STATE LEGISLATIVE PACKET (2) BOB WEISS
FOR THE PROVISIONS OF THE
PROPOSED STATE BILL FOR LYMPHEDEMA TREATMENT
The following material is provided to the lymphedema treatment advocate and to the legislative aide for clarification, explanation and guidance in the development of a lymphedema treatment bill. Examples are given from existing bills to suggest wording and construction. Rationale is given to support each proposed provision. Abstracts from the Massachusetts, New York and Virginia Bills, as well as the California WHCRA-conforming Act follow for reference.
a. TREATMENT MANDATE– A mandate that all health insurance providers cover the costs of diagnosis and treatments for lymphedema;
The legislation should apply to managed care providers, private providers, group policies, individual policies--in short, all providers or insurers except Medicare. Since State Codes differ in how the various providers and insurers are regulated, the wording must key into the appropriate code paragraphs governing each provider or insurer. For example, California regulates managed care providers under the California Health and Safety Code and Insurance under the Insurance Code.
Example: “Notwithstanding the provisions of § 38.2-3419 [which deals with optional coverage], each insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical, coverage on an expense-incurred basis; each corporation providing individual or group accident and sickness subscription contracts; and each health maintenance organization providing a health care plan for health care services shall provide coverage for lymphedema as provided in this section.” (VA H.B. 1737)
Example: “Any policy of accident and sickness insurance described in section 108 which provides hospital expense and surgical expense insurance and which is delivered, issued or subsequently renewed by agreement between the insurer and policyholder in the commonwealth; any blanket or general policy of insurance described in subdivision (A), (C) or (D) of section 110 which provides hospital expense and surgical expense insurance and which is delivered, issued or subsequently renewed by agreement between the insurer and the policyholder, within or without the commonwealth, except policies providing supplemental coverage to Medicare; or any employers’ health and welfare fund which provides hospital expense and surgical expense benefits and which is delivered, issued or renewed to any person or group of persons in the commonwealth, shall provide coverage for the cost of treatment and follow-up treatment for lymphedema, ...” (MA SB 848)
Example: "EVERY POLICY WHICH PROVIDES HOSPITAL, SURGICAL, MEDICAL OR MAJOR MEDICAL COVERAGE SHALL PROVIDE COVERAGE FOR THE DIAGNOSIS AND TREATMENT OF LYMPHEDEMA. SUCH COVERAGE SHALL INCLUDE BENEFITS FOR EQUIPMENT, SUPPLIES, DEVICES, COMPLEX DECONGESTIVE THERAPY, AND OUT-PATIENT SELF-MANAGEMENT TRAINING AND EDUCATION FOR THE TREATMENT OF LYMPHEDEMA, IF PRESCRIBED BY A HEALTH CARE PROFESSIONAL LEGALLY AUTHORIZED TO PRESCRIBE OR PROVIDE SUCH ITEMS UNDER TITLE EIGHT OF THE EDUCATION LAW. SUCH EQUIPMENT, SUPPLIES OR DEVICES SHALL INCLUDE, BUT NOT LIMITED TO, BANDAGES, COMPRESSION SLEEVES AND PRESSURE CUFFS." (NY AB 9208)
b. MEDICAL MANAGEMENT– The course of therapy should be determined by a qualified physician knowledgeable of the diagnosis and current treatment of lymphedema;
A $1500 Medicare cap on outpatient rehabilitation therapy services (physical therapy, occupational therapy, and speech-language pathology services) was originally instituted under the Balanced Budget Act of 1997. In 1999, Congress imposed a two-year moratorium on enforcement of the Medicare therapy cap provision due to concerns expressed by consumers and providers of therapy services (Section 221 of the Balanced Budget Refinement Act (BBRA) of 1999). The moratorium, in place for 2000 and 2001, was enacted to provide CMS the necessary time to develop appropriate mechanisms that can permanently replace the arbitrary caps on beneficiaries’ access to necessary rehabilitation services. Congress subsequently extended the moratorium for another year, until the end of 2002. The Centers for Medicare and Medicaid Services (CMS) have granted a short-term reprieve (to August 31, 2003) to the re-implementation of the caps, but a permanent solution to these arbitrary and punitive caps is needed.
Since it is common for providers and insurers to use Medicare policies of physical therapy and rehabilitation to limit the course of lymphedema treatments, it is necessary in any lymphedema treatment mandate to insure that medical necessity governs the coverage of courses of treatment.
c. MANUAL LYMPH DRAINAGE– Defined treatment shall include a complete course of manual lymph drainage as part of complete decongestive therapy (Phase 1) when medically required, performed by physical therapists, occupational therapists, massage therapists or nurses licensed or certified by the appropriate governing board to perform treatments for lymphedema;
There are a number of issues raised here. The first concerns the explicit definition of the protocols of lymphedema treatment. It should not be the role of legislation to define the medical treatment for any disease or medical condition. But current medical practice in the U.S. frequently does not implement the currently recommended standard of care for lymphedema treatment that has been practiced in Europe for 30 years. It is therefore essential that the legislation explicitly define the recommended protocols for lymphedema treatment as recommended by the American Cancer Society Lymphedema WorkGroup (1998) and the International Society of Lymphology (1995, 2001).
Example: Coverage under this section shall include benefits for equipment, supplies, complex decongestive therapy, and outpatient self-management training and education for the treatment of lymphedema, if prescribed by a health care professional legally authorized to prescribe or provide such items under law.” (VA H.B. 1737)
Example: “...treatment and follow-up treatment for lymphedema, including but not limited to decongestive compression therapy, manual lymph drainage, compression sleeves, bandages, replacement sleeves or bandages or other course of treatment recommended by a physician in accordance with generally accepted current medical standards.” (MA S.B. 848)
The second issue concerns the performance of manual lymph drainage (MLD) by trained massage therapists. A massage therapist, certified by the Lymphatic Association of North America (LANA), is qualified to perform MLD as part of the medical treatment of lymphedema, but may not be accepted by medical providers or licensed by the State. This issue must be worked within the groundrules of the individual State. But whatever is the outcome of the massage therapist issue, it is essential that the therapist who treats lymphedema must have taken specialized training in the treatment of lymphedema from a recognized training program and be certified to do lymphedema therapy.
It is not adequate to be treated by a licensed physical therapist who is practicing within his/her “scope of practice” unless this therapist has been certified in the specific protocols of manual lymphedema drainage (MLD). There is a severe shortage of physical therapists who are certified to perform the labor-intensive and time-consuming MLD. Many massage therapists have been certified in MLD and are qualified to practice this treatment protocol on lymphedema patients but are not reimbursed for their treatment since they are not allowed to practice medicine.
Example: “ The commission shall also provide coverage for treatment of lymphedema by a physical therapist licensed under section 23B of chapter 112 or by a massage therapist licensed by a municipality under section 51 of chapter 140 if the therapist is certified respectively by the board of allied health professions or the municipality to treat lymphedema.” (MA S.B. 848-under discussion)
Example: “A managed care health insurance plan, as defined in Chapter 58 (§ 38.2-5800 et seq.) of this title, may require such health care professional to be a member of the plan's provider network, provided that such network includes sufficient health care professionals who are qualified by specific education, experience, and credentials to provide the covered benefits described in this section.” (VA H.B. 1737)
d. EXTENT OF TREATMENT– 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 guidelines governing rehabilitation therapy;
Current Medicare practice is to include manual lymph drainage (MLD) as a physical therapy and rehabilitative procedure, subject to limitations applicable to rehabilitation. These guidelines are frequently used by medical providers and insurers to limit the number of sessions and sometimes to limit the treatment to once per lifetime. It is important in any lymphedema treatment law to make clear that the duration of this treatment and the number of times it may be given is determined by the treating physician’s determination of medical necessity.
Typically, the initial treatment will reduce swelling to a stable plateau in 1-3 weeks, after which, with training and provision of the appropriate compression bandages and garments, the patient is able to manage the lymphedema at home. In more stubborn cases, where the lymphedema has not been promptly diagnosed and treated, and has progressed to Stage 2 or 3, more lengthy treatment may be required. The length of treatment must be a decision based on medical necessity.
e. PATIENT EDUCATION– Initial course of treatment (Phase 1) shall include training the patient to perform self treatment in a home setting (Phase 2), including self-manual lymph drainage, bandaging, wearing and care of compression garments, conducting an appropriate exercise program, use of specialized manually adjustable compression devices, donning aids, and other required ancillary equipment and techniques for self-measurement. Patient training shall include information on skin care, risk of infection and the steps to be taken if infection occurs;
In order for a program of complex decongestive therapy (CDT) to be effective in treating chronic lymphedema, the patient must be fully compliant with the treatment plan developed by the treating physician or therapist. Instruction on the Phase 2 home procedures must be provided by the medical provider as part of the Phase 1 outpatient treatment. Regular measurements are made by the patient to insure that the self-treatment is effect in maintaining the progress achieved in Phase 1, to evaluate if the patient’s technique remains effective, and to determine when additional professional treatments may be required.
The requirement for post-discharge education of patients already esists in Sections 1262.5, 1262.6, 1262.7, and 1367.5 of the Health and Safety Code, and to in Sections 10117.5 and 10233.25 of the Insurance Code, relating to health facilities.These sections require each hospital to have in effect a discharge planning policy that requires appropriate arrangements for posthospital care and a process that requires that each patient shall be informed of his or her continuing health care requirements.
With respect to diabetes treatment, California Health and Safety Code §1367.51 states:
“(d) Every plan shall provide coverage for diabetes outpatient self-management training, education, and medical nutrition therapy necessary to enable an enrollee to properly use the equipment, supplies, and medications set forth in subdivisions (a) and (b), and additional diabetes outpatient self-management training, education, and medical nutrition therapy upon the direction or prescription of those services by the enrollee's participating physician. If a plan delegates outpatient self-management training to contracting providers, the plan shall require contracting providers to ensure that diabetes outpatient self-management training, education, and medical nutrition therapy are provided by appropriately licensed or registered health care professionals.
“(e) The diabetes outpatient self management training, education, and medical nutrition therapy services identified in subdivision (d) shall be provided by appropriately licensed or registered health care professionals as prescribed by a participating health care professional legally authorized to prescribe the service. These benefits shall include, but not be limited to, instruction that will enable diabetic patients and their families to gain an understanding of the diabetic disease process, and the daily management of diabetic therapy, in order to thereby avoid frequent hospitalizations and complications.”
f. COMPRESSION BANDAGES, GARMENTS AND DEVICES– Coverage shall be provided for any compression garments, bandages and devices deemed by the patient’s qualified caregiver to be medically necessary, with replacements when required to maintain the compressive function or to accommodate changes in the patient’s dimensions;
The second cornerstone of lymphedema treatment by complex decongestive therapy (CDT) is compression therapy. All the beneficial results of manual lymph drainage (MLD) will dissipate quickly if the lymphatic fluid is not prevented from re-collecting in the affected limb. Compression bandages and garments are used as part of Phase 1 treatment in the clinic setting, and it is necessary to replenish these compression systems when they lose elasticity with repeated washing and daily use. These compression systems are also designed to provide “working” of fibrotic tissues during sleep and normal activities, and to provide support and static resistance to the muscles during normal daily activities and during daily exercise, thereby providing stimulation to the lymphatic system.
According to Prof Med Horst Weissleder, MD, leading expert and author on lymphedema diagnosis and treatment: “the treatment of chronic lymphedema requires adequate compression of affected extremities following manual lymph drainage. Without such continuous compression, lymphedema typically deteriorates despite physiotherapy. This in turn leads to higher morbitity, insufficient patient compliance and overall low cost effectiveness of the therapy. Stocking measurements, proper selection of compression grade and stocking material requires extensive experience from the bandaging therapist and the prescribing physician.”
g. FOLLOW-UP TREATMENT– Coverage shall be provided for follow-up treatments when medically required or to periodically validate home techniques, to monitor progress against the written treatment plan and to modify the treatment plan as required;
Since it is common for providers and insurers to use the policies of physical therapy and rehabilitation to limit follow-up treatments it is necessary in any lymphedema treatment mandate to insure that medical necessity governs the coverage of courses of treatment after the initial course. Lymphedema today is not curable, and is a chronic and lifelong medical condition caused by the physiological alteration of the lymphatic system, impairing its ability to transport lymphatic fluid back to the circulatory system. A lapse in the home treatment efficacy, development of fibrotic tissue, a new trauma or overload, or even normal ageing processes may result in the accumulation of lymph that cannot be removed by the patient and require professional medical help. In these cases additional treatments must be allowed.
h. DENIAL OF TREATMENT– 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.
This important provision will save the state millions of dollars in wasted time in battling and refereeing claims disputes caused by the denial of medical treatment for lymphedema. Millions of dollars are being spent unnecessarily in needless appeals of denials around the country--many of which are being reversed by Administrative Law Judges or independent medical reviewers who recognize that the current standard of lymphedema care includes CDT.
It will also accomplish an important educational function, forcing a greater number of physicians to learn more about the current medical standard of lymphedema treatment. With this knowledge, the practice should decrease of prescribing diuretics and pain pills in lieu of referral to qualified therapists. Millions of dollars are being spent unnecessarily by medical providers to treat cellulitis and lymphangitis resulting indirectly from denials of the preventive treatment modalities accepted by NIH NCI, ACS, ISL, NLN, LRF and most other knowledgeable medical and therapeutic organizations;
i. MEASUREMENTS TO DEFINE TREATMENT EFFICACY– Periodic measurements shall be made to insure the efficacy of the treatment plan and patient compliance, and be used to modify the treatment plan as required or to determine the need for followup courses of treatment.
Placing the requirement for measurements into the lymphedema treatment law provides the yardstick by which future researchers can evaluate the effectivity of the treatment, provides a means of determining whether treatment updates under the law are medically indicated, provides a means for the treating physician and therapist to evaluate whether the treatment plan is being followed or needs correction.
Edema volume and patient body weight are the measurements used to measure lymphedema treatment progress. Measurements of limb circumference at 2-8 places are well-correlated with limb edema volume. Measurements are relatively simple, and can be done by the patient with a simple tapemeasure and scale.
j. PROHIBITION OF ADDITIONAL TREATMENT FEES– No additional fees or deductables may be assessed for compliance with this statute other than already exist in the coverage contract for medical services.
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, this bill 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, and having to forego elements of the medical treatment during the lengthy appeal process.
Furthermore, most providers already have, in place, the essential elements of lymphedema treatment, i.e. physicians, physical and occupational therapists and a durable medical equipment department. What is usually missing, is the education and protocol for diagnosing and treating this common ailment. In the absence of this knowledge and protocol the patient is denied treatment while the medical problem worsens and the provider is forced to treat frequent resulting infections on an emergency basis.
k. INFORMED CONSENT— 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 risk of lymphedema associated with the alternative procedures.
“Informed consent” is defined as consent to medical treatment by a patient, or to participation in a medical experiment by a subject, after achieving an understanding of the risks and benefits. While a statutory definition of "Informed Consent" has never been written into California law, it has been extensively discussed in case law and is well understood within the medical and legal communities to mean that a patient "receive sufficient information to make a meaningful decision" regarding their own healthcare. Cobbs v. Grant (1972) 8 Cal.3d 229
Informed consent is more than merely your agreement to a particular treatment or procedure. Informed consent is your agreement to a proposed course of treatment based on receiving clear, understandable information about the treatment's potential benefits and risks.1 You must also be informed about all treatments available for your health condition, and the risks of receiving no treatment.
Informed consent can also be given formally, by signing a document that states your doctor has fully discussed a treatment or procedure with you and that you have acknowledged and agreed to the risks. In a formal consent, you are usually asked to sign a form titled "Informed Consent to Treatment," or something similar. This is especially true in situations involving hospitalization, surgery or invasive testing.
California law requires that your consent be obtained in writing for several specific procedures and treatments for specific types of conditions, including:hysterectomy,(*Cal. Health & Safety Code § 1690); breast cancer (Cal. Health & Safety Code § 109275); prostate cancer (Cal. Health & Safety Code § 109280 and § 109282); and gynecological cancers (Cal. Health & Safety Code § 109278).
Although lymphedema itself is not a fatal medical condition, it is an incurable condition often requiring daily care to avoid worsening and disability, and to prevent infections which can be fatal. The risk of lymphedema must therefore be discussed in considering medical procedures.
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