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Dec 21, 2017
How to build a business case for medical devices awaiting reimbursement


In 2015, Houston Methodist Hospital made the decision to invest in a medical technology that had not yet been approved by the US Food & Drug Administration.

The procedure, called High Intensity Focused Ultrasound (HIFU), was prevalent and in demand in Europe and parts of Asia, but new to the U.S. and largely unknown by urologists across the country.

HIFU is an outpatient procedure that uses concentrated sound waves to destroy targeted tissue in the prostate. Using advanced ultrasound imagery to guide a rectal probe during the procedure, urologists are able to avoid damaging the healthy tissue and nerve bundles that control sexual function and urinary continence, making it an appealing option for eligible patients.

But because HIFU was only cleared by the FDA for the ablation of prostate tissue in November 2015, it was not covered by private insurance or Medicare.[1] Patients had to pay for the procedure in cash.

Houston Methodist, one of the largest medical centers in the US, comprising an academic medical center and six community hospitals, had to weigh the anticipated benefits for patients with the return on investment for the organization.

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