Disclaimer: This material is for educational/informational purposes only and is not legal or medical advice. Rules and interpretations change. Always verify requirements with NYSED Office of the Professions (OP), NYSDOH, and the New York State Board of Pharmacy, and consult qualified counsel.
Executive Summary
- New York’s medical compliance framework is defined by strict physician oversight, clear delegation limits, and robust documentation expectations. Only a New York–licensed physician (MD/DO) may direct or control medical care. Under the Corporate Practice of Medicine (CPOM) prohibition, non-physicians and management entities (MSOs) may manage administrative operations—but they cannot control clinical policy, hire or supervise clinicians, or access patient medical records. All clinical authority must remain within a physician-owned PC or PLLC authorized by the New York State Education Department (NYSED).
- Medical directors must hold an active New York license in good standing and maintain ultimate responsibility for delegation, prescribing oversight, and quality assurance (QA). They must be readily available for consultation and ensure that supervision standards are continuously met across all locations and modalities.
- Nurse Practitioners (NPs) with Full Practice Authority (FPA) may diagnose, treat, and prescribe independently within their certification scope but must comply with iSTOP (Prescription Monitoring Program) for controlled substances. Physician Assistants (PAs) practice under continuous—but not necessarily on-site—physician supervision, with clearly written duties and prescribing parameters. All prescribers must comply with New York’s mandatory e-prescribing law for both controlled and non-controlled drugs.
- Every clinic must demonstrate a functioning Quality Assurance system—including chart reviews, meeting minutes, remediation notes, and competency tracking—to meet the professional conduct standards set out in Regents Rules Part 29. Procedures such as injectables, IV therapy, and energy-based device treatments require written protocols, operator training documentation, and incident reporting processes.
- For telehealth, psychiatry, and weight-loss programs, the standard of care remains the same as in-person care. Clinics must maintain documented patient consent, identity verification, and secure records. Controlled substances may be prescribed via telehealth only when the provider–patient relationship is valid, supported by proper documentation, iSTOP checks, and follow-up plans.
- Medical Director Co. helps practices meet these expectations through New York–specific physician coverage, turnkey supervision frameworks, QA systems, and MSO alignment support—ensuring clinical control remains exactly where the law requires: with the physician.
Compliance in New York is document-driven. Regulators expect a paper trail that proves physician ownership, lawful delegation, QA oversight, and prescribing compliance. A defensible setup includes:
- A physician-owned PC/PLLC with a compliant MSO structure;
- Updated NP/PA agreements, scope-of-practice mapping, and QA logs;
- Device and procedure folders with safety, training, and maintenance records; and
- Policies showing adherence to e-prescribing, iSTOP, and professional conduct rules.
New York Quick Compliance Checklist (2025)
Entity & Ownership Structure
Deliver care only through a physician-owned professional corporation (PC) or professional limited liability company (PLLC) authorized by the New York State Education Department (NYSED). Non-physician MSOs may manage space, staffing, billing, and marketing but must not exert clinical control or engage in fee-splitting, consistent with New York’s Corporate Practice of Medicine (CPOM) prohibition.
Medical Director Credentials
A New York–licensed physician (MD/DO) in good standing must oversee clinical operations. If prescribing or supervising prescribers, they must hold DEA registration and document availability for consultation and coverage in writing.
Delegation & Prescriptive Authority
Nurse Practitioners (NPs):
As of 2022, qualified NPs have Full Practice Authority (FPA), no mandatory written practice agreement — but must practice within their certification scope and comply with iSTOP (Prescription Monitoring Program) when prescribing controlled substances.
Physician Assistants (PAs):
Must practice under continuous physician supervision, which may be remote but requires documented communication, delegated duties, and prescribing authority defined in writing. Also read 10 NYCRR §94.2 – PA Supervision.
Scope of Practice Mapping
Maintain an updated scope-of-practice matrix identifying each clinical service (e.g., injectables, IV therapy, laser/IPL/RF) and specifying:
- Authorized license type
- Required supervision level
- Training prerequisites and renewal cadence
Also read NYSED Title VIII – The Professions.
Quality Assurance Trail
Document all QA activity, including chart-review logs, meeting minutes, incident reports, and device calibration records. These satisfy the professional duty to prevent unprofessional conduct under Regents Rules Part 29.
Laser / Energy Device Governance
Lasers, IPL, and other energy-based devices are considered medical when used on living tissue. Operation must occur under physician authority with written protocols, energy-setting rationale, and proof of operator training. Maintain eye-safety and emergency procedures in compliance with NYSED’s professional conduct rules. See NYSED – §29.1 General Provisions.
Marketing Guardrails
All advertising must be truthful and non-deceptive, reflecting proper titles and licensure. Prohibited: guaranteed results, misleading “medical spa” claims, or any implication of lay ownership or control over medical practice. For more information, read Education Law §6530 – Professional Misconduct
The Legal Frame: CPOM + Who Can Be a “Medical Director”?
What Is CPOM?
Who Can Be a Medical Director?
Delegation & Prescriptive Authority (NPs / PAs / RNs): The Documents that Matter
Delegation of Medical Acts
- Nurse Practitioners (NPs)
Under New York’s Full Practice Authority (FPA) granted in 2022, experienced NPs may independently evaluate, diagnose, treat, and prescribe within their certification scope. Clinic policies should still define device privileges, injectable competency, and escalation procedures for accountability and safety. See AANP – NY FPA Overview and Education Law Article 139 – Nursing.
- Physician Assistants (PAs)
PAs must work under the supervision of a licensed physician, as required by 10 NYCRR §94.2. Supervision must be continuous but not necessarily on-site, allowing flexibility in telehealth and clinic settings. The supervising physician and PA must have a written agreement defining delegated duties, prescribing authority, chart-review expectations, and real-time consultation pathways. See also Education Law Article 131-B – Physician Assistants.
- Registered Nurses (RNs) / Medical Assistants (MAs)
RNs may perform nursing and technical tasks only under medical orders or standing protocols, consistent with their licensure and scope of practice under Education Law Article 139. Unlicensed medical assistants are limited to supportive administrative functions (e.g., rooming patients, documenting vitals) and must not perform medical or nursing acts such as injections or IV placement. Delegation or supervision failures are considered unprofessional conduct under NYSED Regents Rules Part 29.
Prescribing & Monitoring
- All prescribers must use electronic prescribing (e-Rx) for all medications under New York’s Mandatory Electronic Prescribing Law, in effect since March 27, 2016, with limited exceptions (e.g., system failure, hospice).
- Prescribers must also comply with the Prescription Monitoring Program (PMP / iSTOP) to check patient controlled-substance histories before issuing or renewing any Schedule II–IV prescriptions.
- For PAs, some private or hospital settings may impose numeric supervision limits (e.g., a single physician supervising four PAs). If applicable, cite the relevant rule or policy in your clinic’s written supervision plan. See Education Law Supervision Provisions.
Required Elements in Delegation & Prescribing Documents
- Authorized and excluded drug classes / devices (e.g., GLP-1s, phentermine, lasers)
- Medication storage, chain-of-custody, and recordkeeping protocols
- Communication and consultation procedures
- QA / chart-review cadence
- Emergency procedures, including anaphylaxis kits, hyaluronidase protocols, and ocular injury algorithms
Practical Tips That Survive New York Audits
- Promise less, document more: Pick realistic chart-review numbers and meeting frequencies; keep attendance/signature logs and remediation notes.
- Roster & index: Maintain a single index of NPs/PAs/RNs with start dates, renewal dates, device privileges, and alternates.
- Competency proof: Tie each operator’s competency checklist to the protocol; record initial direct observation and annual refreshers.
- Change control: New modality (RF microneedling, PDO threads, compounded GLP-1s) = immediate protocol update, training plan, and marketing review.
iSTOP diligence & e-Rx hygiene: Document PMP queries and follow NYSDOH e-Rx exception rules.
Program-Specific Spotlight
Medspas (Injectables, Energy Devices, Skin Procedures)
- Injectables such as Botox®, dermal fillers, and biostimulators are classified as medical procedures under New York Education Law §6521. Protocols should address patient selection and contraindications, dosing parameters, lot tracking / chain-of-custody, consent forms, clinical photography, and emergency algorithms (e.g., hyaluronidase for vascular occlusion). See NYSED – Regents Rules Part 29 for documentation, delegation, and record-keeping duties.
- Lasers / IPL / RF / Other Devices are treated as medical when used on living tissue and may only be operated by licensed MDs, DOs, NPs, PAs, or RNs trained and authorized under physician-approved written protocols. Clinics must maintain device-specific training records, safety and eyewear policies, test-spot documentation, and maintenance logs, consistent with NYSED Part 29 – Professional Conduct Standards.
Telehealth (Virtual Primary Care, Psychiatry, Weight Management)
- New York law treats telehealth under a modality-neutral standard of care—the same professional expectations apply as in person.
- Practices must obtain and document patient consent, verify identity, use secure HIPAA-compliant technology, and integrate electronic prescribing (e-Rx) and Prescription Monitoring Program (PMP / iSTOP) checks for controlled substances. See NYSDOH – Medicaid Telehealth Provider Manual and Public Health Law §3309-a (PMP / iSTOP).
Psychiatry & Behavioral Health
- Nurse Practitioners (NPs) with Full Practice Authority (FPA) may independently evaluate, diagnose, and prescribe within their certification scope under AANP – NY FPA Update.
- Physician Assistants (PAs) must practice under continuous physician supervision with duties and prescribing authority defined in writing per 10 NYCRR §94.2.
For controlled medications, maintain DEA registration, iSTOP documentation, and structured follow-up protocols as required by Public Health Law §3371.
Weight Loss & Wellness (GLP-1s, Phentermine, IV Therapy)
Each clinic must maintain written protocols listing authorized agents or drug classes, baseline laboratory requirements, contraindications, titration schedules, and stop criteria.
- Controlled substances (e.g., phentermine) require PMP / iSTOP queries before prescribing and periodic rechecks, plus robust documentation and follow-up visits (preferably an initial live or video evaluation). Refer to Public Health Law §3309-a / §3371 (PMP rules).
- IV Therapy & Nutritional Infusions: Keep device and medication logs, compatibility charts, crash-cart inventories, and anaphylaxis drill records to satisfy quality-assurance obligations under NYSED Part 29 – Documentation & Standards.
The Paperwork New York Actually Asks to See
Entity & Governance
- Maintain documentation proving that clinical services are delivered through a physician-owned PC or PLLC authorized by the New York State Education Department (NYSED).
- Include shareholder attestations, operating agreements, and the MSO contract showing clear separation between business administration and clinical control (no fee-splitting or direction of medical care).
Licenses & Registrations
- Keep active MD/DO, NP, PA, and RN licenses, plus DEA registration (if prescribing controlled substances).
- All credentials should be verified through the NYSED Office of the Professions License Verification System and kept on file for audits or payer credentialing reviews.
Policies & Supervision Agreements
- Have current, signed, and accessible delegation documents (e.g., NP standardized procedures, PA practice agreements) and clinic policies covering scope of practice, communication methods, emergency response, and QA cadence. These must be made available to regulators within three business days of request, per 8 NYCRR §29.2(a)(3) (failure to cooperate = misconduct).
Delegation & Scope Matrix
Maintain an updated matrix identifying who may perform each procedure (injectables, IV therapy, devices, etc.), including required training, direct observation sign-offs, and renewal dates. This supports compliance with Education Law Title VIII (scope-of-practice framework) — see NYSED – Title VIII.
Procedure Protocols & Consents
For each procedure type (injectables, lasers/IPL/RF, IV therapy, weight management), keep protocol packets outlining:
- Indications and contraindications
- Complication algorithms
- Documentation templates and consent forms
These must meet the professional conduct standards under 8 NYCRR Part 29 – Records & Documentation.
Device Folder
Each laser, IPL, or medical device should have a dedicated compliance folder containing:
- Proof of purchase under physician order
- Training certificates and competency checklists
- Eyewear and safety policies
- Test-spot documentation and maintenance/service logs
These demonstrate proper supervision and competency as required under NYSED Part 29.
Quality Assurance (QA) Trail
- Maintain evidence of active oversight—including chart-review logs with findings and remediation, QA meeting minutes, incident reports, and staff competency audits. Failure to conduct or document such QA processes can constitute unprofessional conduct under 8 NYCRR §29.1(a)(9).
Prescribing Compliance
- Keep written e-prescribing policies and iSTOP (PMP) logs verifying that controlled-substance queries were performed prior to and during ongoing therapy.
- Document any use of exceptions (e.g., technological failure, hospice) per NYSDOH guidance. See NYSDOH – Electronic Prescribing Requirements and Public Health Law §3309-a (iSTOP).
Telesupervision & Remote QA: What “Good” Looks Like
- Access: Medical director/supervisors can promptly retrieve charts for QA/complaints.
- Cadence: Risk-tiered review percentages; higher for new injectors/high-risk services.
- Feedback loop: Document remediation tasks and re-audits to confirm improvement.
Telehealth Prescribing: Weight Loss & Controlleds
- GLP-1s: Permissible with valid relationship and monitoring at standard of care; document baseline labs and follow-ups.
- Controlleds: Consider at least one live video or in-person exam before initiation; always document iSTOP queries, rationale, and exit criteria.
Common New York Mistakes to Avoid
- Title without control: Calling someone “medical director” while an MSO dictates clinical policy violates CPOM principles.
- Stale policies: Adding PDO threads/RF microneedling/GLP-1s without updating procedures and training.
- Under-documented QA: No minutes, no chart-review logs, no remediation notes = oversight risk.
- Improper device delegation: Allowing unlicensed staff to run lasers/IPL or inject.
- Prescribing gaps: Skipping iSTOP or mishandling e-Rx exceptions.
Step-by-Step: Building a Defensible New York Setup (30/60/90 Plan)
Days 1–30: Foundation
- Confirm that all medical services are delivered through a physician-owned PC or PLLC and that the MSO agreement clearly separates business management from clinical control, consistent with New York’s Corporate Practice of Medicine (CPOM) prohibition.
- Verify that all required licenses and registrations (MD/DO, NP, PA, RN, DEA) are current and accessible. Ensure all prescribers are enrolled in e-prescribing and iSTOP (PMP) systems.
- Update and standardize governance documents: NP standardized procedures, PA supervision agreements, RN delegation policies, and written procedure and device protocols.
- Establish the Quality Assurance (QA) cadence, defining chart-review intervals, meeting schedules, and documentation expectations.
Days 31–60: QA in Motion
- Begin formal chart reviews, logging findings, remediation steps, and follow-up actions.
- Conduct mock inspections modeled after NYSED and NYSDOH audits to test compliance in documentation, delegation, device safety, and consent processes.
- Correct identified deficiencies within two weeks and record all remediation steps in the QA file to demonstrate active oversight.
- Verify that all clinical policies align with current scope-of-practice laws and professional conduct standards under Regents Rules Part 29.
Days 61–90: Harden & Scale
- Complete direct-observation competency sign-offs for injectors, device operators, and new staff; maintain training verification in personnel files.
- Implement automated renewal reminders for licenses, certifications, and delegation agreements.
- Confirm that the medical director or supervising physician can access electronic medical records remotely and produce any documentation upon regulator request.
- For any new procedure or modality (e.g., PDO threads, RF microneedling, GLP-1 therapy), prepare a training plan, revise protocols, update standardized agreements, and review marketing content for compliance before launch.
FAQs
Can a non-physician own a clinic in New York?
A management company can own the MSO, not the practice of medicine. Clinical services must be delivered by a physician-owned PC/PLLC; the MSO must not control clinical decisions.
Who can be a medical director?
A NY-licensed MD/DO in good standing who actually controls medical policies, delegation, and QA—and is available to the team.
Do New York NPs need a written practice agreement?
How are PAs supervised?
Under Education Law/10 NYCRR, supervision must be continuous (not necessarily on-site); duties must be within the physician’s scope and set in writing.
Is e-prescribing mandatory?
Yes—statewide for controlled and non-controlled medications (limited exceptions).
What is iSTOP and when is it required?
New York’s PMP; prescribers must consult it for controlled substances as required by Public Health Law.
How Medical Director Co. Fits into New York Compliance
We help you go beyond “check-the-box” compliance — ensuring your practice meets the letter and spirit of New York law.
- New York–licensed physicians: Experienced in medspas, telehealth, psychiatry, and weight-management, with full understanding of CPOM, NYSED, and iSTOP/PMP requirements.
- Turnkey frameworks: Ready-to-implement NP and PA supervision models built around New York’s rules — including NP Full Practice Authority (FPA) pathways, PA continuous supervision standards, and nursing delegation boundaries.
- Sustainable QA cadence: Risk-tiered chart reviews, structured meeting templates, and corrective-action logs that meet Regents Rules Part 29 oversight expectations.
- Device & procedural compliance: Written protocols, training ladders, safety checklists, and preventive maintenance documentation to satisfy NYSED’s supervision and recordkeeping standards.
- Structure alignment: Review and refinement of PC/PLLC and MSO agreements to preserve physician control and avoid Corporate Practice of Medicine (CPOM) conflicts.
- Regulatory monitoring: Continuous tracking of NYSED, NYSDOH, and legislative updates affecting scope, prescribing, and telehealth to keep your clinic compliant year-round.
Areas We Serve
New York Resources & References (2025)
NYSED Office of the Professions – Physicians (Licensing, Laws & Rules)
https://www.op.nysed.gov/professions/physicians
NYSED – Title VIII: The Professions (Scope & Governance Framework)
https://www.op.nysed.gov/title8/education-law
NYSED – Regents Rules Part 29 (Unprofessional Conduct & Recordkeeping)
https://www.op.nysed.gov/title8/rules-board-regents/part-29
10 NYCRR §94.2 – Physician Assistant Supervision (Continuous, Not On-Site)
https://www.law.cornell.edu/regulations/new-york/10-NYCRR-94.2
AANP – New York Grants Full Practice Authority to Nurse Practitioners (2022)
https://www.aanp.org/news-feed/state-of-new-york-grants-full-and-direct-access-to-nurse-practitioners
NYSDOH – Mandatory Electronic Prescribing (e-Rx Requirements & Exceptions)
https://www.health.ny.gov/professionals/narcotic/electronic_prescribing/
New York Public Health Law – Prescription Monitoring Program (iSTOP / PMP)
https://newyork.public.law/laws/n.y._public_health_law
NYSDOH – Medicaid Telehealth Provider Manual (Standards & Documentation)
https://www.health.ny.gov/health_care/medicaid/redesign/telehealth/docs/provider_manual.pdf
Bolton M. Harris, J.D., is a seasoned attorney with a formidable background in criminal law and a focus on healthcare law and compliance. As the in-house legal counsel at Medical Director Co., Harris brings a unique blend of prosecutorial experience and regulatory expertise to support healthcare professionals across Texas. Her career spans roles as a prosecutor in multiple counties and now as a trusted advisor on the legal intricacies of medical practice operations.
Education & Early Career
Bolton Harris completed her undergraduate studies at Southern Methodist University (SMU) in 2013. During her time at SMU, she was not only a dedicated student but also a competitive athlete on the university’s women’s swimming team. She went on to earn her Juris Doctor from Texas A&M University School of Law in 2016 and became a member of the Texas Bar that same year. Armed with a strong academic foundation and discipline honed as a student-athlete, Harris embarked on a career in criminal law immediately after law school.
Prosecutorial Experience in Texas
Bolton Harris began her legal career in public service as a criminal prosecutor. She served as an Assistant District Attorney in multiple jurisdictions, where she quickly rose through the ranks and handled a broad spectrum of cases. Some highlights of her prosecutorial career include:
- Assistant District Attorney, Dallas County, Texas: Prosecuted a high volume of criminal cases in one of the state’s busiest DA offices, gaining extensive trial experience in both misdemeanor and felony courts.
- Assistant District Attorney, Ellis County, Texas: Continued to hone her courtroom advocacy skills, known for meticulous case preparation and a tenacious pursuit of justice on behalf of the community.
- Assistant District Attorney, Navarro County, Texas: Broadened her legal expertise by handling diverse criminal matters in a smaller county, working closely with law enforcement and community leaders to uphold the law.
Through these roles, Harris built a reputation for being a tough but fair advocate. She brought numerous cases to trial and developed an in-depth understanding of the criminal justice system. This distinguished prosecutorial background laid a strong foundation for the next phase of her career in the private sector.
Healthcare Law & Compliance at Medical Director Co.
After her tenure as a prosecutor, Harris shifted her focus to healthcare law, applying her legal acumen to the medical field. She recognized that the same attention to detail and tenacity that served her in criminal law could benefit healthcare providers navigating complex regulations. Embracing this new direction, Harris became well-versed in the intricate laws governing medical practices – from licensing requirements to patient safety and privacy standards – and is passionate about helping practitioners stay compliant.
In her current role as the in-house attorney for Medical Director Co., Bolton Harris oversees all legal and compliance matters for the organization and its clients. Medical Director Co. is a nurse-owned firm that connects nurse practitioners (NPs), physician assistants (PAs), and registered nurses with qualified medical directors and collaborating physicians, offering fast placements and comprehensive compliance support for healthcare practices. Harris ensures that each of these partnerships and clinical ventures adheres to all applicable state and federal laws. She is responsible for drafting and reviewing collaborative practice agreements, advising on regulatory requirements, and providing ongoing legal counsel as clients establish and grow their clinics. Drawing on her prosecutorial eye for risk management, Harris proactively identifies potential legal issues and addresses them before they escalate, giving healthcare professionals peace of mind.
Bolton M. Harris’s multifaceted expertise – spanning high-stakes courtroom litigation to detailed healthcare compliance – makes her a formidable legal ally. Whether advocating in front of a jury or guiding a medical practice through regulatory hurdles, she remains committed to the highest standards of the legal profession. Her blend of courtroom-tested skill and healthcare law knowledge ensures that clients of Medical Director Co. receive elite-level counsel and steadfast protection in an ever-evolving legal landscape.
