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DBS Team and Documentation Punit Agrawal, DO Movement Disorder Division Department of Neurology The Ohio State University Team for Neuromodulation Neurology/Pain/Anesthesia Neurosurgery Psychiatry/Psychology Radiology Physical Medicine and Rehabilitation Beyond the physicians: Physician assistants, Nurse practitioners, Allied Health Ancillary staff including medical secretary/assistant, office manager, and clinical coordinator Research Ethics Roles of the Team Referrals and scheduling Evaluation for therapy Team review of evaluations Pre-surgical evaluation Surgery Post surgical care Therapy Management Research Documentation Proper documentation and record keeping is important for several reasons including: Allows for increased insurance approval for therapy Records of neuromodulatory therapy results Enhances communication with referring care provider and other team members Assists in proper reimbursement of services When concerns of complications of devices or failure of therapy, previous records are very helpful to identifying potential problems. Medical Records These should include Pre-therapy screening tests including imaging, previous failed therapies, and evaluation reports from various team members Goals of therapy Surgical Reports and subsequent studies Psychosocial evaluations and concerns Post-operative notes and evaluations Records of therapy intervention with results Initial Evaluations - Key Items to Include Severe debilitating disease with indication for therapy Chronological history of disease Previous failed therapies Goals and expectations of therapy and discussion of potential risks/complications Things to Document with Each Programming Visit Disease Indication for Therapy Therapy Target and Goals Electrode/Device Models Date of implant and battery changes Device status (battery life, impedences, etc…) Initial and Final Settings Side effects or Complications Patient/Family Education Provided Date of Programming: ___________ Date of Therapy Initiation:___________ Date Electrode Placement: ___________ Date of IPG Placement: ______ PATIENT INFO Site of implant: IPG: PW: STN VIM Right Left Soletra Kinetra Freq: Contact: Amp (V) Sample of DBS Therapy Monopolar Review Worksheet 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 0 GPi Other___________ Activa PC 1 Activa RC 2 Observations or Comments 3 Sample Therapy Summary Sheet for DBS Patient Name and Identifiers: Date of implant: Date of initial program: Therapy Device: Indication for therapy: Site of implant: STN VIM Right Left GPi Other___________ Initial programming summary: Right PW: Freq: Max Volt. Left PW: Comment/Observation Lead 0 1 2 3 Programming session summary: Date Anode Cathode R L R L R L R L R L Max Volt. Freq: Comment/Observation 0 1 2 3 PW Freq Amp Comments: Sample Letter for Prior Authorization Date Patient Name: Patient Date of Birth: Insurance Identification No.: Physician Name: Tax Identification No.: Projected Surgery Date: Dear {payer name}: The above named patient has been diagnosed with {diagnosis description}, diagnosis code { ICD-9 code) and is being recommended by the physician as a candidate for Deep Brain Stimulation Therapy. I am requesting prior authorization on behalf of the patient for an Activa Deep Brain Stimulation System permanent implant (Associated CPT Codes: 21499, 64999, 70450, 70551, 76376 or 76377, 61863, 61867 or 61867, 61885 or 61886, 95961 or 95962, 95970 or 95978). The procedure will be done at { facility name} in { city, state}. I have attached supporting documentation for your review. I request written confirmation that this therapy is a covered benefit based on medical necessity and that associated professional fees for the surgery will be covered. The charge for the device is included with the hospital fees. Thank you for your prompt review of this information and for your coverage consideration. If you have any questions, please contact me. Sincerely, Sample Letter for Medical Necessity Sample Letter of Medical Necessity DBS Tremor Control Therapy Date: Inside Address Patient: Policy Holder: ID/Social Security #: Dear __________: This letter is to request a predetermination of coverage and/or prior authorization for the implantation of a Medtronic Activa® Tremor Control System for the suppression of tremor in patients with Essential Tremor or Parkinsonian tremor. The therapy involves the unilateral implantation of an insulated wire lead in the ventral intermediate (VIM) nucleus of the thalamus. The lead is connected to a pacemaker-like neurostimulator that provides stimulation of the targeted area in the brain. The totally implantable Activa Tremor Control System includes a quadripolar DBS™ lead for deep brain stimulation, an extension, and the Soletra® implantable neurostimulator. The patient may also receive the Access Review™ Patient Therapy Controller. Activa Tremor Control Therapy has been available for commercial use in Europe, Canada and Australia since February 1995. It was approved by the FDA for commercial release in the United States in July 1997. Medicare has national coverage on Deep Brain Stimulation for Essential Tremor and Parkinson Disease. Effective April 1st, 2003, Medicare will cover unilateral or bilateral thalamic VIM DBS for the treatment of essential tremor (ET) and/or Parkinsonian tremor and unilateral or bilateral STN or GPi DBS for the treatment of Parkinson’s disease. Medicare’s coverage conditions may be found at: www.cms.hhs.gov/manuals/pm_trans/AB03023.pdf. Enclosed you will find further information about this therapy and summaries of clinical studies. Based on my review, I believe that my patient, ________________, is an excellent candidate for this therapy. Document Chronological History (Document the patient’s history of interventional efforts noting therapies/procedures and medications that have previously been attempted. Note the outcome of each. A timeline may be useful.) Recommend Medtronic Activa Tremor Control Therapy (State how this therapy is an appropriate intervention at this point in the patient’s care. Note therapeutic goals, anticipated outcome, risks of performing the procedure, risks of not performing the procedure, and possible complications.) Describe the Implant Procedure (Describe the surgery itself, listing procedure codes (CPT) anticipated. Note the follow-up care associated with the therapy. This could be an attachment rather than in the body of the letter itself.) Because ___________ fits the patient selection criteria and has not responded to other measures, I recommend test stimulation for Activa Therapy. The decision to implant the Activa System will be based on the patient’s intra-operative response to the test stimulation as indicated by tremor suppression and improvement in neurological testing. I request confirmation that this therapy is a covered benefit based on medical necessity, and that associated professional fees for the surgery and follow-up will be covered. I request authorization for all costs associated with this procedure including physician professional fees and hospital fees. The charge for the device is included with the hospital fees. The implant procedure has been scheduled at [name of facility] on [date]. Thank you for your review of this information and for your coverage consideration. If you have any questions, please contact me. Sincerely, _______________, M.D. [Personalize the letter for the particular patient using the information outline which follows. You may require one or more paragraphs for each of the headings listed.] Address each of the following points: Document Current Findings/Status (Describe the patient’s current status including diagnosis, complaints, and level of impairment. Detail functional impairments and state how quality of life, activities of daily living, caretaker (if applicable), employment, etc. are affected.) (This document is a template only. Medtronic staff members would never complete such a form for their customers) Additional Key Elements to Successful Prior Authorization for Therapy and Reimbursement Identify a staff member within the practice to coordinate all prior authorization and pre-certification processes with payers and hospitals. Involve the patient and/or family in the prior authorization process as appropriate. Follow the payer’s conditions for coverage. Prepare a clear and concise letter of medical necessity. Educate the payer regarding the therapy, as needed.