SUGGESTED LEGISLATIVE PRIORITIES IN THE TREATMENT OF LYMPHEDEMA

Robert Weiss, "LymphActivist@aol.com" Handout for Instructional Sessions H6, P8 and H13 Health Insurance Issues 5th International NLN Conference Lymphedema: The Quest for Understanding Chicago, Illinois August 29-September 1, 2002

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;
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.

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 treatment most likely to help them because there is no coverage of this treatment.

Millions of dollars are being wasted in administering pharmaceuticals to manage the pain caused by the swelling of untreated or undertreated lymphedema.

Millions of dollars are being wasted to compensate for the disability caused by inability to walk or drive or to do useful work with the arms and hands because of the swelling of untreated lymphedema.

 

The time has come to fight this "hidden epidemic" lymphedema. The following actions should be brought to the attention of your legislators. The first four concern Federal legislation while the last two concern both Federal and State legislation. Visit your representatives and present the following program for their sponsorship. Make sure they understand that lymphedema treatment is a "win/win" situation. It is good medicine and good business.

1. Correct the faulty Women's Health and Cancer Rights Act of 1998 (WHCRA) 1999 Omnibus Consolidated and Emergency Supplemental Appropriations Act (HR 4328: P.L. 105-277):
   1. Most urgent is the erroneous wording that, if read literally, says that a mastectomy patient must elect reconstructive surgery before being eligible for treatment of lymphedema resulting from the mastectomy. This was obviously not the intent of the law. In a contemporaneous law on the same subject, the Breast Cancer Patients' Protection Act of 1998 (California AB-7 Brown), the wording did not have the logical flaw of the Federal law;
   2. The title of the law needs changing. The title "Women's Health and Cancer Rights Act" implies that it confers certain rights only to women. In fact, this was used in one case I am aware of to deny coverage to a male breast cancer survivor suffering from lymphedema. Nothing in the wording of the law deals with the sex of the patient. In fact, the law deals with obligations of the medical providers who perform mastectomies, and what treatment they must provide to their patients for secondary results of their treatment;
   3. The word lymphedema is used incorrectly in the plural in the Federal law. It should be singular, i.e., "lymphedema" and not "lymphedemas";
   4. Consideration should be given to adding a provision similar to that found in the California Breast Cancer Patient Protection Act of 1998 (AB-7 Brown) prohibiting treatment being denied by anyone who is not a licensed physician or surgeon knowledgeable of the condition for which treatment is being denied. Subparagraph (c) of AB-7 Brown reads: "(c) 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 pursuant to this section."
   5. Support and bring to the floor a version of H.R. 887 Kelly and S. 331 Biden, modified as proposed above, which would amend the Internal Revenue Code of 1986 to incorporate provisions of the WHCRA.
2. The provisions of the three year old Women's Health And Cancer Rights Act of 1998 (WHCRA) have not been implemented by CMS. There are conflicting interpretations of what constitutes the current standard of medical treatment of lymphedema, there are conflicting regional medical policies concerning lymphedema treatment where such policies even exist, Medicare decisions on lymphedema treatment denials around the country are frequently based on irrelevant interpretations of federal regulations and Medicare policies, and patient appeals of Medicare denials are being reversed by Medicare Administrative Law Judges.

   New treatment methods have been accepted in the last ten years but Medicare policies have not been updated to reflect these new procedures. At least one lymphedema treatment center (in Los Angeles) was forced to close because of uncertainties and delays in Medicare reimbursement. There is a shortage of trained lymphedema therapists because therapists are not learning the new treatment techniques and entering the field because of current uncertainties in whether they can subsist. A priority should be the assurance of implementation of previously enacted laws which have not yet been implemented by the DHHS:

   1. Implement the lymphedema treatment provisions of the Women's Health and Cancer Rights Act of 1998 (WHCRA):
      1. Direct the Agency for Healthcare Research and Quality (AHRQ) to review current medical literature and establish a definition of the current standard of care for lymphedema treatment to be used by CMS to develop a National Policy;
      2. Direct CMS to open a National Issue leading to a National Medicare Policy on the treatment of lymphedema. Local policies, where they exist, are conflicting, and coverage is frequently denied. Treatment standards accepted internationally and nationally are being ignored or misinterpreted (e.g., Medicare Coverage Decision on Lymphedema Pumps). At least two strawman national policies have been submitted to HCFA/CMS which could be used a starting points for medical and fiscal discussions.
      3. CMS should be directed to include an essential element of the medically-accepted lymphedema treatment protocols in their coverage, i.e., compression bandage systems and compression garments. Expensive appeals to Medicare Administrative Law Judges frequently lead to reversals of denials;
   2. Section 1869(a)(3)(C) of the Social Security Act was amended by §521 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 H.R. 5661 (BIPA) This revision substantially revises the Medicare claim appeals process and was to have been implemented by 15 October 2001. Implementation was postponed indefinitely by CMS, leaving nowhere to go for further appeals of CMS denials of treatment. DHHS Transmittal AB-02-111 of July 31, 2002 provides guidance to Medicare contractors on the partial implementation of §521 of BIPA by October 1, 2002 as outlined below:
      1. The time limits for requesting a Part B review of an initial claim determination will be changed to 120 days and
      2. The amount in controversy requirement for Part B ALJ requests will be $100, for initial claim determinations made on or after October 1, 2002.

         Meanwhile The Department of Health and Human Services is being sued in Washington by a group of activist organizations on behalf of three plaintiffs who claim that they have been denied Medicare coverage and have been denied the appeal process granted by the BIPA of 2000.

3. Direct new legislation to add an interpretative paragraph to the orthotics definition section of The Social Security Act Section 1861(s)(9). The logic is that compression bandage systems, compression garments and manually-adjustable compression devices are required in the daily care of lymphedema as a part of the medically-accepted treatment protocols, and that the function of these systems is to provide required continuous support to a body organ (the skin) and support to and aid to the functioning of the impaired internal lymphatic system.

   The addition would allow CMS to cover the required compression systems in the treatment of lymphedema at home. Possible wording (with the additional text in CAPS) might be: "Section 1861(s)(9) leg, arm, back, and neck braces, LOW-STRETCH ELASTIC SUPPORT SYSTEMS, and artificial legs, arms and eyes, including replacements if required because of a change in the patient's physical condition;"

   House of Representatives Bill H.R. 4154 has been presented by Hawaii Representative Patsy T. Mink which would add a subsection to Section 1861(s)(9) to cover compression sleeves and stockings (including replacements) for treatment of lymphedema.

4. Direct the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC) to perform a study of the incidence and severity of lymphedema. The study should answer questions such as:
   1. What is the current number of lymphedema sufferers in the U.S.?
   2. What is the distribution of lymphedema between Primary and Secondary?
   3. For primary, what is the incidence of congenital and tarda lymphedema?
   4. For primary and secondary what is the distribution between lower limb, upper limb, abdomen, chest and breast, facial, whole body lymphedema?
5. Authorize and fund a specific study and analysis by the Agency for Healthcare Research and Quality (AHRQ) to demonstrate the economic benefits of treatment of lymphedema. The study would involve the reviewing of the medical records of a group of patients who have been treated for cellulitis or lymphangitis with the object of showing how much was spent to treat cellulitis of the upper or lower limb in patients with diagnosed VS non-diagnosed, and treated VS not treated lymphedema. Statistical review of the data plus a costing of the treatment and the costing of managing the lymphedema would demonstrate the cost efficacy of lymphedema management. Alternatively the study might involve the analysis of all breast cancer patients' records for incidence of cellulitis as a function of diagnosed VS undiagnosed lymphedema and for treated VS untreated lymphedema.
6. Present a new law to treat lymphedema from all causes, primary as well as secondary, as a means of REDUCING medical costs to citizens as well as the Government. Such legislation has been presented at the State level by Senator Susan Fargo in Massachusetts and Delegate Leo Wardrup in Virginia. Elements of this new legislation might include:
   1. A mandate that all health insurance providers cover the costs of treatments for lymphedema;
   2. Treatment defined to include a complete course of manual lymph drainage/ complete decongestive therapy (Phase 1) when medically required performed by physical therapists and message therapists licensed or certified by the appropriate governing board to perform treatments for lymphedema;
   3. Initial course of treatment (Phase 1) shall include training the patient to perform self treatment in a home setting (Phase 2), including self-manual lymphatic drainage, bandaging, wearing and care of compression garments, use of specialized manually adjustable devices, donning aids, and other required ancillary equipment and techniques for self-measurement;
   4. Include coverage for follow-up treatments when medically required or to periodically validate home techniques;
   5. Include coverage of any compression sleeves and bandages recommended by the patient's qualified caregiver with replacements when required to maintain the compressive function;
   6. The course of therapy should be determined by a qualified physician knowledgeable of the diagnosis and current treatment of lymphedema;
   7. Denials of treatment of lymphedema shall only be made by a licensed physician or surgeon who is qualified to treat the condition for which treatment is being denied.
   8. Periodic measurements shall insure the effectivity of the treatment plan and patient compliance, and be used to modify the treatment plan as required or to determine need for followup treatment.
   9. No additional fees shall be imposed to meet the requirements of this law other than the existing fees and copayments which already are a part of the affected medical insurance policy.

Please contact me for any assistance in the above matters.

Robert Weiss
10671 Baton Rouge Avenue
Northridge, CA 91326

Tel: 818-368-6340
Fax: 818-368-6432
E-mail: LymphActivist@aol.com

Back to top
Lymphedema Treatment is Good Business as well as Good Medicine
© 2002 Robert Weiss, Porter Ranch, CA