05/04/2015    David Zuckerman, DPM

ESWCT Coverage (Judith Rubin, DPM)

While there are disappointing reasons ESWT lost
coverage thru national insurance, what is most
important is being able to offer high energy ESWT
to our patients. It is a terrific treatment that
has stood the test of time and scrutiny of double
blind, randomized, placebo controlled, multi-
center studies. Excellence Shockwave Therapy has
been using the Dornier Epos Ultra since its FDA
approval in 2002. The Dornier Epos Ultra is the
only FDA-approved Class-three Device with
ultrasound guided imaging. The Dornier is the only
device that passes the National Blue Shield Tech
Report with flying colors.

When evaluating coverage policies for ESWT, Blue
Cross/Blue Shield lumped all ESWT devices
together. Low, high, and non-ESWT machines such as
the EPAT. Whether this was strategy to eliminate
coverage or confusion is not really known. What it
did was muddy the question of what is ESWT and
what are the results? Manufacturers of low energy
and pressure wave devices were presenting their
product as ESWT without the proven technology, FDA
approval or studies to back up their claims has
created confusion.

The Blue Shield Tech Report’s 5 criteria for
coverage are:
1. The technology must have final approval from
the appropriate government regulatory bodies.
Dornier Epos Ultra YES
2. The scientific evidence must permit conclusions
concerning the effect of the technology on health
outcomes. Dornier Ultra YES
3. The technology must improve the net health
outcome. Dornier Epos YES
4. The technology must be as beneficial as any
established alternatives. Dornier YES
5. The improvement must be attainable outside the
investigational setting. Dornier YES

There is a BIG difference between FDA clearance
and FDA approval. You typically don’t need ANY
studies for an FDA clearance. The Dornier Epos
Ultra is still the Gold Standard with both short
and long-term studies that were double-blind,
randomized, placebo-controlled, multi-center
format. FDA approval is very important and showed
effectiveness and safety. Some machine
manufacturers call their product ESWT to doctors
and buyers, but therapeutic massage devices to the
FDA in order to avoid a Class III proving ground.

The only FDA-approved and proven ESWT is high
energy ESWT. Whether it is high energy, low
energy, focused, or radial the machine should
undergo FDA approval and prove the waves it
creates are truly ESWT and not unfocused sound.

With high energy ESWT the use of anesthesia is
optional and is done in an office setting.
Regional nerve blocks allow proper therapeutic
shockwave dosage to be comfortable for the
patient. Proper dosage is key to outcomes. The use
of regional anesthesia with the Dornier has been
used for over 12 years in the USA. Regional
anesthesia has no negative effects on treatment
outcomes for High Energy ESWT. Only low energy
dosages can be affected by anesthesia to the
treatment site.

While admittedly frustrating, the questioning of
why insurance doesn’t cover, and how to get it
covered has become a powerless conversation. Much
energy, time and money has been spent to get
insurance companies to see the error of their
ways. The truth is, the power is in the hands of
the doctor and the patient.

It is a very effective modality that I personally
would want offer to my family or a loved ones. As
professionals we must be honest with ourselves and
our patients and offer the best treatment plan.
Treatments that are safe, proven, and effective;
whether insurance covers the treatment or not.
The Doctor has great responsibility to educate the
patient on what treatment is right for them and
what equipment will be most effective in their
treatment. If the equipment isn’t FDA-approved, or
even truly ESWT it should not be presented as
such.

High energy ESWT with the Dornier Epos Ultra is
available and being offered to patients daily. A
very encouraging percentage of patients will
choose the treatment if offered over surgery with
proper education. The truth is if the patient is
confidently educated and told about ESWT many will
choose it. If they are never told or if the
treatment is downplayed because of insurance
company policies, they will not even know it is
available to them. This treatment can live or die
in the hands of the doctor. Give the patient the
education and allow them the right and adult
information to choose the treatment over surgery,
many will.

David Zuckerman, DPM, Cherry Hill, NJ

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