REV Medicare

User Manual: REV

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AVAZZIA BEST™
- Microcurrent Biofeedback Electro-Stimulation Technology
  - The Pro-Sport, BEST-Pro1 and BEST-RSI devices are FDA cleared Microcurrent Biofeedback Devices
  - Medicare reimbursement is available, if the correct procedure is carefully followed
AVAZZIA BEST™
- Microcurrent Biofeedback Electro-Stimulation Technology

Innovation in Health and Wellness Technology

Pro-SportTM, BEST PRO 1TM and BEST

RSITM Device

Physician and Patient

Information

Package

Regarding Medicare Reimbursement

This package is presented to physicians and Whole Wellness Club

members for their support in prescribing AVAZZIA Biofeedback

Microcurrent Electro-Stimulation Devices and then patient self-filing

a claim for reimbursement with Medicare without purchasing and

processing through a Medicare DME provider.

Whole Wellness Club is not a Medicare DME provider.

AVAZZIA BEST™

Microcurrent Biofeedback Electro-Stimulation Technology

BEST-Pro1™

BEST-RSITM

The Pro-Sport, BEST-Pro1 and BEST-RSI devices are FDA

cleared Microcurrent Biofeedback Devices

“for symptomatic relief and management of chronic, intractable

pain, and adjunctive treatment in the management of post-

surgical and post-traumatic pain.”

Medicare reimbursement is available, if the correct

procedure is carefully followed

• In-clinic treatments and training

• Device reimbursement

AVAZZIA BESTTM vs. Conventional TENS

AVAZZIA BESTTM devices are FDA cleared as microcurrent biofeedback TENS devices for the

symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the

management of post surgical and post-traumatic pain.

Technical Comparison

AVAZZIA BEST TM Conventional TENS

21st Century Technology

High intensity, very low current, burst

pulses

Voltage Range: 0-450 volts

Amperage Range: Microamps (10-6

Amps)

Signals in the frequency range of 1Hz

to 1000 Hz

Damped asymmetrical biphasic

sinusoidal waveform

Signaling always varies based upon

changes in impedance of the tissue

The AVAZZIA BEST device

forms a somatic biofeedback

between the device and the

tissue

1970’s Technology

Low intensity, higher current, long

duration pulses

Voltage Range: 0-40 volts

Amperage Range: Milliamps (10-3

Amps)

Signals in the frequency range of 1Hz to

100 Hz

Square waveform, mono-phasic or

biphasic

Symmetrical or asymmetrical

Signaling is typically the same

continuous pattern.

No biofeedback

Performance Comparison

AVAZZIA BESTTM Conventional TENS

Somatic biofeedback prevents

neurological habituation and

accommodation, for more effective

pain management

Effectiveness lasts several hours after

treatment

Develops neurological habituation and

accommodation, which severely limits

effectiveness of pain management

Effectiveness often stops when treatment

ends

AVAZZIA BEST™

Microcurrent Biofeedback Electro-Stimulation Technology

Biofeedback is the body’s response to the stimulus, and

the technology’s ability to detect, measure, analyze and

respond to the body.

As the BEST™ product is applied, a “high voltage,

micro-current” signal is passed through the skin. With

each signal, the electrical properties of the tissue

changes. The device detects the change and responds,

resulting in the very next signal being modified.

BEST™ Technology

• New concept in electro-stimulation

• Micro-current Electro-Neuro Stimulation

• Automatic Interactive Biofeedback

• Electro-therapy

• Handheld

• Battery-operated

• Measures and sends electric pulses as the

unit is moved along the skin

BEST-RSITM, Body-StimTM, and BEST-Pro 1TM micro-current biofeedback devices are FDA

cleared for symptomatic relief and management of chronic, intractable pain, and adjunctive

treatment in the management of post-surgical and post-traumatic pain.

In air, there is no conductivity

between the electrodes. The

output signal waveform appears

as shown.

The device immediately detects

when the electrodes are placed

on reactive tissue as shown.

In Relax/Assess mode, the

device will ‘RING’ when it detects

the optimum characteristics.

Office Visit and Reimbursement Process

Step 1: Physician – patient conference for chronic, intractable pain

o Patient appointment and evaluation with physician

o Physician prescribes BESTTM technology to start a trial period

 BESTTM device must be used by patient on trial basis for a minimum of 1 month

(30 days) but not more than 2 months (60 days) to qualify for Medicare

reimbursement

 Physician must document location of pain, duration patient has had the pain, and

the presumed etiology of pain

 Physician must document that pain has been present for at least 3 months and what

other treatments have been tried and that these treatments failed

o Physician’s office or patient faxes, mails, or personally delivers prescription to Medicare

Step 2: Whole Wellness Club delivers the BESTTM device to patient

Step 3: Trial period

o Physician must monitor patient during trial period to determine effectiveness of BESTTM

device in modulating pain

o For purchase of BESTTM device, physician must determine that patient is likely to receive

significant therapeutic benefit from continuous use of the device over a long period of time

o Physician records must document re-evaluation of patient at end of trial period

Step 4: Patient returns to physician’s office after 30-day trial

o Physician documents the trial evaluation confirming effectiveness

o Physician completes and signs Medicare form CMS-848 (included here)

o Physician’s office or patient faxes, mails, or personally delivers the CMS-848 and 1490S

forms to Medicare. Click on the hyperlink to retrieve form 1490S from Medicare's

website.

In this way, the patient is filing their own claim for reimbursement. The 1490S form is for

the purpose of filing your own Medicare claim.

Whole Wellness Club is not a Medicare DME provider.

Your local Medicare center may tell you that you must purchase the device from and file a

claim through a Medicare DME provider. This is not true.

Step 5: Medicare reimburses patient

Note: Conductive garment is not covered for use with BESTTM device during the trial period

Conductive Garment

Conductive garments are covered by Medicare if ordered by physician for use in delivering a covered

BESTTM (TENS) device and one of the following conditions is met:

1. Patient cannot manage without conductive garment because there is such a large area or multiple

sites to be stimulated and stimulation must be delivered so frequently that electrodes are not

feasible

2. Patient cannot manage without conductive garment for treatment because areas or sites to be

stimulated are inaccessible with use of conventional electrodes

3. Patient has documented medical condition, such as skin problem, that preclude the application of

conventional electrodes, adhesive tapes

4. Patient requires electrical stimulation beneath a cast to treat chronic, intractable pain

For Therapist’s Records

Patient Letter of Medical Necessity BESTTM Therapy

Patient name (insert patient info or sticker here)

Symptoms: ____ Pain ____ Stiffness ____ weakness ____ instability ____ other

ICD9 codes: __________________________________________________________

Diagnosis ____________________________________________________________

Therapy is ordered for this patient for AVAZZIA biofeedback micro-current electro-stimulation.

Therapy goals (check goals that apply)

____ Pain relief

____ Pain management at home

Restorative Potential: ____ 25% ____ 50% ____ 75% ____ 90% ____ 100%

Clinical procedures and modalities:

____ Biofeedback ____ Micro-current stimulation – BEST-PRO 1™ or BEST RSI™ Device

____ Self care training

Individual therapy sessions are 30 to 45 minutes in length. Number of therapy sessions required is

expected to be ______________

At follow up office visit, it will be determined if additional therapy sessions are needed.

Reevaluation in _____ days _____ weeks

Patient should begin treatment AS SOON AS POSSIBLE.

Physician’s Name (print):______________________________ NPI number:______________

Clinic Name: ______________________________________ Phone#: ___________________

Physician’s Signature:____________________________________ Date:________________

Physician’s Address:__________________________________________________________

Confidential Information

“Add clinic name, address

phone number and logo”

Physician’s Statement of Medical Necessity (Prescription)

Please Complete, Sign, Date and Fax to Medicare

Patient’s Name: ___________________________________ Date of Birth: ___________ SS#: ___________

Patient’s Address: _________________________________________________________________________

Patient’s Phone #: _________________________________________________________________________

Date of Injury/Onset: _____________________________

Diagnosis / ICD9:

_____

Chronic Pain

338.4

_____

Pain: Joint: Ankle

719.47

_____

Pain: Joint: shoulder (region)

719.41

_____

Pain: Postoperative

338.18

_____

Pain: Joint: Elbow

719.42

_____

Pain: Joint: wrist

719.43

_____

Pain: Postoperative: Acute

338.18

_____

Pain: Joint: Foot

719.47

_____

Pain: face, facial

784.0

_____

Pain: Postoperative: Chronic

338.28

_____

Pain: Joint: Hand

719.44

_____

Pain: face, facial: Atypical

350.2

_____

Pain: Extremity (lower) (upper)

729.5

_____

Pain: Joint: Hip

719.45

_____

Pain: face, facial: Nerve

351.8

_____

Pain: Back (postural)

724.5

_____

Pain: Joint: Knee

719.46

_____

Pain: Finger

729.5

_____

Pain: Back: Low

724.2

_____

Pain: Joint: Multiple Sites

719.49

_____

Pain: Foot

729.5

_____

Pain: Joint

719.40

_____

Pain: Joint: Pelvic Region

719.45

_____

Pain: Hand

729.5

Other ICD-9 Codes: __________________________

Other Diagnosis : _______________________________________________________________________________________

Previous Treatment(s)/Medications: ________________________________________________________________________

Product Description:

Micro-current Biofeedback TENS ____BEST-PRO 1™ or ___ BEST RSI™ or ___ Pro-Sport™ Device with

one lead wire, 1 set conductive pads

Conductive Garment ____ is ____ is not medical necessity. Check any that apply:

___ large area to be treated

___ multiple sites to be treated

___ areas are inaccessible with the use of conventional electrodes, adhesive tapes, and lead wires.

___ medical conditions, such as skin problems, that preclude the application of conventional electrodes

___ therapy required beneath a cast

Left

Right

Both

Carpal wrap

ankle wrap

low back wrap (6 inches tall)

high back wrap (8 inches tall)

elbow wrap

shoulder wrap

arm or leg wrap

cervical wrap

conductive glove

conductive sleeve

conductive sock

conductive leg sleeve

Length of Need:

_______# of Months (short term) _______6-9 months (long term) _______Purchase

I certify that the above prescribed treatment is medically necessary for the patient’s well being. In my

opinion, the treatment is effective and is reasonable in the treatment of this patient’s condition. I also

certify that the information noted above is accurate to the best of my knowledge.

Physician’s Signature:____________________________________ Date:____________________

Physician’s Name (print):_________________________________ NPI number:______________

Clinic Name: ___________________________________________ Phone#: _________________

Physician’s Address:______________________________________________________________

DO NOT SUBSTITUTE CONFIDENTIAL INFORMATION

For Doctor’s Files

Patient Record of In-Office Therapy

Date of Therapy _________

Patient name (insert patient info or sticker here)

Diagnosis (ICD9) ____________________________________________________________

Therapy is ordered for this patient for AVAZZIA biofeedback micro-current electro-stimulation.

Clinical procedures and modalities:

CPT code

Descriptions

Time

started

Time

ended

Duration

(mins)

Therapist

Initials

97032

Attended electrical stimulation

(15 mins)

G0283

Electrical stimulation unattended

(wkrs comp 97014) (15 mins)

97112

Neuromuscular re-education

(15 mins)

90901

Biofeedback

(15 mins)

97535

Self care / home management training to use device _______yes ______no

Patient Signature _________________________________________ Date ______________

Therapist Signature:________________________________________ Date:________________

Therapists Name (print):_________________________________ NPI number:______________

Clinic Name: _________________________________________ Phone#: __________________

Address:_______________________________________________________________________

CONFIDENTIAL INFORMATION

Therapy Codes for

Micro-Current Biofeedback Electro-Stimulation

Technology

CPT codes

Code Description

G0283

Electrical stimulation unattended (wkrs comp 97014) (15 mins)

97032 Attended electrical stimulation (15 mins)

97112 Neuromuscular re-education (15 mins)

90901 Biofeedback (15 mins)

97535 Self care / home management training

97001 Pt evaluation – Complete Specialist examination

97002

Pt re-evaluation – Complete Orthopedic examination

99243 Office consultation detailed

ICD9 codes for Pain

Acute and Chronic Pain

338.0

Central Pain Syndrome

338.11

Acute Pain due to trauma

338.12

Acute post-thoracotomy pain

338.18

REV Medicare

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