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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. MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. 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 postsurgical and post-traumatic pain.” Medicare reimbursement is available, if the correct procedure is carefully followed • In-clinic treatments and training • Device reimbursement MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. 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 1970’s Technology High intensity, very low current, burst pulses Low intensity, higher current, long duration pulses Voltage Range: 0-450 volts Voltage Range: 0-40 volts Amperage Range: Microamps (10-6 Amps) Amperage Range: Milliamps (10-3 Amps) Signals in the frequency range of 1Hz to 1000 Hz Signals in the frequency range of 1Hz to 100 Hz Damped asymmetrical biphasic sinusoidal waveform Square waveform, mono-phasic or biphasic Signaling always varies based upon changes in impedance of the tissue Symmetrical or asymmetrical The AVAZZIA BEST device forms a somatic biofeedback between the device and the tissue 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 Develops neurological habituation and accommodation, which severely limits effectiveness of pain management Effectiveness lasts several hours after treatment MKT-080910-03 Rev A Effectiveness often stops when treatment ends © Copyright 2008, AVAZZIA, Inc. All rights reserved. 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. 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. 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. MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. 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 MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. 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 MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. 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 MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. “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 Pain: Postoperative Pain: Postoperative: Acute Pain: Postoperative: Chronic Pain: Extremity (lower) (upper) Pain: Back (postural) Pain: Back: Low Pain: Joint 338.4 338.18 338.18 338.28 729.5 724.5 724.2 719.40 _____ _____ _____ _____ _____ _____ _____ _____ Pain: Joint: Ankle Pain: Joint: Elbow Pain: Joint: Foot Pain: Joint: Hand Pain: Joint: Hip Pain: Joint: Knee Pain: Joint: Multiple Sites Pain: Joint: Pelvic Region 719.47 719.42 719.47 719.44 719.45 719.46 719.49 719.45 _____ _____ _____ _____ _____ _____ _____ _____ Pain: Joint: shoulder (region) Pain: Joint: wrist Pain: face, facial Pain: face, facial: Atypical Pain: face, facial: Nerve Pain: Finger Pain: Foot Pain: Hand 719.41 719.43 784.0 350.2 351.8 729.5 729.5 729.5 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 Length of Need: _______# of Months (short term) _______6-9 months (long term) conductive glove conductive sleeve conductive sock conductive leg sleeve _______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 MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. 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 97032 Attended electrical stimulation (15 mins) Electrical stimulation unattended (wkrs comp 97014) (15 mins) Neuromuscular re-education (15 mins) Biofeedback (15 mins) G0283 97112 90901 97535 Time started Time ended Duration (mins) Self care / home management training to use device _______yes Therapist Initials ______no Patient Signature _________________________________________ Date ______________ Therapist Signature:________________________________________ Date:________________ Therapists Name (print):_________________________________ NPI number:______________ Clinic Name: _________________________________________ Phone#: __________________ Address:_______________________________________________________________________ CONFIDENTIAL INFORMATION MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. 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 97002 99243 Pt evaluation – Complete Specialist examination Pt re-evaluation – Complete Orthopedic examination Office consultation detailed ICD9 codes for Pain Acute and Chronic Pain Neck and Back Pain 338.0 338.11 338.12 338.18 338.19 338.21 338.22 338.28 338.4 723.1 724.1 724.2 724.5 Central Pain Syndrome Acute Pain due to trauma Acute post-thoracotomy pain Other acute post-operative pain Other acute pain Chronic pain due to trauma Chronic post-thoracotomy pain Other chronic post-operative pain Chronic Pain Syndrome Neck pain Thoracic spine pain Low back pain Backache unspecified - back (postural) Facial Pain 784.0 350.2 351.8 Face, facial pain Atypical Facial pain Nerve facial pain Joint Pain 719.40 719.41 719.42 719.43 719.44 719.45 719.46 719.47 719.48 719.49 729.5 Unspecified, joint pain Shoulder (region) pain Upper arm or elbow pain Forearm or wrist pain Hand pain Hip pain Lower leg or knee pain Ankle and foot pain Other specified site pain Multiple sites Pain in limb, pain in extremity (lower) (upper), finger or hand NO promises are made and NO liability for any damages due to information related to insurance coverage are made or accepted. MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved. Instructions for Physician's Statement of Medical Necessity Prescription Form Under "Other Diagnoses" Be certain to indicate "Chronic Intractable Pain" Under Previous Treatments/Medications Be certain to indicate at least 3 attempted modalities. E.G. aspirin, Tylenol, massage, etc Have your physician fill out this prescription form and file it yourself with Medicare to open a claim file. They may tell you that you must purchase such a device from an authorized Medicare DME provider and have them file the claim. This is not true. Just tell them your doctor prescribed the device and you could not find a Medicare DME provider with the device but purchased it from the Whole Wellness Club. Tell them you want to file the claim yourself using form 1490S or by any other self-filing procedure they advise you to use. Instructions for CMS 848 Certificate of Medical Necessity 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 Under Supplier Name and Address, write: Whole Wellness Club 503 Lincoln Dr Sun Prairie, WI 53590 Phone: 866-549-0267 Section B To be qualified for reimbursement from Medicare the true and honest answer to questions 1, 4, and 5 must be "Yes" or circle "Y". Question 3 must indicate "5. None of the above" Fill out and include Form 1490S with your submission to Medicare If you need help, call 1-800-MEDICARE (1-800-633-4227) MKT-080910-03 Rev A © Copyright 2008, AVAZZIA, Inc. All rights reserved.
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