Tactile Medical braces for new Medicare rules that will tighten access to its pneumatic compression pump

Radiation and surgery are good at killing cancer, but they can leave some people who survive — particularly from breast cancer — with a condition called lymphedema, which causes swollen limbs and dangerous infections.

Medicare already doesn't cover the cheapest device for post-cancer lymphedema, an elastic compression wrap or garment. Now the government insurance program for seniors is rolling out rules on Dec. 1 that will create new hurdles for 25,000 people who may want to use an advanced medical device called a pneumatic compression pump to manage their lymphedema at home.

"It is a progressive disease. If you don't treat it, it's going to get worse. That's why this new change is so devastating for patients with lymphedema," said Jerry Mattys, CEO of Tactile Medical, a 190-employee manufacturer of pneumatic compression devices in Minneapolis. "This will harm patients if we don't take action."

Not everyone agrees. Medicare officials could not offer a comment for this story, but the clinical community has long debated what is the best way to apply compression to the skin to treat lymphedema, whether through machines, garments, therapists' hands or some combination of those.

"My priority for what Medicare should be covering would be compression bandaging materials and compression garments," said certified lymphedema therapist DeCourcy Squire, who works at Hennepin County Medical Center in Minneapolis. "The pump is basically for people who failed conservative treatment, for whatever reason. That is what these Medicare regulations are leaning toward."

Medicare's private contractors have issued several coverage decisions in recent months that were criticized for limiting patient access to care, including for speech-generating devices and lower-limb prosthetics.

"I've heard from patients, providers, and manufacturers about this issue," Rep. Erik Paulsen, R-Minn., said via e-mail, "and I'm working on solutions to address the situation."

Lymphedema is a chronic disease of the immune system that happens when lymph fluid containing white blood cells stops flowing the right way through the system of vessels and nodes clustered throughout the body. Fluid buildup can lead to mild or severe swelling of the arms and legs, and permanent skin damage in severe cases. Stage 3, the most serious form, is sometimes called lymphostatic elephantiasis.

A properly functioning lymphatic system is key to preventing infections; without it, even small cuts may lead to infections including a spreading and potentially dangerous rash called cellulitis. Lymphedema can also lead to dry or scaly skin that is especially susceptible to infection.

Most cases of lymphedema in the U.S. — more than 2 million today — happen as a result of treatments for cancer, which damage the system or remove lymph nodes.

In 2013, the most recent year data are available, Medicare spent about $24 million on compression pumps like the ones sold by Tactile Medical. Prices range between $1,200 and $5,000, depending on the model, Mattys said. Medicare patients must start on the cheap model and do a monthlong trial to see if they need a more complex machine.

As many as 25,000 Americans of Medicare age could benefit from compression machines next year, though the new rules are expected to limit how many people would get one. The rules say patients need documented "chronic and severe" lymphedema, and if their condition improves during a four-week trial of conservative therapy Medicare will not pay for a pneumatic compression machine.

The rules also say the prescribing medical professional cannot have a "financial relationship" with the company whose device would be ordered, though the term is not explicitly defined.

Business has been good for Tactile lately. Revenue hit nearly $49 million last year, a 100-fold increase in a decade's time, Mattys said.

Mattys says the evidence supports use of the device. Last month the medical journal JAMA Dermatology published an analysis of 374 patients with lymphedema from cancer that found a 5 percent incidence of cellulitis infections in the year after they started using Tactile's Flexitouch system. The infection rate was 21 percent in the same group the year before using the device.

But a person doesn't need a machine to apply compression to the skin.

Gentle massage can work the lymph fluid through the skin, as can wearing compression bandages and then doing exercise.

Advocates for using compression machines note that several thousand lymphedema therapists don't have the time to provide therapy to a population of millions of patients with lymphedema.

Squire said that in her experience the pneumatic compression pumps can be helpful as an "adjunct" to conservative treatment. But patients still need to wear compression bandages or stockings when they aren't using the machine, and they often also require manual lymph drainage like she performs.

Mattys said the policy limiting coverage of the machines seemed to contradict statements by Medicare officials that encourage moving health care treatment out of the hospital in situations where home care can be cheap and safe.

He also suggested that the four private companies that oversee the $8.8 billion that Medicare spends on durable medical equipment may have run afoul of the government's complex rules on rolling out new coverage determinations for medical products. He said their rules cannot be more restrictive than the overall national policy set by Medicare, but in this case, they are.

National Government Services, the Medicare durable medical equipment contractor for Minnesota, did not respond to phone calls and e-mails for comment.

Asked if litigation has been threatened, Mattys would say only, "They need to be held accountable, is what we would like to make them understand. I won't go further than that."

Joe Carlson • 612-673-4779

Twitter: @_JoeCarlson