Opinion ID: 790692
Heading Depth: 4
Heading Rank: 1

Heading: Raytel's Pacemaker Testing for Medicare

Text: 6 At times relevant to the indictment, Raytel performed transtelephonic pacemaker testing for Medicare patients at government expense. Transtelephonic monitoring allows a technician at a remote location to test the operation of a pacemaker by having a patient use a portable device to transmit telephonic signals that can then be converted into a conventional electrocardiogram (ECG) report for review by a supervising cardiologist. 7 For Medicare to cover the expense of its transtelephonic testing, Raytel was obliged to comply with Section 50-1 of the Medicare Coverage Issues Manual, which required that a pacemaker be monitored in three functioning modes for thirty seconds each, with the results recorded on strips of magnetic tape (the 30-30-30 test). See Medicare Program; National Coverage Decisions, 54 Fed.Reg. 34,555-03, 34,580 (Aug. 21, 1989). 2 At the first-step of the 30-30-30 test, a technician records on a magnetic strip the pacemaker's operation for thirty seconds in a free-running or demand mode, during which the pacemaker supplies an electric charge to the heart only when it senses that the organ is falling behind the programmed heart rate. At the second step, a technician records a strip of the pacemaker's operation for thirty seconds in a magnetic mode, during which the patient uses a magnet to close a switch inside the pacemaker, causing the device to fire an electric charge to the heart at regular intervals regardless of the patient's pulse. This exercise typically reveals whether the pacemaker's battery needs to be replaced and whether the heart is properly responding to the charge firing. At the third step, a technician records a strip of the pacemaker's operation for a final thirty seconds in the demand-after-magnet mode, during which the magnet is removed and the pacemaker is allowed to return to free-running functioning. This segment of the test permits a technician to verify that a pacemaker's internal switch has reopened and that the patient has suffered no ill effects from the constant firing of the pacemaker during the magnetic-mode phase of the test. 8 Because a cardiologist would typically need to review only representative segments of the first two phases of the test, a technician would generally attach only strip excerpts to the report submitted to the doctor, providing the full test results upon specific request. Before 1995, when Raytel switched to computerized testing, its technicians were able to prepare strip excerpts from the first two test modes as the third was concluding. Because the computer only displayed information as it was being recorded, however, it took longer for technicians employing this technology to identify and prepare representative strips. This delay in processing assumed significance in the aggregate because of the number of tests each Raytel technician was expected to perform—rising in 1999 from thirty-two to thirty-five to forty tests per day. 3 This, in turn, led some Raytel technicians to depart from Medicare specifications and to record only an abbreviated strip—or no strip at all—of the last test phase. At trial, the government offered evidence indicating that, in the period December 1999 to March 2000, technicians at Raytel's Connecticut facility complied with Medicare's pacemaker testing specifications only 22 to 34.7 percent of the time. 9