Association files suit over reimbursement change

Electrical stimulation funding at issue

The American Physical Therapy Association (APTA) filed a lawsuit on July 30 seeking a preliminary injunction to prevent the Health Care Financing Administration (HCFA) from enforcing a recent decision to suspend Medicare coverage for electrical stimulation (ES) therapy for the treatment of wounds. 

"HCFA’s decision that ES should not be covered under any circumstances for the treatment of wounds is indefensible," says APTA president Jan K. Richardson, PT, PhD, OCS. 

The lawsuit was filed in the U.S. District Court for the District of Massachusetts by three patients receiving ES. According to APTA, they and other patients stand to suffer immediate, severe, and irreparable physical harm as a result of the decision. In addition, APTA members will be inhibited in their ability to provide medically necessary treatment to patients and are prohibited from receiving Medicare reimbursement for ES treatment. 

"HCFA made a coverage determination that is utterly at odds with the evidence before it concerning safety, efficacy, and general acceptance of ES therapy within the medical community," says Nancy Garland, APTA director of government affairs. 

Among other supporting data was a clinical practice guideline for pressure ulcers issued in 1995 by the Agency for Health Care Policy and Research (AHCPR), an agency of the same federal government department as HCFA. The guideline recommends ES as an effective therapy for stage III and IV pressure ulcers and for recalcitrant stage II ulcers. 

"Data from five clinical trials involving a total of 147 patients support the effectiveness of ES in enhancing the healing rate of wounds that have been unresponsive to other forms of care covered by Medicare. Without ES, many individuals are at risk for severe infection, possible tissue and limb loss, and even loss of life," says Jerry Connolly, PT, APTA senior vice president of the division of health policy. 

Garland adds that "in addition to being contrary to clear evidence of clinical efficacy, the HCFA noncoverage determination utilized criteria that have never been promulgated through formalized rule-making." 

The HCFA decision was based partly on comparisons of ES to other Medicare-covered therapies and on the fact that ES is not approved by the FDA specifically for wound care treatment. 

Grant Bagley, MD, director of HCFA’s Office of Clinical Standards and Quality, declined to comment on the lawsuit because of the pending litigation. 

Physical therapists have long applied electrical stimulation as standard therapy for both hard- and soft-tissue injuries. In July, however, HCFA finalized its decision to no longer reimburse Medicare beneficiaries who receive electrical stimulation for chronic wounds. For 17 years prior to the ruling, Medicare covered the use of electrical stimulation for wound care. 

The decision was a major setback for the American Physical Therapy Association (APTA), which rigorously opposed the move and for individual physical therapists who are convinced that the use of electrical current accelerates wound healing in many patients. Experimental evidence supporting electrical stimulation for soft-tissue injury is not nearly as convincing as that for hard-tissue damage, yet many clinicians insist that the treatment makes a difference for many chronic wound patients. For instance, one physical therapist reports that in an informal double-blind study the healing rate was 2.4 times faster when electrotherapy was applied. 

HCFA clearly does not agree. "After a thorough review of the additional medical literature by my staff, including our medical staff, we have determined that there is insufficient evidence to support coverage of electrical stimulation for the treatment of wounds at this time. . . . Electrical stimulation does not appear to be markedly superior or inferior to conventional or alternative therapies for chronic wound healing," says Bagley.

Flaws in rationale?

Physical therapists bristle at HCFA’s decision and are quick to point to flaws in its rationale. "The HCFA conclusions are based partly on comparisons of electrical stimulation to other alternative therapies and not to other wound therapies," Garland says. "The researchers themselves admitted that the published studies on electrical stimulation and wound care had design weaknesses and that they could conduct only crude comparisons.’ These assessments are clearly unreliable and may not be valid." 

After HCFA announced its intention to deny coverage in May, APTA organized a multidisciplinary team that presented HCFA officials with research on electrical stimulation, an analysis of case studies, background information on the fundamentals of wound-healing physiology, and numerous studies supporting the effectiveness of electrical stimulation in the treatment of wounds. 

Included in the APTA presentation was an AHCPR study that gave electrical stimulation the second highest rating possible based on extensive review of scientific literature, according to APTA officials. 

"We have confidence in the evidence we have submitted. The patients who risk losing a limb or getting systemic infections without this care do not have the time to wait for HCFA to develop new protocols to measure the progress of wound healing," replies Connolly. "It is in the interest of these patients that APTA is prepared to take legal action to get [patients] the care they need." 

HCFA responded to APTA’s defense by saying that the information did not constitute scientifically valid clinical data but could serve as the basis for additional clinical studies. 

Physical therapists also worry that private health insurers will follow Medicare’s lead and discontinue reimbursement for electrical stimulation for wound healing.

Why should ES work?

Researchers have known for some time that a measurable amount of electrical current is produced at the site of acute and chronic soft-tissue injury, explains Patricia Mertz, professor of dermatology in the Department of Dermatology and Cutaneous Surgery at the University of Miami, who has conducted an extensive review of electrical stimulation research. The current is suspected of playing a role in healing. As long as the wound remains moist, the current remains "turned on." 

One theory as to why ES might aid healing asserts that the therapy reintroduces the electrical current that helps cells mobilize in chronic wounds. There is also compelling evidence showing that certain types of cells pivotal to wound healing are activated by pulsed electrical current, such as epidermal cells and cells containing growth factors. "This has been shown in vitro, but not in vivo," Mertz adds. 

In one study Mertz reviewed, eight pressure ulcers were treated with high-voltage pulsed current while nine ulcers were used as controls. The electrical stimulation appeared to be an effective adjunctive therapy, but the investigators could not precisely identify the physiological mechanisms at work.

No standard protocol

In her investigations Mertz noted that, unfortunately, clinical studies of electrical stimulation have been inconsistent, making the purely scientific case for the therapy weak. 

"Each one of the papers I reviewed used a different treatment regimen, and each one used a different delivery system," she explains. 

"Some researchers used one type of dressing, some used another type. There was not standard protocol. Everyone is talking about something else and saying this works.’ But there hasn’t been a definitive study yet conducted on electrical stimulation and soft tissue," Mertz says.