Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Physician 1: This patient is a 66-year-old female with coronary artery disease, diabetes and hypertension. She underwent cardiac revascularization in 2004 and became symptomatic again in April 2005 with shortness of breath and angina.  The patient has requested authorization and coverage for enhanced external counterpulsation (EECP). The Health Plan has denied this request indicating the requested therapy is considered investigational. The most recent ACC/AHA practice guidelines from 2002 consider enhanced external pulsation (EECP) as a Class IIb therapy for the treatment of chronic stable angina in patients who are refractory to medical therapy who are not candidates for PTCA or surgical intervention. This means its usefulness/efficacy is less well established by evidence or opinion. The guidelines cite two studies that found the treatment to be generally well-tolerated and efficacious; however, the ACC/AHA indicates further studies are needed before EECP can be recommended definitely.In general practice, EECP has been accepted as a reasonable treatment for a specific subset of patients, namely those with refractory angina and unrevascularizable anatomy. This patient clearly falls into this accepted group. Indeed, there are no other treatment options that are likely to be more beneficial for this patient than EECP. In this group of patients, surgical laser and transmyocardial revascularization (class IIa), heart transplant, and spinal cord stimulation (class IIb) are far more invasive and dangerous options.Given that EECP is accepted as clinical practice and is supported by studies in this specific population, and because the patient has no other available standard treatment options, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2: The patient is a 66-year-old woman with coronary artery disease, diabetes and hypertension. She had cardiac revascularization in 2004. In April 2005 she was again symptomatic with shortness of breath and angina. Catheterization revealed that three grafts had closed. The patient was treated with metropolol, Nitro-Dur, Laxix, Plaviz, Zocor and glipizide. She continued to be symptomatic. Her cardiologist recommended EECP. The Health Plan has denied authorization for the requested therapy because it is considered experimental. In 2002 the American College of Cardiology/American Medical Association issued a joint statement indicating the procedure was investigational. In 1999 the Health Care Financing Administration (HCFA) approved EECP as a reasonably and necessary treatment for certain Medicare beneficiaries suffering from stable angina pectoris refractory to medical and/or surgical therapy. The HCFA approval states, Coverage of this therapy is provided for patients who have been diagnosed with disabling angina (Class III or Class IV, CCSF score or equivalent) who, in the opinion of a cardiologist or cardiothoracic surgeon are not readily amenable to surgical intervention.The patient has submitted documentation of medical and surgical management for her angina pectoris. Standard therapy has not been effective for this patient. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3: The case involves a 66-year-old female with unstable angina refractory to maximal medical therapy. Cardiac catheterization for unstable symptoms was performed in April 2005, which identified occluded grafts and anatomy not suitable for revascularization. A request for EECP was made, which was denied by the Health Plan on the basis it is considered experimental/investigational.This patient presents with refractory angina, unable to be controlled by medical therapy. The use of EECP in this setting is a well-known, clinically accepted and appropriate treatment for patients in this exact subset. As per the ACC/AHA recommendation, EECP should only be used (in this subgroup) in patients who cannot be managed adequately by medical therapy and who are not candidates for revascularization therapies (surgical or interventional).EECP is no longer considered experimental/investigational in the treatment of patients in this subgroup. The use of EECP in this clinical setting is an evidenced based clinical practice within the expected and actual standard of care within the community. As such, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.