IconsReg

Regulatory

Before a medical procedure can be considered for clinical use, the technology underlying that procedure – for instance, the focused ultrasound device – must first obtain regulatory approval from a governing body. Approval is based on clinical data demonstrating that the technology is safe and effective. Examples of regulatory approvals include the CE Mark for most countries in Europe and device approval from the US Food and Drug Administration (FDA).

Approvals are also disease-specific, meaning each device must go through the regulatory process for every different disease and/or condition it aims to treat. For instance, Insightec’s Exablate Neuro device underwent the FDA regulatory process twice to be cleared to treat essential tremor and Parkinson’s disease.

Once a regulatory body clears a device for a select indication, physicians can begin treating patients on a commercial basis, but oftentimes on a cash-pay basis. For the treatment to be financially accessible by the greater patient population, it must obtain reimbursement.

Reimbursement

Since very few patients have the capacity to pay out-of-pocket for their medical care, reimbursement of medical procedures by a government or private insurer is a critical element of the healthcare ecosystem and the adoption of new technologies like focused ultrasound. Despite its importance, the process of medical reimbursement is not as straightforward as simply sending a bill and receiving payment. As patients and physicians alike have experienced, the process of getting reimbursed for a medical procedure can be a complicated system that involves a labyrinth of policies and processes.

Because insurers often require preauthorization for procedures and because coverage is regional in some countries, we strongly recommend that patients confirm insurance coverage with their insurer prior to undergoing treatment. The good news is that, despite the complexities of reimbursement, the use of focused ultrasound to treat a wide range of diseases is available in many countries. See insurance coverage by region >

Reimbursment in the US

Currently in the US, there is some level of insurance coverage of focused ultrasound to treat bone metastases, essential tremor, Parkinson’s disease, uterine fibroids, and prostate cancer. Learn more about reimbursement by stakeholder group below.

Reimbursement in Europe

Europe in its broadest, geographical definition is comprised of approximately 50 countries, each with its own legislation and healthcare system. Even within the biggest block of countries – the European Union with 27 member states – healthcare delivery and related funding is organized on a national level, and in some countries, even on a regional level. To assess the full scope of focused ultrasound-based procedure reimbursement in Europe, one must look at individual countries and their respective healthcare governance.

United Kingdom (UK)
In the UK, the National Institute for Health and Care Excellence (NICE) provides health technology assessments for new clinical procedures. These assessments are used as guidance for access to the procedure within the National Health Service (NHS). Learn more about reimbursement in the UK >

Germany
Germany has a universal dual-arm health insurance system with a statutory public arm covering about 89 percent of the population and a private arm covering the remaining 11 percent. The German Operation and Procedure Code base for the statutory health insurance system has several focused ultrasound-specific procedure codes linked to a standard payment for hospital in-patient procedures. Learn more about reimbursement in Germany >

Italy
Healthcare in Italy is governed within each of the 20 regions. There is coverage for focused ultrasound treatment for prostate, uterine fibroids, bone metastases, osteoid osteoma, essential tremor, tremor-dominant Parkinson’s disease, and neuropathic pain in some regions. 

France
Insurance companies can only pay what is in the “big code book,” and no special agreements are allowed; there is currently no code for any focused ultrasound procedure in the book.

Spain
Healthcare in Spain is governed within each of the 17 autonomous regions. There are no known focused ultrasound-specific codes or payments. However, special negotiations and agreements by individual healthcare providers on a regional level are in place.

Israel
Reimbursement is established for essential tremor, bone metastases, and uterine fibroids.

Scandinavia
The Nordic countries of Denmark, Sweden, Norway, Iceland, and Finland are known for their comprehensive public healthcare system. Once the group decides focused ultrasound is a valuable addition to the hospital’s service, respective equipment is purchased, and operating expenses become part of the budget. Focused ultrasound in Scandinavia includes one site in Sweden (uterine fibroids); one site in Finland (uterine fibroids, prostate, bone metastases) and three sites in Norway (uterine fibroids, prostate, research) – all in university hospitals.

Questions?

For inquires related to regulatory and reimbursement in the US, please contact Michael Broad, PhD, the Foundation's Data Strategy Director.

For inquires related to regulatory and reimbursement in Europe, please contact Thomas Andreae, PhD, the Foundation's Ambassador in Europe. 

The Focused Ultrasound Foundation Newsletter

Our newsletter delivers updates for clinicians, researchers and patients. Sign up and stay on top of the rapid advancements of this innovative medical technology.

Sign Up  Read the Latest Issue

Read The Tumor  by John Grisham

From John Grisham, comes a story where today’s medical fiction could become tomorrow’s lifesaving reality.

Download a Free eBook or Audiobook

Contact Details

Call Us
434.220.4993
Find Us
Focused Ultrasound Foundation
1230 Cedars Court, Suite 206 Charlottesville, VA 22903
Email
Whitelist Instructions