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STATE LEGISLATIVE PACKET (5) BOB WEISS

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Lymphedema Legislation

Impact Analysis Written for Virginia Bill

Special Advisory Commission on Mandated Health Insurance Benefits

Guidelines for the Review of Legislation Mandating Health Insurance Coverage

House Bill 383

Patron: Delegate Leo Wardrup

Section IV Evaluation of the Impact of Mandated Health Insurance Coverage

The following criteria should be used by interested parties in developing testimony to present to the Advisory Commission. The issues highlighted are essential to the evaluation of mandated benefits by the Advisory Commission and form the basis of the review process. The Advisory Commission is not limited, however, by these criteria in analyzing mandate proposals and may consider other relevant issues in its deliberations.

1) Social Impact

The extent to which the treatment or service is generally utilized by a significant portion of the population.

The statistics on lymphedema are not currently available. Lymphedema is a seriously undiagnosed and underdiagnosed condition, sometimes called the “hidden epidemic”. The many causes include insufficiency of lymphatic circulatory function including primary and secondary causes, lymphatic vascular valvular insufficiencies, disease of the lymphatic vasculature and developmental disorders of the lymphatic system.

A common secondary cause of lymphedema for which statistics may be developed is breast cancer treatment. Recent ACS estimates predict that 250,000 persons will be diagnosed with breast cancer this year. Assuming that 75 percent (187,500) will be treated and will survive, that 50 percent of these (93,750) will have axillary node dissection or radiation to the nodes, and 49 percent of these (45,937) will develop lymphedema some time in the near future ("Lymphedema In a Cohort of Breast Carcinoma Survivors 20 Years After Diagnosis," Jeanne A. Petrek, MD et. al., September 15, 2001 issue of Cancer), then there will be 45,000 new lymphedema cases in the next year.

Add to these breast cancer survivors the numbers of survivors of cervical cancer, ovarian cancer, prostate cancer, face and neck cancer, melanoma, coronary artery by-pass surgery and the sufferers of primary lymphedema of congenital as well as late-occurring variety, there are anywhere from 2-8 million lymphedema sufferers in the U.S. today. Many of these persons have not been diagnosed, are not made aware that there are medically recommended treatment and management protocols available, and that there are clinics and centers where they may be treated.

The extent to which insurance coverage for the treatment or service is already generally available.

Although there are medically-approved treatment and management protocols available and there are usually no lymphedema exceptions in most insurance policies, none the less lymphedema treatment is widely limited or denied. For example, the only covered procedure provided by Medicare in Virginia is for 1-2 sessions to learn how to use the covered pneumatic pump, which is not a recommended modality for treating lymphedema except after conservative modalities of manual lymph drainage and compression therapy have been tried and have been found to not be effective. The Virginia Physical Medicine/Physical and Occupational Therapy LMRP No. 95-16R1 allows physical therapy procedures for edema, but not specifically for lymphedema. It is recognized that HB 383 does not govern Medicare, but this subject of Medicare coverage in Virginia is raised since it often becomes the model for coverage by medical insurers.

If coverage is not generally available, the extent to which the lack of coverage results in persons being unable to obtain necessary health care treatments.

Current standards of care for lymphedema treatment require the services of a trained lymphedema therapist typically every day for two to three weeks with the daily application of multilayer compression bandages. Included in this initial course of treatment is training of the patient in self manual drainage and application of bandages and compression garments, special lymph draining exercises and the precautions to be taken to avoid infection, including meticulous skin care. Uncovered persons usually are unable to obtain the necessary treatments because of lack of availability of treatment centers, trained therapists, and the expense of the initial two to three week treatment. The lack of insurance coverage for treatment of lymphedema serves to discourage therapists and nurses from taking the specialized lymphedema therapy training, and discourages expansion of availability of lymphedema treatment facilities. The prestigious lymphedema clinic associated with UCLA’s Revlon/UCLA Breast Center was closed three years ago due in part to “complications in federal regulations governing reimbursements” (UCLA Magazine, Winter 2000).

If the coverage is not generally available, the extent to which the lack of coverage result in unreasonable financial hardship on those persons needing treatment.

Untreated or undertreated LE frequently results in loss of work time and uncompensated disability. Lymphedema symptoms are a swelling of the affected arm or leg, slowly-healing oozing sores, and disability requiring elevation of the affected limb. The incidence of infection (cellulitis and lymphangitis) is significantly higher in un- and under-treated persons. The treatment of infection requires intravenous antibiotics in an emergency setting, often with a multi-day hospital stay. Treatment in a clinical setting is followed by the necessity for the patient to continue in the daily regimen of the complex decongestive therapy in which (s)he has just been trained. Cost to the patient is typically $1,000/1,500 per year per lymphedematous arm/leg for the remainder of the patient’s life for the materials necessary to be compliant with this therapy.

It should be noted that untreated or undertreated patients often require prescription painkillers, adding to the expense related to the non-treatment of this medical condition.

The level of public demand for the treatment or service.

The level of public demand for lymphedema treatment is difficult to estimate since so many cases go unreported and surveys have not been made as to its extent. American trained physicians are not, for the most part, trained in the lymphatic system and its pathologies, in diagnosis of this condition and in the medically-accepted protocols recently brought to the U.S. from Europe. The oncologists, radiologists and surgeons who normally treat cancer patients often confuse post-surgical edema with chronic lymphedema. These are usually not the physicians who must diagnose and treat the lymphedema and cellulitis that occur many years later, thereby explaining the under-reporting by cancer specialists of the incidence of this secondary condition resulting from their cancer treatment.

Recent studies of the incidence of post-cancer lymphedema are finding as many as 40 percent of cancer treatment survivors develop lymphedema in the 20 years following treatment. A recent study found that 77 percent of those having axillary dissection develop lymphedema.The results of a recent study revealed that 74% of the women who developed lymphedema had suffered an arm injury or infection that required medical care following breast cancer treatment. ("Lymphedema In a Cohort of Breast Carcinoma Survivors 20 Years After Diagnosis," Jeanne A. Petrek, MD et. al., September 15, 2001 issue of Cancer).

Relatively high incidence of lower limb lymphedema are reported in cervical and ovarian cancer survivors who underwent inguinal node excision or radiation.

The level of interest of collective bargaining organizations in negotiating privately for inclusion of this coverage in-group contracts.

It is greatly to the interest of collective bargaining organizations to negotiate lymphedema treatment coverage in their group contracts. Ultimately the inclusion of full lymphedema treatment including the provision of replacement bandages and garments will reduce the costs of medical care by: helping patients to be compliant with the therapy protocols; reducing the incidence of infection and hence its treatment costs; reducing the necessity of administering costly pain drugs to ameliorate the pain brought on by uncontrolled edema, and; reducing the lost work time while workers are disabled or being treated in the hospital.

Any relevant findings of the state health planning agency or the appropriate health system agency relating to the social impact of the mandated benefit.

2) Financial Impact

The extent to which the proposed insurance coverage would increase or decrease the cost of treatment or service over the next five years.

Although no cost studies are known to have been made, it is believed that the proposed coverage of lymphedema treatment would result in a one-year increase in cost followed by a continuing decrease of many times the initial cost in succeeding years. This is based on the experience of Robert Weiss of Northridge, California, who did an anectdotal analysis of the costs and savings to his medical provider in treating his wife Pearl Weiss’ lymphedema.

In the five years prior to treating Mrs. Weiss’ mild case of post-cancer lymphedema, Mrs. Weiss suffered three infections which required treatment by antibiotics. The interval between each episode decreased from 27 to 24 to 21 months, each infection further scarring her lymphatic system. The cost of these treatments is not known but were all performed in an emergency room setting and required oral and intravenous antibiotics. In the four years since Mrs. Weiss has been treating her lymphedema with the recommended complex decongestive therapy, she has had no infections requiring medical treatment. This sequence is typical and will probably be borne out when formal studies are made.

The extent to which the proposed insurance coverage might increase the appropriate or inappropriate use of the treatment or service.

It is believed that the proposed insurance coverage will both increase the use of the appropriate treatment for lymphedema (i.e. complex decongestive therapy, CDT) and, at the same time reduce the largely inappropriate use of expensive pneumatic pumps and pain medication which are greatly overused in the absence of knowledge of the efficacy of CDT.

A pump Survey of members of the Greater Boston Lymphedema Support Group conducted in Spring 1997 by Marianne Lynnworth, Dr. rer.nat. This survey about the short- and long-term results of pneumatic pump use in lymphedema cases was conducted within the Greater Boston Lymphedema Support Group in the spring of 1997. “Out of the 56 members of our support group who had used a pump for some time, 43 members are not using the pump anymore, 25 of those haven't used their pump for one year or longer. The most frequently voiced reasons for discontinuing are that the pump "is doing nothing", "not helping anymore", that it has caused various negative results like swelling in adjacent area, pain and soreness. It seems that some members initially experienced good results, reduction, less pain and less discomfort. For the majority of the members, however, pumping delivered after a while too many negative results and they stopped using their pumps.”

Millions of dollars are being wasted because the expensive Medicare-approved pneumatic pumps are ending up unused by patients who find that they don't help or have caused further bodily damage--and these same patients are discouraged from seeking the conservative treatment that is most likely to help them because there is no coverage of this treatment.

The extent to which the mandated treatment or service might serve as an alternative for more expensive or less expensive treatment or service

The availability of the the conservative protocols of CDT will make unnecessary the prescription of expensive (Medicare-covered) pumps. Also, control of swelling due to lymphedema ameliorates the pain and could reduce the need for pain management drugs.

The extent to which insurance coverage may affect the number and types of providers of the mandated treatment or service over the next five years.

Physical and Occupational Therapists currently on the provider’s staff could be sent for training and certification course on CDT. There are currently about a dozen reputable schools available in the U.S. and a national certifying entity Lymphology Association of North America (LANA) grants certification. This one-time certification is not expected to affect the number or types of providers. The added expense of providing manual lymph drainage and compression bandages and garments are expected to be more than offset by savings in cellulitis treatment and pain management costs.

The extent to which insurance coverage might be expected to increase or decrease the administrative expenses of insurance companies and the premium and administration expenses of policyholders.

Administrative costs and premium costs would be expected to decrease as a result of extending coverage of lymphedema treatment and encouraging patient compliance with CDT protocols. Administrative costs would decrease because there would be a decrease in denials of treatment and denials of compression bandages and garments, and elimination of the costly denial appeal process. Millions of dollars are being spent unnecessarily in needless appeals of Medicare denials around the country--many of which are being reversed by Administrative Law Judges who recognize that the current standard of lymphedema care includes CDT.

Premium costs would decrease because of the reduction in total costs of care of lymphedema patients. Millions of dollars are being spent unnecessarily by medical providers to treat cellulitis and lymphangitis resulting indirectly from denials by Medicare of the preventive treatment modalities accepted by NIH NCI, ACS, ISL, NLN, LRF and most other knowledgeable medical and therapeutic organizations.

The impact of coverage on the total cost of health care.

The total cost of health care is expected to decrease when treatment is provided according to the current standards of lymphedema treatment recommended by the International Society of Lymphology and the Americal Cancer Society.

3) Medical Efficacy

The contribution of the benefit to the quality of patient care and the health status of the population, including the results of any research demonstrating the medical efficacy of the treatment or service compared to alternatives or not providing the treatment or service.

The protocols of complex decongestive therapy (CDT) have been used for decades in Europe to treat and manage swelling due to lymphatic system deficiency. These protocols have been brought to the U.S. about 10 years ago and are being shown to be an effective and conservative treatment for lymphedema of all causes, primary and secondary. The International Lymphology Society and the American Cancer Society have issued consensus recommendations for CDT

1) “The Diagnosis and Treatment of Peripheral Edema: Consensus document of the International Society of Lymphology Executive Committee”, Lymphology, 1995, Vol. 28, pp.. 113-117)

2) “Workgroup III: Diagnosis and Management of Lymphedema”, Rockson, MD, S. G., Miller, PT, L. T., Senie, PhD, R., Brennan, MD, M. J., Casley-Smith, MD, PhD, J. R., Földi, MD, E., Földi, MD, M., Gamble, MD, G.L., Kasseroller, MD, R. G., Leduc, PhD, A., Lerner, MD, R., Mortimer, MD, P.S., Norman, PhD, S. A., Plotkin, MD, C. L., Rinehart-Ayres, PhD, PT, M. E.,Walder, MD, PhD, A. L.: Cancer, Vol. 83, No. 12, December 15, 1998, (Supplement), American Cancer Society Workshop on Breast Cancer Treatment-Related Lymphedema, New York, NY, February 20-22, 1997, pp. 2882-2885.)

Although they have been accepted by knowledgable physicians and therapists, their general acceptance and application has been hampered by the fact that few physicians and surgeons have been schooled in the physiology and pathology of the lymphatic system, and Medicare has been adamant about not covering the therapy or the compression systems used in these protocols. They do cover the use in the treatment of lymphedema of expensive sequential compression pumps which were developed for use in treating chronic venous insufficiency. The ready availability of the pumps and the lack of coverage for the more conservative CDT has been responsible for the inadequate or incorrect treatment of many lymphedema patients.

There have been many studies of the efficacy of CDT and its components in the treatment of lymphedema. The studies have demonstrated that:

1. Lymphedema treatment modalities include elevation of the affected limb; manual lymphatic drainage, which is a form of massage that mobilizes edema fluid from distal to proximal areas and from areas of stasis to areas of healthy lymphatics; use of multilayered compression bandages and custom-fitted graded-pressure garments; meticulous skin hygiene to prevent infection; and weight control. A number of these modalities have been combined in a strategy known as complex physical therapy (or complex decongestive therapy), which consists of manual lymphedema treatment, compression wrapping, individualized exercises, and skin care, followed by a maintenance program. Complex physical therapy has been recommended by consensus panels and is an effective approach for lymphedema that is unresponsive to standard elastic compression therapy. (Lymphedema PDQ®, Supportive Care - Health Professionals, NIH NCI, 2002)

Casley-Smith JR, Casley-Smith JR: “Modern treatment of lymphoedema. I. Complex physical therapy: the first 200 Australian limbs”, Australasian Journal of Dermatology 33(2): 61-68, 1992,

Boris M, Weindorf S, Lasinski B: “Persistence of lymphedema reduction after noninvasive complex lymphedema therapy”, Oncology, (Huntington NY) 11(1): 99-109, 1997

Daane S, Poltoratszy P, Rockwell WB: “Postmastectomy lymphedema management: evolution of the complex decongestive therapy technique”, Annals of Plastic Surgery 40(2): 128-134, 1998.)

2. Effectiveness of the protocols of CDT have been demonstrated. The following is an abstract of a typical study on the efficacy of CDT ( “Effective Treatment of Lymphedema of the Extremities”, Dicken S. C. Ko, MD; Robert Lerner, MD; Guenter Klose, CCDPI; A. Benedict Cosimi, MD, Archives of Surgery, April 1998; 133:452-458)

Results were recently described of a test designed to define the immediate and long-term volumetric reduction following complete decongestive physiotherapy (CDP) for lymphedema. The subjects were 299 patients referred for evaluation of lymphedema of the upper (2% primary, 98% secondary) or lower (61.3% primary, 38.7% secondary) extremities were treated with CDP for an average duration of 15.7 days. Lymphedema reduction was measured following completion of treatment and at 6- and 12-month follow-up visits. Complete decongestive physiotherapy is a 2-phase noninvasive therapeutic regimen. The first phase consists of manual lymphatic massage, multilayered inelastic compression bandaging, remedial exercises, and meticulous skin care. Phase 2 focuses on self-care by means of daytime elastic sleeve or stocking compression, nocturnal wrapping, and continued exercises. Average limb volumes in milliliters were calculated prior to treatment, at the end of phase 1, and at 6- to 12-month intervals during phase 2 to assess percent volume reduction. Lymphedema reduction averaged 59.1% after upper-extremity CDP and 67.7% after lower-extremity treatment. With an average follow-up of 9 months, this improvement was maintained in compliant patients (86%) at 90% of the initial reduction for upper extremities and lower extremities. Noncompliant patients lost a part (33%) of their initial reduction. The incidence of infections decreased from 1.10 infections per patient per year to 0.65 infections per patient per year after a complete course of CDP.

The conclusion of this and other studies is that Complete Decongestive Physiotherapy is a highly effective treatment for both primary and secondary lymphedema. The initial reductions in volume achieved are maintained in the majority of the treated patients who remain compliant. These patients typically report a significant recovery from their previous cosmetic and functional impairments, and also from the psychosocial limitations they experienced from a physical stigma they felt was often trivialized by the medical and payor communities. And the incidence of infections requiring hospitalizations is greatly reduced for compliant patients.

If the legislation seeks to mandate coverage of an additional class of practitioners:

The results of any professionally acceptable research demonstrating the medical results achieved by the additional class of practitioners relative to those already covered.

The methods of the appropriate professional organization that assure clinical proficiency.

The objective and purposes of the Lymphology Association of North America are to promote standards for management of individuals with Lymphedema and or related disorders, to establish and maintain certification for medical professions who provide such services and to promote the awareness and science of lymphology.The National Certification Project is a public/national forum to unite the opinion of lymphologists and therapists from multiple disciplines on the fundamentals of treatment. It will identify lymphedema treatment as a specialty that requires advanced training and provide a basis from which insurance companies can establish more consistent reimbursement guidelines. The ultimate goal, of course, is to protect the consumer.

Certification requirements include defined minimum hours of basic science and CDT classroom training, hands-on practice of CDT in direct patient care, license to practice as a health care provider and passage of a proficiency exam.

4) Effects of Balancing the Social, Financial and Medical Efficacy Considerations

The extent to which the benefit addresses a medical or a broader social need and whether it is consistent with the role of health insurance.

House Bill 383 addresses a medical need by bringing a new treatment to patients of lymphedema and encouraging compliance with the protocols of this new treatment. In doing so it offers the possibility of great improvements in the quality of life of sufferers, the opportunity to reduce the incidence of repeated life-threatening infections with progressive deterioration of the condition, and force the medical community to upgrade their education on this condition which afflicts over 2 million persons.

The extent to which the need for coverage outweighs the costs of mandating the benefit for all policyholders.

In a sense the treatment of lymphedema is already covered in most insurance policies, but the understanding of the diagnosing and current standards of treatment are absent. By defining the coverage to include equipment, supplies, CDT and outpatient training, H.B. 383 clarifies the elements of the treatment and helps to preclude denial of essential elements of the treatment, forcing the patient to initiate a lengthy and expensive appeals process to obtain medical treatment according to current medical standards.

The extent to which the need for coverage may be solved by mandating the availability of the coverage as an option for policyholders.

It should not be the task of the patient to decide whether to take an option to be treated for a particular medical condition. Coverage contracts agree to treat all the medical conditions of the enrolee and the patient is not asked to pick and choose the specific diseases for which he will be covered. Lymphedema is a common secondary result of treatment for cancer, and by at least one federal law (Womens Health and Cancer Rights Act of 1998) it must be treated.
.........

The foregoing is the opinion of Robert Weiss, lymphedema activist in response to the request of Keenan A. Caldwell, Government Relations Manager, American Cancer Society. Please direct any questions and comments to: Robert Weiss, Tel: 818-368-6340, FAX: 818-368-6432, E-mail: LymphActivist@aol.com.

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Lymphedema People / Advocates for Lymphedema

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Lymphedema People New Wiki Pages

Have you seen our new “Wiki” pages yet?  Listed below are just a sample of the more than 140 pages now listed in our Wiki section. We are also working on hundred more.  Come and take a stroll! 

Lymphedema Glossary 

http://www.lymphedemapeople.com/wiki/doku.php?id=glossary:listing 

Lymphedema 

http://www.lymphedemapeople.com/wiki/doku.php?id=lymphedema 

Arm Lymphedema  

http://www.lymphedemapeople.com/wiki/doku.php?id=arm_lymphedema 

Leg Lymphedema 

http://www.lymphedemapeople.com/wiki/doku.php?id=leg_lymphedema 

Acute Lymphedema 

http://www.lymphedemapeople.com/wiki/doku.php?id=acute_lymphedema 

The Lymphedema Diet 

http://www.lymphedemapeople.com/wiki/doku.php?id=the_lymphedema_diet 

Exercises for Lymphedema  

http://www.lymphedemapeople.com/wiki/doku.php?id=exercises_for_lymphedema 

Diuretics are not for Lymphedema 

http://www.lymphedemapeople.com/wiki/doku.php?id=diuretics_are_not_for_lymphedema 

Lymphedema People Online Support Groups 

http://www.lymphedemapeople.com/wiki/doku.php?id=lymphedema_people_online_support_groups 

Lipedema 

http://www.lymphedemapeople.com/wiki/doku.php?id=lipedema 

Treatment 

http://www.lymphedemapeople.com/wiki/doku.php?id=treatment 

Lymphedema and Pain Management 

http://www.lymphedemapeople.com/wiki/doku.php?id=lymphedema_and_pain_management 

Manual Lymphatic Drainage (MLD) and Complex Decongestive Therapy (CDT)

http://www.lymphedemapeople.com/wiki/doku.php?id=manual_lymphatic_drainage_mld_complex_decongestive_therapy_cdt 

Infections Associated with Lymphedema 

http://www.lymphedemapeople.com/wiki/doku.php?id=infections_associated_with_lymphedema 

How to Treat a Lymphedema Wound 

http://www.lymphedemapeople.com/wiki/doku.php?id=how_to_treat_a_lymphedema_wound 

Fungal Infections Associated with Lymphedema 

http://www.lymphedemapeople.com/wiki/doku.php?id=fungal_infections_associated_with_lymphedema 

Lymphedema in Children 

http://www.lymphedemapeople.com/wiki/doku.php?id=lymphedema_in_children 

Lymphoscintigraphy 

http://www.lymphedemapeople.com/wiki/doku.php?id=lymphoscintigraphy 

Magnetic Resonance Imaging 

http://www.lymphedemapeople.com/wiki/doku.php?id=magnetic_resonance_imaging 

Extraperitoneal para-aortic lymph node dissection (EPLND) 

http://www.lymphedemapeople.com/wiki/doku.php?id=extraperitoneal_para-aortic_lymph_node_dissection_eplnd 

Axillary node biopsy 

http://www.lymphedemapeople.com/wiki/doku.php?id=axillary_node_biopsy

Sentinel Node Biopsy 

http://www.lymphedemapeople.com/wiki/doku.php?id=sentinel_node_biopsy

 Small Needle Biopsy - Fine Needle Aspiration 

http://www.lymphedemapeople.com/wiki/doku.php?id=small_needle_biopsy 

Magnetic Resonance Imaging 

http://www.lymphedemapeople.com/wiki/doku.php?id=magnetic_resonance_imaging 

Lymphedema Gene FOXC2

 http://www.lymphedemapeople.com/wiki/doku.php?id=lymphedema_gene_foxc2

 Lymphedema Gene VEGFC

http://www.lymphedemapeople.com/wiki/doku.php?id=lymphedema_gene_vegfc

 Lymphedema Gene SOX18

 http://www.lymphedemapeople.com/wiki/doku.php?id=lymphedema_gene_sox18

 Lymphedema and Pregnancy

http://www.lymphedemapeople.com/wiki/doku.php?id=lymphedema_and_pregnancy

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Page Updated: Dec. 17, 2011