In April, the Centers for Medicare & Medicaid Services (CMS) floated the rate cut proposal for inpatient surgeries involving external assist devices inserted into the heart, such as Impella.
The proposed “dramatic decrease” in reimbursement “will result in significant underpayment to hospitals’ treatment of the highest acuity Medicare heart failure patients, such as those suffering from heart attacks leading to cardiogenic shock and heart failure patients being treated with percutaneous coronary intervention,” the company wrote in a letter to CMS. “In addition, we believe this will limit access to care for newly FDA-approved indications for critical heart pumps.”
The FDA decided in May to allow a clinical trial exploring the Impella CP Heart pump’s ability to treat patients undergoing treatment for an ST-segment elevation myocardial infarction, or STEMI heart attack.
Health systems, hospitals and individual cardiologists also responded with letters citing 13 recent changes in American Hospital Association coding that CMS failed to consider in setting its proposed reimbursement rate. The agency also did not take into consideration that 22% of hospitals that used Impella on patients charged for the procedure but not for the device or associated services, which cost about $25,000, according to the Danvers, Mass.-based company.
CMS responded that although it would adopt “a temporary one-time measure” to maintain the fiscal year 2019 reimbursement for Impella and other external cardiac assist devices for FY 2020, which begins October 1, 2019.
“When CMS did its final analysis, it determined this was ‘an outlier circumstance,'” Abiomed said in an email to MassDevice. “The analysis showed 68% of claims contained inaccuracies, with many hospitals not charging for Impella at all. The inaccurate data resulted from an unprecedented level of coding changes over a short period of time.”