Disclaimer: This material is provided for educational and informational purposes only. It does not constitute legal or medical advice or regulatory guidance. Requirements and interpretations may vary and change over time. Always verify current rules directly with the Pennsylvania Department of State (BPOA), the State Board of Medicine, the State Board of Osteopathic Medicine, and the Pennsylvania Department of Health, and seek advice from qualified legal counsel before making decisions or taking action.
Executive Summary
- Pennsylvania does not have a single CPOM statute; compliance is enforced through unlicensed practice prohibitions and physician unprofessional conduct rules.
- A Pennsylvania-licensed MD or DO must retain actual control over medical decision-making, delegation, supervision, and quality assurance.
- CRNPs and PAs require written agreements (CRNP collaborative agreements filed in PALS; PA supervising agreements maintained and available upon request).
- Delegation must be documented, including scope-of-practice matrices, physician-signed protocols, and competency validation for delegated medical acts.
- Quality assurance must be real and documented, including chart reviews, QA meetings, incident logs, and corrective actions.
- Medspa, telehealth, psychiatry, and weight-loss services are permitted when delivered within licensure, supervision, and standard-of-care requirements.
- Controlled substances require DEA registration and PDMP checks; telemedicine is allowed but held to in-person standards of care.
- Marketing and advertising must be accurate and non-misleading, with titles and claims aligned to actual licensure and supervision.
- Investigators routinely request governance documents, agreements, protocols, QA records, and marketing materials to assess compliance.
- A structured 30/60/90 implementation plan helps clinics establish, document, and sustain a defensible Pennsylvania compliance posture.
Quick Compliance Checklist
Structure & Ownership
- Physicians retain control of medical decision-making, including diagnosis, treatment plans, prescribing, and clinical protocols.
- Management Services Organization (MSO) agreements must not grant lay entities control over clinical judgment, physician hiring/firing, or medical policies.
- Structure complies with Pennsylvania’s prohibition on unlicensed practice of medicine and unprofessional conduct rules.
Supervision & Collaboration Records
- CRNP collaborative agreements are properly filed and current in PALS.
- PA supervising physician agreements are executed, current, and reflect actual clinical duties.
- Agreements are updated promptly when:
- Scope of services changes
- Practice locations change
- Supervising/collaborating physician changes
Licenses & Credentials
- Active, unencumbered Pennsylvania MD or DO license for the medical director.
- Current Pennsylvania licenses for:
- CRNPs
- Physician Assistants
- RNs and LPNs (if applicable)
- DEA registration for any clinician prescribing controlled substances.
- Pennsylvania PDMP registration for prescribers and required delegates.
Professional Liability Coverage
- Maintain malpractice insurance for:
- Medical director
- CRNPs and PAs
- Other licensed clinical staff as required by contracts or payors
- Coverage limits are appropriate for services provided (e.g., injectables, weight loss prescribing, IV therapy).
Delegation & Clinical Protocols
- Written scope-of-practice matrix identifying which licensed personnel may perform specific services, including:
- Injectable treatments
- Laser, IPL, or other energy-based device procedures
- Radiofrequency or ultrasound treatments
- IV therapy
- Diagnostic testing or laboratory-related tasks
This documentation is used to demonstrate appropriate supervision and to prevent unlicensed practice.
- Physician-signed clinical protocols for each delegated modality, addressing:
- Patient selection criteria
- Contraindications and exclusion factors
- Adverse-event recognition and response
- Escalation and referral procedures
- Competency and training documentation, including:
- Initial and ongoing competency checklists
- Sign-off by the supervising physician or qualified designee
- Records for each staff member performing delegated medical acts
These materials are commonly requested by Pennsylvania regulators to evaluate supervision, delegation, and compliance with professional standards.
Collaborative & Supervisory Agreements
- CRNP Collaborative Agreement
- Filed through PALS
- Defines scope, prescribing authority, consultation, referral, and chart review
- Updated when duties, drugs, or practice sites change
- PA Supervising Agreement
- Covers delegated medical acts
- Defines prescriptive authority
- Specifies chart review and physician availability
- Agreements are readily available to the State Board of Medicine or Osteopathic Medicine upon request.
Collaborative & Supervisory Agreements
- Chart-review logs showing:
- Required frequency
- Reviewing physician
- Findings and follow-up actions
- QA meeting minutes (monthly or quarterly, based on clinic policy).
- Incident and adverse-event logs with documented corrective actions.
- Device maintenance records and staff safety training logs.
Board expectation:
- QA must be documented, not just described.
Marketing & Advertising
- Titles and credentials accurately reflect licensure (no “doctor” references for non-physicians).
- No claims implying unlicensed individuals perform medical procedures.
- Weight-loss and aesthetic claims are:
- Truthful
- Substantiated
- Not misleading
- Advertising complies with Pennsylvania’s Unfair Trade Practices and Consumer Protection Law.
The Legal Frame: CPOM + Who Can Be a “Medical Director”?
Corporate Practice of Medicine in Pennsylvania
Who Can Be a Medical Director in Pennsylvania?
Delegation & Prescriptive Authority (CRNPs & PAs): The Documents That Matter
Regulations:
49 Pa. Code §§ 21.285–21.287
Requirements:
- Written collaborative agreement with a Pennsylvania-licensed physician.
- Agreement must define scope of practice, prescriptive authority, consultation and referral requirements, and quality assurance/chart review processes.
- Collaborative agreement must be filed and kept current in PALS.
- Schedule II prescribing is permitted, but is subject to statutory limits, including quantity restrictions and clinical justification requirements under the Controlled Substance Act and Board guidance.
Regulations:
49 Pa. Code §§ 18.141–18.148
Requirements:
- Written supervising physician agreement.
- Agreement must specify delegated medical tasks, prescriptive authority, supervision method, and chart review requirements.
- Supervising agreement must be available to the State Board of Medicine upon request.
- Remote or alternate-site supervision is permitted if expressly described in the agreement and supervision remains meaningful.
Regulations:
Professional Nursing Law – 63 P.S. § 211
- RNs and LPNs may perform tasks within their licensed scope of practice and pursuant to physician or CRNP orders.
- Injectables, lasers, and energy-based devices are considered medical acts, requiring appropriate training, written protocols, and physician or CRNP supervision.
- Tasks may not be delegated if they constitute independent medical judgment beyond nursing scope.
Program-Specific Spotlight
Injectables
- Injectable treatments (e.g., neuromodulators and dermal fillers) are considered medical procedures under Pennsylvania law.
- Procedures may be performed only by licensed clinicians (MD/DO, CRNP, PA, RN/LPN acting under proper orders).
- Services must be provided under physician or CRNP oversight.
- Written protocols should address:
- Patient selection and contraindications
- Dosing parameters
- Adverse-event management
- Clinical documentation requirements
Lasers, IPL, RF, Microneedling
- Pennsylvania does not license or register laser technicians as a separate profession.
- Use of lasers, IPL, radiofrequency, ultrasound, and medical microneedling is treated as a medical act.
- Device use requires:
- A physician or CRNP order
- Written, device-specific clinical protocols
- Training and documented competency validation
- Appropriate supervision, based on the licensure of the operator
- Telemedicine in Pennsylvania is governed by professional licensure statutes, Board guidance, and the applicable standard of care, rather than a single telehealth statute.
- Telehealth requirements include:
- Establishment of a valid practitioner–patient relationship
- An adequate clinical evaluation (synchronous video when clinically necessary)
- Documentation equivalent to in-person care
- Pennsylvania licensure for the treating clinician
- Prescribing GLP-1 medications or phentermine must fall within the scope authorized by:
- The CRNP collaborative agreement, or
- The PA supervising agreement.
- Phentermine prescribing requires:
- PDMP review
- Appropriate clinical justification
- Best-practice documentation includes:
- Baseline assessments and labs (when clinically indicated)
- Defined follow-up intervals
- Emergency and adverse-event response plans
- IV therapy requires:
- Physician or CRNP oversight
- Written nursing protocols
- Competency validation
- Emergency preparedness (e.g., anaphylaxis response)
The Paperwork Pennsylvania Investigators Actually Request
- Physician entity and governance documents, including professional entity formation records and any management services organization (MSO) agreement, to evaluate compliance with the Medical Practice Act of 1985 and to identify potential unlicensed practice or improper control of medical decision-making
(Medical Practice Act of 1985, 63 P.S. § 422.41) - Proof of active licensure for all clinical staff (MD/DO, CRNP, PA, RN, LPN), and DEA registration where controlled substances are prescribed, as required for lawful practice and prescribing authority
(63 P.S. § 422.41; 49 Pa. Code § 16.61; 35 P.S. § 780-101 et seq.) - CRNP collaborative agreements, properly executed and filed in the Pennsylvania Licensing System (PALS), documenting scope of practice, prescriptive authority, consultation requirements, and quality assurance obligations
(49 Pa. Code §§ 21.285–21.287) - PA supervising physician agreements, specifying delegated medical tasks, supervision methods, and chart-review requirements, and maintained for Board review upon request
(49 Pa. Code §§ 18.141–18.148) - Delegation protocols and procedure-specific clinical policies (e.g., injectables, energy-based devices, IV therapy), demonstrating appropriate supervision and avoidance of unlicensed practice
(63 P.S. § 422.41; 49 Pa. Code § 16.61) - Competency checklists and training records documenting initial and ongoing proficiency for staff performing delegated medical acts, used to evidence adequate supervision and patient safety
(49 Pa. Code § 16.61) - Quality assurance documentation, including chart-review logs, QA meeting records, incident reports, and corrective action documentation, demonstrating ongoing oversight and compliance with professional standards
(49 Pa. Code § 16.61) - Marketing and advertising materials, reviewed for accurate use of professional titles and avoidance of misleading or deceptive claims, consistent with Pennsylvania consumer protection and unlicensed practice laws
(Pennsylvania Unfair Trade Practices and Consumer Protection Law, 73 P.S. § 201-1 et seq.; 63 P.S. § 422.41)
Avoid These Common Pennsylvania Mistakes
- Treating “medical director” as a ceremonial title rather than a role with actual authority over clinical policies, delegation, supervision, and quality assurance, which may expose physicians to unprofessional conduct findings.
- Using outdated, incomplete, or inaccurate CRNP collaborative agreements or PA supervising agreements, including failure to update scope, locations, or prescriptive authority in PALS or internal records.
- Allowing untrained or improperly supervised staff to perform medical or cosmetic procedures, which may constitute unlicensed practice or improper delegation under Pennsylvania law.
- Promising chart-review or quality-assurance cadence in agreements or policies but failing to maintain documentation, creating exposure during Board investigations or complaints.
- Using marketing or advertising language that implies unlicensed, independent, or unsupervised practice, including inaccurate titles or claims inconsistent with actual supervision and delegation.
Step-by-Step: Building a Defensible Pennsylvania Setup (30/60/90 Plan)
Days 1–30: Foundation
- Confirm physician clinical control over medical decision-making and review the MSO contract to ensure it does not grant lay control over diagnosis, treatment, prescribing, or medical records.
- Update, execute, or file CRNP collaborative agreements and PA supervising agreements, ensuring scope, locations, prescriptive authority, and QA obligations are current (and filed in PALS where applicable).
- Build or revise delegation protocols and procedure-specific policies for injectables, energy-based devices, IV therapy, and other delegated medical acts.
- Complete a license and credential inventory for all clinicians (MD/DO, CRNP, PA, RN, LPN) and verify DEA registration where controlled substances are prescribed.
Days 31–60: Quality Assurance in Motion
- Begin the chart-review and QA cadence described in collaborative/supervisory agreements and internal policies.
- Hold and document the first QA meeting, including minutes, findings, and any corrective actions.
- Conduct a mock inspection using Pennsylvania Board enforcement expectations (supervision, delegation, unlicensed practice risk).
- Review and update marketing and advertising content to ensure accurate titles, supervision disclosures, and non-misleading claims.
Days 61–90: Harden & Scale
- Complete competency validation and sign-offs for injectors and device operators, with documentation retained for inspection.
- Ensure secure access to medical records for supervising physicians to perform chart review (including remote access where used).
- Implement a formal new-modality launch process, requiring training, updated agreements/protocols, competency validation, and marketing review before services go live.
FAQs
Can a nonphysician own a clinic or medspa in Pennsylvania?
Who can be a medical director?
Do CRNPs and PAs require written agreements?
Yes. CRNPs must have written collaborative agreements that are kept current and filed in PALS. PAs must have written supervising physician agreements specifying delegated tasks, supervision, and chart review.
Can RNs perform injectables or laser procedures?
Is telemedicine permitted for weight-loss medications?
Are laser technicians licensed in Pennsylvania?
How Medical Director Co. Fits into Pennsylvania Compliance
Medical Director Co. helps Pennsylvania clinics do more than “check boxes.” We provide practical, defensible compliance support aligned with Pennsylvania Board enforcement standards, including:
- Pennsylvania-licensed MDs and DOs experienced in outpatient models such as medspas, telehealth, psychiatry, weight loss, and wellness clinics.
- CRNP collaborative agreements and PA supervising agreements, drafted and reviewed to reflect Pennsylvania scope, prescriptive authority, QA expectations, and PALS filing requirements.
- Quality assurance systems you can sustain, including chart-review cadence guidance, QA meeting templates, documentation workflows, and audit-ready records aligned with Board expectations.
- Delegation and clinical protocol development, including injectables, energy-based devices, IV therapy, and other delegated medical acts, with physician oversight and competency validation.
- MSO and governance alignment, ensuring business arrangements do not create unlicensed practice risk or improper control over medical decision-making under Pennsylvania law.
- Telemedicine compliance guidance, including practitioner–patient relationship standards, documentation expectations, and controlled-substance safeguards such as PDMP integration.
- Regulatory monitoring and updates, tracking Pennsylvania Board guidance, enforcement trends, and statutory changes so your agreements, protocols, and policies stay current before issues arise.
Find a Licensed Pennsylvania Medical Director for Your Clinic Today
Medical Director Co. connects you with experienced, Pennsylvania-licensed physicians who provide real clinical oversight—not just a name on paper.
Areas we serve:
Pennsylvania Resources & References
Pennsylvania Statues: https://codes.findlaw.com/pa/title-63-ps-professions-and-occupations-state-licensed/pa-st-sect-63-422-41/
Pennsylvania Code and Bulletin: https://www.pacodeandbulletin.gov
Pennsylvania Licensing System (PALS): https://www.pals.pa.gov
Pennsylvania Prescription Drug Monitoring Program (PDMP): https://www.pa.gov/agencies/health/healthcare-and-public-health-professionals/pdmp
DEA Diversion Control Division (Controlled Substances): https://www.deadiversion.usdoj.gov
Pennsylvania Unfair Trade Practices & Consumer Protection Law
https://www.attorneygeneral.gov/wp-content/uploads/2018/02/Unfair_Trade_Practices_Consumer_Protection_Law.pdf
Pennsylvania Telemedicine Guidance (Board Policies): https://www.dos.pa.gov/ProfessionalLicensing/BoardsCommissions/Medicine/Pages/Telemedicine.aspx
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.
