FRONT LINE INTAKE

1. WHAT IS TELEHEALTH?

Telehealth involves the delivery of healthcare services using interactive audio, video, or other electronic communications when you and your provider are not in the same physical location. This practice uses HIPAA-compliant telehealth platforms with end-to-end encryption and business associate agreements.

2. TECHNOLOGY REQUIREMENTS

• Device with camera and microphone
• Reliable, private internet connection
• Private location where consultation cannot be overheard

3. BENEFITS

• Increased access to care
• Reduced travel time and costs
• Continuity of care
• Scheduling convenience

4. RISKS AND LIMITATIONS

• Technology may fail during consultation
• Physical examination is limited to visual assessment
• Some conditions require in-person evaluation
• Electronic communications carry inherent privacy risks despite encryption
• Emergencies cannot be managed via telehealth - call 911

5. PRESCRIBING VIA TELEHEALTH

• DEA telemedicine flexibilities for controlled substances are extended through December 31, 2026, allowing Schedule II-V prescribing via audio-video without a prior in-person evaluation.
• If flexibilities expire, controlled substance prescribing may require prior in-person evaluation under the Ryan Haight Act.
• Some states impose additional restrictions (e.g., New York, Florida). Your prescriber will comply with the laws of the state where you are physically located.
• Non-controlled medications (GLP-1 agonists, compounded therapies) may be prescribed via telehealth where state law permits.

6. PRIVACY

• All sessions use HIPAA-compliant platforms. You are responsible for a private location. Sessions are documented in your record but not recorded without consent.

7. YOUR RIGHTS

• You may refuse telehealth and request in-person care at any time.
• You may end a session at any time. Refusal does not affect future care.

8. STATE-SPECIFIC REQUIREMENTS

The provider must be licensed in the state where you are physically located. You must disclose your location at each visit.

9. PATIENT ACKNOWLEDGMENTS

• I understand the nature, benefits, risks, and limitations of telehealth.
• I understand telehealth is not for emergencies.
• I will provide accurate information about my physical location.
• I consent to receiving healthcare services via telehealth.
• I may withdraw consent at any time.

Semaglutide & Tirzepatide - Brand-Name and Compounded Formulations

1. PURPOSE OF THIS CONSENT

This document provides information about GLP-1 receptor agonist medications that may be prescribed as part of your weight management or metabolic health treatment. GLP-1 receptor agonists include semaglutide (brand names: Ozempic, Wegovy, Rybelsus) and tirzepatide (brand names: Mounjaro, Zepbound). These medications may be prescribed in their FDA-approved brand-name form or, where legally permitted, as compounded formulations prepared by a licensed compounding pharmacy.

2. FDA APPROVAL STATUS

FDA-Approved Brand-Name Products: Ozempic and Rybelsus are approved for type 2 diabetes. Wegovy is approved for chronic weight management. Mounjaro is approved for type 2 diabetes. Zepbound is approved for chronic weight management. If your prescriber uses any of these products for a purpose other than its FDA-approved indication (e.g., Ozempic for weight loss), this constitutes off-label use.

Compounded Formulations: Compounded semaglutide and tirzepatide are prepared by licensed compounding pharmacies under FDCA Section 503A or 503B. Compounded medications are NOT FDA-approved, have NOT undergone FDA review for safety, efficacy, or manufacturing quality, and may differ from brand-name products in formulation, concentration, and inactive ingredients (excipients).

PROHIBITED FORMULATIONS

Semaglutide sodium and semaglutide acetate are PROHIBITED salt forms. The FDA determined on February 4, 2026 that these are different active ingredients than semaglutide base and there is no lawful basis for their use in compounding. Your prescriber should only use semaglutide base (not sodium or acetate salt) or tirzepatide base from a licensed compounding pharmacy. Retatrutide and cagrilintide also cannot be used in compounding.

3. CLINICAL DIFFERENCE REQUIREMENT (POST-SHORTAGE)

Following the resolution of FDA-recognized shortages, compounded GLP-1 medications may only be legally prescribed under Section 503A when your prescriber determines, through individualized clinical assessment, that a change between the compounded and commercially available product produces a "significant difference" for you specifically. This must be documented on the prescription and in a separate Clinical Difference Attestation form. Price alone is never a sufficient justification.

Acceptable significant differences may include:

• Documented allergy or hypersensitivity to a specific excipient in the brand-name product (e.g., phenol, m-cresol, polysorbate)
• Medical necessity for a dosage strength or form not commercially available
• Documented intolerance to preservatives in multi-dose commercial formulations
• Other patient-specific clinical justifications supported by your medical record

Note: California imposes a heightened standard requiring a "clinically significant difference" (effective June 17, 2025), with an additional pharmacist verification duty. Your prescriber will advise if state-specific requirements apply.

4. RISKS AND SIDE EFFECTS

• Nausea, vomiting, diarrhea, constipation
• Abdominal pain, bloating, decreased appetite
• Headache, fatigue, dizziness
• Injection site reactions (redness, swelling, itching)
• Thyroid C-cell tumors (BOXED WARNING): GLP-1 receptor agonists carry an FDA black box warning regarding medullary thyroid carcinoma (MTC) risk based on animal studies. Contraindicated in patients with personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Pancreatitis: Seek immediate medical attention for severe, persistent abdominal pain radiating to the back.
• Gastroparesis / delayed gastric emptying: Symptoms include severe nausea, vomiting, abdominal pain, and early satiety.
• NAION (Non-Arteritic Anterior Ischemic Optic Neuropathy): Report any sudden vision changes immediately.
• Gallbladder disease including cholelithiasis and cholecystitis
• Hypoglycemia, particularly when combined with insulin or sulfonylureas
• Acute kidney injury, including worsening of chronic kidney disease
• Diabetic retinopathy complications in patients with type 2 diabetes
• Increased heart rate
• Allergic reactions including anaphylaxis
• Suicidal ideation (under ongoing FDA investigation)

ANESTHESIA / SURGICAL RISK

GLP-1 receptor agonists delay gastric emptying, which increases the risk of pulmonary aspiration during anesthesia. The American Society of Anesthesiologists has issued preoperative management guidance. YOU MUST INFORM YOUR ANESTHESIOLOGIST AND SURGEON that you are taking a GLP-1 medication before any procedure requiring sedation or general anesthesia. Your prescriber may advise you to hold doses before scheduled procedures.

WEIGHT REGAIN AFTER DISCONTINUATION

GLP-1 receptor agonists are intended as long-term treatment. Clinical trial data demonstrates significant weight regain after discontinuation. Discuss long-term treatment planning with your prescriber.

TIRZEPATIDE AND ORAL CONTRACEPTIVES

Tirzepatide may reduce the efficacy of oral hormonal contraceptives. Use a non-oral barrier method of contraception for four (4) weeks after initiating tirzepatide and for four (4) weeks after each dose escalation.

ADDITIONAL RISKS OF COMPOUNDED FORMULATIONS

Compounded medications carry additional risks including: variability in potency and sterility between batches, absence of FDA manufacturing oversight, lack of standardized excipient profiles, potential for contamination, and limited adverse event reporting infrastructure.

5. CONTRAINDICATIONS

GLP-1 receptor agonists should NOT be used if you have: a personal or family history of medullary thyroid carcinoma (MTC) or MEN 2; a known hypersensitivity to semaglutide, tirzepatide, or any component of the formulation; a history of pancreatitis; current pregnancy, plans to become pregnant, or current breastfeeding.

6. ALTERNATIVES

Alternatives include: lifestyle modifications (diet and exercise), other FDA-approved weight management medications, bariatric surgery, or no treatment. Your prescriber can discuss which alternatives may be appropriate.

7. PATIENT ACKNOWLEDGMENTS

• I have read and understand this entire informed consent document.
• I understand the differences between brand-name and compounded GLP-1 medications.
• I understand that compounded medications are NOT FDA-approved.
• I have been informed of the risks including NAION (vision), gastroparesis, thyroid cancer risk, weight regain, and anesthesia complications.
• I understand I must inform any anesthesiologist or surgeon that I am taking a GLP-1 medication.
• I have had the opportunity to ask questions and have received satisfactory answers.
• I understand that results are not guaranteed and individual responses vary.
• I understand this medication is intended as long-term treatment and significant weight regain occurs after discontinuation.
• I agree to follow all prescriber instructions regarding dosing, administration, and follow-up.
• I agree to immediately report any adverse effects including vision changes, severe abdominal pain, or allergic reactions.
• I understand I may withdraw consent at any time without penalty.
• If receiving a compounded formulation, I understand a Clinical Difference Attestation has been or will be completed by my prescriber.

1. PURPOSE

This consent covers HRT including testosterone, estrogen, progesterone, DHEA, and/or pregnenolone, in FDA-approved or compounded formulations. Routes may include IM/SubQ injection, transdermal cream/gel, oral capsules, sublingual troches, or pellet implantation.

2. EXPECTED BENEFITS

• Improved energy, mood, and cognitive function
• Improved libido and sexual function
• Increased muscle mass and bone density (testosterone)
• Relief from menopausal symptoms (estrogen/progesterone)
• Improved sleep quality

3. RISKS BY HORMONE

Testosterone:

• Acne, oily skin, hair changes; polycythemia (requires monitoring); mood changes/irritability; testicular atrophy, reduced sperm (males); voice deepening, clitoral enlargement (females, may be irreversible); cardiovascular risk (monitoring required); liver effects (oral); sleep apnea exacerbation

Estrogen:

• Breast tenderness, bloating, headaches; increased DVT/PE risk (especially oral); potential breast cancer risk (long-term); endometrial hyperplasia (if without progesterone); mood changes

Progesterone:

• Drowsiness, dizziness, breast tenderness; mood changes, bloating; breakthrough bleeding

DHEA / Pregnenolone:

• Acne, hair changes; hormonal imbalance if not monitored; limited long-term safety data

4. MONITORING

• Baseline: CBC, CMP, lipid panel, hormone panel, PSA (males >40)
• Every 3-6 months during treatment
• Annual mammogram (females on estrogen) and DRE/PSA (males on testosterone) per guidelines

5. CONTRAINDICATIONS

• Hormone-sensitive cancers; uncontrolled cardiovascular disease/blood clots; pregnancy/breastfeeding; severe liver disease; undiagnosed vaginal bleeding

6. PATIENT ACKNOWLEDGMENTS

• I understand HRT may involve compounded formulations that are not FDA-approved.
• I have been informed of risks, benefits, and alternatives.
• I agree to complete all recommended monitoring.
• I will report adverse effects including mood changes, vision changes, chest pain, leg swelling, or unusual bleeding immediately.
• I understand I may withdraw consent at any time.

For Non-GLP-1 Peptide Treatments

1. WHAT IS PEPTIDE THERAPY?

Peptides are short chains of amino acids that serve as signaling molecules in the body. Peptide therapy involves the administration of specific peptides to support various physiological functions. Only peptides with a lawful compounding pathway may be prescribed at this practice.

2. REGULATORY STATUS OF COMMON PEPTIDES

Peptides That May Currently Be Compounded (Category 1 or component of approved drug):

• Sermorelin (growth hormone-releasing hormone analog)
• Other peptides currently on the FDA 503A Category 1 bulks list

Your prescriber will confirm the current regulatory status of any peptide recommended for your treatment, as the FDA bulks list is subject to change.

Peptides That CANNOT Be Legally Compounded (Category 2 / Prohibited):

• BPC-157 - Category 2 since September 2023. No FDA-approved use. No human clinical trials completed.
• TB-500 (thymosin beta-4) - Category 2. Zero human clinical trials. May be classified as a biologic (>40 amino acids).
• AOD-9604, CJC-1295, Ipamorelin - Removed from Category 2 in September 2024, but PCAC voted against bulks list inclusion in December 2024. Not available for routine compounding.
• Thymosin alpha-1 - Regulatory gray zone. PCAC voted against inclusion. Component of an approved orphan drug but not available for routine compounding.
• Retatrutide, cagrilintide - Not FDA-approved, not a component of any approved drug. Compounding strictly prohibited.

RUO PRODUCTS ARE ILLEGAL FOR HUMAN USE

Products labeled "For Research Use Only - Not for Human Consumption" (RUO) are NOT prescribed at this practice. The FDA has stated that RUO labels are a "ruse to avoid FDA scrutiny." Use of RUO products on patients constitutes distribution of unapproved new drugs. APIs used in compounding must be pharmaceutical grade from licensed sources. If you are obtaining peptides from non-pharmacy sources, inform your prescriber immediately.

3. BENEFITS

• Support for tissue repair and recovery
• Enhanced immune function
• Improved sleep quality and growth hormone optimization
• Support for cognitive function

Individual results vary. No specific outcomes are guaranteed. Many peptides lack long-term clinical trial data in humans.

4. RISKS AND SIDE EFFECTS

• Injection site reactions: redness, swelling, pain, bruising
• Nausea, headache, dizziness, flushing
• Allergic reactions including anaphylaxis (rare)
• Changes in blood pressure or heart rate
• Water retention or joint discomfort
• Fatigue, mood changes
• Unknown long-term effects - many peptides lack completed human clinical trials
• Batch-to-batch variability in compounded formulations
• Drug interactions with current medications

5. ALTERNATIVES

Alternatives may include conventional pharmaceutical treatments, lifestyle modifications, surgical interventions, physical therapy, or no treatment. Your prescriber will discuss appropriate alternatives.

6. PATIENT ACKNOWLEDGMENTS

• I understand that peptide therapy involves compounded medications that are NOT FDA-approved.
• I understand that many formerly available peptides (including BPC-157 and TB-500) can no longer be legally compounded.
• I have been informed of the potential risks, benefits, and alternatives.
• I understand that results are not guaranteed and many peptides lack long-term human safety data.
• I agree to report any adverse effects immediately.
• I agree to attend all recommended follow-up appointments and laboratory monitoring.
• I will not obtain or use RUO or non-pharmaceutical-grade peptide products.
• I understand I may withdraw consent at any time.

1. WHAT IS RETATRUTIDE?

Retatrutide is Eli Lilly's first-in-class triple hormone receptor agonist targeting GIP, GLP-1, and glucagon receptors simultaneously. It is currently in Phase 3 clinical trials (the TRIUMPH program).

2. REGULATORY STATUS

• Retatrutide is NOT FDA-approved for any indication.
• It is NOT a component of any FDA-approved drug product.
• It does NOT appear on the FDA 503A or 503B bulks list and has NO USP monograph.
• There is NO legal pathway for compounding retatrutide.
• The FDA has specifically warned state boards that retatrutide cannot be used in compounding.
• Multiple states (including Ohio) have announced immediate enforcement action.
• Any retatrutide obtained outside of a registered clinical trial is unapproved and unregulated.

3. RISKS

The full risk profile is unknown. Known risks from clinical trial data include all GLP-1 agonist risks (nausea, vomiting, diarrhea, gastroparesis, pancreatitis, thyroid tumor risk) PLUS risks from glucagon receptor activation (increased heart rate, lipid metabolism effects, potential hepatic effects). Unknown long-term risks may emerge.

4. ASSUMPTION OF RISK

• I understand retatrutide is investigational and NOT FDA-approved.
• I understand there is NO legal compounding pathway.
• I understand the full risk profile is unknown.
• I voluntarily assume ALL risks, known and unknown.
• I release FRONT LINE, its owners, employees, and affiliates from liability for adverse outcomes.
• I have had the opportunity to ask questions and received satisfactory answers.
• I understand I may discontinue treatment at any time.

Effective Date: February 25, 2026

This notice describes how medical information about you may be used and disclosed and how you can get access to this information.

PLEASE REVIEW IT CAREFULLY.

REGULATORY COMPLIANCE NOTE

This Notice of Privacy Practices has been updated to comply with: (1) the February 2024 Final Rule aligning 42 CFR Part 2 (Substance Use Disorder records) with HIPAA, effective February 16, 2026; and (2) the vacatur of the reproductive health NPP provisions following Purl v. HHS (N.D. Tex., June 18, 2025). This notice is provided pursuant to 45 CFR § 164.520.

OUR PLEDGE REGARDING YOUR MEDICAL INFORMATION

We understand that your health information is personal and we are committed to protecting it. We create a record of the care and services you receive at this practice. We need this record to provide quality care and to comply with legal requirements. This notice applies to all records of your care generated by this practice.

HOW WE MAY USE AND DISCLOSE YOUR HEALTH INFORMATION

Treatment: We may use your health information to provide, coordinate, or manage your healthcare and related services. This includes sharing information with other healthcare providers involved in your care.

Payment: We may use and disclose your health information to bill and receive payment for services provided to you, including contacting your insurance company for prior authorization or claims processing.

Healthcare Operations: We may use and disclose your health information for operational purposes including quality assessment, training, accreditation, compliance activities, and business management.

Other Permitted Uses and Disclosures:

• As required by law, including mandatory reporting obligations
• Public health activities (disease reporting, FDA reporting, workplace safety)
• Victims of abuse, neglect, or domestic violence
• Health oversight activities (audits, inspections, investigations)
• Judicial and administrative proceedings (court orders, subpoenas)
• Law enforcement purposes as permitted or required by law
• Coroners, medical examiners, funeral directors
• Organ and tissue donation organizations
• Research, subject to HIPAA requirements
• To avert a serious threat to health or safety
• Military, veterans, national security, and intelligence activities
• Workers' compensation as authorized by law
• Inmates and law enforcement custodial situations

Substance Use Disorder (SUD) Records - Part 2 Alignment

Effective February 16, 2026, records relating to substance use disorder treatment that were previously protected under 42 CFR Part 2 are now aligned with HIPAA protections. These records may be used and disclosed for treatment, payment, and healthcare operations under HIPAA with the same protections as other medical records. SUD records may NOT be used against you in criminal proceedings absent a court order meeting specific criteria. A general HIPAA authorization is sufficient for SUD record disclosures - a separate Part 2 consent is no longer required for most purposes.

USES AND DISCLOSURES REQUIRING YOUR WRITTEN AUTHORIZATION

• Marketing communications (with limited exceptions for treatment communications)
• Sale of your PHI
• Most uses and disclosures of psychotherapy notes
• Any other use or disclosure not described in this notice

YOUR RIGHTS REGARDING YOUR HEALTH INFORMATION

Right to Inspect and Copy: You have the right to inspect and obtain a copy of your health information. You may request electronic copies in the format maintained by the practice. We may charge a reasonable, cost-based fee. We must respond within 30 days (15 days if the Privacy Rule NPRM is finalized).

Right to Amend: You may request an amendment to your health information if you believe it is incorrect or incomplete. We may deny the request under certain circumstances but must provide a written explanation.

Right to an Accounting of Disclosures: You may request a list of certain disclosures we have made of your health information.

Right to Request Restrictions: You may request restrictions on how we use or disclose your information for treatment, payment, or healthcare operations. We are not required to agree to all restrictions, but we must comply with requests to restrict disclosures to health plans for services you paid for in full out of pocket.

Right to Request Confidential Communications: You may request that we communicate with you by alternative means or at alternative locations.

Right to a Paper Copy: You have the right to obtain a paper copy of this notice at any time, even if you previously agreed to receive it electronically.

Right to Breach Notification: You have the right to be notified in the event of a breach of your unsecured PHI.

CHANGES TO THIS NOTICE

We reserve the right to change this notice and make the new provisions effective for all PHI we maintain. Revised notices will be posted in our office and available upon request.

COMPLAINTS

If you believe your privacy rights have been violated, you may file a complaint with this practice or with the U.S. Department of Health and Human Services, Office for Civil Rights. You will not be retaliated against for filing a complaint.

CONTACT INFORMATION

Privacy Officer: [NAME]
Address: [PRACTICE ADDRESS]
Phone: [PHONE NUMBER]
Email: [EMAIL]
HHS Office for Civil Rights: www.hhs.gov/ocr/privacy/hipaa/complaints

1. INFORMATION TO BE DISCLOSED

I authorize the release of the following information (check all that apply):

2. DISCLOSE TO / RECEIVE FROM

3. PURPOSE OF DISCLOSURE

4. EXPIRATION

If no date or event is specified, this authorization expires twelve (12) months from the date signed.

5. YOUR RIGHTS

• I understand I have the right to revoke this authorization at any time by submitting a written request, except to the extent that action has already been taken in reliance on this authorization.
• I understand that information disclosed pursuant to this authorization may be subject to re-disclosure by the recipient and may no longer be protected by HIPAA. However, SUD records disclosed under this authorization may not be re-disclosed without additional authorization except as permitted by 42 CFR Part 2 as aligned with HIPAA.
• I understand that treatment, payment, enrollment, or eligibility for benefits may NOT be conditioned on signing this authorization, except in limited circumstances permitted by HIPAA.
• I understand I am entitled to a copy of this signed authorization.

1. AGREEMENT TO ARBITRATE

The patient and FRONT LINE, including its owners, medical directors, providers, employees, and affiliates ("Practice"), agree that any dispute arising out of or relating to the patient's treatment, care, or services provided by the Practice, including but not limited to claims of medical malpractice, negligence, breach of contract, violation of statute, or any other claim however denominated, shall be resolved by binding arbitration rather than in court.

This agreement is governed by the Federal Arbitration Act (9 U.S.C. §§ 1-16) ("FAA"). The substantive law of the state where the patient received treatment shall apply to the merits of any dispute.

2. ARBITRATION PROCEDURES

• Arbitration shall be administered by JAMS or AAA under their applicable healthcare or consumer arbitration rules.
• The arbitration shall take place in the county where the patient received treatment, or another mutually agreed location.
• The arbitrator shall be a retired judge or attorney with experience in healthcare disputes.
• Each party shall bear its own attorney's fees unless the arbitrator determines otherwise. The Practice shall pay all arbitration filing fees and arbitrator compensation beyond the equivalent of a court filing fee.
• The arbitrator shall have the authority to award any remedy that would be available in court, including compensatory damages, injunctive relief, and attorney's fees where authorized by law.
• The arbitrator's decision shall be final and binding and may be entered as a judgment in any court of competent jurisdiction. Consistent with Smith v. Spizzirri (2024), any court action shall be stayed (not dismissed) pending arbitration.

3. CLASS ACTION WAIVER

Both parties agree that any arbitration shall be conducted on an individual basis only. Neither party may participate in a class, consolidated, or representative action in arbitration or in court. If this class action waiver is found unenforceable, the parties agree that the dispute shall proceed in court rather than in arbitration.

4. MULTI-STATE TELEHEALTH PROVISION

If the patient receives services via telehealth while located in a state other than the Practice's home state, the FAA shall govern arbitrability, and the substantive law of the state where the patient was physically located at the time of the telehealth encounter shall apply to the merits of the dispute.

5. RIGHT TO OPT OUT

The patient may opt out of this arbitration agreement by delivering written notice to the Practice within thirty (30) calendar days of signing. The opt-out notice must be in writing, signed by the patient, and delivered by mail or email to the Practice's address listed below. Opting out will have no effect on the patient's treatment or the patient-provider relationship.

6. SEVERABILITY

If any provision of this agreement is found unenforceable, the remaining provisions shall remain in full force and effect.

7. ACKNOWLEDGMENTS

• I have read this entire arbitration agreement.
• I understand that by signing, I am waiving my right to a jury trial.
• I understand treatment is NOT conditioned on signing this agreement.
• I understand I have 30 days to opt out in writing.
• I have been given adequate time to review and ask questions.

IMPORTANT: POWER OF ATTORNEY / HEALTHCARE AGENTS

Pursuant to Harrod v. Country Oaks (2024, Cal. Supreme Court), a healthcare agent under a Healthcare Decisions Law does NOT have authority to sign an arbitration agreement on behalf of a patient unless the power of attorney specifically grants authority to agree to arbitration. If signing on behalf of a patient, attach documentation of specific arbitration authority.