MEDICARE OPT-OUT

 This Private Contract is entered into by and between:

"Patient" and John Christy Carrozzella, MD ("Doctor") pursuant to the Medicare requirements that relate to physicians who have opted out of Medicare. Doctor has filed the required Affidavit with Medicare within the time period required for this Private Contract to be effective.

 1. Doctor's Obligations. Doctor hereby informs Patient of the following and agrees to undertake the following actions:

 a. Doctor has not been excluded from participation in Medicare under §§1128, 1156 or 1892 of the Social Security Act. The decision to opt out of Medicare was a strictly voluntary one.

 b. Doctor will make a copy of this Private Contract available to CMS upon its request.

 c. The expected or actual effective date and the expiration date of the opt-out period to which this Private Contract applies are indefinite unless otherwise notified.

 d. Doctor and Patient must enter into a new Private Contract for each opt-out period.

 e. Doctor will provide a photocopy of this Private Contract to Patient or to Patient's legal representative before items or services are furnished to Patient under the terms of this Private contract.

 f. Doctor will retain an original of this Private Contract with original signatures of both parties, for the duration of the opt-out period, although a scanned copy shall carry the same weight as the original.

 2. Patient's Obligations. The Patient or the Patient's legal representative agrees to the following:

 a. Patient accepts full responsibility for payment of Doctor's charge for all services furnished by Doctor.

 b. Patient understands that Medicare limits do not apply to what Doctor may charge for items or services furnished to Patient by Doctor.

 c. Patient agrees not to submit a claim to Medicare or to ask Doctor to submit a claim to Medicare.

 d. Patient understands that Medicare payment  will  not  be made  for  any items  or  services  furnished by Doctor that would have otherwise been covered by Medicare if there was no Private Contract and a proper Medicare claim had been submitted.

 e. Patient has entered into this Private Contract with the knowledge that Patient has the right to obtain Medicare-covered items and  services  from a  physician  who  has  not  opted  out  of  Medicare,  and  that Patient is not compelled to enter into Private Contracts that apply to other Medicare-covered services furnished by other physicians who have not opted out.

 f. Patient understands that Medigap plans do not, and that other supplemental plans may elect not to, make payments for items and services not paid for by Medicare.

 g. Patient entered into this Private Contract at a time when Patient did not require any emergency or urgent care services.

 3. Controlling Law. The terms of this Private Contract shall be interpreted and controlled by applicable Medicare regulations, as amended from time to time. Both parties agree to comply with all such Medicare regulations and enter into such agreements as may be required from time to time by such regulations.

 4. Patient Representative. If this Private Contract is being signed by a Patient Representative on Patient's behalf, the Patient Representative will provided Doctor with the documentation required to demonstrate that Patient Representative has the requisite legal authority to sign this Private Contract on Patient's behalf.

 The parties have read and understood the provisions of this Private Contract and enter into this agreement freely and voluntarily.

  

NEW PATIENT PAPERWORK POLICY:

One thing that you will notice in my office is that I work very hard to run on time. It is our commitment that you do not sit in our waiting room; something that happens far too often in most other offices. To help me stay on schedule, EITHER YOU MUST COMPLETE AND SEND YOUR PAPERWORK PRIOR TO YOUR APPOINTMENT OR YOU MUST SHOW UP AT LEAST 30 MINUTES BEFORE YOUR SCHEDULED APPOINTMENT TIME SO THAT YOU HAVE TIME TO COMPLETE YOUR PAPERWORK. 

 Out of respect for the patients that follow your appointment, if your paperwork is not complete by the time your appointment is scheduled to begin, my staff may be forced to re-schedule your appointment.

Please read and complete all the paperwork that pertains to your health history and all the forms that pertain to your demographic information, FCHW Policies and Procedures. Beyond those forms, at a minimum, please read and review all the consent forms so that you are familiar with their contents. This will allow you to formulate any questions that you might have. If you are comfortable signing them, go right ahead. If you want to discuss their contents, you will have plenty of opportunity to do so, either with my staff or with me.  

RETURNING THE PAPERWORK:

We ask that you fax or email the completed paperwork to the office 48 hours in advance of your visit. That way, we will be able to review your information and once you arrive, you will be ready to go. If for some reason you are unable to complete, please let us know. Our fax number is: (407) 720-3521 and the direct email to our Patient Liaison is: [email protected]

APPOINTMENT POLICY

In order to make your appointment run as efficiently as possible, it is best if you arrive at least 15 minutes early if your paper work has been filled out. If you need to complete your paperwork at the time of your visit you should arrive at least 30 minutes prior to your appointment to complete the necessary paperwork. Please notify us 24 hours before your scheduled appointment time if you want to cancel, change or reschedule your appointment. Failure to do so will result in a cancellation fee of $50. Arriving late for your appointment may result in rescheduling your appointment.

FINANCIAL POLICY

Payment is expected at the time of your visit. We will accept cash or most credit/debit cards. We do not accept checks.

Presently, we do not accept any insurances and are not contracted with any. We do not participate in the Medicare or the Medicaid programs. Payment for the full amount of the day's service is due at the time of service unless other arrangements are made. If the patient desires, we can provide a superbill for patient insurance filling. This office will not accept any assignment of benefits. Upon patient filing of claims, you should request that all payments be sent directly to you. Should any payment from the Insurance Company be received by this office, it will either be sent to the Insured or it will be returned to the Insurance Company. It is your responsibility to know all possible & potential outcomes for filling a claim. Our financial office is available for consultations on payment plans. In the unlikely event that your account would be turned over to our collection agency due to non-compliance of payment plan agreements/seriously past due amounts, patients or guarantors will be responsible for all outstanding balances, regardless of the type of treatment, procedure or sale, in addition to a 25% collection fee charged to us by the collection agency. Future appointments cannot be scheduled until these balances are paid in full by cash or credit card. Accounts that are forwarded to our collection agency may be reported to the credit bureau and may impact your credit record/rating.

Reproduction of Medical Records: For patients and governmental agencies requesting copies of medical records, the fees charged shall be $1.00 per page for the first 25 pages and the $0.25 for each page thereafter. For all other entities, copying charges shall be $1.00 per page. Payment for reproduction shall be made in advance of the copies being produced. Postage for mailing may be an additional charge.

Letters, Forms and Special Reports: The fee for completion of simple forms and letters will be $25 per page. Special Reports will start at $100 and shall be charged commensurate with the work required to complete the report. 

BLOODWORK:

If you need to have your blood work completed prior to your first visit, please make sure that you have it drawn at least 7 days in advance so that it will be completed by the lab prior to your arrival. Our office is able to draw blood for most labs, so if it is more convenient, you can always book a blood draw appointment in this office. Fasting is not necessary. If you are fasting, please make sure it is 8 hours prior to your appointment. There are countless insurance rules covering blood work. Unfortunately, my staff does not know them and cannot give you any advice as to what your co-payment or deductibles might be, so it is your responsibility to know exactly what your insurance will or will not cover.

If your Insurance does not cover the cost of your labs; if you have a high deductible or co-payment of if you just simply want to be completely "self-pay" we have arranged to have a very "low cost" cash price in the office. I have been able to get very favorable pricing from a private lab. This allows me to provide my patients a usual hormone evaluation panel for only $250. Many times, this price is even below the deductible on many Insurance Plans. If you would like to take advantage of that option, please contact our office at {407) 507-3837 to let us know you would like to take advantage of this option. The office is open M-Th from 9-5 and on Friday from 9-3. Notify the receptionist that you would like to schedule an appointment to have your blood work done and that you would like to take advantage of our low-priced labs.

  

Patient Rights and Responsibilities

 You have the right, as a patient, to be informed about your condition and the recommended conventional, integrative, complementary, alternative, non-conventional or non-standard procedures to be used so that you make an informed decision whether or not to undergo the treatments after knowing the potential risks and benefits involved. This disclosure is not meant to scare or alarm you; it is simply an effort to make you better informed so you may have the information needed to give or withhold your consent to the recommended treatment.

Alternatives may be the use of specific nutritional supplements and other hormonal therapies such as HCG or Clomiphene. Alternative therapies as such may lessen or eliminate the potential risks of testosterone therapy, but these alternatives may or may not be as effective in the treatment of your condition. Of course not taking the therapy is an alternative that will eliminate any risk of complications or side effects but may carry non-treatment risks as well

• I understand that this prescription for Testosterone is indicated for the treatment of Androgen Deficiency, sometimes called Andropause or Hypogonadism, for Testosterone Deficiency, based upon medical history, physical findings and laboratory tests or for the symptoms of Testosterone deficiency alone.

• Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.  Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.

None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.

Thus, in many cases, especially where a person may have symptoms of low Testosterone but still have “normal” levels of Testosterone, the prescription of Testosterone might be considered an “Off Label” use.

• The FDA has issued the following warnings concerning the prescription of Testosterone:

• There is a possible increased cardiovascular risk, heart attack, stroke or cardiovascular death associated with testosterone use.

• There is a possible increased risk of blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE).

• In addition, the following side effects or adverse reactions have been commonly thought to be associated with the use of Testosterone products:

• Worsening of Benign Prostate Hyperplasia

• Risk of the development of Prostate Cancer

• Polycythemia, thickening of the blood with potential to cause blood clots

• DVT or blood clots

• Cardiovascular risk; heart attacks, sudden cardiac death, stroke and other Major Adverse Cardiac Events

• Negative effect on sperm formation and fertility

• Adverse effects on the liver

• Edema, ankle swelling

• Shrinking of the testicles

 • Gynecomastia, enlargement of the breasts

• Sleep Apnea

• Adverse effects on lipid profile

• Elevated calcium levels

• Decreased thyroid binding protein

• The FDA has issued the following warnings regarding Testosterone and its possible transference:

• Testosterone, especially in the topical application form may result in transference that may manifest in virilization (development of adult male characteristics)

• In women

• In Children

• House pets

• Other acquaintances

• In particular, the use of topical Testosterone should be done with care and the testosterone should be placed in areas that limit the exposure to others. And proper administration techniques should be used and proper handwashing carried out immediately after the application of the topical agent.

• I have been advised by the treating health care provider that bio-identical testosterone therapy has substantial medical literature in support of the improvement of men’s health and longevity. It is the opinion of the treating heath care provider that the medical literature strongly contradicts the FDA warnings about the use of testosterone in men. Specifically, there is medical evidence to suggest that bio-identical testosterone therapy:

 • Reduces the risk of coronary artery and other cardiovascular diseases

• Reduces the risk of osteoporosis and the risk of death from osteoporosis related fractures

• Reduces the risk of age related dementias and Alzheimer’s disease

• Reduces the risk of certain cancers

• Reduces the risk of “all-cause mortality”; meaning that men who are hormone balanced live longer lives

• Reduces the risk of the decline in sexual responsiveness

• Reduces the effects of age related/hormone mediated psychogenic symptoms

• Improves libido and sex drive

• Improves physical stamina, endurance and results of exercise

• Improves muscle bulk and tone

• Improves lipid metabolism

• Improves Glucose/sugar metabolism and reduces the risk of type 2 diabetes

• Provides a more beneficial hormonal environment for weight management

 

• Overall, it is the opinion of the treating health care provider that the risks of prolonged hormone imbalance in the aging years is far greater than any risk shown to be associated with the use of bio-identical hormone therapy. That is, the risks of illness and dying early is greater if treatment is withheld as opposed to initiating and continuing bio-identical hormone therapy through the aging years.

• I understand that the treating health care provider cannot guarantee any positive results or that there will be no side effects or harm. The goal and potential benefit of this therapy is to prevent, reduce or control the symptomatic dysfunction and physiologic imbalance that occurs as a result of testosterone deficiency or the aging process and the low testosterone production that occurs in aging males.

• Bio-identical testosterone therapy is available in various forms including pills, capsules, sublingual drops, troches, topical creams, pellets and injection.

 • I understand that typical side effects associated with the use of Testosterone might include oily skin, acne, moodiness, irritability, chronic priapism (persistent, abnormal erection of the penis), change in libido, hirsutism (facial hair growth) and scalp hair loss, hair growth where topical Testosterone is applied, voice changes, water retention, slight bruising or infection at the injection/pellet insertion site(if injection or pellet therapy is used), increased hematocrit in the blood count, alteration of lipid profile, changes in blood pressure, and insulin sensitivity changes. I agree to cease using the testosterone and contact my provider and if necessary, seek immediate medical attention, in the event I knowingly develop any adverse side effects.

• I understand that when Testosterone is applied topically as a cream or a gel, it may cause transference to others resulting in hair growth or other signs of Testosterone excess in those to whom the transference has occurred

• I understand that the conventional medical community and many Medical Doctors believe that Testosterone supplementation is contra-indicated in a patient with past history of a variety of different prostate disease states including but not limited to Prostate Hypertrophy (BPH and Prostate Cancer). I have been fully informed, and I am totally satisfied with my understanding that this proposed treatment may be viewed by the conventional medical community as new, controversial or detrimental, and/or unnecessary by the Food and Drug Administration. I am also aware that there is a substantial body of evidence that supports Testosterone supplementation in appropriate male patients.

• While a study published in the New England Journal of Medicine, January 2004, reviewed 72 medical studies and found no evidence that testosterone therapy causes prostate cancer, I understand that questions have been raised about Testosterone as a cause of prostate cancer, since it is an anabolic hormone and has previously been thought to increase the growth rate of cancer cells.

• I understand that the long term use of exogenous testosterone may result in a mild to moderate testicular atrophy (shrinkage) and a lowered sperm count, and that my ability to father children may be lessened or permanently impaired.

• I understand the importance of maintaining a healthy lifestyle with the use of Testosterone, and agree to continue with a recommended program of healthful nutrition, regular exercise, stress management and nutritional supplementation with the use of Testosterone. I further agree to continue any other hormone replacement therapies recommended by my physician.

• I understand that careful monitoring is crucial with Testosterone replacement therapy and agree to comply with the following monitoring recommendations while receiving Testosterone replacement therapy:

• Total and Free Testosterone levels, PSA, CBC, estradiol, fasting glucose, fasting insulin and hemoglobin A1C are measured initially, then at appropriate intervals thereafter.

• PSA is measured every 6 – 12 months in men over the age of 40.

• Other hormone levels may be monitored, as well as other blood tests appropriate for treatment.

• Assessment for physical side effects 4-8 weeks after initial replacement and regularly thereafter.

• Annually: Physical examination, baseline blood testing, baseline prostate exams and digital prostate exams.