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Proposed Lymphedema Treatment Cost Saving Bill of 2005

S. (TBD) or H.R. (TBD)

To amend title XVIII of the Social Security Act to diagnose and treat individuals with and at risk for lymphedema according to current medical treatment standards with the goal of reducing total healthcare costs through avoidance of periodic infections and disabilities resulting from this medical condition, and to conform other acts to this Act.

(TBD) introduced the following bill:


     to provide diagnosis and treatment of individuals with and at risk for lymphedema according to current medical treatment standards with the goal of reducing total healthcare costs through avoidance of periodic infections, pain and disabilities resulting from this medical condition;
     to enhance quality of lymphedema patient care by providing therapist qualification requirements;
     to provide for informed consent of patients requiring surgery and radiotherapy of the relative risks of lymphedema for alternate treatments considered;
     to provide for lymphedema patient education in the procedures for self-treatment so as to transfer the treatment from the clinical to the home setting; and
     to encourage patient self-treatment plan compliance by providing necessary medical supplies for use at home.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,


This Act may be cited as the "Lymphedema Treatment Cost Saving Act of 2005"


This Act amends Title XVIII of the Social Security Act, specifically to:
add lymphedema diagnosis and treatment services to the scope of Part B services in section 1832 [42 U.S.C. 1395k];
define the newly added services in section 1861 [42 U.S.C. 1395x];
add a new benefits category for compression therapy medical items to section 1861 [42 U.S.C. 1395x];
add lymphedema patient training to section 1861 [42 U.S.C. 1395x];
provide payment rules for compression therapy items to Section 1834 [42 U.S.C. 1395m] and for therapist services to Section 1833 [42 U.S.C. 1395l];


TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED of the Social Security Act is amended as follows:

(a). LYMPHEDEMA TREATMENT COVERAGE of costs of diagnosis and treatment of lymphedema from all sources.


Section 1832 [42 U.S.C. 1395k] is amended in subsection (a)(2)--
          (A) by striking "and" at the end of subparagraph (I); and
          (B) by replacing "." with ";" at the end of subparagraph (J); and
          (C) by adding "and" at the end of subparagraph (J); and
          (D) by adding at the end the following new subparagraph:

"(K) lymphedema diagnosis and treatment services for treatment of lymphedema from all causes (as described in section 1861 (ww)) and coverage of medically-necessary lymphedema compression treatment items (as described in section 1861 (s)(18))."

     (2) DEFINITIONS--Section 1861 [42 U.S.C. 1395x] is amended

          (A) PATIENT EDUCATION AND TRAINING--in subsection (s)(2)(S)--
               (i) by adding "and lymphedema" after "diabetes"; and
               (ii) by adding "and subsection (ww)" after " subsection (qq)"; and
          (B) LYMPHEDEMA DIAGNOSIS AND TREATMENT SERVICES--by adding at the end the following new subsection:

"Lymphedema Diagnosis and Treatment Services

"(ww)(1) LYMPHEDEMA DIAGNOSIS AND TREATMENT SERVICES-- The term "lymphedema diagnosis and treatment services" means treatment according to current medical standards of lymphedema treatment (i.e. "complex decongestive therapy") described in paragraph (2)(A) by, or under the direction of, a certified provider as described in paragraph (2)(B) in an outpatient setting by an individual or entity who meets the quality standards described in paragraph (2)(C) and (2)(D), 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 diagnosed lymphedema condition.

     (2) DEFINITIONS In paragraph (1)

          (A) The current standard of lymphedema diagnosis and treatment as defined by the American Cancer Society and the International Society of Lymphology is called "complex decongestive therapy", a multi-modal therapy comprising manual lymph drainage, compression therapy, exercise and skin care. The initial phase of treatment is performed by medical personnel on an outpatient basis (Phase 1 treatment) and the continuing (maintenance) phase (Phase 2 treatment) is performed in a home setting by the patient or patient's aide after receiving instruction described in (5); and

          (B) a "certified provider" is a qualified physician knowledgeable of the diagnosis and current medical standard of treatment of lymphedema, or other individual or entity designated by the Secretary, that, in addition to providing lymphedema outpatient self-management training services, provides other items or services for which payment may be made under this title; and

          (C) a physician, or such other individual or entity, meets the "quality standards" described in this paragraph if the physician, or individual or entity, meets quality standards established by the Secretary, provided that the physician or other individual or entity meets applicable standards originally established by the Lymphology Association of North America and subsequently revised by organizations who participated in the establishment of standards by such organization, or is recognized by an organization such as the National Lymphedema Network that represents individuals (including individuals under this title) with lymphedema as meeting standards for furnishing the services; and

          (D) notwithstanding the scope of practice of a treating therapist, or such other individual or entity, the quality standard is not deemed to be met unless the treating therapist meets the standards defined in (2)(C); and

          (E) no individual, other than a licensed physician and surgeon competent to evaluate the specific clinical issues involved in the care requested, may deny requests for authorization of health care services or materials pursuant to this section (as described in section 1861 (s)(18)); and

          (F) the term “lymphedema diagnosis” refers to 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. Diagnostic tools such as the lymphoscintigraphic function test to directly observe lymphatic system function may be indicated when medical history or tests to rule out other causes are not adequate to provide a clear positive diagnosis of lymphedema.


          (A) Covered treatment shall include an initial course of manual lymph drainage (MLD) as part of complete decongestive therapy (Phase 1) when medically required by the certified provider defined in (2)(B); and

          (B) MLD may be performed by physical therapists, occupational therapists, massage therapists, physicians or nurses licensed or certified by the appropriate governing board to perform treatments for lymphedema as defined in (2)(C) and (2)(D); and

          (C) The schedule and number of manual lymph drainage treatment sessions shall be determined by the treating physician or therapist as required by medical necessity, and not the limits governing rehabilitation therapy described in section 1833 (g).


          (A) The materials and aids used in lymphedema compression therapy, while physically resembling items in other benefits categories such as surgical dressings, durable medical equipment, orthotics and prosthetics described in sections 1861 (s)(5), (s)(6) and (s)(9), do not serve the same function. Their therapeutic characteristics and use differ significantly, and they are specified in section 1861(s)(18) as a separate benefit category; and
          (B) Coverage shall include any compression garments, binding systems and devices (described in 1861(s)(18)) deemed by the patient's qualified caregiver to be medically necessary; and
          (C) Replacements are provided when required to maintain their medically required compressive function or to accommodate changes in the patient's dimensions or medical condition.


          (A) Initial course of treatment (Phase 1) shall include training of the patient to perform self-treatment in a home setting, including any of the following home treatment modalities which are determined by the provider to be medically required and are a part of the written Phase 2 home treatment plan:

               (i) self-manual lymph drainage; and
               (ii) bandaging; and
               (iii) donning and care of compression garments; and
               (iv) an appropriate decongestive exercise program; and
               (v) use of specialized manually adjustable compression devices, donning aids, and other       required  ancillary equipment; and if medically indicated
               (vi) use of sequential compression pneumatic pump.

          (B) Patient training shall include instruction on periodic self-measurements, skin care, indications of infection and the steps to be taken if infection occurs.

          (C) 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 by an individual or entity who meets the quality standards described in paragraph (2)(C and (2)(D)), 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 to provide the individual with necessary skills and knowledge (including skills related to the self-administration of manual lymph drainage and donning of compression bandage systems and compression garments) to participate in the management of the individual's condition.


 Periodic measurements shall be made to insure the efficacy of the treatment plan and patient compliance, and be used to modify the treatment plan or to determine the need for follow-up courses of treatment.


 Coverage shall be provided 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.


 No additional fees or deductibles may be assessed for compliance with this statute other than already exist in the coverage contract for similar medical services.


 Patients undergoing any surgery or radiotherapy procedure shall be given information on the risk of lymphedema associated with that procedure, and the potential post-procedure symptoms of lymphedema. Informed consent agreements for all surgeries and radiation therapies shall include information on the risks of lymphedema associated with the alternative procedures.


 In establishing payment amounts under section 1848 of the Social Security Act for physicians' services consisting of lymphedema outpatient self-management training services, the Secretary of Health and Human Services 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) of such Act."


in subsection(s)--
               (i) by replacing "." with ";" at the end of subparagraph (17)(B); and
               (ii) by adding at the end the following new subsection:

"(18) 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- and medium-stretch compression bandages; cotton, synthetic or foam padding; gauze or elastic finger and toe bandages; foam pads; and tubular bandages; and
     (B) compression garments and compression pads for compression treatment of lymphedematous arms, legs, torso, face and neck, abdomen and genitalia; and
     (C) manually-adjustable compression sleeves and padded sleeves for use on upper and lower limbs."


Section 1833 [42 U.S.C. 1395l] is amended


in subsection (a)(1)
               (i) by deleting the ";" at the end of the subsection; and
               (ii) by adding the text ", (V) with respect to lymphedema compression therapy items described in section 1861(s)(18) the amount paid shall be determined under section 1834(n);" at the end of the section; and

          (B) OUTPATIENT THERAPY SERVICESin subsection (a)(8)--
               (i) by adding the following new paragraph after paragraph (B):

          (C) outpatient lymphedema therapy services furnished by a qualified lymphedema therapist (defined in sections 1861(ww)(1) and (ww)(2); and" ; and

          (C) in subsection (a)--
               (i) by replacing "." with "; and" at the end of subparagraph (9); and
               (ii) by adding the following new subsection:
"(10) in the case of services described in section 1832(a)(2)(K), the amounts described in section 1834(k)."; and

          (D) in subsection (g)--
               (i) by adding new subparagraph as follows:
"(5) This subsection shall not apply to expenses incurred with respect to lymphedema treatment services described in section 1861(ww)."


Section 1834 [42 U.S.C. 1395m] is amended

          (A) PAYMENT FOR LYMPHEDEMA COMPRESSION THERAPY ITEMS--by the addition of new subsection (n) after subsection (m) as follows:


          (A) IN GENERAL.--With respect to a covered item (as defined in section 1861(s)(18)) for which payment is determined under this subsection, 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 is the actual charge for the item.

          (C) EXCLUSIVE PAYMENT RULE.--This subsection shall constitute the exclusive provision of this title for payment for covered items 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) Paragraph (B) shall not apply to items that are furnished as an incident to a physician's professional service.

          (A) ALLOWABLE ITEMS.--Items allowable (described in section 1861(s)(18)) under this section must meet all the requirements for durable medical equipment except for durability and rentability, i.e.:
               (i) The item meets the definition of DME in subsection (iv); and
               (ii) The item is necessary and reasonable for the treatment of a patient's illness or injury or to improve the functioning of a malformed body member; and
               (iii) The equipment is used in the patient's home.
               (iv) DME includes items which:
                    (I) can withstand repeated use, and
                    (II) is primarily and customarily used to serve a medical purpose, and
                    (III) generally is not useful to a person in the absence of an illness or injury, and
                    (IV) is appropriate for use in the home.

          (B) ALLOWABLE QUANTITIES--When it is determined that compression therapy demands daily compression as part of lymphedema treatment according to section 1861(ww)(1) , then the following quantities are covered:
               (i) compression binding systems (described in section 1861(s)(18)(A)--2 sets; and
               (ii) compression garments (described in section 1861(s)(18)(B)--2 garments; and
               (iii) compression devices (described in section 1861(s)(18)(C)--1 each.

          (C) ALLOWABLE USE.--The compression items described in this section are coverable only:

               (i) when prescribed by a certified provider as defined in section 1861(ww)(2)(B); and

               (ii) when used as part of a lymphedema treatment plan as described in section 1861(ww)(1); and
               (iii) is used by a patient who has been instructed in lymphedema self-management as described in section 1861(ww)(5); and

              (iv) is used to treat a diagnosed condition of chronic lymphedema.


The compression items coverable under this section must provide a compression no less than 30mmHg and no greater than 60mmHg.

          (E) QUALIFIED FITTERS.The compression items coverable under this section must be measured and fitted by a qualified fitter who is an individual who--                   
                    (i) is a qualified lymphedema therapist who meets the quality standards of section 1861(ww)(2)(C); or
                    (ii) in the case of a State that provides for the licensing of orthotics and prosthetics, is licensed in orthotics or prosthetics by the State in which the item is supplied; or
                    (iii) in the case of a State that does not provide for the licensing of orthotics and prosthetics, 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 to fit the particular garment or device.

          (F) REQUIREMENTS FOR SUPPLIERS OF COMPRESSION THERAPY ITEMS-- The suppliers of the compression therapy items described in this subsection must meet the requirements of section 1834(j).

          (A) IN GENERAL

Payment shall be made 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 patient;
               (ii) A loss of required compression of the item that is not restorable by washing and drying; or
               (iii) An irreparable change in the condition of the device, or in a part of the device.


The reasonable useful lifetime of an item of durable medical equipment under this subparagraph 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, the lifetimes below 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-- six months or per manufacturer's warrantee
               (ii) Compression garments--four months or per manufacturer's warrantee
               (iii) Compression devices--3 years or per manufacturer's warrantee"
          (B) Section 1834 [42 U.S.C. 1395m] is amended in subsection (j)(5)--
               (i) by replacing "." with "; and" at the end of ubparagraph (5)(F); and
               (ii) by adding the following new subparagraph:
"(G) compression therapy items (as described in section 1861(s)(18))."


The amendments made by this section shall apply to items and services furnished on or after July 1, 2005.


Version 5.5
25 April 2004

Please communicate any comments or changes to:
Robert Weiss, Lymphedema Treatment Advocate
10671 Baton Rouge Avenue
Northridge, CA 91326

Tel: 818-368-6340
Fax: 818-368-6432




Lymphedema is a swelling of a limb and/or other part of the body because of a functional inability of the lymphatic system to transport intercellular lymphatic fluid back to the circulatory system. Lymphatic fluid becomes stagnant, leaving the patient prone to infection. When infection occurs it progresses with uncommon rapidity, many patients requiring immediate emergency treatment with antibiotics and costly hospitalization. Lymphedema can affect arms, legs, breast, back, side, face, neck, abdomen, groin and genitalia as well as internal organs.

     (1) Congenital (primary) lymphedema, caused by a malformed or underdeveloped lymphatic system, can be present at birth, develop at puberty (lymphedema praecox), or occur at older ages (lymphedema tarda).

     (2) Secondary lymphedema can result from blunt trauma, surgical procedure, radiation, infection, parasites or disease involving the lymphatic system. The greatest incidence of secondary lymphedema in the United States occurs in cancer treatment survivors (breast, melanoma, sarcoma, gynecological, prostate).

     (3) Other common non-cancer-related causes of lymphedema are vein-harvesting surgery associated with cardiac artery by-pass procedures and abdominal, hip and knee replacements.


     (1) There are more than 9,600,000 individuals in the United States today who are cancer survivors (living with, through, and beyond cancer).

     (2) 61 percent of cancer survivors are 65 years of age and older.

     (3) 30 percent of all breast cancer axillary node dissection and inguinal node dissection patients will develop lymphedema over their lifetime.

     (4) In the entire United States, of the 203,500 newly diagnosed cases of breast cancer projected for YR2002, 61,000 will develop lymphedema! Also requiring treatment are the survivors of uterine and cervical cancer, prostate cancer and melanoma treatment, adding an estimated 88,500 new lymphedema patients requiring treatment in 2002. (American Cancer Society Facts and Figures 2002.)

     (5) The above estimated 149,000 new cases of lymphedema will be added to the 2-5 millions of existing diagnosed and undiagnosed cases of primary and secondary lymphedema.


Treatment procedures have been developed in Europe over the last 30 years, and have been accepted by American medicine for the last 10 years. 

     (1) The current standard of treatment for lymphedema is called complex (or complete) decongestive therapy (CDT) and has been the recommended lymphedema treatment protocol in Europe since 1995 (International Society of Lymphology) and in the U.S. since 1998 (American Cancer Society Lymphedema Workshop, Cancer Supplement December 15, 1998, Volume 83, Number 12. ) CDT comprises a number of interrelated treatment modalities that are most efficacious when utilized in an interdependent fashion.

     (2) Complex decongestive therapy for the acute treatment program (Phase 1) consists of manual lymph drainage, short-stretch bandaging, remedial exercise, skin care, and instruction on self massage and home maintenance, including the fitting and procurement of compression garments, bandages and devices. Pneumatic compression pumps may be beneficial as an adjunct to CDT but should never be used in its absence. Treatment duration and frequency for the acute treatment program (Phase 1) as well as follow-up treatments, shall be dictated by medical necessity, as determined by a licensed physician knowledgeable in diagnosis and current management standards of the treatment of lymphedema.

     (3) After effective volume reduction has been accomplished through the combined effects of these modalities, Phase 2 of the treatment program, the home treatment phase, continues for the life of the patient according to an individual medical treatment plan, and comprises, as directed by a licensed physician knowledgeable in diagnosis and current management standards of the treatment of lymphedema: self-manual lymph drainage; day-time use of well-fitted compressive garments, night-time bandaging with multi-layer low-stretch bandages or manually-adjustable compression devices; skin care; and exercise while under compression. It is generally not helpful to fit compressive garments prior to the institution of volume-reducing techniques. The compressive garment should be fitted to apply an appropriate range of external pressure, generally between 30 and 60 mmHg. It is recommended that garments be replaced every 3 months to maintain maximal therapeutic benefit.

     (4) There are numerous accredited schools which teach the CDT protocols for lymphedema treatment to licensed physical therapists, occupational therapists, massage therapists and nurse practitioners. The Lymphology Association of North America (LANA) provides national certification of lymphedema therapists who meet stringent academic and experiential requirements and who are qualified to perform the medical protocols involved in lymphedema treatment.


 Medicare has no national medical policy for the treatment of lymphedema, currently covers procedures and equipment not medically accepted for primary treatment of lymphedema and routinely denies coverage for components of the currently accepted conservative treatment.

     (1) Many patients have had Medicare denials for compression bandage systems and compression garments reversed by Medicare Administrative Law Judges, but only after many expensive appeals.

     (2) Procedures for patients and patient advocates to appeal adverse decisions and medically-unsound national coverage determinations have been severely limited by new appeal procedures implemented by DHHS in August and November 2002.

     (3) Only half of the states have implemented legislation requiring private health insurers to provide lymphedema coverage for breast cancer survivors in conformance with the Women’s Health and Cancer Rights Act of 1998, and Medicare coverage is not in compliance with this Act.

     (4) Some states have lymphedema treatment policies and will cover manual lymph drainage, but only as rehabilitative physical therapy and not medical treatment, and are therefore subject to Medicare annual limits.

          (5) Many medical providers fail to provide medical treatment in accordance with the current recommended standard of care partly because of lack of knowledge of the current medical standard of treatment for lymphedema, and partly because they do not understand the favorable economics of lymphedema treatment.

     (6) There is currently no law mandating treatment of lymphedema from causes other than breast cancer, and patients suffering from lymphedema and its disabling and life-threatening sequela are routinely denied diagnosis and treatment according to current standards.

     (7) Patient compliance is essential to the efficacy of the management of lymphedema. Medicare does not cover compression garments, bandages, and devices and provide replacements of compression orthotics to enable patient compliance with their lymphedema treatment plan.

     (8) Medicare provides coverage for expensive pneumatic sequential pumps for the treatment of lymphedema. Current medical standards for lymphedema treatment recommend use of pumps only in conjunction with manual lymph drainage, compression therapy and exercise, but these conservative treatments are not covered.


Treatment of lymphedema can be shown to save significant amounts of money for the medical provider, the Government and the patient.

     (1) Treatment of lymphedema has been shown to reduce and/or eliminate the incidence of infection (cellulitis and lymphangitis) encouraged by stagnant lymph.

     (2) By reducing the number of hospital admissions and doctor visits, providers will experience reduced cost. It can be demonstrated that proper treatment of lymphedema and compliance by patients with daily protocols is not only good medicine, but it is good business and a cost saving tool for insurance companies. For example, savings in medical expenses over a forty-year survival lifetime for treating a woman diagnosed with breast cancer at age 40 has been estimated at close to $400,000.

     (3) Proper treatment and management of lymphedema can enable patients living with lymphedema to continue to live productive lives, require less disability assistance, and eliminate pain medication for the pain of untreated lymphedema.

     (4) This is not a new healthcare mandate. The staff, facilities and support services required to provide the medically recommended treatment already exist at most providers. Most providers surveyed in Virginia, where a lymphedema treatment statute goes into effect in 2004, claim to provide treatment for lymphedema, and it is not excluded in most medical coverage contracts. The projected savings in avoided emergency medical treatment of cellulitis and lymphangitis are in excess of the cost of medically indicated manual lymph drainage and compression bandages, garments and devices.

     (5) With the implementation of the current conservative standard for treatment of lymphedema, CDT, there will be a significant cost saving in not requiring the often un-needed and sometime harmful sequential compression pumps currently provided by Medicare to treat lymphedema.

     (6) With a law that clearly defines the current standard of treatment of lymphedema, providers will be less likely to deny necessary treatment and have to engage in lengthy and expensive beneficiary appeals.

Courtesy of Bob Weiss


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