Transcript BiowavePWP - All Care Consultants Inc

BiowavePENS
Percutaneous Electrical
Nerve Stimulation System
Presented by BIOMEDI, INC.
Introduction
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The BiowavePRO is an FDA, 510(k) cleared percutaneous electrical
nerve stimulator (PENS)
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PENS is a DIAGNOSTIC MODALITY used in the continuum of care
process to determine next steps; confirm or rule out the potential
therapeutic usefulness of a permanent electrical nerve stimulator for
patients suffering from chronic pain
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BiowavePRO holds six US utility patents: Four on the signal
technology and two on the electrodes
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The surgical procedure requires physicians to utilize a surface
implantable needle electrode to deliver electrical signals to deep
tissue nerve fibers
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Based on the recommended frequency of the procedures (2 x wk x 3-4
wks), a physician should be able to rule out or confirm the
appropriateness of an implantable pain management device within 30
days
Percutaneous Electrical
Nerve Stimulation System
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BiowavePRO is the only FDA cleared PENS device
on the market
Utilizes patented deep tissue signal
technology
Signals are optimized for passing through
skin into deep tissue
Utilizes patented percutaneous needle
electrodes
Percutaneous needle electrode provides direct
conductive pathway through skin into deep
tissue
More comfortable than other forms of electrical
stimulation
No programming
Only control is intensity
Active feedback control prevents patients from
receiving a burn
Two Sets of Electrodes
B-Set
• Two round equal area percutaneous electrodes (2.5 inch
diameter) for treating two equal points of pain. Used for
bilateral or unilateral pain in the lower back, buttocks,
cervical spine, and shoulders, for radiculopathies, for pain
centered directly over the spine, for pain throughout the
knee, and for pain over large areas
E-Set
• One round percutaneous electrode (2.5 inch diameter) for
a primary site of pain and one rectangular noninvasive
electrode (2 inches x 4 inches) for a secondary pain site,
or to be placed over a bony prominence in the region
being treated. Used for pain in the extremities including
the knee, ankle, foot, neck, shoulder, elbow, wrist, hand
and finger
Implantable Percutaneous Needle Electrode
• Two US utility patents on the Biowave
electrode
• The needle electrode bypasses the
impedance and capacitance of skin
• Allows for the delivery of electrical
signals to deep tissue nerve fibers
• Sterile, single-use only
• 2.5” diameter electrode
contains 1014 microneedles, 0.74mm in length
• Feels like velcro to the touch
• Allows for 3”- 3.5” diameter
hemisphere treatment area
Patented Signal Technology
• Four US utility patents on the signal technology
• Biowave delivers two continuously summed high frequency
alternating current electric signals (sine waves)
• Contact with polarized tissue (C-Fiber, A Delta Fibers, and muscle
tissue) causes the two high frequency sine waves to further multiply
• This creates a new spectrum of electrical signals forming in approx.
a 3”- 3.5” diameter beneath and surrounding the percutaneous
electrode
• The multiplication of the two sine waves creates a LOW
FREQUENCY SIGNAL in the form of an active electrical field
Mechanism of Action
Neurogenic Pain
• C-Fibers: The low frequency signal blocks the transmission of pain
signals by preventing the sodium and potassium ion exchange across the
membrane of the C-Fibers
• A Delta Fibers: Numbness is induced in the area where the low frequency
signal is present, which is approximately a 3”- 3.5” diameter beneath and
surrounding each electrode
Myofascial Pain
• Muscle Tissue: The low frequency signal causes the muscle tissue to be
held in tension during the treatment, which creates a deep smooth
pressure sensation
• The low frequency signal also causes increased blood flow in the volume
of tissue beneath and surrounding each percutaneous electrode
Biowave Clinical Studies
• Randomized Controlled Study on the treatment of post-operative pain from
TKA surgery - Hospital for Special Surgery, New York City
• Podium Presentation at Eastern Orthopedic Association Annual Meeting, Oct
2008; Poster Presentation at AAOS Annual Meeting Feb 2009; Study
submitted to the Journal of Arthroplasty
• Randomized Blinded Controlled Study Treating OA Knee Patients Rush Univ.
Medical Center - Published in ORTHOPEDICS June 2007
• Weill Cornell Medical College Chronic Low Back Pain Study (Phase 1 + 2) Abstract from Anesthesia & Analgesia, Mar 2003
• NY Giants White Paper - IRB approved study on treatment of Acute Sports
Injuries on NY Giants football players June 2003-Dec 2005, 600 treatments on
55 players
• Clinical Study on treating extremities to reduce pain and improve range of
motion - August 2005
Biowave Clinical Studies
Excellent outcomes
• 75% patient response rate
• 75% reduction in VAS Pain scores
• Significant increase in ROM, Reduction in
stiffness and muscle spasm
Long carry over effect
• 30-minute treatment provides up to 72 hours
of continued pain relief and functional
improvement
Extremely Comfortable
• Deep smooth pressure sensation
• Excellent patient compliance
Reduction in Pain Medication
• Biowave has been shown to reduce
the need for morphine, narcotics, and other pain
medications resulting in better quality of life
scores
Indications
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PENS – Percutaneous Electrical Nerve Stimulation is a
Medicare covered benefit (CMS NCD 160.7.1). PENS is
covered as a modality used as a diagnostic tool in the
continuum of care process to determine next steps;
confirm or rule out the potential therapeutic usefulness of
an implantable electrical nerve stimulator.
Patient Selection / Medical Necessity
• The patients whom you select for the procedure should present
with conditions / diagnoses that are compatible from a continuum
of care standpoint; the goal is to assess the patient’s suitability for
the therapeutic usefulness of ongoing treatment via a permanent
stimulator
• It is important that the physician’s documentation entails all prior
conventional & conservative interventions.
• TENS, P.T., and medications (e.g., NSAIDS, Narcotics, and Opioids)
are all examples of interventions that would be expected to have
been tried and failed prior to proceeding with the use of PENS for
the treatment of chronic pain.
Sample Patient Type
• Patient is a 55 y/o female who presents with lumbar
post-laminectomy syndrome, and lumbar radiculitis,
which has not responded favorably to conventional
treatments.
• Patient is currently taking the following medications:
Percocet, Lyrica, Elavil, Voltaren gel, Lidoderm patches.
• Previous interventions have included prednisone,
physical therapy, TENS and nerve blocks, all of which
have failed to control the patient’s pain resulting in an
increase in functional declines and a decreased quality
of life.
Recommended Treatment Protocol
• 6-8 treatments within 30 days (2 x wk x 3-4 wks)
• 30 minutes per treatment
• After completing 6-8 treatments the patient’s VAS score should be
documented
• In most cases a positive response is considered to be a reduction in
the VAS score by 30% or more
• If the patient’s VAS score represents a positive response, then the
patient may be considered for a trial for a permanent electrical nerve
stimulator
• If the patient’s VAS score represents a negative response, then the
patient should be reevaluated at appropriate intervals for further
treatment options
• Biowave training video for providers on Youtube
Contraindications
Biowave is contraindicated if patients have the
following:
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Implanted Electrical Device
Cardiac Pacemaker
Defibrillator
Metal Allergy
Epilepsy
Biowave electrodes may not be placed over the
following areas:
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Open wound
Heart
Front or Side of Neck
Top of the Head
“Incident to” Procedure
• In your office, qualifying “incident to” services must be provided by
a caregiver whom you directly supervise, and who represents a
direct financial expense to you (such as a “W-2” or leased employee,
or an independent contractor).
• You do not have to be physically present in the treatment room while
the service is being provided, but you must be present in the
immediate office suite to render assistance if needed.
• If you are a solo practitioner, you must directly supervise the care.
• If you are in a group, any physician member of the group may be
present in the office to supervise.
Commonly Used ICD9
ICD9
DESCRIPTION
722.10 -722.11
Displacement of thoracic or lumbar intervertebral disc without
myelopathy
722.51 – 722.52
Degeneration of thoracic or lumbar intervertebral disc
722.72
Intervertebral thoracic disc disorder with myelopathy, thoracic
region
722.73
Intervertebral disc disorder with myelopathy, lumbar region
722.83
Post-laminectomy syndrome, lumbar region
723.4
Brachial neuritis or radiculitis NOS
724.2
Lumbago
724.3
Sciatica
724.4
Thoracic or lumbosacral neuritis or radiculitis, unspecified
729.2
Neuralagia, neuritis, and radiculitis, unspecified neuropathic pain
CPT / HCPCS
Payer
CPT / HCPCS
Average Reimbursement Per Procedure
Medicare 2015
64555
$600.00
Includes invoice price per electrode
E1399 or L8699 or A4649 (Electrodes)
Medicare Replacement Plans
Private Sector
64555
L8680 (Electrodes)
$700.00
Aetna
64565
E1399 (Electrodes)
$500.00 – 600.00
BCBS - Florida
64999
L8680 (Electrodes)
$700.00
Highmark
64555
L8680 (Electrodes)
$700.00
Horizon BCBS
64999
L8680 (Electrodes)
$700.00
United Health Care – no standard
policy determination
64999
L8680 (Electrodes)
$600.00
Workers Compensation
64555 or 64999
L8680 (Electrodes)
$500.00 – 700.00
FL – WC
64999
$500.00 – 600.00
Tricare / Champ VA
64999
L8680 (Electrodes)
$800.00
*WC coverage will differ in accordance with state
guidelines.
THESE CPT CODES ARE BEING PROVIDED AS EXAMPLES OF CPT CODES THAT PHYSICIANS HAVE REPORTED USING IN CONNECTION WITH SEEKING REIMBURSEMENT FOR
PROCEDURES RELATED TO THE BIOWAVE DEVICE. IT IS THE RESPONSIBILITY OF EACH PHYSICIAN TO INDEPENDENTLY VERIFY AND USE THE APPROPRIATE CPT CODE
WHEN SEEKING REIMBURSEMENT FOR ANY PROCEDURES RELATED TO THE BIOWAVE DEVICE. BIOMEDI HAS NOT INDEPENDENTLY VERIFIED THAT THESE CPT CODES ARE
APPROPRIATE FOR SEEKING REIMBURSEMENT FOR ANY PROCEDURES AND BIOMEDI IS NOT COMPETENT TO RENDER AN OPINION AS TO WHETHER ANY CPT CODE IS
APPROPRIATE FOR BILLING ANY PROCEDURE.
Direct Cost to Provider
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BiowavePRO System: $3,500.00
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One year manufacturer warranty on the BiowavePRO
(excludes attachment cables)
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Electrodes: 6 sets per pack @ $1,200 per pack
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Capital investment options available through a third party
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Priority Capital Memo provided
Summary
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BiowavePRO is an FDA cleared, patented PENS
device
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Proven efficacy through clinical trials
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Excellent diagnostic procedure to support your
existing pain management treatment regimen
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Reimbursed by Medicare, most Medicare
Replacement Products, and Commercial Carriers
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Expert billing support services available
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Capital investment options available
Biowave Set-up
• Device needs to be charged before use
• Charger is shipped with each device
• Full charge last 8-9 hours, office should charge
overnight for best results
• Electrode wire is pushed in and turned to lock in
tightly
• Unit timer is automatically set to 30 minutes
• Staff can adjust timer by pressing timer button to
the left of +/- buttons
Sales Call
What To Bring
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This Powerpoint presentation
Provider Inserts, i.e., (CMS - NCD, Medicare Advantage PENS Policy,
Procedure Note, LMN)
Rep Docs, i.e., (Order Form)
Sales Call Flow
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What it is
How it works
Stress Compliance (Patient Selection, Medical Necessity,
Documentation)
ASK for sale and complete Order Form
Best Practices
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Biowave is a DIAGNOSTIC modality used in the treatment of
neurogenic pain
Drs can use a credit card to purchase Biowave and equipment and get
first reimbursements in 30-60 days
RIGHT patient, RIGHT documentation, RIGHT codes = COMPLIANCE