How to Build a Business Case for Medical Devices Awaiting Reimbursement
By Michael Garcia, RN, JD
When does it make sense to invest in a medical technology that had not yet been approved by the US Food & Drug Administration? In 2015, Houston Methodist dealt with this question and ultimately chose to invest in new medical technology used to treat prostate disease, High Intensity Focused Ultrasound (HIFU). HIFU was new in the U.S. and largely unknown by urologists across the country, but prevalent and in demand in Europe and parts of Asia.
Concentrated sound waves are used to destroy targeted tissue in the prostate during HIFU. Using advanced ultrasound imagery during the outpatient procedure, urologists are able to avoid damaging healthy tissue and nerve bundles that control urinary continence and sexual function, and preserve patients’ quality of life. This makes it an appealing option for eligible patients.
Because HIFU was only cleared by the FDA for the ablation of prostate tissue in November 2015, it was not yet covered by private insurance or Medicare. Patients paid for the procedure in cash.
One of the largest medical centers in the US, with one academic medical center and six community hospitals, Houston Methodist weighed the anticipated benefits for patients against the return on investment for the organization.