New York Healthcare
Compliance Guide

New York presents a complex yet evolving regulatory landscape for healthcare companies, characterized by a strong emphasis on patient protection, robust professional licensing, and a cautious but progressive approach to telehealth. The state maintains a generally favorable stance towards expanding access to care through technology, particularly post-pandemic, but often couples this with stringent requirements for provider-patient relationships, informed consent, and prescribing practices. Key regulatory bodies include the New York State Department of Health (NYSDOH), the Office of the Professions within the New York State Education Department (NYSED), and various professional licensing boards (e.g., Board for Medicine, Board for Nursing, Board for Pharmacy). The business climate for healthcare operations is shaped by strict Corporate Practice of Medicine (CPOM) doctrines, detailed fee-splitting prohibitions, and specific requirements for professional entities. Recent legislative actions have primarily focused on solidifying telehealth flexibilities made permanent after the COVID-19 public health emergency, addressing mental health access, and refining reimbursement policies. While New York is not as 'telehealth-friendly' as some western states that permit asynchronous-only encounters or have more relaxed CPOM, it offers significant opportunities for compliant telehealth models. Companies must navigate a nuanced environment that prioritizes in-state licensure, appropriate supervision, and adherence to established standards of care, even when delivered remotely. The state's regulatory framework aims to balance innovation with patient safety and professional accountability, making a thorough understanding of its specific rules paramount for successful operation.

New York maintains a robust and strictly enforced Corporate Practice of Medicine (CPOM) doctrine, primarily rooted in statutory law and long-standing judicial precedent. This doctrine generally prohibits corporations and other non-professional entities from practicing medicine or employing licensed professionals to provide medical services. The underlying principle is to prevent commercial interests from interfering with the independent clinical judgment of licensed healthcare providers.

Legal Basis:

• Education Law § 6512(1): Prohibits the unauthorized practice of a profession. A corporation that is not a professional service corporation (PC) or professional service limited liability company (PLLC) cannot practice medicine.
• Education Law § 6521: Defines the practice of medicine.
• Business Corporation Law Article 15 (Professional Service Corporations): Mandates that only licensed professionals can own and operate professional corporations providing professional services. Similar provisions exist for PLLCs.
• Case Law: Numerous court decisions, such as Sachs v. Saloshin, have affirmed the prohibition against corporate practice by unlicensed entities.

Ownership Structures and Restrictions:

• Professional Corporations (PCs) and Professional Service Limited Liability Companies (PLLCs): These are the primary legal structures permitted to practice medicine, dentistry, chiropractic, and other licensed professions in New York. Ownership of a PC or PLLC is restricted to individuals licensed in that specific profession. For example, a medical PC must be owned solely by physicians licensed in New York. This means non-physicians, including lay individuals or corporations, cannot own a medical practice.
• Non-Physician Ownership: Generally prohibited for entities directly practicing medicine. This extends to other licensed professions like dentistry, optometry, and chiropractic. For instance, a layperson cannot own a dental practice or a medspa that provides medical services (e.g., injectables, laser treatments requiring a physician's supervision or delegation).
• Impact on Telehealth Companies: Telehealth companies that directly employ or contract with physicians to provide medical services and bill for those services are subject to CPOM. They must typically operate through a PC or PLLC model, where the professional entity is owned by licensed physicians. The non-clinical, administrative, and technological aspects can be managed by a separate management services organization (MSO).
• Impact on Medspas, Dental Practices, and Wellness Clinics:
  • Medspas: If a medspa provides services considered the practice of medicine (e.g., Botox, dermal fillers, medical-grade lasers, IV therapy, prescription weight loss), it must be owned by a licensed physician or operated under a compliant MSO arrangement with a physician-owned PC/PLLC. Lay ownership of the entity providing medical services is prohibited.
  • Dental Practices: Must be owned by licensed dentists, typically structured as a Dental Professional Corporation (DPC) or PLLC.
  • Chiropractic Practices: Must be owned by licensed chiropractors.
  • Wellness Clinics: The applicability of CPOM depends on the nature of services. If services involve diagnosis, treatment, or prescribing (e.g., hormone therapy, GLP-1 programs), they fall under CPOM and require physician ownership of the professional entity. Services like personal training or nutritional counseling that do not constitute the practice of medicine are generally not subject to CPOM.

Specific Restrictions:

• Fee-Splitting: New York strictly prohibits fee-splitting between licensed professionals and unlicensed individuals or entities. This is codified in Education Law § 6530(19) for physicians and similar provisions for other professions. Arrangements must ensure that the professional entity retains full control over clinical decisions and professional fees, while the MSO is compensated for legitimate administrative services at fair market value, independent of the volume or value of referrals or services rendered.
• Control over Clinical Decisions: Unlicensed individuals or entities cannot exert control over the clinical judgment, treatment decisions, or professional standards of licensed providers.

Enforcement: The NYSED Office of the Professions and the Attorney General's Office are responsible for enforcing CPOM. Violations can lead to professional misconduct charges for licensees, corporate dissolution, civil penalties, and even criminal charges for unauthorized practice.

New York has significantly advanced its telehealth regulatory framework, particularly solidifying many flexibilities introduced during the COVID-19 Public Health Emergency (PHE). The state generally supports telehealth as a means to expand access to care, but maintains specific requirements to ensure quality and patient safety.

Establishment of Provider-Patient Relationship:

• Yes, generally. A provider-patient relationship can be established via telehealth in New York, provided it meets the same standard of care as an in-person encounter. There is no explicit requirement for an initial in-person visit to establish the relationship for most services. The definition of 'telehealth' in Public Health Law § 2999-cc emphasizes that it must be 'appropriate for the patient and the service.'
• Standard of Care: Providers must exercise the same standard of care whether the service is provided in-person or via telehealth. This includes obtaining a medical history, performing an appropriate assessment, and formulating a treatment plan.

Permitted Modalities: New York permits a range of telehealth modalities:

• Live Two-Way Audio-Visual (Synchronous): This is the preferred and most widely accepted modality for establishing a new patient relationship and for complex medical encounters. It allows for real-time interaction and visual assessment.
• Audio-Only (Synchronous): Permitted for many services, especially for established patients or when audio-visual is not available or appropriate. Public Health Law § 2999-cc(1)(b) includes 'audio-only telephone communication' as a telehealth modality, provided it is 'clinically appropriate.' This was a significant permanent change post-PHE, expanding access for those without reliable internet or video capabilities.
• Asynchronous (Store-and-Forward): Permitted for specific applications, such as radiology, pathology, or dermatology where images or data are transmitted for review at a later time. It is generally not sufficient for establishing a new patient relationship or for primary care encounters that require real-time interaction and assessment. Public Health Law § 2999-cc(1)(c) defines 'store and forward technology' as a permitted modality.
• Remote Patient Monitoring (RPM): Also permitted, involving the electronic transmission of patient health information to a provider for review and monitoring. Public Health Law § 2999-cc(1)(d) addresses RPM.

Telehealth Registration Requirements:

• No specific 'telehealth registration' for providers. Unlike some states, New York does not require a separate telehealth registration or license for providers already licensed in New York. However, providers must hold a valid, active license issued by the New York State Education Department (NYSED) for their respective profession (e.g., MD, DO, NP, PA) to provide telehealth services to patients located in New York.
• Out-of-State Providers: Generally, an out-of-state license is not sufficient. Providers must be licensed in New York to treat New York patients, even via telehealth. Exceptions may exist for specific interstate compacts (e.g., IMLC, NLC), but New York is not a member of all such compacts.

Informed Consent Requirements:

• Mandatory. New York requires specific informed consent for telehealth services. Public Health Law § 2999-dd mandates that providers obtain informed consent from the patient (or their legal guardian) prior to the delivery of telehealth services. This consent must include:
  • An explanation of telehealth and how it works.
  • Confirmation that the patient understands the services to be provided.
  • Information on privacy and security measures.
  • Details on how to obtain follow-up care.
  • The patient's right to withdraw consent at any time.
  • An explanation of potential risks and benefits.
• Documentation: The informed consent must be documented in the patient's medical record.

Geographic Restrictions:

• No specific in-state geographic restrictions on patient location. As long as the patient is located within New York State at the time of the telehealth encounter, and the provider is licensed in New York, services can be rendered. There are no prohibitions on providing telehealth to patients in rural areas versus urban areas, for example. The key is the patient's physical location within New York at the time of service, which dictates the licensing jurisdiction.

New York has stringent rules for prescribing, particularly for controlled substances, which apply equally to telehealth as to in-person care. The state's focus is on preventing misuse and diversion while ensuring appropriate access to necessary medications.

Controlled Substance Prescribing via Telehealth:

• Schedules II-V: Generally permitted for all schedules (II, III, IV, V) via telehealth, provided the prescribing practitioner has established a valid practitioner-patient relationship and conducted an appropriate medical evaluation. The federal Ryan Haight Act's in-person examination requirement for controlled substances was waived during the federal PHE, and New York aligned with this flexibility. Post-PHE, the DEA has proposed new rules that would generally require an in-person visit or a referral from a practitioner who has conducted one, with exceptions for certain situations. However, as of early 2025, the federal rules are still evolving, and state law generally permits it if the standard of care is met.
• New York Specifics: New York's Public Health Law § 3332 and 10 NYCRR Part 80 govern controlled substances. There is no blanket prohibition on prescribing controlled substances via telehealth, but the standard of care and all other prescribing rules must be met. The practitioner must ensure the telehealth encounter is sufficient for a proper diagnosis and treatment plan, including the decision to prescribe a controlled substance.

DEA Requirements:

• DEA Registration: Practitioners must hold a valid DEA registration associated with their New York practice address to prescribe controlled substances in New York, regardless of whether the service is in-person or via telehealth.
• Federal Telehealth Rules (Ryan Haight Act): The federal Ryan Haight Act generally requires an in-person medical evaluation prior to prescribing controlled substances. However, during the COVID-19 PHE, this requirement was waived. As of early 2025, the DEA is still in the process of finalizing new rules regarding the in-person requirement for telehealth prescribing of controlled substances. Practitioners must monitor federal DEA guidance closely, as New York generally follows federal law in this regard unless state law is more restrictive. For now, the PHE flexibilities largely remain in effect until new rules are finalized.

Prescription Monitoring Program (PDMP) Checking:

• Mandatory: New York has a robust PDMP, known as the Internet System for Tracking Over-Prescribing (I-STOP). Public Health Law § 3330(6) and 10 NYCRR Part 80.60 mandate that practitioners consult the PDMP for a patient's prescription history prior to prescribing or dispensing any Schedule II, III, IV, or V controlled substance. This check must occur for each patient and for each controlled substance prescription, with limited exceptions (e.g., emergency situations, hospice care). This requirement applies fully to telehealth prescribing.

Quantity or Refill Limitations:

• 7-Day Supply Limit for Opioids: For acute pain, New York generally limits initial opioid prescriptions to a 7-day supply. This is codified in Public Health Law § 3331(5-a). This applies to telehealth as well.
• Other Controlled Substances: Quantity and refill limitations for other controlled substances are generally guided by clinical appropriateness and federal/state scheduling regulations. Refills for Schedule II substances are prohibited; new prescriptions are required. Schedule III-V substances may have up to five refills within six months.

Special Rules for Specific Drug Classes:

• GLP-1s (e.g., Ozempic, Wegovy, Mounjaro): While not controlled substances, these medications require a thorough medical evaluation, diagnosis, and ongoing monitoring. Prescribing via telehealth is permitted if the standard of care is met, including appropriate patient selection, screening for contraindications, and follow-up. The provider must ensure the telehealth platform allows for sufficient assessment.
• Testosterone/Hormone Therapy: Requires comprehensive evaluation, including lab work and clinical assessment. Telehealth prescribing is permissible if the standard of care is met, which often involves a combination of synchronous video visits and lab review. Inappropriate prescribing without proper diagnosis and monitoring can lead to professional misconduct.
• Stimulants (e.g., Adderall, Ritalin): These are Schedule II controlled substances. Prescribing via telehealth requires careful adherence to the standard of care, including a comprehensive diagnostic evaluation for conditions like ADHD. Given their high potential for abuse, practitioners must be particularly diligent in their assessment, PDMP checks, and monitoring. The evolving federal DEA rules on telehealth prescribing of Schedule II substances will be particularly relevant here. Some providers may opt for an in-person assessment for initial stimulant prescriptions due to the federal Ryan Haight Act's historical requirements and ongoing uncertainty, though current flexibilities generally allow it.

New York has distinct and often complex scope of practice regulations for various mid-level providers, particularly Nurse Practitioners (NPs) and Physician Assistants (PAs). These rules dictate the level of independence, supervision, and delegation permitted.

Nurse Practitioners (NPs):

• Full Practice Authority (Conditional): New York grants a form of conditional full practice authority to NPs. Since January 1, 2015, and further expanded by recent legislation, experienced NPs in New York can practice independently without a written collaborative agreement with a physician, provided they meet specific criteria. This is often referred to as 'Attestation to Practice Independently.'
• Education Law § 6902(3)(a) and (b):
  • Experienced NPs: NPs who have maintained a valid New York State registration as an NP for more than 3,600 hours (equivalent to approximately 2 years of full-time practice) and have a current collaborative agreement or practice under a facility protocol may file an 'Attestation to Practice Independently' with the NYSED. Once attested, they can practice without a written collaborative agreement, but they must still refer patients to physicians and other health care providers as appropriate.
  • Newer NPs: NPs who do not meet the 3,600-hour experience requirement or have not filed the attestation must still practice in accordance with a written practice agreement and a 'collaborative relationship' with a physician. This agreement outlines the scope of practice and communication protocols. The physician is not required to be on-site but must be available for consultation.
• Prescribing: NPs have prescribing authority, including controlled substances, within their scope of practice, provided they have completed specific pharmacology education and are registered with the DEA.

Physician Assistants (PAs):

• Supervision Required: PAs in New York practice under the supervision of a licensed physician. While the supervision requirements have been modernized, PAs do not have independent practice authority.
• Education Law § 6540 et seq.: Defines the practice of PAs and the requirements for supervision.
• Supervision Requirements: Supervision does not necessarily mean constant on-site presence. It typically involves a continuous working relationship between the PA and the supervising physician, where the physician is responsible for the overall care of the patient. The physician must be readily available for consultation, either in person or by telecommunication. The supervising physician must review and countersign patient records and orders as required by regulation or facility policy. The degree of supervision can vary based on the PA's experience and the complexity of the patient's condition.
• Delegation: PAs can perform medical services that are within their scope of practice and delegated by their supervising physician, provided the services are consistent with the physician's scope of practice and the PA is competent to perform them.
• Prescribing: PAs have prescribing authority, including controlled substances, under the supervision of a physician, provided they have completed appropriate education and are registered with the DEA.

Other Mid-Level Providers and Delegation:

• Registered Nurses (RNs): RNs perform nursing functions and cannot independently diagnose, prescribe, or perform medical procedures without a physician's order or within a specific protocol (e.g., standing orders in a hospital setting). They cannot delegate medical tasks to unlicensed personnel.
• Licensed Practical Nurses (LPNs): Practice under the direction of an RN, NP, PA, or physician.
• Medical Assistants (MAs): In New York, Medical Assistants are generally considered unlicensed assistive personnel. Their scope of practice is limited to administrative and certain clinical support tasks that are delegated by and performed under the direct supervision of a licensed physician, NP, or PA. They cannot independently perform tasks that require clinical judgment or assessment. This is crucial for medspas and wellness clinics:
  • Delegation Rules in Medspas: MAs cannot perform procedures considered the practice of medicine (e.g., injectables like Botox/fillers, advanced laser treatments, IV insertions, blood draws for therapeutic purposes) unless explicitly permitted by regulation under direct, on-site supervision for very specific, limited tasks. Generally, these procedures require a licensed professional (physician, NP, PA, or RN under specific protocols/supervision). The NYSED Office of the Professions frequently clarifies that tasks requiring professional judgment cannot be delegated to MAs. For example, IV therapy administration is typically restricted to licensed nurses or physicians.
• Aestheticians: Licensed by the NYS Department of State, their scope is limited to cosmetic services on the superficial layers of the skin. They cannot perform medical procedures, diagnose skin conditions, or use devices that penetrate the dermis or require medical oversight (e.g., certain lasers, microneedling with depths beyond superficial).

Navigating New York's Corporate Practice of Medicine (CPOM) and fee-splitting prohibitions is critical for any healthcare business. The Professional Corporation (PC) / Management Services Organization (MSO) model is the predominant compliant structure.

PC-MSO Structures:

• When Needed: The PC-MSO model is essential for any healthcare business (telehealth, medspa, dental, chiropractic, wellness clinic providing medical services) where the entity providing professional services is not wholly owned by licensed professionals of that specific discipline. Since CPOM prohibits lay ownership of professional practices, the PC-MSO structure allows non-licensed individuals or entities to participate in the business's administrative and non-clinical aspects while ensuring compliance with professional practice laws.
• How it Works:
  • Professional Corporation (PC) or Professional Service Limited Liability Company (PLLC): This entity is owned exclusively by New York-licensed professionals (e.g., physicians for a medical practice, dentists for a dental practice). The PC/PLLC employs or contracts with the licensed providers who deliver the clinical services, makes all clinical decisions, and receives all professional fees.
  • Management Services Organization (MSO): This is a separate, non-professional entity (e.g., LLC, C-Corp) that can be owned by licensed or non-licensed individuals/entities. The MSO enters into a Management Services Agreement (MSA) with the PC/PLLC. The MSO provides all non-clinical administrative, technical, and business support services to the PC/PLLC (e.g., billing, scheduling, marketing, IT, human resources, facilities, equipment, non-clinical staff).

Fee-Splitting Rules:

• Strict Prohibition: New York has one of the strictest prohibitions on fee-splitting in the nation. Education Law § 6530(19) for physicians (and similar provisions for other professions) makes it professional misconduct to 'directly or indirectly offer, pay, solicit, or receive any fee or other consideration to or from a third party for the referral of a patient or in connection with the performance of professional services.'
• Impact on MSO Compensation: The MSO's compensation from the PC/PLLC must be structured carefully to avoid any appearance of fee-splitting. Compensation must be for legitimate administrative services rendered and must be set at fair market value (FMV). It cannot be tied to a percentage of professional fees, the volume of patients, or the value of services provided by the PC/PLLC. Common compliant compensation models include a fixed monthly fee, a cost-plus model, or a percentage of the MSO's operational costs, but never a direct percentage of the PC's clinical revenue.

Management Services Agreement (MSA) Requirements:

• Comprehensive and Detailed: The MSA is the cornerstone of the PC-MSO relationship. It must clearly delineate the roles and responsibilities of both parties. Key provisions include:
  • Services Provided by MSO: A detailed list of administrative, non-clinical services.
  • Compensation Structure: Clearly define the FMV compensation for MSO services, ensuring it's not tied to professional revenue.
  • Clinical Control: Explicitly state that the PC/PLLC retains sole control over all clinical decisions, patient care, and professional judgment.
  • Term and Termination: Standard contract provisions.
  • Ownership of Patient Records: Typically, the PC/PLLC owns the patient records.
  • Compliance: Provisions ensuring both parties comply with all applicable laws (HIPAA, Stark, Anti-Kickback, CPOM, etc.).
• Avoidance of Control: The MSA must not grant the MSO any control over the PC/PLLC's clinical operations or the licensed professionals' practice of their profession.

Professional Corporation (PC) Requirements:

• Formation: PCs (e.g., P.C., P.L.L.C.) are formed under New York Business Corporation Law Article 15 or Limited Liability Company Law Article 12. They must obtain a Certificate of Authority from the NYSED before filing with the Department of State.
• Ownership: All shareholders/members must be licensed in the profession for which the PC/PLLC is organized. If a shareholder loses their license, they must divest their shares.
• Name: The name must include 'P.C.' or 'P.L.L.C.' and generally reflect the profession.

How to Structure Ownership for Compliance:

• Direct Clinical Services: The entity directly providing medical, dental, or other licensed professional services must be a PC or PLLC owned by New York-licensed professionals in that field.
• Non-Clinical/Administrative Services: A separate MSO, which can be lay-owned, provides all non-clinical support to the PC/PLLC under a compliant MSA.
• Transparency: All arrangements must be transparent and clearly delineate the roles to avoid any perception of unauthorized practice or fee-splitting. Legal counsel experienced in New York healthcare law is essential for drafting and reviewing these complex agreements.

New York's healthcare regulatory landscape is dynamic, with several recent developments and pending legislation impacting telehealth, CPOM, and professional practice. Staying abreast of these changes is crucial for compliance.

Legislative Actions (2024-2026 Focus):

• Permanent Telehealth Flexibilities: Many of the telehealth expansions enacted during the COVID-19 PHE have been made permanent or extended. This includes the permanent inclusion of audio-only telehealth as a reimbursable modality under certain circumstances (Public Health Law § 2999-cc). Legislation has focused on ensuring continuity of care and expanding access, particularly for behavioral health services. Expect ongoing efforts to refine reimbursement parity for telehealth services.
• Mental Health Access: New York continues to prioritize mental health access. Recent legislation and budget proposals often include provisions to expand telehealth for mental health and substance use disorder services, streamline licensing for behavioral health professionals, and enhance reimbursement. This includes efforts to increase the number of licensed mental health professionals and support innovative delivery models.
• Interstate Licensure Compacts: New York has been exploring participation in various interstate licensure compacts, though progress can be slow. While New York is a member of the Nurse Licensure Compact (NLC), it is not currently a member of the Interstate Medical Licensure Compact (IMLC). There is ongoing advocacy for New York to join additional compacts to ease multi-state practice, but no definitive legislation has passed to join the IMLC as of early 2025. Companies should not assume compact participation for physicians without explicit legislative action.
• CPOM and MSO Scrutiny: While no major legislative overhaul of CPOM is anticipated, there is an ongoing focus by regulatory bodies on ensuring MSO arrangements are truly compliant and do not undermine the CPOM doctrine or fee-splitting prohibitions. This includes scrutinizing compensation models and the degree of MSO control over clinical operations.
• GLP-1 and Weight Loss Services: The rapid growth of GLP-1 medications for weight loss has led to increased scrutiny. While not specific legislation, regulatory bodies (NYSED, NYSDOH) are closely monitoring prescribing practices to ensure adherence to the standard of care, appropriate diagnosis, and patient safety. Expect potential guidance or enforcement actions related to aggressive marketing or inappropriate prescribing of these drugs, especially via telehealth.

Recent Board Actions or Enforcement Cases:

• Professional Misconduct: The NYSED Office of the Professions regularly publishes disciplinary actions against licensees for various forms of professional misconduct, including unauthorized practice, prescribing violations, and improper supervision. These often highlight the strict enforcement of scope of practice and prescribing rules.
• Telehealth Enforcement: While New York has embraced telehealth, enforcement actions have occurred for providers practicing without a New York license, failing to establish a proper patient-provider relationship, or engaging in inappropriate prescribing via telehealth. These cases underscore the importance of adhering to New York's specific telehealth and prescribing regulations.
• MSO/CPOM Cases: While public enforcement cases specifically targeting MSO structures are less frequent than individual professional misconduct cases, the threat of CPOM violations remains a significant concern. The state's Attorney General and the NYSED maintain vigilance against arrangements that appear to circumvent professional practice laws or involve illegal fee-splitting.

Key Takeaways: New York continues to balance innovation with strong regulatory oversight. Companies should anticipate continued emphasis on licensure, patient safety, and adherence to established professional standards, even as telehealth expands. Monitoring NYSED and NYSDOH announcements, as well as legislative updates, is essential.

Entering the New York healthcare market requires meticulous planning and strict adherence to its unique regulatory framework. Here's actionable guidance to ensure compliance:

Step-by-Step Compliance Checklist:

1. Entity Formation: Establish a New York Professional Corporation (PC) or Professional Service Limited Liability Company (PLLC) for the clinical entity, owned exclusively by New York-licensed professionals in the relevant field. Simultaneously, form a separate Management Services Organization (MSO) (e.g., LLC, C-Corp) for administrative functions.
2. Licensure: Ensure all providers (physicians, NPs, PAs, dentists, chiropractors, etc.) hold active, unrestricted New York State licenses. Initiate the licensing process well in advance, as it can be lengthy.
3. DEA Registration: All prescribers of controlled substances must have an active New York-specific DEA registration.
4. Management Services Agreement (MSA): Draft a robust MSA between the PC/PLLC and the MSO. Ensure MSO compensation is at Fair Market Value (FMV) for administrative services and is explicitly not tied to professional revenue or volume of services.
5. Telehealth Policy Development: Create comprehensive telehealth policies and procedures covering:
   • Informed Consent: Implement a clear, documented informed consent process specifically for telehealth, as required by Public Health Law § 2999-dd.
   • Modality Use: Define when synchronous video, audio-only, or asynchronous modalities are appropriate for different services.
   • Patient Identification: Robust protocols for verifying patient identity.
   • Emergency Protocols: Clear procedures for handling emergencies during telehealth encounters.
   • Privacy & Security: HIPAA-compliant platforms and data security measures.
6. Prescribing Protocols: Develop strict prescribing protocols, especially for controlled substances, including mandatory PDMP checks (I-STOP) for every controlled substance prescription, and adherence to quantity limits (e.g., 7-day opioid limit).
7. Scope of Practice Adherence: Clearly define and enforce the scope of practice for all licensed professionals and delegated tasks for unlicensed personnel (e.g., MAs). Ensure all supervision requirements for PAs and newer NPs are met.
8. Billing & Reimbursement: Understand New York's specific telehealth reimbursement rules, including parity laws and eligible services for various payers (Medicaid, commercial).
9. Compliance Officer: Designate a compliance officer responsible for ongoing monitoring and updates.

Common Pitfalls to Avoid:

• Ignoring CPOM: Attempting to operate a medical practice with lay ownership or control, or structuring MSO fees as a percentage of clinical revenue, will lead to severe penalties.
• Unlicensed Practice: Allowing providers to treat New York patients without a valid New York license.
• Inadequate Telehealth Consent: Failing to obtain proper informed consent for telehealth services.
• Skipping PDMP Checks: Not performing mandatory I-STOP checks for controlled substance prescriptions.
• Improper Delegation: Allowing unlicensed staff (e.g., MAs in medspas) to perform tasks outside their legal scope or without proper supervision.
• Lack of Documentation: Insufficient documentation of patient encounters, medical necessity, and compliance activities.

Timeline Expectations for Licensing and Setup:

• Provider Licensing: Can take 3-6 months or longer for initial licensure with the NYSED Office of the Professions, especially for out-of-state applicants. Start this process immediately.
• DEA Registration: Typically 4-8 weeks after state licensure.
• Entity Formation (PC/PLLC & MSO): 4-8 weeks, including obtaining the Certificate of Authority from NYSED for the professional entity.
• Contracting (MSA, Provider Agreements): 1-3 months, depending on complexity and legal review.
• Technology & Platform Setup: Varies widely but can be 1-3 months for HIPAA-compliant solutions.
• Overall Launch: Expect a minimum of 6-12 months from initial planning to full operational readiness in New York, assuming all steps are executed efficiently.