Focused Ultrasound Reimbursement Landscape in Europe

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Europe mapEurope 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 (e.g., Italy, Spain, and Scandinavian countries), even on a regional level. With this, a view on focused ultrasound-based procedure reimbursement in Europe becomes a look at individual countries and their respective healthcare governance.

The decision-making process for introducing new technologies in each country reflects the organization of its healthcare system. Countries with a national healthcare system, like the United Kingdom (UK), France, or Germany, have central institutions that base their approval decisions on health technology assessments and clinical evidence (preferably from multiple randomized controlled trials, which are thus far not available for most focused ultrasound procedures). In countries with local or regional healthcare governance, criteria are not always clear, and the decision-making process may not be fully transparent.

Below is an overview of the current reimbursement processes and status in the UK, Germany, France, Italy, Spain, Israel, and Scandinavia.

United Kingdom (UK)

In the UK, the National Health Service (NHS) is the public, tax funded healthcare system providing free service to every citizen. The National Institute for Health and Care Excellence (NICE) provides Health Technology Assessments for new clinical procedures, which are used as guidance for reimbursement by the NHS. However, a positive NICE guidance does not automatically result in NHS coverage. Below is an overview of NICE guidance and available NHS coverage for focused ultrasound procedures where such data are available. With no agreed NHS access except for prostate cancer and essential tremor from April 2021 onwards, focused ultrasound treatments in the UK are limited to either private out-of-pocket pay or grant funded research.

Reimbursement landscape in Europe chart October 2020

Overview NICE guidance and NHS coverage:
Safety: RED – Current evidence is inadequate in quantity and quality and there may be serious safety concerns; YELLOW – Well-known risks for complications the user needs to mitigate; GREEN – Evidence raises no major safety concerns.
Efficacy: RED – Current evidence is inadequate in quantity and quality; YELLOW – Evidence is limited in quantity and quality; GREEN – Current evidence appears adequate.
Use: RED – Should not be used; YELLOW – Should only be used in the context of research; GREEN – Used with normal or special arrangements for clinical governance, consent, and audit in place.
Coverage: RED – No coverage; YELLOW – Coverage in consideration, decision pending; GREEN – Coverage in place
* Efficacy for MRI-guided Uterine Fibroid FUS: Short-term evidence is adequate (GREEN), although further treatment may be required (YELLOW).

See more details with respective ICD-10 diagnosis and OPCS procedure codes >

Germany

Germany has a universal dual arm health insurance system, a statutory public arm covering about 89% of the population and a private arm covering the remaining 11%. Health insurance is part of a comprehensive social security system, which consists of statutory health insurance, a pension fund, and unemployment benefit. Instead of being a state-run public health service (like in the UK), the system is characterized by a close cooperation between the health insurance funds, the medical professions, hospitals, and other related services. The state provides the necessary statutory legal framework (Social Code Book V, SGB V). The governing body for the health care system is the joint federal commission – Gemeinsamer Bundesausaschuss, usually referred to as G-BA – with representatives of the hospital association, the sickness funds, physicians, and patients.

Statutory Health Insurance
The statutory health insurance funds (about 130 nationwide) are self-governing, non-profit organizations by law, and are legal entities under public law. Their mandate is to provide comprehensive coverage to their members. They are responsible for balancing their own budget between member contributions as income and services to members as expenditure.

The statutory health insurance is contribution-based (i.e., not levied via risk-premiums or taxes). The contribution rate is calculated as a percentage of the members wage/salary (currently 15.9%, paid by employee and employer in equal parts) and also covers any dependent children or spouse (who are not earning themselves) at no extra cost. The choice of statutory health insurance fund is up to everybody’s own preference, but the employer automatically deducts the contributions to the state social security system from the member’s wages. Social welfare beneficiaries are also enrolled in statutory health insurance, and municipalities pay respective contributions.

Insured parties are entitled to any services and benefits within the legal parameters set by German law. There are no geographical limits to accessing these benefits within Germany, but there are differences between the service levels offered by individual health insurance funds. Under the statutory health insurance, patients are free to choose their health care provider (GP, medical specialist, dentist, hospital, etc.).

Reimbursement in the public health insurance system
The German Operation and Procedure Code base (OPC) has several focused ultrasound specific procedure codes for treating a variety of indications. These OPCs are linked to Diagnostic Related Groups (DRGs), which in turn are linked to a standard payment for hospital in-patient procedures. Only hospitals can bill for procedures against these codes. There is no mechanism or codes for ambulatory/ outpatient focused ultrasound treatments. This means all focused ultrasound patients need to spend minimum one night in a hospital.

See a table of specific and generic codes that cover focused ultrasound procedures > 

Introducing reimbursement for new procedures to the public health insurance system
Introducing new methods and technologies in the German healthcare system is different for the outpatient ambulatory setting and the hospital setting. In the outpatient setting, only such methods, procedures, or technologies can be performed or used that have a positive risk-benefit rating by the G-BA. In the hospital setting in contrast, any method, procedure, or technology can be used, unless it is explicitly forbidden by the G-BA after a risk-benefit analysis with a negative rating. However, being able to perform a procedure or use a technology does not mean there is any or sufficient reimbursement available. With this context, it is much easier to introduce new procedures or technologies in the hospital setting and all discussion here is only valid for a hospital setting.

The way to establish universal reimbursement for a new method or technology (and not only for a specific hospital) is to apply for an assessment of said new method or technology by the G-BA (§137e SGB V). The assessment can have three possible outcomes

  1. The new method or technology is considered unproven, not likely to have a potential for a necessary treatment alternative or is potentially dangerous.
  2. The new method or technology is considered to have the potential of a necessary treatment alternative, but the benefit has not yet been adequately proven.
  3. The new method or technology is considered to be a necessary treatment alternative and the benefit has been adequately proven.

With the first possible outcome, the G-BA will issue a directive to prohibit the future use of this method or technology.

With the third possible outcome, the law also stipulates that a necessary treatment alternative needs to be reimbursed adequately for the hospital to be able to offer the service.

With the second possible outcome, the law also stipulates that a potential for a necessary treatment alternative is sufficient to be eligible for adequate reimbursement. The potential of a necessary treatment alternative is seen if the new method or technology is associated with the expectation that other methods being more complex, more invasive for the patient or unsuccessful for certain patients can be replaced, the method has fewer side effects, it means an optimization of the treatment, or the method can otherwise enable a more effective treatment.

The G-BA may decide to set up a clinical trial to evaluate the new method against the established standard procedure in Germany for the given indication. In cases of high-risk devices or procedures and a recognized potential, the G-BA must initiate such a clinical trial (e.g., MRgFUS neuro procedures fall under this label). During such a trial, treatment cost shall be reimbursed adequately by the statutory health insurance.

The first focused ultrasound procedure for which the G-BA issued a directive for such an evaluation trial was MR-guided focused ultrasound for uterine fibroids, and the first patients were treated in 2019:

Private health insurance
In addition to the statutory/compulsory public health insurance system, there is a private system, which serves higher salaried employees (above a certain threshold of annual income, which is adjusted over time and €62,550.00 for 2020), public servants, and entrepreneurs/private businesspeople. About 11% of the population are covered via this system, moreso in the Western part of the country. Private health insurance is provided by profit-based insurance companies and is based on a cost reimbursement principle. This does not cover any other family members, and once you have signed up for private health insurance, you are no longer allowed to become a member of a statutory health insurance fund.

In the private insurance system, the patient receives two invoices: one from the hospital for technical and boarding costs and one from the physician for the professional fees. In case of surgery, patients may also be billed by the anesthesiologist. It is challenging to determine the payments in this code system, as every part of the procedure is billed separately. As a rule of thumb, the private health insurance companies pay 2-3 times of the public insurance payments, which makes private patients more attractive to healthcare providers.

There are no focused ultrasound codes in the code system for the private insurance billing. However, private payors are more forthcoming to agree on reimbursement of patient preferred procedures to differentiate in a highly competitive market.

Other countries in Europe
The situation regarding FUS reimbursement in other countries is far less structured and mainly based on out-of-pocket payments and/or site-specific arrangements with local health authorities or insurance companies. Some examples:

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.

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.

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.

Regulatory and Reimbursement Consultants with Prior Focused Ultrasound Experience

Argenta Advisors, Inc.
Location: United States
Area of Expertise: Reimbursement

CardioMed Device Consultants, LLC.
Location: United States
Area of Expertise: Regulatory

CD HealthCare Consulting
Location: France
Area of Expertise: Regulatory, Reimbursement

Dobson | DaVanzo & Associates, LLC.
Location: United States
Area of Expertise: Reimbursement

Greenleaf Health, Inc.
Location: United States
Area of Expertise: Regulatory

Hogan Lovells US, LLP.
Location: Global
Area of Expertise: Regulatory, Reimbursement

Hull Associates, LLC.
Location: United States
Area of Expertise: Reimbursement

Institut TakeCare, GmbH.
Location: Germany
Area of Expertise: Regulatory, Reimbursement

JD Lymon Group, LLC.
Location: United States
Area of Expertise: Reimbursement

Keystone Regulatory Services, LLC.
Location: United States
Area of Expertise: Regulatory

Medical Technology Partners, Inc.
Location: United States
Area of Expertise: Reimbursement

Medicologic A/S
Location: Denmark
Area of Expertise: Regulatory

MedValue Offshore Solutions, Inc.
Location: United States
Area of Expertise: Reimbursement