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The American Physical Therapy Association in Alexandria, VA, filed a lawsuit this summer seeking a preliminary injunction to prevent the Baltimore-based 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 association 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 the association, these and other patients stand to suffer immediate, severe, and irreparable physical harm as a result of the decision. In addition, therapists will be inhibited in their ability to provide medically necessary treatment to patients and prohibited from receiving Medicare reimbursement for ES treatment, the association says.
Nancy Garland, the association’s director of government affairs, says, "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."
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), a Rockville, MD-based 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.
Jerry Connolly, PT, the association’s senior vice president of the division of health policy, says, "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."
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 Rockville, MD-based U.S. Food and Drug Administration 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 ES 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 ES for chronic wounds. For 17 years prior to the ruling, Medicare covered the use of ES for wound care.
Experimental evidence supporting electrical stimulation for soft-tissue injury is not nearly as convincing as for hard-tissue damage, yet many clinicians insist that the treatment makes a difference for many chronic wound patients. For instance, one researcher reports that for one patient, 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," says Bagley.
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," says Garland. "The researchers themselves admitted that the published studies on ES 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, the association organized a multidisciplinary team that presented HCFA officials with research on ES, an analysis of case studies, background information on the fundamentals of wound-healing physiology, and numerous studies supporting the effectiveness of ES in wound treatment.
Included in the presentation was an AHCPR study that gave ES the second highest rating possible based on extensive review of scientific literature, according to association officials.
"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 the association’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.