(1) What Is the Difference Between Coaching and Therapy?

Psychotherapy and other licensed clinical mental health services are regulated services.  In Florida, for example, psychotherapy may be provided by a licensed clinical social worker, licensed mental health counselor, licensed marriage and family therapist, or a licensed physician or physician assistant operating within their authorized scope of practice.  These services are governed by professional licensing statutes, including Chapter 491 and Chapter 458 of the Florida Statutes.  Licensed providers are subject to board oversight, scope of practice limitations, and professional discipline.

Coaching, by contrast, is not a licensed profession in Florida or most other states.  There is no state licensing board for coaches, no regulated scope of practice, and no statutory definition of “coaching” as a health care service.  Coaching is generally understood to be a forward-focused, goal-oriented relationship that supports a client’s personal or professional development—without diagnosing, treating, or managing mental health conditions.  The International Coaching Federation and similar bodies offer voluntary credentials, but these are not state-issued licenses and do not carry the legal weight of a professional license.  When an individual is a licensed practitioner and wishes to also provide coaching, it is very important to discuss the risks of doing so with counsel before providing coaching.  Patients may not appreciate the distinction, which can pose compliance concerns with the practitioner.

(2) Why the Distinction Matters Legally

When a licensed mental health provider also offers coaching, two legal risks emerge if the services are not clearly distinguished.

First, there is a risk of unlicensed practice.  Florida’s mental health licensing statutes broadly define the “practice” of psychotherapy and counseling to include services that a court or licensing board might find are effectively therapeutic, even if labeled as coaching.  If a coaching relationship involves a client presenting with mental health symptoms and the coach responds in ways that constitute assessment or treatment—regardless of what the relationship is called—the provider may be found to have engaged in the unauthorized practice of a licensed profession.  Florida’s Section 491.014 imposes penalties for unlicensed practice, and the same individual can face discipline on their professional license for conduct that blurs these lines.

Second, there is a risk related to the unauthorized practice of medicine or scope of practice violations.  For physician assistants and other mid-level providers, services rendered outside of a supervising physician’s delegated scope of practice can constitute a scope violation—regardless of how the service is marketed.  Coaching offered by a licensed PA that crosses into clinical assessment or treatment could expose both the PA and the supervising physician to professional discipline.

(3) Ideas for Maintaining the Distinction in Practice

Practices that still choose to offer both services should consider implementing the following:

• Separate consent forms. Patients receiving clinical services should sign a therapy or clinical services consent that identifies the provider’s license and the nature of the licensed service. Coaching clients should sign a separate coaching consent that explicitly states: (a) the coaching relationship is not a clinical or therapeutic relationship; (b) no provider-patient relationship is formed; and (c) the coaching relationship will not become a clinical one.  A single combined form invites confusion.
• Separate documentation and records. Coaching should be documented separately and should not use clinical terminology—such as “diagnosis,” “treatment,” or “symptom”—in coaching notes.
• Clear intake and marketing language. The practice’s website, intake materials, and verbal communications should clearly describe which services are clinical and licensed and which are coaching. Referring to coaching as “mental health coaching” or presenting it alongside clinical services without clear differentiation can create the appearance that it is a clinical service.
• Do not allow the relationship to morph. If a coaching client begins presenting with mental health symptoms or requesting clinical guidance, a response to consider is to refer the client to a licensed provider—not to address the concerns within the coaching relationship. Coaching consent forms should address this scenario explicitly.
• Billing and financial agreements. Coaching services are not clinical services and are not covered by insurance. The practice’s financial agreements should reflect this clearly.  Submitting coaching sessions to insurance as if they were clinical services could implicate federal and state fraud and abuse statutes.

The coaching-therapy distinction is not a technicality—it is a structural compliance requirement for any practice that offers both types of services.  Getting the documentation right at the outset is far less costly than addressing a licensing complaint or a billing audit later.

If you would like to discuss practice structuring, scope of practice questions, or coaching-therapy distinctions for your mental health practice, or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com.  You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state.  Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.

(1) The No Surprises Act Has Multiple Components

The No Surprises Act was enacted as part of the Consolidated Appropriations Act of 2021 and created a suite of consumer protections against unexpected medical bills.  It is important to understand that not all of those protections apply to the same entities.  Some provisions—particularly those addressing surprise billing for emergency services and certain non-emergency services—are tied specifically to “health care facilities,” a defined term that encompasses hospitals, hospital outpatient departments, critical access hospitals, and ambulatory surgical centers.  Those facility-specific provisions are primarily designed for the insured-patient context, where a patient receives care at an in-network facility but is unknowingly treated by an out-of-network provider.  A cash-only outpatient clinic or telemedicine practice is unlikely to fall within those facility-specific provisions.

The GFE requirement, however, is different.  It is codified at Section 2799B-6 of the Public Health Service Act and implemented through 45 C.F.R. § 149.610.  The statutory text imposes the GFE obligation on “health care providers” and “health care facilities”—but the operative language of the GFE requirement, and the implementing regulations, appear to attach primarily to licensed providers rather than to facility status.  This distinction matters for practices that are not enumerated facilities but whose clinicians hold professional licenses.

(2) The GFE Requirement Arguably Follows the Provider’s License, Not Facility Status

Under the implementing regulations at 45 C.F.R. § 149.610, the GFE obligation applies to “convening providers” and “convening facilities”—terms defined to include any provider or facility that schedules a service or receives a request for a GFE.  A “convening provider” is defined broadly as a health care provider who schedules an item or service for an individual.  Because the definition references the provider’s status as a licensed health care provider—rather than whether the provider operates within an enumerated facility type—the GFE requirement appears to apply to any licensed clinician who schedules services for self-pay or uninsured patients.

The precise reach of the GFE requirement to every practice setting has not been conclusively resolved, and the regulatory framework has continued to evolve since the Act’s enactment.  Practices should consult with a healthcare attorney to evaluate their specific facts.  Because the No Surprises Act is predominantly structured around the insured-patient context and surprise billing in network-based care, there is a reasonable statutory interpretation question about whether the GFE obligation was intended to reach providers who have no relationship with any insurer or government payer and transact entirely in cash. CMS’s implementing guidance does not draw that distinction, however, and until the question is resolved through rulemaking or litigation, licensed providers scheduling services for self-pay patients should treat the GFE requirement as applicable.  That said, the CMS guidance on the GFE requirement is framed broadly and addresses independent practitioners, group practices, and other provider settings without limiting the obligation to hospital-based or enumerated facility providers.  The safer and more defensible compliance position for any licensed provider—including a solo or small-group telemedicine practice—is likely to treat the GFE requirement as applicable, but we recommend discussing your specific practice and services with your healthcare counsel.

(3) What Happens If the Actual Bill Exceeds the Estimate?

If a patient is billed an amount that exceeds the GFE by $400.00 or more, the patient has the right to initiate a patient-provider dispute resolution process administered through CMS.  A certified dispute resolution entity reviews the charges and can determine the appropriate payment amount.  The $400.00 threshold is not a buffer or safe harbor—it is the trigger for the dispute process, which can result in the provider being required to accept a lower payment.  Providers should treat the GFE as a meaningful commitment and keep their fee schedules current and documented.

(4) Practical Compliance Steps for Cash-Only and Telemedicine Practices

For a cash-only or telemedicine practice whose clinicians hold professional licenses, GFE compliance generally requires the following:

• Establish and document a current fee schedule for all services offered, identified by CPT or HCPCS code where applicable.
• Create a GFE form or workflow that captures the patient’s name, date of birth, date of estimate, the scheduled service, anticipated diagnosis or reason for visit, and estimated cost of care for the period ahead.
• Provide the written GFE to the patient automatically—without waiting for the patient to request it—within the timeframe required: at least one business day before the appointment if scheduled three or more days in advance, or at least three business days before the appointment if scheduled ten or more days in advance.
• Retain a copy of each GFE provided, as CMS may request documentation of compliance.
• Update the GFE promptly if the expected services or charges change materially before the scheduled appointment.

CMS has published guidance and model GFE forms that practices may use as a starting point.  Cash-only and telemedicine practices that do not yet have a GFE process in place should treat this as a priority compliance item, particularly given that the obligation runs with the provider’s license and attaches to every scheduled self-pay encounter.  If you would like to discuss No Surprises Act compliance or GFE requirements for your practice, or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com.  You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state.  Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.

Georgia law and regulations do not have clear rules on who can or cannot draw blood. Regarding blood donation centers, for example, phlebotomists must have the same or similar qualifications than that of a licensed practical nurse, clinical laboratory technician, or equivalent level of training or experience. Someone with more experience and who is a registered nurse, clinical laboratory technologist, licensed practical nurse, or physician assistant is required to be a supervisor.

In terms of testing for alcohol or drugs in blood for criminal DUI purposes, Georgia law specifically allows a physician, registered nurse, laboratory technician, emergency medical technician, or other qualified person to withdraw blood at the request of a law enforcement officer. Emergency medical technicians also draw blood as part of their scope of practice, which allows intermediate and advanced emergency medical technicians, cardiac technicians, and paramedics to draw blood, provided they have the appropriate training and certification.

If you are planning to draw blood as part of your scope of practice, respond to a licensing dispute about drawing blood, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

Who Can Administer Botox Depends on Whether Botox Is Being Administered for Cosmetic or Non-Cosmetic Purposes.

The South Carolina State Boards of Dentistry, Medical Examiners, and Nursing issued a joint advisory opinion about administering neuromodulators, including Botox, for cosmetic and non-cosmetic purposes. The opinion discusses certain requirements to administer Botox. A practitioner must have an active license to practice dentistry, medicine, or nursing, to administer Botox. The physician or practitioner must have a relationship with the patient before administering Botox. A registered nurse cannot establish this relationship, but a physician, physician assistant, or nurse practitioner can.

If Botox is being administered for cosmetic purposes, such administration can be delegated to qualified, licensed personnel, and the physician, dentist, or nurse practitioner must be on site and readily available for any potential adverse complications. A registered nurse can perform Botox injections only for cosmetic purposes pursuant to a written prescription, but a physician or nurse practitioner must be onsite while the registered nurse administers Botox. Physician assistants and nurse practitioners can perform Botox injections but pursuant to a scope of practice or written practice agreement, respectively. Finally, only physicians or dentists can perform Botox injections for non-cosmetic purposes, such as for migraines.

If you are planning to start a med spa in South Carolina, administer Botox in your practice, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

(1) Why the Covered vs. Non-Covered Distinction Matters

As a Medicare-participating provider, you have agreed—through your provider agreement—to accept Medicare’s approved payment amount as payment in full for covered services. That means if a service is covered by Medicare, you generally cannot bill the patient a separate or higher fee for that same service. Doing so can result in severe penalties, including civil monetary penalties and exclusion from the Medicare program.

On the other hand, if a service is never a covered service, you are not bound by Medicare’s billing rates, are not required to submit a claim to Medicare, and can generally charge patients directly—provided you are transparent about the fact that the service is non-covered.  Understanding where your services fall within this framework is essential before you set your pricing or marketing strategy.

(2) How to Analyze Whether a Service Is Covered

There is no single master list that resolves the coverage question for every clinical scenario, but the analysis generally involves three steps.

Step 1: Identify the Applicable CPT or HCPCS Code. Most Medicare-covered services are billed using Current Procedural Terminology (CPT) codes or Healthcare Common Procedure Coding System (HCPCS) codes. The starting point is identifying which billing code, if any, would apply to the service you intend to offer. There are many CMS Manuals, local and national coverage determinations, and other resources that can help with this analysis.  For instance, CMS publishes a Medicare Physician Fee Schedule and a Preventive Services reference chart that identify covered services, applicable codes, frequency limitations, and billing requirements.

Step 2: Review the Code’s Requirements. Even if a code exists for a type of service, coverage depends on whether your service actually meets all of the code’s requirements. Many codes have specific conditions that must be satisfied—such as minimum time thresholds, the type of clinical encounter required (e.g., synchronous vs. asynchronous), the setting in which the service is delivered (e.g., primary care setting), or the frequency with which the service may be billed. If the service you offer does not satisfy all of the code’s requirements, it is not properly billed under that code.  If the service offered in the way that it is offered is a covered service, but not covered in a specific situation (for example, because it exceeds the number permitted within a time period), then it is still considered a covered service, however, the practice may be able to bill the patient for it provided the practice complies with the Advanced Beneficiary Notice of Non-Coverage (“ABN”) (see Section 4 below).  ABNs are not required when a service is never covered.

Step 3: Determine Whether a Non-Covered Service Can Be Documented as Medically Appropriate. When a service does not meet the requirements of a covered code, it may appropriately be classified as a non-covered service. However, non-covered does not mean unregulated. You must still be able to demonstrate that the service is medically appropriate and that a proper patient-provider relationship has been established before the service is rendered. If a service is non-covered, there’s an inherent question about why the provider is offering it.  There are many reasons why a provider will offer a non-covered service, such as purely aesthetic reasons or to learn more about the patient’s health status in a preventative way.

(3) Preventive Services: A Common Area of Complexity

Preventive services are a frequent source of coverage questions, particularly for providers offering wellness-oriented services. Medicare covers a defined set of preventive services, many of which involve screening or counseling for specific conditions. The full list is available in CMS’s Medicare Preventive Services chart.

As an example of how this analysis works in practice, consider a provider looking to offer asynchronous questionnaire-based services related to alcohol use and smoking cessation. Medicare does cover preventive services in both of those areas—CPT codes 99406 and 99407 for smoking and tobacco cessation counseling, and HCPCS codes G0442 and G0443 for alcohol misuse screening and counseling. However, several of those codes are time-dependent and require synchronous or face-to-face interactions. A provider offering only asynchronous questionnaire review—without any synchronous counseling visit—may not satisfy the billing requirements for those covered codes and can, with appropriate analysis, structure those services as non-covered. That conclusion, however, requires careful examination of the billing manual requirements for each specific code, the mode of service delivery, and the clinical setting. The same type of careful code-by-code analysis applies whenever a provider introduces a new service.

(4) What to Do If a Service Is or May Be Covered

If after your analysis you conclude that a service you intend to offer is a covered service—or if there is meaningful uncertainty about whether it is—you have two primary options. First, you can structure your billing to comply with Medicare’s requirements: accept assignment, bill Medicare at the approved rate per the Medicare Physician Fee Schedule, and collect only applicable cost-sharing amounts from the patient. Second, if a beneficiary wants a service that Medicare covers but the provider believes is not medically necessary in a particular case, you can use an ABN to notify the patient in advance that Medicare may not pay, allowing the patient to decide whether to proceed and pay out of pocket.

What you cannot do is charge Medicare patients a different rate for a service that is covered, or omit billing Medicare for a covered service in order to charge patients directly. The penalties for doing so—including civil monetary penalties and exclusion from the Medicare program—are severe and apply regardless of whether the violation was intentional.

As your practice evolves and you add new services, we recommend revisiting the coverage analysis for any new offering, particularly if your service model, delivery method, or patient population changes. If you would like to discuss Medicare billing compliance or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.

(1) Background: FDA Warning Letters on Compounded GLP-1s

GLP-1 medications such as semaglutide (the active ingredient in Ozempic® and Wegovy®) and tirzepatide (the active ingredient in Mounjaro® and Zepbound®) have become among the most prescribed drugs in the United States. Given high demand and prior drug shortages, a large market for compounded versions of these drugs developed. As the FDA resolved shortage designations for these drugs, it began more actively scrutinizing how compounders and telehealth platforms were marketing their compounded GLP-1 products.

On February 20, 2026, the FDA’s Center for Drug Evaluation and Research (CDER) issued a wave of warning letters to companies offering compounded semaglutide and tirzepatide products. Three of those letters—sent to Lean Rx, Inc. dba SkinnyRx, Strut Health, LLC dba Strut, and Newman Clinic, PLLC—are representative examples of the FDA’s enforcement focus. Each letter was issued by the Acting Director of the Office of Compounding Quality and Compliance and identifies violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”). The letters demand written responses within fifteen (15) working days and warn that failure to comply may result in legal action, including seizure and injunction.

(2) The FDA’s Top Concerns

Reviewing these warning letters, the FDA’s enforcement concerns fall into two principal categories.

A. Misbranding Through False or Misleading Labeling—Incorrectly Identifying the Compounder

Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.

In many of the warning letters, including the three linked above, the FDA found that the company’s website depicted product labels bearing the company’s own name—“SkinnyRx,” “Strut,” or “Newman Clinic”—when in fact that company was not the actual compounder of the drug. Under 21 CFR § 201.1(h)(2), placing a name on a drug label without qualification represents that the named entity is the sole manufacturer. When that is not the case, the label is false or misleading, and the product is misbranded. Companies that are marketing or reselling compounded GLP-1 products without being the licensed compounder must be mindful of how their name appears on product labels and advertising.

B. Misbranding Through Claims That Imply FDA Approval

The second major concern in each letter involves website marketing language that implies a compounded product has been FDA-approved or is equivalent to an FDA-approved drug. Compounded drug products are not FDA-approved. The FDA identified the following types of claims as false or misleading:

• “From the same family as GLP-1 treatments like Mounjaro® and Zepbound®” (SkinnyRx)
• “Get access to the same active ingredient as name-brand GLP-1 medications” (SkinnyRx)
• “Generic Zepbound, Mounjaro” (Strut)
• “Same Ingredient as Ozempic® and Wegovy®” (Newman Clinic)

The FDA’s position is that these types of claims mislead consumers into believing the compounded product has undergone the same approval process as the brand-name drug. Referring to a compounded product as a “generic” is particularly problematic, as FDA-approved generic drugs are not the same as compounded drugs. With an FDA-approved generic drugs, the manufacturer must demonstrate to the FDA that the generic is bioequivalent to the brand-name drug.  Compounded drugs are patient-specific drugs that are not specifically FDA approved.

If you offer compounded GLP-1s, it is important to review your marketing materials to ensure compliance, particularly following the FDA’s recent wave of warning letters.  If you would like to discuss GLP-1 compliance matters, compounding regulations, or telehealth practice issues, or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.

Providers Who Accept Medicare and Medicaid Also Need to Comply with Federal Fraud and Abuse Requirements to Ensure the Compensation for the Shared Rental Space Reflects the Fair Market Value of the Rental Space.

Federal regulators have flagged rental arrangements where entities share space with physicians for over 25 years. In 2000, the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued a Special Fraud Alert highlighting concerns that rental payments may appear to be disguised kickbacks to induce referrals. Federal fraud and abuse laws, such as the Anti-Kickback Statute, have regulatory exceptions and safe harbors for rental spaces, and rental arrangements must meet all the requirements of the exception or safe harbor to comply with the exception or safe harbor. Although federal fraud and abuse laws, such as the Anti-Kickback Statute, apply to practitioners who take Medicare and Medicaid, and providers who do not accept insurance carry less risk than providers who accept Medicare and Medicaid of violating these laws, providers should be aware of the regulatory requirements for rental arrangements to reduce their risk of non-compliance.

To satisfy the exception or safe harbor, the rental arrangement must meet the following requirements: (1) The lease arrangement is set out in writing, signed by the parties, and specifies the premises it covers; (2) the duration of the lease arrangement is at least one year; (3) the rented or leased space does not exceed what is reasonable and necessary for the legitimate business purposes of the lease arrangement and is used exclusively by the lessee; (4) the rental charges over the term of the lease arrangement are set in advance and consistent with fair market value; (5) the rental charges over the term of the lease arrangement do not take into account the volume or value of referrals; and (6) the lease arrangement would be commercially reasonable even if no referrals were made between the lessee and lessor.

As it relates to rental arrangements, “fair market value” means the value of the rental property without adjusting the value of the rental space for referrals. As it relates to shared spaces, “fair market value” is the based on the ratio of the amount of space used by the provider sharing the space to the total amount of space in that rented space. For example, if a physician is renting a room from another provider, the fair market value of the rental arrangement for renting the room should be based on the square footage of the room itself.

If you are starting a practice or med spa and plan to sublease or rent space from another practice or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

Importantly, this obligation is not limited to practices that specialize in SUD treatment. The updated NPP requirements apply to any HIPAA-covered health care provider that creates or maintains Part 2 records — including providers who receive SUD treatment records from other sources in the course of treating a patient, such as through care coordination, referrals, or integrated care arrangements. In other words, if your practice could receive records identifying a patient as having received SUD diagnosis, treatment, or a referral for treatment at a federally assisted program, your NPP must address Part 2’s requirements.

The changes require NPPs to include the following:

This blog post discusses the bill in the South Carolina General Assembly that proposes to eliminate non-competes and highlights other common provisions of concern found in physician employment agreements. As of March 30, 2026, the bill has passed the South Carolina House and is currently in the South Carolina Senate. If you are a South Carolina physician who has concerns about their employment agreement, is planning to negotiate their employment agreement, is about to enter a new employment agreement for a new job, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

House Bill 4767 (H. 4767) first declares that non-competes in physician contracts are against South Carolina public policy, and certain provisions in physician contracts are void and unenforceable. These provisions include non-competes, restrictions on physicians continuing to treat patients, at the patient’s request, after their termination of employment, restrictions on physicians to establish a physician-patient relationship with a patient, at the patient’s request after their termination of employment, and restrictions on physicians’ obligations to notify patients of their departure from employment to ensure continuity of care. The notification must be given within 30 days of the physician’s departure or the physician giving the new practice information to his employer.

H. 4767 also allows employers to require physicians to repay relocation expenses, signing bonuses, or retention bonuses, as outlined in their employment agreements, if physicians worked for an employer for less than three years. The bill would also allow employers to require physicians to repay retention bonuses, provided that the repayment period for the retention bonus does not exceed two years from the date that the physician signed the employment agreement. The bill also does not restrict employers’ ability to protect trade secrets or other confidential information necessary for their practice, including compensation, management and marketing plans, software, and business strategies. H. 4767 applies only to contracts or contract renewals that are entered into on or after the bill is signed by South Carolina’s governor.

If you are a South Carolina physician who has concerns about their employment agreement, is planning to negotiate their employment agreement, is about to enter a new employment agreement for a new job, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

Our healthcare law firm works with many providers and healthcare practices to assist them in complying with federal, state, and local laws. Several of our clients have asked if they can administer ketamine for off-label use, especially for treatment-resistant depression. Ketamine has started being administered in psychiatric practices and ketamine clinics, and states are starting to respond to the proliferation of these ketamine clinics. This blog post discusses a bill in the Georgia General Assembly that proposes to regulate ketamine clinics. As of March 30, 2026, the bill has passed both the Georgia House and Senate but has not yet become law. If you are planning to administer ketamine in your practice, would like to set up a ketamine clinic, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

House Bill 717 (HB 717) proposes to regulate facilities that administer “psychedelic-assisted treatment and therapy,” which includes ketamine that is administered intravenously. “Psychedelic-assisted treatment and therapy” is defined as any treatment or therapy using psychedelic, dissociative, or other related substances that can produce hallucinations or other similar feelings. This bill also covers other treatments similar to ketamine, including Spravato®. The Georgia Medical Board would also be required to establish rules and regulations by no later than the end of 2026 that govern how ketamine is prescribed and administered in the clinic, what equipment and certifications are required for a clinic, and who can provide psychedelic-assisted treatment and therapy.

HB 717 would also require that effective July 1, 2027, clinics to file for a two-year license with the Georgia Medical Board so the clinic could administer ketamine and other psychedelic-assisted treatment and therapy. It would also require these clinics to be owned only by physicians or certified registered nurse anesthetists (CRNAs), but this requirement would not apply to any existing clinic, and existing clinics would still need to comply with the other requirements in the bill. Licensed clinics would also have certain requirements, including executing an agreement with a nearby hospital to ensure there is backup for potential complications, and that patients can be transferred to that hospital if those complications arise.

The bill would also limit who could administer ketamine and other psychedelic-assisted treatment and therapy to physicians with advanced airway management training; CRNAs under physician direction; anesthesiologist assistants under the direct supervision of a licensed anesthesiologist; nurse practitioners with airway management training, at least five years of clinical experience, with a nurse protocol agreement, and with express written Board approval; or physician assistants with airway management training, at least five years of clinical experience, with a job description, and with express written Board approval. Before the treatment is administered, the bill would also require the administering provider to review the prescription drug monitoring program and report the administration of any psychedelic-assisted treatment and therapy to the prescription drug monitoring program. The bill also provides criminal penalties for those who operate a clinic without a license, including imprisonment of 1-5 years or fines of $1,000-$5,000.

If you are planning to administer ketamine in your practice, would like to set up a ketamine clinic, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.