Appendix D: Draft Telehealth Clinical Services Agreement

# Appendix D: Draft Telehealth Services Agreement

INSTRUCTIONS FOR ATTORNEY REVIEW

Telehealth arrangements carry significant state-by-state regulatory complexity. Before using this template: 1. Have counsel review the scope of services for each state in which you intend to operate 2. Confirm that the prescribing protocols are consistent with the standard of care for the relevant peptide therapies 3. Review the financial terms for anti-kickback compliance 4. Assess the supervision structure and confirm it is appropriate for each state 5. Verify that the informed consent procedures meet state-specific requirements 6. Confirm that the platform's technology meets HIPAA requirements 7. Ensure the provider credentialing requirements are sufficiently robust ---

TELEHEALTH CLINICAL SERVICES AGREEMENT

This Telehealth Clinical Services Agreement ("Agreement") is entered into as of [DATE] by and between: [PLATFORM NAME], a [STATE] [ENTITY TYPE] ("Platform"), and [PROVIDER NAME / PROVIDER GROUP NAME], a [STATE] [ENTITY TYPE] with principal offices at [ADDRESS] ("Provider"). ---

RECITALS

WHEREAS, Platform operates a telehealth platform connecting licensed healthcare providers with patients seeking peptide therapy consultations; WHEREAS, Provider is a licensed [MD/DO/NP/PA] [or Provider Group comprised of licensed providers] desiring to provide clinical services to patients through Platform; WHEREAS, Platform and Provider wish to establish the terms under which Provider will provide clinical services through the Platform; NOW, THEREFORE, the Parties agree as follows: ---

ARTICLE 1: DEFINITIONS

1.1 "Clinical Services" means the clinical evaluation, consultation, prescription management, and related services to be provided by Provider to Patients through the Platform, as described in Exhibit A. 1.2 "Patients" means individuals who have registered with the Platform and requested Clinical Services. 1.3 "Prescription" means a valid, patient-specific prescription issued by Provider for a peptide therapy, consistent with the Prescribing Protocols. 1.4 "Prescribing Protocols" means the clinical protocols and standards for prescribing peptide therapies established by Provider and described in Exhibit B, as amended by Provider from time to time. 1.5 "State of Patient" means the state in which the Patient is physically located at the time of the Clinical Service. ---

ARTICLE 2: PLATFORM SERVICES

2.1 Platform Services. Platform shall provide the following services to support Provider's delivery of Clinical Services: - (a) Patient intake and registration; - (b) Scheduling and encounter management; - (c) Secure telehealth technology compliant with HIPAA; - (d) Documentation and medical records management; - (e) Transmission of Prescriptions to the designated pharmacy; and - (f) Billing and coding services, as described in Article 8. 2.2 No Clinical Control. Platform shall not direct, control, or influence Provider's clinical judgment. Provider's decisions regarding patient evaluation, diagnosis, and prescribing are the sole professional responsibility of Provider. 2.3 Independent Contractor. Provider is an independent contractor. Nothing in this Agreement shall create an employment, partnership, or joint venture relationship between the Parties. ---

ARTICLE 3: SCOPE OF CLINICAL SERVICES

3.1 Services. Provider shall provide Clinical Services to Patients through the Platform in accordance with: - (a) The Prescribing Protocols; - (b) Applicable state and federal law; - (c) The standard of care for the relevant peptide therapies; and - (d) Provider's professional judgment. 3.2 Evaluation Standards. Provider shall conduct clinical evaluations that meet the standard of care, including: - (a) Review of the patient's medical history and relevant records; - (b) Clinical evaluation sufficient to establish a medical indication; - (c) Assessment of contraindications and risk factors; - (d) Development of a treatment plan; and - (e) Documentation of clinical decision-making in the patient's medical record. 3.3 Synchronous and Asynchronous Encounters. Provider may provide Clinical Services through synchronous video, synchronous audio-only, or asynchronous (store-and-forward) encounters, as appropriate for the clinical context and permitted by the laws of the State of Patient. 3.4 Excluded Services. Provider shall not prescribe peptide therapies to Patients for whom Provider determines that such therapy is not clinically appropriate, or for whom Provider cannot complete a clinically adequate evaluation. ---

ARTICLE 4: PRESCRIBING STANDARDS

4.1 Prescription Requirements. Each Prescription issued by Provider shall: - (a) Be patient-specific and issued in Provider's professional judgment; - (b) Include all elements required by applicable state and federal law; - (c) Be issued pursuant to a documented clinical evaluation; - (d) Be supported by a medical record that reflects clinical decision-making; and - (e) Be issued in accordance with the Prescribing Protocols. 4.2 No Formulary Restrictions. Platform shall not restrict Provider's ability to prescribe clinically appropriate medications. Platform may establish general clinical guidelines, but Provider retains full prescribing authority and responsibility. 4.3 Prescription Transmission. Platform shall transmit each Prescription to the pharmacy designated by the Patient, or to the default pharmacy identified in Exhibit C, within [24] hours of issuance. 4.4 No Perverse Incentives. Provider's compensation under this Agreement shall not be calculated on a per-prescription or per-patient volume basis in a manner that creates a financial incentive to prescribe. See Article 8. ---

ARTICLE 5: PATIENT ELIGIBILITY AND INFORMED CONSENT

5.1 Eligibility Criteria. Platform shall ensure that Patients meet minimum eligibility criteria for access to Clinical Services, as described in Exhibit D. 5.2 Informed Consent. Prior to the initial Clinical Service, Platform shall obtain and document the Patient's informed consent in accordance with the requirements of the State of Patient, including: - (a) The nature and purpose of peptide therapy; - (b) Material risks and benefits; - (c) Alternative treatments; - (d) The telehealth nature of the encounter; and - (e) The limitations of telehealth evaluations. 5.3 Consent Documentation. Informed consent documentation shall be maintained in the Patient's medical record. ---

ARTICLE 6: PROVIDER OBLIGATIONS

6.1 Licensure. Provider shall, throughout the term of this Agreement: - (a) Maintain a valid, active license in each State of Patient; - (b) Maintain all required certifications and registrations; - (c) Notify Platform immediately of any change in licensure status; and - (d) Ensure that Provider Group providers maintain licensure as required. 6.2 Credentialing. Provider shall complete Platform's credentialing process and shall provide updated credentials annually and upon request. Provider Group shall ensure all affiliated providers are credentialed with Platform. 6.3 HIPAA Compliance. Provider shall comply with all HIPAA requirements applicable to the Clinical Services, including the use of Platform's HIPAA-compliant technology. 6.4 Medical Records. Provider shall document all Clinical Services in the medical record in accordance with applicable standards. Medical records shall be retained for the period required by applicable state and federal law. 6.5 Adverse Events. Provider shall promptly report to Platform any adverse event of which Provider becomes aware in connection with a Patient's use of a peptide therapy prescribed through the Platform. ---

ARTICLE 7: PLATFORM OBLIGATIONS

7.1 Technology. Platform shall maintain a HIPAA-compliant telehealth platform and shall notify Provider of any security incidents or technology failures that may affect the delivery of Clinical Services. 7.2 Support. Platform shall provide Provider with reasonable technical and administrative support. 7.3 Insurance. Platform shall maintain professional liability insurance and general commercial liability insurance in amounts customary for telehealth platforms. ---

ARTICLE 8: COMPENSATION

8.1 Provider Compensation. Provider's compensation for Clinical Services shall be as set forth in Exhibit E. [Note to attorney: Structure compensation carefully. Per-prescription or per-volume fee arrangements may implicate anti-kickback statutes if they are structured to reward prescribing volume rather than clinical service time.] 8.2 No Fee-Splitting. Compensation shall reflect the fair market value of Clinical Services provided and shall not constitute illegal fee-splitting or kickback arrangements. 8.3 Invoicing. Platform shall pay Provider within [30] days of receipt of a monthly invoice. ---

ARTICLE 9: REGULATORY COMPLIANCE

9.1 State Law Compliance. Each Party shall be responsible for compliance with applicable state law in the States in which it operates. 9.2 Telehealth Regulations. Each Party shall comply with applicable telehealth regulations, including state telehealth registration requirements, prescribing standards, and informed consent requirements. 9.3 DEA Compliance. Provider shall comply with all applicable DEA regulations if prescribing controlled substances through the Platform. 9.4 Anti-Kickback. The Parties shall structure the financial terms of this Agreement in compliance with the federal Anti-Kickback Statute and applicable state anti-kickback laws. ---

ARTICLE 10: CONFIDENTIALITY

10.1 Patient Information. Each Party shall protect Patient information in accordance with HIPAA and applicable state privacy laws. 10.2 Business Information. Each Party shall maintain the confidentiality of the other Party's proprietary information. ---

ARTICLE 11: TERM AND TERMINATION

11.1 Term. [Insert term] 11.2 Termination for Cause. [Insert termination provisions] 11.3 Patient Transition. Upon termination, Provider shall cooperate in good faith to ensure orderly transition of Patients to other providers. ---

ARTICLE 12: INDEMNIFICATION

12.1 Provider Indemnification. Provider shall indemnify Platform for losses arising from Provider's negligence, willful misconduct, or breach of this Agreement. 12.2 Platform Indemnification. Platform shall indemnify Provider for losses arising from Platform's negligence, willful misconduct, or breach of this Agreement. ---

SIGNATURE PAGE

[PLATFORM NAME] By: _________________ Name: _______________ Title: _______________ Date: _______________ [PROVIDER / PROVIDER GROUP NAME] By: _________________ Name: _______________ Title: _______________ Date: _______________ ---

EXHIBIT A: Clinical Services Description

[To be completed — specific types of peptide therapies, scope of clinical services]

EXHIBIT B: Prescribing Protocols

[To be completed — clinical protocols, evaluation requirements, prescribing criteria]

EXHIBIT C: Designated Pharmacy

[To be completed — name and contact information for the default dispensing pharmacy]

EXHIBIT D: Patient Eligibility Criteria

[To be completed — minimum age, medical history requirements, exclusion criteria]

EXHIBIT E: Compensation

[To be completed — fee structure, payment terms, no-volume-per-prescription structure] --- *END OF APPENDIX D*