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Notification

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Disclaimer

I have had full opportunity to read and consider the contents of this Consent form and Optima Health and Wellness Notice of Privacy Practices. I understand that as part of treatment, payment or health care operations, it may become necessary to disclose my protected health information to another entity, and I consent to such disclosure for these uses as permitted by law.
Note: Proof of signature will be required with our first contact

Document A

Patient Consent for the Use and Disclosure of Health Information I understand that as part of my health care, Optima Health and Wellness physician and staff originates and maintains paper and/or electronic records describing my health history, symptoms, examination and test results, diagnoses, treatment, and any plans for future care of treatment. I understand that this information serves as:
  • A basis of planning my care and treatment
  • A means of communication among the many health professionals who contribute to my care
  • A source of information for applying my diagnosis to my bill
  • A means by which a third-party payer can verify that services billed were actually provided
I understand and have been provided with Notice of Privacy Practices that provides a more complete description of information uses and disclosures. I understand that I have the following rights and privileges:
  • The right to review the notice prior to signing this consent
  • The right to object to the use of my health information for directory purposes, and
  • The right to request as to how my health information may be used or disclosed to carry out treatment, payment, or health care operations
I understand that Optima Health and Wellness is not required to agree to the restriction requested. I understand that I may revoke this consent in writing except to the extent that the organization has already taken action in reliance thereon. I also understand by refusing to sign the consent or revoking this consent, this organization may refuse to treat me as permitted by Section 164.506 of the Code of Federal Regulations. I further understand that Optima Health and Wellness reserves the right to change their notice and practices and prior to implementation, in accordance with Section 164.520 of the Code of Federal Regulations. If Optima Health and Wellness changes its privacy notices, we will issue a revised noticed of Privacy Practices, which will contain the changes. Those changes may apply to any of your protected health information Optima Health and Wellness maintains, I understand that I may obtain a copy of Optima Health and Wellness Notice of Privacy Practices, including revisions of Notices, at any time by contacting Optima Health and Wellness at: 1050 Glenbrook Way Suite 480-103 Hendersonville TN 37075. If there is any person(s) in which you authorize to receive treatment ort account status, please list name and relationship

Document B

Sale of Nutritional Supplements at Optima Health and Wellness

You are under no obligation to purchase nutritional supplements through this office.

As a service to you, we make nutritional supplements available in our office. We provide these products only from manufacturers who have gained our confidence through considerable research and experience. We determine quality by considering: (1) the quality of science behind the product; (2) the quality of the ingredients themselves; (3) the quality of the manufacturing process; and (4) the synergism among product components. The brands of supplements that Optima Health and Wellness offers meet our high standards and tend to produce predictable results. We only use nutritional supplements that have achieved GMP (Good Manufacturing Practices) certification from leading independent, quality organizations.

While these supplements may come at a higher financial cost than those found on the shelves of pharmacies or health food stores, the value must also include assurance of their purity, effectiveness, quality, bioavailability (ability to be properly absorbed and utilized by the body) and absence of toxins. The chief reason we make these products available is to ensure quality. You are not guaranteed the same level of quality when you purchase your supplements from the general market place. We are not suggesting that such products have no value; however, given the lack of stringent testing requirements for dietary supplements, product quality varies widely.

Informed Consent Regarding Nutritional Supplements

According to the Federal Food, Drug, and Cosmetic Act, as amended, Section 201 (g) (1), the term drug is defined as an “article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Technically, vitamins, minerals, trace elements, or amino acids are not classified as drugs. However, these substances can have significant effects on physiology and must be used rationally. In this office, we provide nutritional counseling and make individualized recommendations regarding use of these substances in order to upgrade the quality of foods in a patient’s diet and to supply nutrition to support the physiological and biochemical processes of the human body. Although these products may also be suggested with a specific therapeutic purpose in mind, their use is chiefly designed to support given aspects of metabolic function. Use of nutritional supplements may be safely recommended for patients already using pharmaceutical medications (drugs), but some potentially harmful interactions may occur. For this reason, it is important to keep all your healthcare providers fully informed about all medications and nutritional supplements you may be taking.

If you have any questions regarding Nutritional Supplements, please discuss them with our staff.

Document C – Concent for treatment

Consent to Treatment

I.)   The Nature of the Treatment

I hereby give my consent to evaluation and treatment of andropause, thyroid disorders, adrenal fatigue/stress, menopause and other hormone imbalances by the administration of Hormone Replacement Therapy (“HRT”) and/or nutritional supplements, including vitamins, minerals and anti-oxidants and/or drugs designed to alter hormone levels. The nature of the procedure is to raise levels of hormones in my body to levels which will improve quality of life, as well as functional ability, the goal of which being to decrease the incidence of sickness and disease.

II.)  Alternative Treatment Approach

The reasonable alternatives to these therapies have been EXPLAINED to me and they include, but are not limited to:

  • MAINTAINING HEALTHY BODY MASS INDEX “BMA” AND WEIGHT
  • MAINTAINING CURRENT HORMONE LEVELS
  • TREATING CHRONIC (PERSISTENT) DISEASES AS THEY OCCUR
  • TREATING SYMPTOMS WITH NON BIP-IDENTICAL MEDICATION(S)

III.) The General Nature and Extent of Treatment-Related Risks

Most hormone deficiencies are indicated by symptoms and may implicate the potential for illness when certain hormone levels are too high or low. Along with my doctor, I believe that it is when hormones are within a safe range to reduce my unwanted symptoms, that we will obtain the optimum goal in my health.

In andropause, men gradually lose their ability to produce testosterone and some men develop elevated levels of estrogen. As men undergo an ever-increasing loss of testosterone, they are faced with anxiety, irritability, erectile dysfunction, bone loss, muscle loss, loss of strength, and loss of energy and memory impairment.

Possible side effects of male testosterone replacement include, but are not limited to: unwanted hair growth, enlargement of the prostate, loss of sperm production (sterility), enlargement of breast tissue, testicular atrophy ( shrinking), acne, oily skin and hair, and in some studies, an increased risk of prostate cancer growth.

In hypothyroidism, studies have shown that physicians may under-treat this condition. I understand that my physician will be working with me to suppress my symptoms and improve my quality of life by considering my symptoms as well as my thyroid hormone levels to monitor the treatment of my disease. I understand that the potential side effects in using thyroid medication include osteoporosis palpitations, dizziness, psychiatric problems ( mania), and elevated or irregular heart rate.

With respect to age and incidence of Adult Growth Hormone Deficiency Syndrome, I appreciate that there are certain risks associated with the use of Sermorelin, Ipamorelin growth hormone releasing hormone and/or growth hormone releasing peptides. While Sermorelin, Ipamorelin, growth hormone releasing hormone and/or growth hormone releasing peptides have been shown to help stimulate endogenous growth hormone production, and increased endogenous production of growth hormone, thus, may stimulate lean muscle mass, lower fat mass and improve bone density, the clinical guidelines for the use of such medications in the treatment of adult growth hormone deficiency have yet to be clearly established. Therefore, my physician at Optima Health and Wellness and I have discussed the benefits of human growth hormone therapy using such medications, as well as the associated risks. These risks may include but are limited to: water retention, which may result in leg swelling and elevated blood pressure, mild increase in fasting blood sugar and occasional bruises at the injection site. I may also develop infection at the injection site if I use improper technique. Most all of these side effects are reversible by dosage adjustment or discontinuing therapy.

I understand that there are reasons to avoid the use of Sermorelin, Ipamorelin growth hormone releasing hormone and/or growth hormone releasing peptides if I am prescribed such medication(s). Some of these reasons are as follows: preexisting cancer or tumor(s), uncontrolled diabetes, unusual lung diseases such as pulmonary fibrosis, pneumoconiosis, proliferative disease, bronchiolitis, obliterans, systematic sclerosis or pregnancy. I do not currently have nor have I been diagnosed with any of these medical problems. I understand that if I am diagnosed with any of these medical problems, I should stop the entire treatment protocol immediately and notify my physician, so that my treatment plan can be re-evaluated. I understand that taking Sermorelin, Ipamorelin, growth hormone releasing hormone and/or growth hormone releasing peptides raises IGF-1 levels in the blood. In addition to the risks discussed above, I am aware that there are reports that indicate there may be an increased risk of prostate cancer associated with higher IGF-1 levels.

In menopause, women lose the majority of their hormones within a few years, causing in many cases, severe distress, both mental and physical. Through the use of the hormone replacement therapy, one can counter this decline and help alleviate the symptoms due to menopause. Additionally, studies now indicate that hormone therapy is effective in the treatment of osteoporosis, as well as other disease processes associated with hormone decline as we age.

The potential adverse effects for women using estrogen, progesterone and/or testosterone include, but are not limited to: breast swelling and/or discomfort, fluid retention, dizziness, palpitations, break through bleeding, requiring an endometrial biopsy, acne, unwanted hair growth, oily skin and hair, and headache.

I also understand that if I am female and become pregnant, I should discontinue the entire treatment protocol immediately and notify

Optima Health and Wellness. I understand that this hormone therapy is not for the purpose of preventing pregnancy. If I should become pregnant during the course of therapy, there are potential risks to the fetus (unborn child).

IV.) Safety of Hormone Replacement

Although in my physician’s opinion, the majority of data points toward safety, no one has yet proven or disproven a causal relationship between the use of hormone therapy and cancer. I understand that careful surveillance and close monitoring are requirements of all patients to minimize any possible risk.

I understand that there are other studies that point to a higher incidence of cancer in patients who take Hormone Replacement Therapy. However, these studies, which show an association (two variables present simultaneously), do not demonstrate cause and effect. I realize that it may be a number we know if there is any true cause and effect between hormones and increased risk for cancer in women or men.

I understand that although each hormone has been approved by the Food and Drug Administration (*FDA) for use in the treatment of certain diseases, the FDA only approves or disapproves of products made by manufacturers which are produced in an established dosage and form. Therefore, by definition, the FDA does not “approve” or “disapprove” of hormones which are given in an individual dose and in an appropriate form for each patient as determined by my doctor at Optima Health and Wellness. I also understand that my doctor may choose to discuss with me and provide to me medications that are off-label in order to offer to me the widest range of therapies possible, (*Offlabel” use means the use of FDA approved drugs for purposes other than those for which the FDA has approved them.) *Off-label” prescribing is a legal and common practice by physician in the United States. A recent study found that more than 20% of overall prescription drugs in the U.S. and close to 50% of drugs in some specialties are used in off-label manner.

V.) Administering the hormones; Remedies; Termination of Treatment

Any questions I have regarding this treatment have been answered to my satisfaction. I understand that I will be responsible for administering the hormones prescribed to me. I will conform and comply with the recommended dose and methods of administration. I also agree to conform to the request for initial and subsequent blood tests, as required to monitor my hormone levels. I understand that failure on my part to follow my physician’s recommendation in dosage and use of my hormones and medication may result in unwanted and potentially harmful side effects /results. I understand that failure to have appropriate laboratory testing completed at the interval established by my physician and failure to follow up with my physician at the recommended appointments may lead also to adverse (unwanted) side effects.

I also understand there are possible benefits associated with these procedures. I understand that no guarantee has been made to me regarding outcomes neither of this treatment nor on resolution of my symptoms. I understand that not all patients receive the same degree of response. I also understand that the benefits derived from therapy will cease and those derived from hormone therapy and drugs that alter hormone levels may not reverse if the therapy is discontinued.

I authorize Optima Health and Wellness to perform this treatment. I understand they may be assisted by other health professionals, as necessary, and I agree to their participation in my care as it relates to nutritional supplementation and hormone modulation therapy. I certify that I am under the regular care of another physician for all other medical conditions. I understand that this is a specialized practice and does not hospitalize patients. I also understand that I will continue under the care of my other physician(s) for any ongoing medical conditions as well as any medical consultation that I may need.

I ASSUME FULL LIABILITY FOR ANY ADVERSE EFFECTS THAT MAY RESULT FROM THE NON-NEGLIGENT

ADMINISTRATION OF THE PROPOSED TREATMENT. I WAIVE ANY CLAIM IN LAW OR EQUITY FOR REDRESS OF ANY GRIEVANCE THAT I MAY HAVE CONCERNING OR RESULTING FROM THIS PROCEDURE, EXCEPT AS THAT CLAIM PERTAINS TO NEGLIGENT ADMINISTRATION OF THE PROCEDURE.

I hereby confirm that the nature and purpose of portions of the aforementioned treatment are considered by some to be medically unnecessary and/or experimental, as there are no long-term studies documenting the results. The risks involved and the possibilities of complication have been explained to me. I fully understand that some aspects of the treatment to be provided may be considered experimental and unproven by scientific testing and peerreviewed publication. I understand that I may suspend or terminate treatment at any time and hereby agree to immediately notify Optima Health and Wellness physician of any such suspension or termination.

The undersigned certifies that HE/SHE has read and understands all the above, and as the Patient, agrees to and accepts the terms. I acknowledge I have been encouraged to ask any questions regarding this therapy. To attest to

MY FULL, COMPETENT, AND INFORMED CONSENT to this treatment, I hereby affix my signature to this Consent to Treatment.

Note: Proof of signature will be required with our first contact

Document D

Patient Medical/Medication Management Agreements

This agreement between ______________ (Patient’s Name) and Optima Health and Wellness establishes guidelines and conditions required for the proper use of Hormone Replacement Therapy (HRT). Optima Health and Wellness and patient agree that these guidelines and conditions are an essential factor in maintaining a successful patient/physician relationship.

The patient accepts and agrees to all of the following conditions (1-11):

  1. I agree that the Optima Health and Wellness patient/physician relationship is not intended to replace the existing patient/physician relationship with my current Primary Care Provider (PCP). I also understand that I am contracting with Optima Health and Wellness for specific HRT conditions only and that any other medical problems I may experience now, or in the future, must be diagnosed and treated by my own physician.
  2. I agree to contact Optima Health and Wellness 4-6 weeks into the start of my therapy (and every 3-4 months thereafter) to arrange for any follow-up blood testing and/or an office visit/consultation as required.
  3. I understand that the hormone replacement therapy I have undergone is prescribed for me based on diagnoses derived from my submitted medical history, blood/lab work and a physical examination. They are to be used exclusively for treatment of these diagnoses. I agree that I will use my medications at the prescribed rate and dosage.
  4. Although adverse reactions to any of the products or medications recommended by Optima Health and Wellness are rare ad uncommon, I will immediately report any adverse side effects related to the use of my medication to Optima Health and Wellness and discontinue use until advised to resume therapy by Optima Health and Wellness.
  5. I understand that Optima Health and Wellness is available for questions and/or concerns during normal business hours (9am-5pm EST, Mon-Fri) throughout the course of my treatment. I understand that Optima Health and Wellness does not maintain admitting privileges at any hospital.
  6.  
  7.  
  8. IN CASE OF EMERGENCY, IMMEDIATELY CONTACT A PHYSICIAN OR GOT TO AN EMERGENCY ROOM.
  9. I will not attempt to obtain “scheduled” hormone replacement therapy medications illegally or receive hormone replacement therapy from another healthcare practitioner without disclosing my current medication usage.
  10. I agree that these medications are for my personal use only and no other purpose. I will not share, sell or trade my medications.
  11. I will safeguard my medications from loss or theft and will be responsible for their safekeeping. Furthermore, I will keep the medication in its respective labeled container.
  12. I will not use my prescribed medications for “anti-aging,” body building or as a performance enhancement substance.
  13. Optima Health and Wellness wishes to provide consistent, quality care to each patient. In this regard, we recommend specific compounds of medications which are formulated by select compounding pharmacies approved by Optima Health and Wellness. Each compounding pharmacy approved by Optima Health and Wellness passes a series of stringent third party tests to validate the purity, potency, sterility and absence of toxins. These pharmacies also have the ability to produce and readily provide our prescribed delivery methods, strengths, quantities and supplies needed for our patients to safely and consistently administer and reconstitute the physician’s recommended treatment. Our office receives discounted physician medication pricing. This discount still represents a lower price than what a typical patient would pay for the same products as a retail customer. Patients may obtain medications from another provider. However, alternative professional fees may apply in order to adjust therapy protocols on an individual basis. For patient safety and therapy continuity, Optima Health and Wellness reserves the right to deny a provider if they cannot meet the compounding criteria of one of more individualized prescriptions.
  14. I will check my shipment(s) as soon as it/they arrive(s) for completeness and accuracy. All discrepancies must be reported to Optima Health and Wellness and the compounding pharmacy within 48 hours of receipt of shipment(s).
  15. I understand that all laboratory and medication sales provided by Optima Health and Wellness are non-refundable. 

Note: Proof of signature will be required with our first contact

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