WHAT IS The Definition of a Clinic in Florida?
The answer to that question is not easy to figure out if you are about to embark on something that is non-traditional type of business.
Florida's Agency For Health Care Administration – pamphlet for AHCA.
According to AHCA it states as follows as of March 2024:
These questions and answers are provided as a resource for health care clinic licensure. A wealth of information may also be found on the Agency for Health Care Administration's website at (http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/HealthCareClinic/index.shtml) including links to applicable statutes and rules, application forms, survey regulation sets and other related information.
The health care clinic licensure laws allow for many “exemptions” from licensure, each listed in section 400.9905(4), Florida Statutes (F.S.). (See item 3 below.) The Agency for Health Care Administration will determine whether an entity qualifies for an exemption from licensure only after an application has been submitted and reviewed as a determination is based upon the individual entity's ownership structure and other factors. Each entity must review the law and decide if it qualifies; the Agency for Health Care Administration cannot make this determination over the phone or via email.
1. Is my practice or facility a health care clinic?
Answer: A health care clinic is an entity that provides health care services and tenders charges for reimbursement for these services to payors such as Medicare, private insurance or other sources. If an entity meets this complete definition, then it is a health care clinic. See section 400.9905(4), F.S.
2. If my practice or facility is a health care clinic, am I required to license it as such?
Answer: Health care clinics are required to be licensed in Florida unless they qualify for exemption from licensure (see 3 below). Health care clinic licensing information and applications may be obtained at: http://ahca.myflorida.com/healthcareclinic.
3. Does my practice or facility qualify for an exemption as a health care clinic?
Answer: Exemptions from licensure as a health care clinic are listed in sections 400.9905(4)(a)-(q), F.S. Please note: An entity must be licensed as a health care clinic in order to receive reimbursement under the Florida Motor Vehicle No-Fault Law [known as Personal Injury Protection (PIP) insurance] unless also exempt under section 627.736(5)(h), F.S.
4. How do I obtain a certificate of exemption from licensure as a health care clinic?
Answer: If an entity self-determines it qualifies for an exemption from licensure as a health care clinic and desires proof of this qualification, then it must submit an application along with fees and supporting documentation to the Agency. If the Agency determines the exemption criteria is met after review of the submitted documentation, then a certificate of exemption will be issued.
5. What is the fee for a health care clinic license or certificate of exemption?
Answer: The application fee for a health care clinic license is $2,000 every two years. See section 400.9925(3), F.S. and section 59A-33.002, Florida Administrative Code (F.A.C.).
The application fee for a certificate of exemption from licensure as a health care clinic is $100 every two years. See section 400.9935(6), F.S. and section 59A-33.006, F.A.C.
6. For the purposes of health care clinic regulation, what is the difference between a mobile clinic and a portable equipment provider?
Answer:
Mobile Clinic is a movable or detached self-contained health care unit, such as a vehicle or trailer, within or from which direct health care services are provided and which otherwise meets the definition of a health care clinic. See sections 400.9905(6) and 400.991(1), F.S.
Portable Equipment/Service Provider is a single administrative office from which treatment, services and/or diagnostic testing is provided to individuals in multiple locations and which otherwise meets the definition of a health care clinic. See sections 400.9905(7) and 400.991(1), F.S.
7. Who is eligible to serve as the medical or clinic director of a health care clinic?
Answer: As referenced in section 400.9905(5), F.S. and section 59A-33.008, F.A.C., a “medical director” is a physician who is employed or under contract with a clinic and who maintains a full and unencumbered physician license in accordance with chapter 458 (medical physician), 459 (osteopathic physician), 460 (chiropractic physician) or 461 (podiatric physician).
However, if the clinic does not provide services pursuant to the practice acts in chapters 458, 459, 460 or 461, F.S., it may appoint a Florida-licensed health care practitioner to serve as a clinic director who is responsible for the clinic's activities. If a health care clinic licensure applicant employs a clinic director rather than a medical director, the licensed health care practitioner may not supervise services beyond the scope of the practitioner's license and certification. Health care clinic applicants must submit information explaining how services provided are within the proposed clinic director's licensed scope of practice as regulated by the Florida Department of Health.
A health care practitioner may not serve as the clinic director if the services provided at the clinic are beyond the scope of that practitioner's license, except that a licensee specified in s. 456.053(3)(b), F.S. who provides only these services (speech-language pathology and audiology, occupational, and physical therapy) may serve as clinic director of an entity providing these services.
8. Is there a maximum number of health care clinics a medical or clinic director can serve?
Answer: A medical or clinic director may supervise up to five health care clinics provided the cumulative total of employees and persons under contract does not exceed two hundred (200). A medical or clinic director may not supervise a health care clinic more than 200 miles from any other health care clinic supervised by the same medical or clinic director.
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Florida statute 400.9905 provided defines "clinic" as an entity that provides health care services to individuals and charges for such services. However, it also explicitly excludes several types of entities from this definition. The document does not specifically mention IV therapy stores.
Whether an IV therapy store is considered a clinic under this statute would likely depend on several factors, including the specific services provided, the licensing and certification of the providers, and the nature of the charges tendered for reimbursement.
If the IV therapy store is providing health care services and charging for these services, it might be considered a clinic under the general definition. However, if it falls under one of the specific exclusions listed in the document (e.g., it is a sole proprietorship, group practice, partnership, or corporation providing health care services by certain types of licensed practitioners and meeting certain ownership conditions; it is a clinical facility affiliated with an accredited medical school or a college of chiropractic; it is owned by a corporation meeting certain conditions, etc.), it would not be considered a clinic according to this statute.
To make a definitive determination, you would need to know more about the specific circumstances of the IV therapy store and consider all relevant laws and regulations, not just this statute. It may be advisable to consult with a legal professional who is familiar with health care law in the relevant jurisdiction.
Here's a brief overview of those Florida Statutes chapters referenced in the definition statute:
1. Chapter 390: This chapter focuses on termination of pregnancies, outlining the regulations and requirements for performing abortions in the state of Florida.
2. Chapter 394: This chapter is titled "Mental Health," and it covers the administration and management of services for mental health, including the rights of patients and procedures for involuntary commitment.
3. Chapter 397: This chapter deals with substance abuse services, outlining the state's regulations for the provision of substance abuse treatment and prevention services.
4. This chapter except part X: Without knowing the specific chapter being referred to, I can't provide a summary. However, the 'except part X' notation suggests that part X of the chapter has different regulations or requirements.
5. Chapter 429: This chapter is titled "Assisted Living Facilities," outlining the regulations, licensing, and enforcement for assisted living facilities in the state.
6. Chapter 463: This chapter is about optometry, detailing the practice and regulation of optometry in Florida.
7. Chapter 465: This chapter focuses on pharmacy, outlining the laws related to the practice of pharmacy, including licensure and regulation of pharmacies.
8. Chapter 466: This chapter deals with dentistry, dental hygiene, and dental laboratories, outlining regulations and licensure for these professions.
9. Chapter 478: This chapter is titled "Electrolysis," and it covers the regulations and licensure requirements for the practice of electrolysis.
10. Chapter 484: This chapter deals with dispensing of optical devices and hearing aids, outlining the regulations and licensure for these practices.
11. Chapter 651: This chapter is titled "Continuing Care Contracts," and it covers the regulations and requirements for providers of continuing care and continuing care at-home services, which often involve long-term care arrangements for elderly individuals.
Remember, while this overview gives you a general idea of what each chapter covers, the actual statutes contain much more detailed requirements and regulations. For a thorough understanding, you should read the full text of each chapter.
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Florida Statute 400.9905
(4) “Clinic” means an entity where health care services are provided to individuals and which tenders charges for reimbursement for such services, including a mobile clinic and a portable equipment provider. As used in this part, the term does not include and the licensure requirements of this part do not apply to:
(a) Entities licensed or registered by the state under chapter 395; entities licensed or registered by the state and providing only health care services within the scope of services authorized under their respective licenses under ss. 383.30-383.332, chapter 390, chapter 394, chapter 397, this chapter except part X, chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, chapter 484, or chapter 651; end-stage renal disease providers authorized under 42 C.F.R. part 494; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 485, subpart B, subpart H, or subpart J; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 486, subpart C; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 491, subpart A; providers certified by the Centers for Medicare and Medicaid services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder; or any entity that provides neonatal or pediatric hospital-based health care services or other health care services by licensed practitioners solely within a hospital licensed under chapter 395.
(b) Entities that own, directly or indirectly, entities licensed or registered by the state pursuant to chapter 395; entities that own, directly or indirectly, entities licensed or registered by the state and providing only health care services within the scope of services authorized pursuant to their respective licenses under ss. 383.30-383.332, chapter 390, chapter 394, chapter 397, this chapter except part X, chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, chapter 484, or chapter 651; end-stage renal disease providers authorized under 42 C.F.R. part 494; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 485, subpart B, subpart H, or subpart J; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 486, subpart C; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 491, subpart A; providers certified by the Centers for Medicare and Medicaid services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder; or any entity that provides neonatal or pediatric hospital-based health care services by licensed practitioners solely within a hospital licensed under chapter 395.
(c) Entities that are owned, directly or indirectly, by an entity licensed or registered by the state pursuant to chapter 395; entities that are owned, directly or indirectly, by an entity licensed or registered by the state and providing only health care services within the scope of services authorized pursuant to their respective licenses under ss. 383.30-383.332, chapter 390, chapter 394, chapter 397, this chapter except part X, chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, chapter 484, or chapter 651; end-stage renal disease providers authorized under 42 C.F.R. part 494; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 485, subpart B, subpart H, or subpart J; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 486, subpart C; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 491, subpart A; providers certified by the Centers for Medicare and Medicaid services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder; or any entity that provides neonatal or pediatric hospital-based health care services by licensed practitioners solely within a hospital under chapter 395.
(d) Entities that are under common ownership, directly or indirectly, with an entity licensed or registered by the state pursuant to chapter 395; entities that are under common ownership, directly or indirectly, with an entity licensed or registered by the state and providing only health care services within the scope of services authorized pursuant to their respective licenses under ss. 383.30-383.332, chapter 390, chapter 394, chapter 397, this chapter except part X, chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, chapter 484, or chapter 651; end-stage renal disease providers authorized under 42 C.F.R. part 494; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 485, subpart B, subpart H, or subpart J; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 486, subpart C; providers certified and providing only health care services within the scope of services authorized under their respective certifications under 42 C.F.R. part 491, subpart A; providers certified by the Centers for Medicare and Medicaid services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder; or any entity that provides neonatal or pediatric hospital-based health care services by licensed practitioners solely within a hospital licensed under chapter 395.
(e) An entity that is exempt from federal taxation under 26 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan under 26 U.S.C. s. 409 that has a board of trustees at least two-thirds of which are Florida-licensed health care practitioners and provides only physical therapy services under physician orders, any community college or university clinic, and any entity owned or operated by the federal or state government, including agencies, subdivisions, or municipalities thereof.
(f) A sole proprietorship, group practice, partnership, or corporation that provides health care services by physicians covered by s. 627.419, that is directly supervised by one or more of such physicians, and that is wholly owned by one or more of those physicians or by a physician and the spouse, parent, child, or sibling of that physician.
(g) A sole proprietorship, group practice, partnership, or corporation that provides health care services by licensed health care practitioners under chapter 457, chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, chapter 490, chapter 491, or part I, part III, part X, part XIII, or part XIV of chapter 468, or s. 464.012, and that is wholly owned by one or more licensed health care practitioners, or the licensed health care practitioners set forth in this paragraph and the spouse, parent, child, or sibling of a licensed health care practitioner if one of the owners who is a licensed health care practitioner is supervising the business activities and is legally responsible for the entity's compliance with all federal and state laws. However, a health care practitioner may not supervise services beyond the scope of the practitioner's license, except that, for the purposes of this part, a clinic owned by a licensee in s. 456.053(3)(b) which provides only services authorized pursuant to s. 456.053(3)(b) may be supervised by a licensee specified in s. 456.053(3)(b).
(h) Clinical facilities affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows.
(i) Entities that provide only oncology or radiation therapy services by physicians licensed under chapter 458 or chapter 459 or entities that provide oncology or radiation therapy services by physicians licensed under chapter 458 or chapter 459 which are owned by a corporation whose shares are publicly traded on a recognized stock exchange.
(j) Clinical facilities affiliated with a college of chiropractic accredited by the Council on Chiropractic Education at which training is provided for chiropractic students.
(k) Entities that provide licensed practitioners to staff emergency departments or to deliver anesthesia services in facilities licensed under chapter 395 and that derive at least 90 percent of their gross annual revenues from the provision of such services. Entities claiming an exemption from licensure under this paragraph must provide documentation demonstrating compliance.
(l) Orthotic, prosthetic, pediatric cardiology, or perinatology clinical facilities or anesthesia clinical facilities that are not otherwise exempt under paragraph (a) or paragraph (k) and that are a publicly traded corporation or are wholly owned, directly or indirectly, by a publicly traded corporation. As used in this paragraph, a publicly traded corporation is a corporation that issues securities traded on an exchange registered with the United States Securities and Exchange Commission as a national securities exchange.
(m) Entities that are owned by a corporation that has $250 million or more in total annual sales of health care services provided by licensed health care practitioners where one or more of the persons responsible for the operations of the entity is a health care practitioner who is licensed in this state and who is responsible for supervising the business activities of the entity and is responsible for the entity's compliance with state law for purposes of this part.
(n) Entities that employ 50 or more licensed health care practitioners licensed under chapter 458 or chapter 459 where the billing for medical services is under a single tax identification number. The application for exemption under this subsection shall contain information that includes: the name, residence, and business address and phone number of the entity that owns the practice; a complete list of the names and contact information of all the officers and directors of the corporation; the name, residence address, business address, and medical license number of each licensed Florida health care practitioner employed by the entity; the corporate tax identification number of the entity seeking an exemption; a listing of health care services to be provided by the entity at the health care clinics owned or operated by the entity and a certified statement prepared by an independent certified public accountant which states that the entity and the health care clinics owned or operated by the entity have not received payment for health care services under personal injury protection insurance coverage for the preceding year. If the agency determines that an entity which is exempt under this subsection has received payments for medical services under personal injury protection insurance coverage, the agency may deny or revoke the exemption from licensure under this subsection.
(o) Entities that are, directly or indirectly, under the common ownership of or that are subject to common control by a mutual insurance holding company, as defined in s. 628.703, with an entity issued a certificate of authority under chapter 624 or chapter 641 which has $1 billion or more in total annual sales in this state.
(p) Entities that are owned by an entity that is a behavioral health care service provider in at least five other states; that, together with its affiliates, have $90 million or more in total annual revenues associated with the provision of behavioral health care services; and wherein one or more of the persons responsible for the operations of the entity is a health care practitioner who is licensed in this state, who is responsible for supervising the business activities of the entity, and who is responsible for the entity's compliance with state law for purposes of this part.
(q) Medicaid providers.
