TESTOPEL INSERTION NOTE Patient placed on the exam table in the left lateral jackknife position. Identified upper outer quadrant of hip for insertion; prepped area with Betadine and injected 7cc’s Lidocaine 2% with Epinephrine to anesthetize superficially and distally along trocar tract. Made 3mm incision using #11 blade scalpel; trocar with sharp ended stylet was inserted into subcutaneous tissue in line with femur. Sharp Stylet was withdrawn and 6 Testopel® were placed into trocar well. Testopel advanced into the tissue using blunt ended stylet. Trocar removed and incision closed using 3 steri-strips. Cleansed area to remove betadine and covered steri-strips with outer band-aid. Careful inspection of insertion area done and patient informed of post procedure instructions. Patient will return in 1 month to monitor T levels and again at 4 months to determine scheduling of next insertion AGREEMENT TO AND CONSENT FOR SURGERY, SEDATION, ANESTHESIA, OR SPECIAL PROCEDURES Patient Name:__________________________________________________ DOB___________________ I consent to do the following procedure(s) performed by_______________________ _____________MD Hormone Pellets Subcutaneous Implantation My Physician ________________________ has explained this procedure to me. I understand why it is recommended, the indications for such, what the procedure entails, and the most common risks associated with this procedure. I have been informed of the alternatives and their associated benefits and risks. I also understand that this is an elective procedure. Specific Risks of Procedure: Bleeding, infection, medication reaction. Contraindications: Men with carcinoma of the breast or with known or suspected carcinoma of the prostate. Risks of Androgen Abuse: Exceeding recommended dosage: Hypertension, dyslipidemia, cardiovascular disease, cerebrovascular disease, hepatic failure, hepatic peliosis, hepatocellular carcinoma, renal failure, neuroendocrine suppression, cancer. I agree that sedation or anesthetics may be given by Dr.__________ as indicated. I understand that surgery, special procedures, and the use of sedation or anesthesia sometimes, but rarely, lead to serious reactions, injury or even death. I also understand that there is no guarantee that this treatment will be successful. On rare occasions, other conditions may present themselves prior to during or immediately following the aforementioned procedure. These conditions may require immediate treatment for my well-being. Should this occur, I consent to such additional treatments or procedures. I HAVE READ, UNDERSTAND AND AGREEE WITH THE ABOVE STATEMENTS. THE PROCEDURES AND POSSIBLE RISKS HAVE BEEN CLEARLY EXPLAINED TO ME. I HAVE BEEN GIVEN ALL THE INFORMATION ABOUT THE PROCEDURE THAT I HAVE REQUESTED. I CONSENT TO THIS TREATMENT OR PROCEDURE OF MY OWN FREE WILL. May 25, 2012 Dear , I wanted to make you aware of a new option for your testosterone replacement therapy, a product called Testopel®. Testopel® is the only FDA approved long-acting testosterone pellet. Once in place, the pellets will deliver a steady dose of testosterone, keeping you in your normal testosterone range for 4-6 months. The pellets are very small (about the size of a grain of rice) and are inserted in a simple and painless 5-10 minute procedure at my office. The pellets are covered by most insurance plans, making it a convenient and cost effective alternative to your current therapy. In fact, studies have shown that about 93% of patients who try Testopel® are so happy with it, that they want to continue to use it rather than go back to their old treatments. If you’d like more information about Testopel® or if you’d like to schedule an appointment to discuss if Testopel® may be right for you, please contact me and I’d be happy to talk with you in further detail. Sincerely, Hoyme, MD May 25, 2012 Insurance Company Name Address City/State/Zip Re: Patient: , Member ID No: , Date of Birth: , Service / Drug: Testopel Letter of Medical Necessity To Whom It May Concern: I am writing this letter of medical necessity for my patient, [insert patient name], a member of your health plan, who has been diagnosed with hypogonadism, which causes low testosterone. [insert patient name], requires testosterone replacement therapy and the most effective treatment for, [insert patient name] is Testopel. I am asking you to review, [insert patient name] case and provide coverage for this essential and necessary treatment. [insert patient name], was diagnosed with hypogonadism in/on [insert date of diagnosis] and suffers from symptoms including [insert symptoms] [insert patient name] test levels show a value of [insert testosterone measurement] which places him below the normal range. Testopel is the one and ONLY implantable testosterone pellet approved by the Food and Drug Administration for the treatment of hypogandism (ICD-9 code 257.2, 257.8, 257.9). Testopel is indicated for replacement therapy associated with the deficiency or absence of endogenous testosterone including primary or secondary hypogandism for male patients. Testopel is different from other forms of testosterone replacement therapy as it does not require daily applications or frequent injections into the muscle. Additionally, Testopel keeps the prescribing of testosterone within my control as it in administered in- office every 3-6 months. The procedure to implant hormone pellets including Testopel is CPT 11980. Testopel also has a unique HPCPS code: S0189. Studies have demonstrated that implantable testosterone pellets are not only the preferred form of therapy, but also helps alleviate potential compliance issues associated with the other treatment modalities, they are also more economical. Testopel is approximately half the cost of the testosterone gels. I know that [insert patient name] will experience better results with an easier option for compliance. Plus, I will feel comfortable knowing that [insert patient name] is on a testosterone therapy with years of demonstrated safety. I strongly believe that Testopel is both clinically indicated and the most effective treatment option for [insert patient name]. I am requesting that you provide coverage for [insert patient name] to receive Testopel. Please notify me in writing of your decision and feel free to contact me if you have any questions. Sincerely, Hoyme, MD 708-423-8706 TESTOPEL® Patient Instructions Before TESTOPEL® Insertion • Consult your healthcare provider for instructions regarding medication use prior to insertion. • Observe normal behavior unless otherwise instructed by your healthcare provider. After TESTOPEL® Insertion • Apply ice for approximately 15 minutes to assist with swelling and/or discomfort. • Refrain from showering or bathing until the day after insertion. • Top dressing can be removed after approximately 24-48 hours. • Steri-strip bandages will come off naturally after approximately 4-5days. • Refrain from use of swimming pool or jacuzzi/hot tub for approximately 48-72 hours. • Refrain from heavy lifting or activity that can exert pressure on insertion site. • Contact your healthcare provider if discomfort persists for more than 5 days. • Contact your healthcare provider immediately if infection or pellet extrusion is suspected. IMPORTANT SAFETY INFORMATION TESTOPEL® may produce the following adverse events: breast development and breast discomfort, extra fluid in the body (edema), prostate enlargement accompanied by difficulty in urinating and changes in cholesterol blood levels. Men with carcinomas of the breast or with known or suspected carcinomas of the prostate should not take TESTOPEL®. Pregnant women should also not take TESTOPEL®.
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