph (3)(C)(iii)), provides other
items or services for which payment may be made under this
title.
``(C)(i) Subject to clause (ii), the quality standards
described in this subparagraph are quality standards
established by the Secretary equivalent to the practice
standards established by the Lymphology Association of North
America.
``(ii) In applying this subsection during the 3-year period
beginning on the date of the enactment of this subsection, a
therapist who has completed at least 135 hours of lymphedema
treatment training and is certified by the training school is
deemed to have met the requirement of clause (i), and may
practice under a certified provider within a plan of care
developed by the certified provider; regardless of whether the
therapist meets the experience standards established by the
Lymphology Association of North America.
``(D) The term `lymphedema diagnosis' means the
differential diagnosis of the source of the patient's edema and
the identification of the specific etiology in order to develop
the lymphedema treatment plan. Such term shall include
diagnostic tools such as the lymphoscintigraphic functional
test or other test the Secretary determines to be efficatious
to directly observe lymphatic system function may be indicated
if medical history or tests to rule out other causes are not
adequate to provide a clear positive diagnosis of lymphedema.
``(3) Coverage.--With respect to lymphedema diagnosis and treatment
services coverage under this part, the following shall apply:
``(A) Manual lymph drainage.--
``(i) Lymphedema diagnosis and treatment services
coverage under this part shall include an initial
course of manual lymph drainage as part of complete
decongestive therapy (Phase 1) when medically required
by the qualified provider described in paragraph
(2)(B).
``(ii) The schedule and number of manual lymph
drainage treatment sessions shall be determined by the
treating physician or lymphedema therapist as required
by medical necessity, and not the limits governing
rehabilitation therapy described in section 1833(g).
``(B) Compression binding systems, garments and devices.--
``(i) For purposes of this part, the materials and
aids used in lymphedema compression therapy--
``(I) while physically resembling items in
other benefit categories such as surgical
dressings, durable medical equipment, splints
and braces, orthotics and prosthetics described
in subsections (s)(5), (s)(6), and (s)(9), do
not serve the same medical function as such
items in such other categories and have
significantly different therapeutic
characteristics and uses; and
``(II) are specified in subsection (iii) as
a separate benefit category.
``(ii) Such coverage shall include any compression
garments, binding systems and devices described in
subsection (iii) deemed by the patient's qualified
caregiver to be medically necessary as part of the
treatment of lymphedema.
``(iii) Such coverage shall include replacements
when required to maintain their medically required
compressive function or to accommodate changes in the
patient's dimensions or medical condition.
``(C) Lymphedema self-management training.--
``(i) In general.--
``(I) The initial course of treatment
(phase 1) described in paragraph (2)(A), with
respect to such services, shall include
training of the patient and an aide or family
member as required to perform self-treatment in
a home setting, including any of the following
home treatment modalities which are determined
by the qualified provider to be medically
required and are a part of the continuing
maintenance phase (phase 2) home treatment plan
described in paragraph (2)(A):
``(aa) Self-manual lymph drainage
(simple lymph drainage).
``(bb) Compression bandaging.
``(cc) Donning and care of
compression garments.
``(dd) Performance of an
appropriate decongestive exercise
program.
``(ee) Use of specialized manually
adjustable compression devices, donning
aids, and other required ancillary
equipment; and if medically indicated.
``(ff) Use of sequential gradient
compression pneumatic pump.
``(II) As part of such treatment, patient
training shall include instruction on periodic
self-measurements, skin care, indications of
infection, and the steps to be taken if
infection occurs.
``(III) The term `lymphedema outpatient
self-management training services' means
educational and training services furnished to
an individual diagnosed with lymphedema by a
certified provider (as described in paragraph
(2)(B)) in an outpatient setting but only if
the physician who is managing the individual's
lymphedema condition certifies that such
services are needed under a comprehensive plan
of care related to the individual's lymphedema
condition.
``(ii) Consultation with organizations in
establishing payment amounts for services provided by
physicians.--In establishing payment amounts under
section 1848 for physicians' services consisting of
lymphedema outpatient self-management training
services, the Secretary shall consult with appropriate
organizations, including such organizations
representing individuals or Medicare beneficiaries with
lymphedema, in determining the relative value for such
services under section 1848(c)(2).
``(D) Measurements to define treatment efficacy.--Periodic
measurements shall be made to enable evaluation of the efficacy
of the treatment plan and patient adherence, to modify the
treatment plan or to determine the need for follow-up courses
of treatment.
``(E) Follow-up treatment.--Such coverage shall provide for
follow-up treatments whenever medically required to
periodically validate home techniques, to monitor progress
against the written treatment plan, and to modify the treatment
plan as required.
``(F) Denial.--No individual other than a licensed
physician or certified lymphedema therapist competent to
evaluate the specific clinical issues involved in the care
requested, may deny or modify requests for authorization of
health care services or materials described in subsection (iii)
pursuant to this subsection.
``(G) Prohibition of additional treatment fees.--No
additional fees or deductibles may be assessed, with respect to
such treatment, for compliance with this title other than
assessed for similar medical services.
``(iii) Lymphedema Compression Treatment Items.--
``(1) Definition.--The term `lymphedema compression
treatment item' means compression therapy materials and
supplies used daily in the medical treatment of lymphedema upon
prescription of the treating physician or therapist,
including--
``(A) compression binding systems comprising, as
medically required, short-stretch and medium-stretch
compression bandages; cotton, synthetic, or foam
padding; gauze or elastic finger and toe bandages; foam
pads; and tubular bandages;
``(B) compression garments and compression pads for
compression treatment of lymphedematous arms, legs,
torso, face and neck, breast and chest, abdomen, and
genitalia;
``(C) manually-adjustable compression sleeves and
padded directional flow sleeves for use on upper and
lower limbs;
``(D) orthotic shoes; and
``(E) donning aids, bandage rollers, and other
specialized items used with the items described in
subparagraphs (A) through (D).
``(2) Special requirement on lymphedema pumps.--Such term
shall include a pneumatic pump for the treatment of lymphedema
only if the treating physician or therapist's prescription for
such pump is accompanied by a certificate of medical necessity
which specifies as a minimum--
``(A) the differential diagnosis of lymphedema and
any related co-conditions such as venous insufficiency,
peripheral arterial disease, lipedema, morbid obesity,
myxedema, and any other condition which may be
significant in the selection of a type, specification,
and usage of the pump; and
``(B) the physician's or therapist's judgement of
the type and specifications of the pump based on the
patient's medical necessity.''.
(b) Payment.--
(1) Lymphedema outpatient self-management training services
included as physicians' services.--Section 1861(s)(2)(S) of
such Act (42 U.S.C. 1395x(s)(2)(S)) is amended by inserting
``and lymphedema outpatient self-management training services
under subsection (hhh)(3)(C)'' after ``subsection (qq))''.
(2) Lymphedema compression treatment items.--
(A) In general.--Section 1833(a) of such Act (42
U.S.C. 1395l(a)) is amended--
(i) in paragraph (8), by striking at the
end ``and'';
(ii) in paragraph (9), by striking at the
end the period and inserting a semi-colon; and
(iii) by adding at the end the following
new paragraph:
``(10) in the case of lymphedema compression treatment
items described in section 1861(iii), the amount determined
under section 1834(n); and''.
(B) Payment determined.--Section 1834 of such Act
(42 U.S.C. 1395m) is amended by adding at the end the
following new subsection:
``(n) Payment for Lymphedema Compression Treatment Items.--
``(1) General rule for payment.--
``(A) In general.--With respect to a lymphedema
compression treatment item described in section
1861(iii) for which payment is determined under this
subsection, subject to subparagraph (D), payment shall
be made in an amount equal to 80 percent of the payment
basis described in subparagraph (B).
``(B) Payment basis.--The payment basis described
in this subparagraph, with respect to a lymphedema
compression treatment item described in section
1861(iii), is the actual charge for the item.
``(C) Exclusive payment rule for home health
agencies.--This subsection shall constitute the
exclusive provision of this title for payment for
lymphedema compression treatment items described in
section 1861(iii) under this part or under part A to a
home health agency.
``(D) Exceptions.--
``(i) Subparagraph (B) shall not apply to
an item furnished by a public home health
agency (or by another home health agency which
demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low income) free of charge or at
nominal charges to the public.
``(ii) Subparagraph (B) shall not apply to
items that are furnished as an incident to a
physician's professional service.
``(2) Special payment rules.--
``(A) Allowable items.--To be eligible for payment
under this subsection, an item described in section
1861(iii) must--
``(i) be ordered by a qualified physician
or lymphedema therapist for treatment of
diagnosed lymphedema;
``(ii) primarily and customarily be used to
serve a medical purpose;
``(iii) generally not be useful to a person
in the absence of an illness or injury; and
``(iv) be appropriate for use in the home.
``(B) Allowable quantities.--In the case it is
determined by the qualified physician or qualified
lymphedema therapist involved that compression therapy
demands daily compression as part of lymphedema
treatment according to section 1861(hhh)(1), then
payment may be made in accordance with this subsection
for the following quantities--
``(i) in the case of compression binding
systems described in section 1861(iii)(1)(A), 2
sets for each affected body part;
``(ii) in the case of compression garments
described in section 1861(iii)(1)(B), 2
garments for each affected body part;
``(iii) in the case of compression devices
described in section 1861(iii)(1)(C), 1 each
for each affected body part; and
``(iv) in the case of compression therapy
aids described in section 1861(iii)(1)(D), as
determined by the qualified physician or
qualified lymphedema therapist.
``(C) Allowable use.--Payment may be made under
this subsection for a lymphedema compression treatment
item described in section 1861(iii) only if such item--
``(i) is prescribed by a certified provider
as defined in section 1861(hhh)(2)(B);
``(ii) is used as part of a lymphedema
treatment plan described in section
1861(hhh)(1);
``(iii) is used by a patient who has been
instructed in lymphedema self-management
described in section 1861(hhh)(5); and
``(iv) is used to treat a diagnosed
condition of chronic lymphedema.
``(D) Compression range.--The lymphedema
compression treatment items for which payment may be
made under this section must provide a compression no
less than 30mmHg and no greater than 60mmHg.
``(E) Qualified fitters.--The lymphedema
compression treatment items for which payment may be
made under this section must be measured and fitted by
a qualified fitter who is an individual who--
``(i) is a qualified lymphedema therapist,
as defined in section 1834(o)(2), who meets the
quality standards of section 1861(hhh)(2)(C);
``(ii) in the case of a State that provides
for the licensing of orthotists and
prosthetists, is licensed in orthotics or
prosthetics by the State in which the item is
supplied;
``(iii) in the case of a State that does
not provide for the licensing of orthotists and
prosthetists, is specifically trained and
educated to provide or manage the provision of
prosthetics and custom-designed or -fabricated
orthotics, and is certified by the American
Board for Certification in Orthotics and
Prosthetics, Inc. or by the Board for
Orthotist/Prosthetist Certification, or is
credentialed and approved by a program that the
Secretary determines, in consultation with
appropriate experts in orthotics and
prosthetics, has training and education
standards that are necessary to provide such
prosthetics and orthotics; or
``(iv) is certified by the qualified
manufacturer of the item to be qualified to fit
the particular garment or device.
``(F) Requirements for suppliers of compression
therapy items.--A supplier of the lymphedema
compression treatment items described in this
subsection must meet the requirements of section
1834(j) in order to receive payment under this
subsection.
``(3) Replacement of compression therapy items.--
``(A) In general.--Payment shall be made under this
subsection, with respect to an individual, for the
replacement of compression bindings, compression
garments, or compression devices if an ordering
physician determines that the provision of a
replacement item, or repair of such an item, is
necessary because of any of the following:
``(i) A change in the physiological or
medical condition of the individual.
``(ii) A loss of required compression of
the item that is not restorable by washing and
drying.
``(iii) An irreparable change in the
condition of the device, or in a part of the
device.
``(B) Length of reasonable useful lifetime.--The
reasonable useful lifetime of a lymphedema compression
treatment item described in section 1861(iii) shall be
as follows, except that, if the Secretary determines
that, on the basis of prior experience in making
payments for such an item under this title, such
lifetimes are no longer appropriate with respect to a
particular item, the Secretary shall establish an
alternative reasonable lifetime for such item:
``(i) Compression binding kit.--In the case
of compression binding systems described in
section 1861(iii)(1)(A), the greater of 6
months or per manufacturer's warrantee.
``(ii) Compression garments.--In the case
of compression garments described in section
1861(iii)(1)(B), the greater of 4 months or per
manufacturer's warrantee.
``(iii) Compression devices.--In the case
of compression devices described in section
1861(iii)(1)(C), the greater of 3 years or per
manufacturer's warrantee.
``(iv) Aids.--In the case of compression
therapy aids described in section
1861(iii)(1)(D), as required to maintain
functional usefulness.''.
(C) Supplier requirements.--Section 1834(j)(5) of
such Act (42 U.S.C. 1395m(j)(5)) is amended--
(i) in subparagraph (E), by striking at the
end ``and'';
(ii) in subparagraph (F), by striking at
the end the period an inserting ``; and''; and
(iii) by adding at the end the following
new subparagraph:
``(G) lymphedema compression treatment items (as
described in section 1861(iii)).''.
(3) Lymphedema diagnosis and treatment services.--
(A) In general.--Section 1833(a) of such Act, as
amended by paragraph (2)(A), is further amended by
adding at the end the following new paragraph:
``(11) with respect to lymphedema diagnosis and treatment
services (as defined in subsection (hhh)(1))--
``(A) furnished by a qualified physical therapist
or qualified occupational therapist, as defined in
section 1834(o)(2)(A), the amounts described in section
1834(k); or
``(B) furnished by a lymphedema therapist, as
defined by 1834(o)(2)(B), under direction of a
qualified physical therapist or qualified occupational
therapist, the amounts described in section 1834(o).''.
(B) Payment method.--Section 1834 of such Act, as
amended by paragraph (2)(B), is further amended by
adding at the end the following new subsection:
``(o) Payment for Outpatient Lymphedema Diagnosis and Treatment
Services.--
``(1) In general.--For purposes of section 1833(a)(11)(B),
in the case of lymphedema diagnosis and treatment services
described in section 1861(hhh) for which payment is determined
under this subsection and that are performed by a qualified
lymphedema therapist (as defined in paragraph (2)) under the
direction of a qualified physician therapist or qualified
occupational therapist, the payment basis shall be 80 percent
of the lesser of--
``(A) the actual charge for the service; or
``(B) the applicable fee schedule amount (as
defined in paragraph (3)) for the services.
``(2) Qualified therapists.--For purposes of this
subsection:
``(A) In general.--The term `qualified', with
respect to a physical therapist, occupational
therapist, or lymphedema therapist, means that the
physical therapist, occupational therapist, or
lymphedema therapist meets the quality requirements
described in section 1861(hhh)(2)(C).
``(B) Lymphedema therapist.--The term `lymphedema
therapist' means any of the following individuals so
long as such individual is legally authorized to
practice by the State in which the lymphedema diagnosis
and treatment service involved is performed and meets
the quality requirements described in subparagraph (A):
``(i) A registered nurse, nurse
practitioner, family nurse practitioner or
clinical nurse specialist (as described in
section 1861(aa)(5)).
``(ii) A doctor of medicine or doctor of
osteopathy (as described in section 1861(r)(1).
``(iii) A physician assistant (as described
in section 1861(aa)(5)).
``(iv) A chiropractor.
``(v) A licensed massage therapist.
``(vi) A licensed home health practitioner.
``(3) Applicable fee schedule amount.--In this subsection,
the term `applicable fee schedule amount' means, with respect
to services furnished in a year, the amount determined under
the fee schedule established under section 1848 for such
services furnished during the year or, if there is no such fee
schedule established for such services, the amount determined
under the fee schedule established for such comparable services
as the Secretary specifies.
``(4) Uniform coding.--For claims for services for which
the amount of payment is determined under this subsection, the
claim shall include a code (or codes) under a uniform coding
system specified by the Secretary that identifies the services
furnished.
``(5) Restraint on billing.--The provisions of
subparagraphs (A) and (B) of section 1842(b)(18) shall apply to
lymphedema diagnosis and treatment services for which payment
is made under this subsection in the same manner as they apply
to services provided by a practitioner described in section
1842(b)(18)(C), except that in applying such subparagraphs the
practitioner described shall be any practitioner described in
paragraph (2)(B).''.
(C) Exclusion from certain therapy services.--
Section 1833(g)(4) of such Act (42 U.S.C. 1395l(g)(4))
is amended by inserting ``or to expenses incurred with
respect to lymphedema diagnosis and treatment services
(as defined in subsection (hhh)(1))'' before the period
at the end.
(c) Effective Date.--The amendments made by this section shall
apply to items and services furnished on or after the date that is 90
days from the date of the enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to House Energy and Commerce
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.
Referred to House Ways and Means
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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