Maryland Healthcare
Compliance Guide

Maryland presents a dynamic and generally favorable regulatory environment for healthcare companies, balancing patient protection with innovation. The state has actively embraced telehealth, particularly post-pandemic, codifying many emergency measures into permanent law. Key regulatory bodies include the Maryland Board of Physicians (MBP), the Maryland Board of Nursing, the Maryland Board of Pharmacy, and the Maryland Department of Health (MDH). The state's Corporate Practice of Medicine (CPOM) doctrine is present but nuanced, allowing for specific compliant structures. Recent legislative actions have focused on expanding telehealth access, ensuring payment parity, and refining prescribing rules, particularly for controlled substances. Maryland's commitment to expanding healthcare access through technology makes it an attractive market for telehealth providers, though strict adherence to professional licensure, scope of practice, and patient-provider relationship requirements is paramount. The general business climate is supportive, but companies must navigate a complex web of state-specific regulations that govern everything from ownership structures to prescribing protocols and data privacy. Companies expanding into Maryland must prioritize a thorough understanding of these state-specific nuances to ensure operational compliance and mitigate legal risks. The state's participation in various interstate compacts further streamlines multi-state practice for certain professions, indicating a forward-thinking approach to healthcare delivery.

Maryland maintains a Corporate Practice of Medicine (CPOM) doctrine, though it is not as strictly enforced as in some other states. The legal basis for Maryland's CPOM stems primarily from common law principles and statutory provisions that prohibit the unlicensed practice of medicine and uphold the professional independence of licensed practitioners. Specifically, Maryland Code, Health Occupations Article, Title 14, governs the practice of medicine and prohibits individuals from practicing medicine without a license. While there isn't a single definitive statute explicitly stating 'no corporate practice of medicine,' the regulatory framework implies that only licensed medical professionals or entities controlled by them can provide medical services. Consequently, a general business corporation cannot directly employ physicians or other licensed healthcare providers to deliver medical services, as this would constitute the unlicensed practice of medicine by the corporation. This principle extends to dental practices (Maryland Code, Health Occupations Article, Title 4) and other licensed professions.

Ownership Structures Permitted:

• Professional Corporations (P.C.) or Professional Limited Liability Companies (P.L.L.C.): These entities are specifically designed for licensed professionals to practice their profession. Ownership of a P.C. or P.L.L.C. that provides medical services must be held exclusively by licensed healthcare professionals (e.g., physicians, dentists, optometrists) who are licensed to practice in Maryland. Maryland Code, Corporations and Associations Article, Title 5, Subtitle 1, governs professional service corporations.
• Non-Physician Ownership: Generally, non-physicians cannot own entities that directly provide medical services. However, non-physicians can own Management Services Organizations (MSOs) that provide administrative and non-clinical support to professional medical practices. This MSO-PC structure is a common compliant model in Maryland.

Specific Restrictions and Impact:

• Employment of Physicians: A lay entity cannot employ physicians to provide medical services. Physicians must generally be employed by or be owners of a professional entity.
• Fee-Splitting: Maryland prohibits fee-splitting, where a professional shares fees with an unlicensed person or entity for patient referrals or services not rendered. This is codified in regulations such as COMAR 10.32.01.08 for physicians. This impacts how MSO-PC arrangements are structured, requiring fair market value for MSO services.
• Control over Clinical Decisions: Non-licensed entities or individuals cannot exert control over the clinical judgment or treatment decisions of licensed professionals. This is a core tenet of maintaining professional independence.

Impact on Specific Businesses:

• Telehealth Companies: Must utilize an MSO-PC model where the professional entity (PC) employs the licensed providers and delivers the clinical services, while the MSO handles administrative, technological, and marketing functions.
• Medspas: If medical procedures (e.g., injectables, laser treatments) are performed, the medical component must be owned and operated by a licensed physician or professional entity. Non-physicians can own the spa portion, but not the medical practice itself.
• Dental Practices: Must be owned by licensed dentists, typically structured as a professional entity.
• Wellness Clinics: If any services constitute the practice of medicine (e.g., IV therapy, hormone therapy, GLP-1 prescribing), the medical component must adhere to CPOM requirements, necessitating a professional entity owned by licensed practitioners.

Maryland has a robust framework for telehealth, largely codified following the COVID-19 public health emergency. The state defines telehealth broadly to include the use of electronic information and communication technologies to provide health care services when the patient and health care practitioner are in different locations. This includes services provided by physicians, nurses, physician assistants, and various other licensed professionals.

Establishment of Patient-Provider Relationship: Maryland law explicitly permits the establishment of a patient-provider relationship via telehealth. A prior in-person examination is generally not required to establish this relationship, provided the healthcare practitioner meets the same standard of care as if the service were provided in person. The practitioner must conduct an appropriate examination and evaluation sufficient to diagnose and treat the patient's condition. (Maryland Code, Health-General Article, § 15-101(m) and § 15-101.2).

Permitted Modalities: Maryland law is inclusive regarding telehealth modalities:

• Video Conferencing: Real-time, interactive audio-visual communication is explicitly permitted and is often preferred or required for initial consultations and complex diagnoses.
• Audio-Only Telehealth: Maryland allows for audio-only telehealth, particularly for behavioral health services, follow-up care, and when video is not available or appropriate. Reimbursement parity extends to audio-only services under certain conditions (Maryland Code, Health-General Article, § 15-101.2).
• Asynchronous (Store-and-Forward): This modality, involving the transmission of medical information (e.g., images, pre-recorded video, data) for review by a practitioner at a later time, is also permitted. However, it must be used in a manner that ensures appropriate diagnosis and treatment, and may not be sufficient for establishing an initial patient-provider relationship for all conditions.

Telehealth Registration Requirements: Maryland does not impose a separate 'telehealth registration' requirement for practitioners already licensed in the state. However, out-of-state practitioners wishing to provide telehealth services to Maryland residents must be licensed in Maryland or practice under a recognized interstate compact. For physicians, Maryland is a member of the Interstate Medical Licensure Compact (IMLC), facilitating expedited licensure for eligible physicians. Other professions may have similar compacts or specific reciprocity agreements.

Informed Consent Requirements: Informed consent for telehealth services is mandatory. Practitioners must obtain verbal or written consent from the patient (or their legal guardian) before initiating telehealth services. This consent must include: (1) a description of the telehealth services, (2) the risks and benefits of telehealth, (3) confidentiality protections, (4) patient rights to withdraw consent, and (5) emergency protocols. Documentation of informed consent is crucial (COMAR 10.32.01.07).

Geographic Restrictions: There are no specific geographic restrictions within Maryland for telehealth services, meaning a licensed practitioner can provide telehealth services to any patient located within the state. However, the practitioner must be physically located in a state where they are licensed to practice, and the patient must be in Maryland. Cross-state telehealth requires the practitioner to be licensed in both the originating and distant sites or operate under a compact.

Maryland's prescribing rules for telehealth, particularly concerning controlled substances, are stringent and align with federal guidelines while incorporating state-specific nuances. The overarching principle is that the standard of care for prescribing via telehealth must be equivalent to in-person care.

Controlled Substances via Telehealth:

• Schedules II-V: Maryland generally permits the prescribing of Schedule II-V controlled substances via telehealth, provided a legitimate patient-provider relationship has been established and an appropriate medical evaluation has been conducted. This aligns with federal DEA guidance, which, after the COVID-19 PHE, continues to allow for certain telehealth prescribing flexibilities. However, the DEA's proposed rules for prescribing controlled substances via telehealth without an in-person exam are still under review. As of 2025-2026, practitioners should monitor DEA's final rules. Until then, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires an in-person medical evaluation prior to prescribing controlled substances via the internet, with exceptions for public health emergencies or specific DEA waivers. Maryland's law (Maryland Code, Health Occupations Article, § 14-404) emphasizes that a physician must conduct a physical examination or a medical history and physical examination sufficient to meet the standard of care.
• Specific DEA Requirements: Practitioners must be registered with the DEA and hold a Maryland Controlled Dangerous Substance (CDS) registration. All prescriptions, including those issued via telehealth, must comply with DEA record-keeping requirements.

PDMP Checking (Prescription Drug Monitoring Program):

• Mandatory Use: Maryland law mandates that prescribers check the state's Prescription Drug Monitoring Program (PDMP) database before prescribing an opioid or benzodiazepine to a patient for the first time, and at least every 90 days thereafter for ongoing prescriptions. This requirement applies equally to telehealth encounters. (Maryland Code, Health-General Article, § 21-2A-04). Failure to comply can result in disciplinary action.

Quantity or Refill Limitations:

• Opioids: Maryland has specific limitations on initial opioid prescriptions for acute pain, generally restricting them to a 7-day supply for adults and 5-day supply for minors, with exceptions for chronic pain, cancer treatment, or palliative care (COMAR 10.32.08).
• Other Controlled Substances: While there are no blanket quantity limits for all controlled substances beyond the opioid rules, practitioners must exercise sound clinical judgment. Refills for Schedule II substances are generally prohibited, while Schedule III-V substances may have up to 5 refills within 6 months. These rules apply to telehealth prescribing.

Special Rules for Specific Drug Classes:

• GLP-1s (e.g., Ozempic, Wegovy): While not controlled substances, prescribing GLP-1 agonists requires a thorough medical evaluation, diagnosis of appropriate conditions (e.g., Type 2 Diabetes, obesity), and ongoing patient monitoring. Telehealth providers must ensure they meet the standard of care for these complex medications.
• Testosterone/Hormone Therapy: Prescribing testosterone or other hormone replacement therapies via telehealth requires a comprehensive evaluation, including lab work, and careful monitoring for side effects. Maryland's Board of Physicians emphasizes the need for a legitimate patient-provider relationship and appropriate diagnostic testing.
• Stimulants (e.g., Adderall, Ritalin): Prescribing Schedule II stimulants for ADHD or narcolepsy via telehealth is permissible but subject to heightened scrutiny. An initial in-person evaluation may be strongly recommended by some boards, or required under the Ryan Haight Act unless specific exceptions apply. Careful documentation of diagnosis, treatment plan, and ongoing monitoring is essential. Practitioners should be aware of the DEA's evolving stance on telehealth prescribing for Schedule II substances.

Maryland's scope of practice laws define the services that various licensed healthcare professionals can legally perform. Understanding these boundaries is critical for compliant operations, especially in multi-disciplinary or telehealth settings.

Nurse Practitioners (NPs):

• Full Practice Authority: Maryland grants Nurse Practitioners (NPs) full practice authority, meaning they can practice independently without physician supervision or collaborative practice agreements after meeting specific experience requirements. Specifically, a Certified Registered Nurse Practitioner (CRNP) who has completed 18 months or 2,000 hours of clinical practice under the supervision of a physician or experienced CRNP can apply for independent practice. (Maryland Code, Health Occupations Article, § 8-302 and COMAR 10.27.07.03).
• Prescriptive Authority: NPs with independent practice authority can prescribe medications, including controlled dangerous substances (CDS), within their scope of practice and specialty, provided they have a valid Maryland CDS registration and DEA registration. They must adhere to the same prescribing standards as physicians.

Physician Assistants (PAs):

• Collaborative Practice: PAs in Maryland practice under the supervision of a licensed physician. While the term 'supervision' has evolved to be less direct than in the past, a PA must have a written delegation agreement with a supervising physician. This agreement outlines the specific medical acts the PA is authorized to perform, which must be within the PA's education, training, and experience, and within the supervising physician's scope of practice. (Maryland Code, Health Occupations Article, § 15-302 and COMAR 10.32.06).
• Prescriptive Authority: PAs can prescribe medications, including controlled substances, as delegated by their supervising physician and within their scope of practice, provided they hold a Maryland CDS registration and DEA registration. The supervising physician remains ultimately responsible for the PA's actions.

Delegation Rules for Medical Assistants (MAs) in Medspas:

• Limited Scope: Medical Assistants (MAs) in Maryland have a limited scope of practice focused on administrative and basic clinical tasks that do not require independent medical judgment. They cannot diagnose, prescribe, or perform invasive procedures. In medspas, MAs can assist licensed practitioners (physicians, NPs, PAs, RNs) with non-invasive tasks, but they cannot independently perform procedures such as injections (e.g., Botox, fillers), laser treatments, or advanced skin care that constitute the practice of medicine or nursing. These procedures must be performed by or directly supervised by a licensed professional. (Maryland Code, Health Occupations Article, Title 14 for physicians, and Title 8 for nurses).
• Supervision Requirements: Any task delegated to an MA must be within the delegating practitioner's scope of practice, and the MA must be trained and competent to perform it. Direct supervision by a licensed professional is typically required for any hands-on patient care in a medspa setting, especially for procedures involving medical devices or medications.

Other Mid-Level Providers: Maryland also defines scopes of practice for other professionals like Certified Nurse Midwives (CNMs), Certified Registered Nurse Anesthetists (CRNAs), and various therapists, each with specific regulations governing their practice and supervision requirements.

Navigating Maryland's Corporate Practice of Medicine (CPOM) doctrine necessitates careful business structuring, with the Professional Corporation-Management Services Organization (PC-MSO) model being the most common compliant approach for many healthcare companies.

PC-MSO Structures – When are they needed?

• The PC-MSO model is essential whenever a non-licensed individual or entity (the MSO) wishes to own or control the non-clinical aspects of a healthcare business that provides services constituting the practice of medicine, dentistry, or other licensed professions. This structure allows the MSO to provide administrative, marketing, IT, billing, and facility management services to a professional entity (PC) that is owned by licensed practitioners and directly employs or contracts with the clinical staff.
• Professional Corporation (PC) Requirements: In Maryland, a professional service corporation (or PLLC) must be formed under the Maryland Corporations and Associations Article, Title 5, Subtitle 1. The shareholders/members must be licensed professionals in the specific field for which the corporation is organized (e.g., physicians for a medical PC). The PC is the entity that directly employs or contracts with the licensed providers and delivers the clinical services. Its name must typically indicate its professional nature (e.g., 'P.C.' or 'P.A.').

Fee-Splitting Rules:

• Maryland has strict prohibitions against fee-splitting, which generally means a licensed professional cannot share professional fees with an unlicensed person or entity for patient referrals or services not rendered. This is codified in regulations such as COMAR 10.32.01.08 for physicians, which states a physician may not 'divide a fee for professional services with another person who is not a physician.' This rule is critical in MSO-PC arrangements.
• Compliance: To avoid illegal fee-splitting, the MSO's compensation from the PC must be for legitimate, fair market value (FMV) administrative and management services, not based on a percentage of professional fees or patient referrals. The MSO's compensation should be fixed, or based on a reasonable cost-plus model, or a percentage of gross revenues that is demonstrably FMV for the services provided and not tied to the volume or value of referrals.

Management Services Agreement (MSA) Requirements:

• The relationship between the MSO and the PC is governed by a comprehensive Management Services Agreement (MSA). This agreement is crucial for delineating responsibilities and ensuring compliance with CPOM and anti-kickback laws.
• Key MSA Provisions: The MSA must clearly define:
  • The specific administrative and non-clinical services provided by the MSO (e.g., billing, scheduling, marketing, IT, real estate, equipment leasing).
  • The compensation structure for the MSO, which must be at fair market value and not tied to referrals or the volume of professional services.
  • That the PC retains sole control over all clinical decisions, hiring/firing of clinical staff, and patient care.
  • Term and termination clauses.
  • Compliance with all applicable federal and state laws.

How to Structure Ownership for Compliance:

• MSO Ownership: The MSO can be owned by non-licensed individuals or entities, as it provides non-clinical services.
• PC Ownership: The PC must be owned exclusively by licensed professionals (e.g., physicians) who are licensed in Maryland. These professionals act as the clinical decision-makers and hold the ultimate responsibility for patient care.
• Separation of Control: A clear separation must exist between the MSO's administrative control and the PC's clinical control. The MSO cannot dictate clinical protocols, treatment plans, or interfere with the independent medical judgment of the PC's providers.
• Telehealth Considerations: For telehealth companies, the MSO typically provides the technology platform, marketing, and administrative support, while the PC employs the licensed telehealth providers who conduct the virtual consultations and prescribe medications.

Maryland continues to be an active legislative and regulatory environment for healthcare, with several key developments and ongoing discussions impacting telehealth, CPOM, and prescribing practices in 2024-2026.

Legislative Actions (2024-2026):

• Telehealth Reimbursement Parity: Maryland has largely codified telehealth reimbursement parity into law (Maryland Code, Health-General Article, § 15-101.2), ensuring that health insurers provide coverage for services delivered via telehealth at the same rate as in-person services. While the core principle is established, ongoing legislative efforts often refine the specifics, such as extending certain temporary provisions or clarifying what constitutes an 'equivalent' service for reimbursement purposes. Expect continued monitoring of these parity laws for any sunset clauses or adjustments.
• Interstate Compacts: Maryland is a member of the Interstate Medical Licensure Compact (IMLC), facilitating multi-state practice for eligible physicians. The state is also a member of the Nurse Licensure Compact (NLC). There are ongoing discussions and legislative efforts to join other compacts, such as the Physical Therapy Compact or the Psychology Interjurisdictional Compact (PSYPACT), which would further streamline cross-state practice for these professions. Companies should monitor the status of Maryland's participation in these compacts.
• Controlled Substance Prescribing: While the federal DEA's proposed rules for telehealth prescribing of controlled substances without an initial in-person exam are still pending, Maryland's legislature and regulatory bodies are closely watching these developments. State laws may be adjusted to align with or supplement federal guidance once finalized. There's a continuous focus on combating the opioid crisis, which may lead to further refinements in PDMP utilization or prescribing limits.
• Mental Health Access: There's a strong legislative push to expand access to mental and behavioral health services, often leveraging telehealth. This includes initiatives to increase provider reimbursement, simplify licensing for out-of-state practitioners in certain circumstances, and enhance crisis intervention services via virtual platforms.

Board Actions or Enforcement Cases:

• The Maryland Board of Physicians and Board of Nursing regularly issue guidance and take enforcement actions related to unprofessional conduct, including improper prescribing practices, inadequate supervision, and violations of telehealth standards of care. Recent cases often highlight the importance of proper patient evaluation, documentation, and adherence to the Ryan Haight Act for controlled substances. Companies should regularly review board newsletters and disciplinary actions for insights into enforcement priorities.
• There has been increased scrutiny on 'medspa' operations, particularly concerning the delegation of medical procedures to unlicensed personnel and adherence to CPOM principles. The Boards emphasize that procedures constituting the practice of medicine must be performed by or under the direct supervision of licensed professionals.

Future Trends:

• Expect continued emphasis on data privacy and security in telehealth, potentially leading to new regulations aligning with federal standards or unique state requirements.
• The integration of AI into healthcare delivery is a nascent but growing area, and Maryland's regulators will likely begin to address its implications for diagnosis, treatment, and provider liability.

Entering the Maryland healthcare market requires a methodical approach to ensure full compliance. Here's actionable guidance for companies:

Step-by-Step Compliance Checklist:

1. Entity Formation & CPOM Compliance:
   • If providing clinical services, form a Maryland Professional Corporation (P.C.) or Professional Limited Liability Company (P.L.L.C.) owned by licensed Maryland practitioners.
   • If a non-licensed entity, form a Maryland Management Services Organization (MSO) to provide administrative services to the P.C./P.L.L.C.
   • Draft a comprehensive Management Services Agreement (MSA) ensuring fair market value compensation for the MSO and clear delineation of clinical vs. administrative control.
2. Licensure:
   • Ensure all healthcare professionals (physicians, NPs, PAs, etc.) are individually licensed by their respective Maryland boards. For physicians, explore the Interstate Medical Licensure Compact (IMLC) for expedited licensure if applicable.
   • Verify any additional state-specific registrations (e.g., Maryland CDS registration for controlled substance prescribers).
3. Telehealth Protocols:
   • Develop clear policies and procedures for establishing a patient-provider relationship via telehealth, including informed consent, patient identification, and emergency protocols.
   • Ensure technology platforms are HIPAA-compliant and secure.
4. Prescribing Compliance:
   • Implement protocols for mandatory PDMP checks for opioids and benzodiazepines.
   • Ensure adherence to Maryland's specific prescribing limits for opioids and federal DEA requirements for controlled substances, especially regarding initial in-person exams for Schedule IIs (monitor DEA's final telehealth rules).
   • Train providers on appropriate documentation for all prescriptions, particularly for complex drug classes like GLP-1s and stimulants.
5. Scope of Practice:
   • Clearly define the roles and responsibilities of all clinical staff (NPs, PAs, MAs) based on Maryland's scope of practice laws.
   • Establish formal supervision or delegation agreements where required (e.g., for PAs).
   • Ensure non-licensed staff (e.g., MAs in medspas) do not perform medical procedures.

Common Pitfalls to Avoid:

• Ignoring CPOM: Operating as a general business corporation directly employing physicians without a compliant MSO-PC structure.
• Illegal Fee-Splitting: Structuring MSO fees as a percentage of professional revenue or based on referrals rather than fair market value for services rendered.
• Inadequate Patient Evaluation: Prescribing medications, especially controlled substances, without a thorough medical history, appropriate examination (virtual or in-person), and diagnostic work-up.
• Lack of Informed Consent: Failing to obtain and document proper informed consent for telehealth services.
• Non-Compliance with PDMP: Not checking the Maryland PDMP database as required.
• Improper Delegation: Allowing unlicensed staff to perform tasks outside their legal scope of practice, particularly in medspas or wellness clinics.

Timeline Expectations for Licensing and Setup:

• Entity Formation: 2-4 weeks (including state filings and obtaining EIN).
• Professional Licensure: 2-6 months for individual practitioners, depending on the board and completeness of application (IMLC may expedite physician licensure).
• DEA/CDS Registration: 4-8 weeks after state licensure.
• Policy & Procedure Development: Ongoing, but initial drafts 1-2 months.
• Technology & Platform Setup: Varies widely, but 1-3 months for integration and security audits.
• Overall Launch: Expect a minimum of 4-6 months for full compliance readiness from initial planning.