For a condition that affects 1 to 3 percent of the U.S. population and one out of every five mastectomy patients, lymphedema and the equipment to treat it aren't hot topics in the home care industry.
Lymphedema is a disorder of the lymphatic system which parallels the body's circulatory system. According to Deborah Gross, vice president of marketing for Manalapan, N.J.-based manufacturer Lympha Press, "The lymphatic system is like a sewer system. The water drains out of the capillaries, gets picked up, purified, drained, junk gets taken out and it goes back for recycling. This happens every day. Your body recycles quarts and quarts of lymphatic fluid every day."
However, in a system affected by lymphedema, the body's recycling system has been obstructed; pipes have been cut or made of the wrong material or are the wrong shape, causing blockage. If one of the lymphatic system's intersections — the lymph nodes — is compromised, the fluid gets stuck and causes swelling, or edema.
In the world's eastern regions, lymph node disruption is usually triggered by a bug bite. In the western world, however, it is common to acquire secondary lymphedema following a surgery in which lymph nodes are dissected or removed. After tissue is removed from a mastectomy, for example, the area may be blasted with radiation, which damages healthy tissue and can damage lymphatic channels as well.
Congenital lymphedema, sometimes called primary lymphedema, is also possible. And, lymphedema can begin for no apparent reason.
Seen in both women and men, lymphedema can affect upper extremities such as arms, underarms, the chest or back area as well as the truncal area. Lower extremities can also be affected, such as the feet, legs or genitalia. The swollen limbs may become vulnerable to infection, and repeated infection can cause scarring that makes the tissue vulnerable to more swelling and infection. In some cases lymphedema becomes chronic, and the condition becomes progressively debilitating.
"These people become restricted in their mobility and become exacerbated and become upset, and they eat and become obese and it builds and builds," Gross says. "Lymphedema has been neglected for many, many years. It is disfiguring, disabling, debilitating, it hurts and it's something that needs to be treated."
Medicare recognizes lymphedema and covers treatment with certain diagnoses, as do many insurance plans. And a number of other manufacturers make home products to treat the condition, among them Bio Compression Systems, Moonachie, N.J.; Chattanooga Group, Hixson, Tenn.; Huntleigh Healthcare, Eatontown, N.J.; and Talley Medical, Lansing, Mich.
Lympha Press, for example, offers 56 garments and compression therapy systems such as pants, a jacket and arm sleeves, that treat specific areas. A pump supplies air to the garments' compression centers, which inflate in a special order for 26 seconds, followed by a four-second intermission.
According to Gross, treatment of lymphedema with compression pump technology "has been proven effective in 30 years of medical research."
Another way to treat lymphedema is a process called manual lymph drainage, which involves massaging and bandaging of the affected area. This treatment is offered by therapists who specialize in lymphedema massage, but it is not available in all areas, Gross says. She also notes there are patients who have a limited number of therapy sessions based on insurance. For these patients, she says, home equipment is a viable option.
Called The Optimal, Lympha Press' newest system treats the torso and abdomen, massaging the area closest to the blockage first as therapists suggest. But it also keeps in place a regular inflation cycle.
"We tell [providers that the Optimal] is only for patients who have truncal lymphedema. Other patients can use [the garments] that massage extremities only, because we feel strongly that there is a place for this equipment with people who really need it," she says. The Optimal, however, allows therapists to lock in a pump pressure so patients can't change it at home.
"If patients can do the therapy in the privacy of their own home, especially in situations where they may be embarrassed such as with genital lymphedema, it's a great way to treat it," says Gross. "Instead of wearing compression garments all day long to go outside, they can do it in their own home."
Lymphedema treatment products also give providers an opportunity to differentiate their companies with equipment for patients in their areas who have no other place to get it — and a way to differentiate themselves in the community.
According to Lympha Press' Fred Levine, director of sales, "If a provider already sells compression stockings, the people who buy those are usually already lymphedema patients. This device adds to the modality of treatment.
"If you look at the statistics, this product is needed, and if [patients] don't get it from you, they will get it from another source."
A Note on Definition and Billing
According to a definition included on a Jan. 13 billing reminder from NHIC, Corp., the Jurisdiction A DME MAC:
"Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid. The accumulation of lymph fluid results from impairment to the normal clearing function of the lymphatic system and/or from an excessive production of lymph. Lymphedema is divided into two broad classes according to etiology. Primary lymphedema may be due to such causes as Milroy's Disease or congenital anomalies. Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as radical surgical procedures with removal of regional groups of lymph nodes, post-radiation fibrosis and spread of malignant tumors to regional lymph nodes with lymphatic obstruction, among other causes.
"Pneumatic compression devices are covered in the home setting for the treatment of lymphedema if the patient has undergone a four-week trial of conservative therapy and the treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise and elevation of the limb. The garment may be prefabricated or customer-fabricated but must provide adequate graduated compression."
For all devices, the MAC reminder said, "the determination by the physician of the medical necessity of a pneumatic compression device must include:
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the patient's diagnosis and prognosis;
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symptoms and objective findings, including measurements which establish the severity of the condition;
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the reason the device is required, including the treatments which have been tried and fails (prior conservative therapy); and
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the clinical response to an initial treatment with the device. The clinical response includes the change in pre-treatment measurements, ability to tolerate the treatment session and parameters and ability of the patient (or caregiver) to apply the device for continued use in the home."
