PLEASE READ THIS CONSENT DOCUMENT IN ITS ENTIRETY. PLEASE SCROLL DOWN TO REVIEW THE CONSENT TO SEMAGLUTIDE AND TIRZEPATIDE THAT LISTS ALL OF THE RISKS AND BENEFITS OF THESE MEDICATIONS.
Consent to Telehealth
Thank you for choosing Bask Health Inc. (“Bask”) and Beluga Health, P.A. (“Beluga”) to provide you with medical weight loss services via the Nexa Vitality platform. You are viewing this form because you have elected to engage in telemedicine visits with a Beluga healthcare practitioner via Bask. All visits will be asynchronous (as described below), unless a real-time synchronous telemedicine visit is required by state law. Your practitioner is a board-certified physician licensed in your state.
By clicking “I Agree,” you acknowledge and agree to the following:
I ACKNOWLEDGE I HAVE READ AND UNDERSTAND THE TERMS PRESENTED BELOW, AND UNDERSTAND THE RISKS AND BENEFITS OF TELEMEDICINE, INCLUDING ASYNCHRONOUS TELEMEDICINE, AND BY ACCEPTING THESE TERMS OF USE I HEREBY GIVE MY INFORMED CONSENT TO PARTICIPATE IN ASYNCHRONOUS TELEMEDICINE (OR REAL-TIME SYNCHRONOUS VIDEO CONSULTATION IF REQUIRED BY STATE LAW) UNDER THESE TERMS.
What is Telemedicine?
Telemedicine is the delivery of healthcare services, including examination, consultation, diagnosis, and treatment, through electronic communication technologies when you (the patient) are located in a different location than your healthcare practitioner. Beluga allows you to receive treatment from a healthcare practitioner without having to travel to another location or schedule a separate appointment and helps you avoid long wait times that you might otherwise experience at an in-person visit.
What is Asynchronous Telemedicine?
Asynchronous telemedicine is one way to deliver telemedicine. Asynchronous communication is often referred to as “store-and-forward” communication, where participants submit and collect data at different times. An example of asynchronous communication is a telemedicine encounter with a healthcare practitioner that involves sending photos, video, or other communications via email or text message. “Asynchronous” means “not occurring at the same time” and is different from “synchronous” telemedicine, which generally includes visits conducted in real-time between patients and healthcare practitioners through audio or video means (e.g., live phone calls or video-conferencing). Healthcare practitioners may use asynchronous telemedicine to aid in diagnoses and medical consultations when live communication or face-to-face contact is not possible or necessary.
Beluga and its medical providers provide services through Nexa Vitality’s platform (the “Nexa Vitality Platform”) which in particular, allows for the following asynchronous telemedicine services: 1) text-based healthcare practitioner-patient interactions through short message service (“SMS”) and multimedia messaging service (“MMS”) communications; and 2) secure information collection through asynchronous store-and-forward patient questionnaires.
What are the Possible Risks to Using Telemedicine, including Asynchronous Telemedicine?
As with any medical treatment, there are potential risks associated with the use of telemedicine in general and asynchronous telemedicine specifically. Beluga believes that the likelihood of these risks materializing is very low.
These risks may include, without limitation, the following:
Due to lack of physical exam, certain information may not be known about your health which could affect your care and the treatment you get.
Delays in medical evaluation and consultation or treatment may occur due to deficiencies or failures of the equipment or the Internet, which may include poor data quality, Internet outages, or other service interruption issues. You may reschedule the visit with your healthcare practitioner should these interruptions occur.
Security protocols could fail, causing a breach of privacy of personal medical information.
Because Beluga does not have access to your complete medical records, if you do not disclose to your healthcare practitioner a full list of your medical history including diagnoses, treatments, medications/supplements, and allergies, adverse treatment, drug interactions or allergic reactions, or other negative outcomes may occur.
Telemedicine services are NOT emergency services and your Personal Data (as defined in the Bask Privacy Policy) WILL NOT BE MONITORED 24/7. If you think you are experiencing a medical emergency, CALL 911 IMMEDIATELY.
THE CARE YOU RECEIVE WILL BE AT THE SOLE DISCRETION OF THE HEALTHCARE PRACTITIONER WHO IS TREATING YOU, WITH NO GUARANTEE OF DIAGNOSIS, TREATMENT, OR PRESCRIPTION. THE HEALTHCARE PRACTITIONER WILL DETERMINE WHETHER OR NOT THE CONDITION BEING DIAGNOSED AND/OR TREATED IS APPROPRIATE FOR THE CARE PROVIDED THROUGH AN ASYNCHRONOUS OR REAL-TIME TELEMEDICINE ENCOUNTER VIA THE PLATFORM.
Your Rights and Acknowledgements:
You have the same privacy rights via telemedicine that you would have during an in-person visit. Dissemination of any identifiable images or information from the telemedicine visit to researchers or other entities will not occur without your written consent. For more information about how we protect your privacy, please read the Bask Health, Inc. and Beluga Health, PA HIPAA Privacy Statement at the bottom of this document. You acknowledge that you have been provided with a copy of the Beluga HIPAA Private Statement.
Telemedicine may involve electronic communication of your personal medical information to healthcare practitioners who may be located in other areas, including out of state.
You understand that you may expect the anticipated benefits from the use of telemedicine, but that no results can be guaranteed or assured.
You understand that all information submitted to Beluga via text message and entered by your healthcare practitioner in the Beluga Platform will be part of your medical record and available to you by emailing [email protected]. This information will have the same restrictions on dissemination without your consent.
You understand that your healthcare practitioner’s initial text message to you will include his/her name and credentials, and this will be recorded in the Beluga Platform as part of your medical record.
You understand you may withdraw your consent and delete your patient profile at any time by emailing [email protected].
You understand that your healthcare information may be shared with other individuals in accordance with the Beluga Privacy Policyand regulations or laws in state or territory in which you are located.
You further understand that your healthcare information may be shared in the following circumstances:
When a valid court order is issued for medical records.
Reporting suspected abuse, neglect, or domestic violence.
Preventing or reducing a serious threat to anyone's health or safety
Call/Email/Text Messaging Consent: You expressly consent to allow Beluga or its healthcare practitioners to call, email, or text you (via SMS and/or MMS) with or regarding Personal Data (as defined in the Beluga Privacy Policy), appointments, or similar matters related to your telemedicine encounters using the contact information you have provided. Any calls or texts to you may be placed using an auto-dialer or a pre-recorded or artificial voice, even if your number is on a do-not-call list. Your phone carrier’s normal rates may apply. This is consent, not a condition of purchase. You may revoke this consent at any time by emailing us at [email protected].
This Consent to Telehealth is valid during your entire treatment with Beluga.
Informed Consent to Semaglutide and Tirzepatide
The purpose of this informed consent form is to give you written information regarding the potential benefits, risks and alternatives to Semaglutide and Tirzepatide prescription medications in order for you to make an informed decision as to whether or not to proceed with treatment. Please read this form carefully and ask any questions you have.
During your telehealth visit, your licensed provider connected with you via Nexa Vitality will perform a thorough evaluation reviewing your medical history, medications you’re taking, and other medical information to determine if Semaglutide or Tirzepatide are appropriate for you.
Semaglutide:
Semaglutide is a GLP-1 receptor agonist, which means that it works by mimicking a hormone called glucagon-like peptide 1 (GLP-1) that helps prevent the liver from releasing too much sugar, thereby reducing blood sugar levels, and also promotes satiety—in other words, provokes a feeling of fullness. This happens because the drug slows down the digestive system, so you feel fuller longer.
Ozempic® and Wegovy® are the same medication (Semaglutide) and work the same way, though Wegovy® has a higher maximum dose and is FDA approved for weight loss.
The US FDA has approved Ozempic® as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. Ozempic® may also be used off-label for weight loss in patients who are overweight to improve health outcomes, like high blood pressure.
The US FDA has approved Wegovy® for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity.
Both Ozempic and Wegovy are once weekly subcutaneous injections.
Compounded Semaglutide has not been approved by the FDA for weight loss or any other condition and is currently used on a research basis only. If you choose to use compounded Semaglutide, you understand that it is not FDA approved.
Tirzepatide:
Tirzepatide is both a GIP and GLP-1 receptor agonist. Agonists are drugs that activate receptors. In this case, GIP and GLP-1 regulate gut hormones called incretins, which help our bodies know when we feel full and help prevent the liver from releasing too much sugar, thereby reducing blood sugar levels. This happens because the drug slows down the digestive system, so you feel fuller longer.
Mounjaro®, also known as Zepbound®, is the brand name patented version of Tirzepatide injectable that recently FDA approval for obesity. Compounded Tirzepatide has not been approved by the FDA and is currently used on a research basis.
Side Effects, Risks and Complications: Every treatment involves a certain amount of risk, and it is important that you understand these risks and the possible complications associated with use of Semaglutide and Tirzepatide. An individual’s choice to take a medication is based on the comparison of the risk to potential benefit.
The most common side effects from taking Semaglutide and Tirzepatide include, but are not limited to:
Nausea, vomiting, diarrhea, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, hypotension, abdominal distension (bloating), eructation (burping), hypoglycemia in patients with type 2 diabetes, flatulence (gas), gastroenteritis, and gastroesophageal reflux disease. We will work with you to limit and treat these side effects. You may also experience redness or pain at the injection sites.
Additionally, many individuals notice that their face may become excessively thin and their cheeks hollow looking due to rapid weight loss.
Potential Serious Side Effects and Complications include, but are not limited to:
Gastroparesis and chronic gastrointestinal issues (constipation and/or diarrhea).
Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. Do not use if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Change in vision in patients with type 2 diabetes (Diabetic Retinopathy). Tell your healthcare provider if you have changes in vision during treatment. Patients with a history of diabetic retinopathy should have their vision monitored regularly while taking these medications.
Inflammation of your pancreas (pancreatitis). Stop using treatment and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
Gallbladder problems. Treatment may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
Increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery.
Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
Serious allergic reactions. Stop and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
Increased heart rate. Treatment can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.
Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse or worry you.
This is not a complete list of side effects and complications, and others may occur and some may not currently be known, particularly longer term effects.
Contraindications and Additional Information Regarding Potential Risks:
Semaglutide and Tirzepatide should not be used in combination with other GLP-1 receptor agonists or other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal products. Therefore, you must not take any other weight loss drugs, including over-the-counter weight loss products, while taking Semaglutide or Tirzepatide unless prescribed or recommended by your provider.
You should not use Semaglutide or Tirzepatide if you have multiple endocrine neoplasia type 2 (tumors in your glands), or a personal or family history of medullary thyroid cancer.
Pregnancy and Breastfeeding: You should stop using Semaglutide and Tirzepatide at least three (3) months before you plan to get pregnant and should not use it while breastfeeding. If you are a woman, use adequate contraception to ensure you do not become pregnant while taking Semaglutide or Tirzepatide. Please tell your provider if you plan to become pregnant, and immediately contact your provider if you inadvertently become pregnant while taking Semaglutide or Tirzepatide.
Semaglutide and Tirzepatide also have warnings for the possibility of causing pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, diabetic retinopathy, increased heart rate and suicidal behavior or thinking. Therefore, Semaglutide and Tirzepatide should either not be used or should be used with extreme caution in people with a history of pancreatitis, decreased kidney function, diabetic retinopathy or history of suicidal ideation.
I understand this list is not complete and it describes the most common side effects and risks. I understand symptoms may be worse after there has been a change in my medication dose or when first starting the medication.
Contact your Nexa Vitality provider or urgent care immediately if you experience any of the following while taking Semaglutide or Tirzepatide: vision changes; unusual mood changes, thoughts about hurting yourself; pounding heartbeats or fluttering in your chest; a light-headed feeling, like you might pass out; signs of a thyroid tumor--swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath; symptoms of pancreatitis--severe persistent pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate; gallbladder problems--upper stomach pain, fever, clay-colored stools, jaundice (yellowing of the skin or eyes); low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; kidney problems--swelling, urinating less, feeling tired or short of breath; or stomach flu symptoms--stomach cramps, vomiting, loss of appetite, diarrhea (may be watery or bloody).
Alternatives: Alternatives to Semaglutide and Tirzepatide for weight loss and blood sugar management include diet and exercise, other diabetic drugs, weight loss surgery, and natural herbal supplements. Other diabetic drugs, weight loss surgery and supplements also have potential benefits and risks to be discussed with your Nexa Vitality provider.
By clicking “I Agree,” you acknowledge and agree to the following in order to proceed with treatment with Semaglutide or Tirzepatide through the Nexa Vitality platform:
I have read and understand all of the above statements and have been informed of potential side effects and risks that may be associated with the use of Semaglutide and Tirzepatide prescriptions. I fully understand what I am signing and hereby request and consent to treatment using Semaglutide or Tirzepatide as prescribed to me. I understand that other treatment alternatives are available for weight loss and blood sugar management.
I agree that I am, and will be, under the care of my primary medical provider for all other conditions. I understand that Nexa Vitality providers are not providing primary care.
NO GUARANTEES: I acknowledge that there are no guarantees or assurances made with respect to weight loss or any results of taking the Semaglutide or Tirzepatide prescribed for me, and I understand that it works best when combined with diet and exercise.
OFF-LABEL USE OF OZEMPIC: I understand that while Ozempic® is FDA approved for blood sugar control, it used off-label for weight loss.
NO FDA APPROVAL FOR COMPOUNDED MEDICATIONS: I understand that compounded Semaglutide and compounded Tirzepatide are not approved by the FDA for any purpose and are formulated and used on a research basis only.
NO REFUNDS: I understand that results may vary, and I understand that there are no refunds. I understand that my prescription is in my individual name and cannot be returned.
Complete Medical History: I understand that Semaglutide and Tirzepatide may be inappropriate and unsafe if I have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, I understand that it is vital that I truthfully and accurately disclose all health information requested by my Nexa Vitality provider including allergies, medications I am taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep my provider updated as to any changes in my health conditions and history during treatment with Semaglutide and Tirzepatide, and there shall be no liability on the part of Nexa Vitality or my Nexa Vitality provider if I fail to do so. I understand that if I become pregnant or start trying for pregnancy, I must stop this medication.
Directions for use and Following Instructions:
I understand that I will be in charge of administering the medication prescribed to me. I will follow and comply with the recommended doses and methods of administration and understand this is very important for the safety of the treatment. I understand that failure to comply with the dosage and administration instructions could alter the weight loss results and the safety of treatment.
I understand this medication must be self-injected in the subcutaneous tissue once weekly.
I understand that I will be instructed on how to administer the injections myself, or I will need to plan to have someone assist me.
I will not adjust my medications up or down without prior instruction to do so.
I understand that the medication must be either kept frozen or refrigerated.
I will not share needles, and I will dispose of needles safely.
I agree that I will not use any medications after the Beyond Usage Date (BUD).
CERTIFICATION OF CONSENT TO PROCEED WITH TREATMENT: By clicking “I Agree” when asked, I confirm and agree that:
I have read this entire Informed Consent, and I understand and agree to the information herein. The nature of the therapy, and the potential risks, benefits and alternatives have been explained to me, and I have had the opportunity to ask questions and all my questions have been answered to my satisfaction. I hereby freely and voluntarily accept all risks associated with Semaglutide and/or Tirzepatide and a prescribed healthy diet for the purpose of losing weight and elect and consent to proceed with treatment.
Bask Health, Inc. and Beluga Health, P.A.
HIPPA Privacy Statement:
Effective Date: 5/25/2024
This Notice of Privacy Practices ("Notice") describes how Beluga Health, P.A. and its affiliated licensed medical groups and healthcare providers providing medical weight loss services through the Nexa Vitality platform ("we", "us", or "our") may use and disclose your Protected Health Information (PHI) to carry out treatment, payment, or healthcare operations and for other purposes that are permitted or required by law. This Notice also describes your rights regarding your PHI. We are required by law to maintain the privacy of your PHI, provide you with this Notice of our legal duties and privacy practices, and to abide by the terms of this Notice.
Uses and Disclosures of PHI
We may use and disclose your PHI for the following purposes:
Your Rights Regarding PHI
You have the following rights with respect to your PHI:
Transmission of PHI
We are committed to protecting the privacy of your PHI and will ensure that any electronic transmission of PHI complies with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR 164). This includes the use of Secure-Socket Layer (SSL) or equivalent technology for the transmission of PHI, as well as adherence to all applicable security standards for online transmissions of PHI.
Changes to This Notice
We reserve the right to change this Notice and the revised Notice will be effective for PHI we already have about you, as well as any information we receive in the future. We will post a copy of the current Notice in our office and on our website. The Notice will contain the effective date on the first page.
Complaints
If you believe your privacy rights have been violated, you may file a complaint with our Privacy Officer or with the Secretary of the Department of Health and Human Services. You will not be retaliated against for filing a complaint.
Contact Information
To exercise any of your rights, or if you have any questions about this Notice or our privacy practices, please contact the Bask Privacy Officer at: [email protected]
This Notice is provided in accordance with the Notice of Privacy Practices for Protected Health Information from the Department of Health and Human Services' Model and is applicable across all US states. Rights of Specific Jurisdictions within the US Certain states may have additional privacy protections that apply to your PHI. The following is an example of specific rights in the state of California. If you reside in a state with additional privacy protections, you may have additional rights related to your PHI.
Notice of Privacy Practices for Protected Health Information (PHI) - State-Specific Provisions
In addition to the privacy practices described in our Notice of Privacy Practices for Protected Health Information, we comply with applicable state-specific privacy laws related to PHI.
California:
For residents of California, we comply with the Confidentiality of Medical Information Act (CMIA), as well as California's specific privacy laws related to marketing, sale of PHI, and minors' rights. We will obtain written consent before disclosing certain information and adhere to additional privacy protections, as required by California law.
New York:
For residents of New York, we comply with the New York State Confidentiality of Information Law, which provides additional privacy protections for HIV-related information, mental health records, and genetic testing results. We will obtain written consent before disclosing such information, even for treatment, payment, or healthcare operations.
Texas:
For residents of Texas, we comply with the Texas Medical Privacy Act, which offers privacy protections beyond HIPAA, including requiring consent for certain disclosures of PHI, additional safeguards for electronic PHI, and specific requirements for the destruction of PHI. We also adhere to Texas's specific privacy protections for mental health records and substance use treatment records.
Florida:
For residents of Florida, we comply with Florida's privacy laws, which offer additional protections for mental health records, HIV/AIDS-related information, and substance abuse treatment records. We will obtain written consent before disclosing such information, even for treatment, payment, or healthcare operations. We also implement specific security measures to protect electronic PHI, as required by Florida law.
Illinois:
For residents of Illinois, we comply with Illinois's specific privacy laws related to mental health records, HIV/AIDS-related information, and genetic testing results. We will obtain written consent before disclosing such information, even for treatment, payment, or healthcare operations. In addition, we will notify patients of any unauthorized access to their electronic PHI, as required by Illinois law.
Massachusetts:
For residents of Massachusetts, we comply with Massachusetts's specific privacy laws related to mental health records, HIV/AIDS-related information, and genetic testing results. We will obtain written consent before disclosing such information, even for treatment, payment, or healthcare operations. We also implement specific security measures to protect electronic PHI, as required by Massachusetts law.
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