[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>