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Atraumatic procedure bypasses the bypass for patients with no other hope
The Health Care Financing Administration (HCFA) in Baltimore has extended Medicare coverage as of July 1 to enhanced external counterpulsation (EECP), the noninvasive, atraumatic outpatient treatment for patients with coronary artery disease (CAD). Coverage includes patients with disabling angina who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical interventions such as angioplasty or bypass. Often candidates have undergone multiple invasive procedures that either failed or no longer suffice, and additional interventions may be too risky or refused by the patient. The procedure can also be used before a bypass or angioplasty when they are not unequivocally indicated.
The Medicare reimbursement for EECP has not been established, but experts estimate it will be $7,000 per full treatment course — one-third typical charges associated with angioplasty ($23,200) and one-sixth those for bypass surgery ($35,700). Because EECP carries almost no risks or complications, costs over time are also kept down.
Donald Caton, director of managed care at Healthcorp of America in Atlanta, says he and colleagues are working with HCFA on developing a new code for EECP. At first, HCFA instructed carriers to use CPT code 97016 in addition to modifier "GO" or "GP" until a specific code for EECP could be developed. "But the ACC [American College of Cardiology in Bethesda, MD] would not accept 97016," he says. "So HCFA backtracked and reissued a directive to use 93799 — cardiac procedure by report.’ Providers of EECP must submit clinical notes explaining the procedure, patient indications, and what was wrapped into EECP — plethysmography, three-lead EKG, oxygen saturation." Paper-work is now more complicated than it used to be.
Before Medicare covered EECP, most patients at Healthcorp were covered by Medicare secondary plans that pay if Medicare doesn’t. "Now, their supplement plans will usually pick up what Medicare doesn’t pay," says Caton. "Some patients who cannot self-pay and are without insurance apply for financial assistance through this company. We use the same criteria as other institutions — below poverty level, they pay nothing then we provide from $4,700 on up to the full billable charges of $11,439."
Medicare assigns every procedure a number of points. That number is multiplied by a dollar amount that changes every year, depending upon the federal budget. "This year that dollar amount is $35," says Caton. "If the procedure is worth seven points, the Medicare allowable amount would be $245 per session." That would come out to $8,575 for the course. Medicare reimburses 80% of that, or about $7,000. "We charge $11,439," he says, "but will be reimbursed about $7,000. We can’t bill Medicare different from any other carrier."
But that point structure for EECP has not yet been established, and HCFA has delegated that decision to providers in the field. "We’re all in the process of talking with the HCFA claims administration office in each jurisdiction to understand what the cost inputs are," says Caton. "Then, they will be broken down into the point system, and we’ll know what the allowable charge is."
Picking the right patients
Karen Manzo, RN, clinical director of HeartCare Centers of Ohio (part of Grant Riverside Methodist Hospital in Columbus) says, "Patients eligible for EECP must be in Canadian Cardiovascular Classification [CCC] 3 or 4." HeartCare uses the New York Heart Association (NYHA) classification for congestive heart failure (CHF) patients and the CCC classification for CAD. "They also must have a clinical condition that warrants them unsuitable to have bypass surgery or other surgical intervention."
When Manzo submits for reimbursement, she lists the disqualifier that makes a patient inoperable or puts him at high risk for operative complications. "Sometimes a patient’s coronary anatomy may not be amenable to an operative procedure," she says, "or he may have a comorbidity that creates risk, such as cancer or a pulmonary problem."
HeartCare does about 20 EECP procedures a day. "Until Medicare covered this, patients usually self-paid," says Manzo. "It is typically a seven-week course, 35 hours in all; but occasionally, if the patient comes from a distance, two one-hour sessions are given in a day. There’s no data on the benefit of twice-a-day vs. once-a-day therapy."
Three centers involved in CHF study
HeartCare, along with two other centers in the United States — the University of Pittsburgh and the University of California at San Francisco — is currently involved in a clinical study of EECP for CHF patients. "We are looking at 40 patients with CHF and the safety of their undergoing EECP," says Manzo. There is no data yet.
EECP is thought to promote a natural bypass around blocked heart vessels and has been shown to be most effective in patients who have single- or double-vessel disease. (See www.eecp.com on the Internet for extensive information on EECP. Also, see Cost Management in Cardiac Care, July 1997, p. 87, for earlier coverage of the subject including contraindications and precautions.)
The procedure uses hemodynamic principles to relieve angina by increasing coronary blood flow to ischemic areas of the myocardium. It involves a series of compressive air cuffs placed on the patient’s legs and buttocks. Timed by the patient’s EKG signal, a microprocessor controls inflation and deflation of the cuffs at specific points during the cardiac cycle. During diastole, the cuffs sequentially compress vascular beds, creating a retrograde pressure wave and increasing perfusion pressure, blood flow, and oxygen supply. During systole, the cuffs are deflated simultaneously to produce unloading, decreasing oxygen demand. Patients often begin to experience alleviation of angina after 15 to 20 hours of the recommended 35-hour regimen. The beneficial effects are sustained between treatments, and may persist long after completion of a course of therapy. (See photo, p. 98.)
Cardiomedics in Irvine, CA, manufactures a product that creates external sequential counterpulsation, but HCFA restricts its Medicare coverage "to those enhanced external counterpulsation systems that have sufficiently demonstrated their medical effectiveness in treating patients with severe angina in well-designed clinical trials," and the EECP system produced by Westbury, NY-based Vasomedical is the only such system to have undergone such testing. "Any other company’s equipment is not included in the coverage even if it has a 510 clearance by the FDA," says Manzo. "It does not satisfy HCFA’s requirement."
Researchers recently conducted a study on 139 CAD outpatients with angina and positive exercise treadmill tests in seven university hospitals to assess the safety and efficacy of EECP.1
Patients were given 35 hours of active or inactive counterpulsation over a four- to seven-week period. Exercise duration increased in both groups, and time to 1-mm ST-segment depression increased significantly in active counterpulsation as compared with inactive counterpulsation. Active-counterpulsation patients had fewer angina episodes as compared with inactive-counterpulsation patients. Nitroglycerin usage decreased in active counterpulsation but did not change in the inactive-counterpulsation group. The investigators concluded that the procedure reduces angina and extends time to exercise-induced ischemia in patients with symptomatic CAD. Treatment was relatively well-tolerated and free of limiting side effects in most patients.
1. Arora RR, Chou TM, Jain D, et al. The multicenter study of enhanced external counterpulsation (MUST-EECP): Effect of EECP on exercise-induced myocardial ischemia and anginal episodes. JACC 1999; 33:1,833-1,840.