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Florida Telehealth Licensing Outlook

Generally, telehealth providers must be licensed within the state where the patient resides or is receiving care. In response to the COVID-19 pandemic, nearly every state issued temporary waivers to medical professionals licensed in other U.S. states, which allowed providers to offer telehealth services to patients across state lines without the need to obtain licensing from the particular state in which the patient resided or received care. To combat the pandemic and expand telehealth services within the state, the Florida Department of Health issued an emergency order on March 16, 2020, which permitted medical professionals unlicensed in Florida to provide healthcare services to Florida residents affected by the coronavirus. Florida’s telehealth emergency waivers ended on June 26, 2021, after Governor Ron DeSantis decided to let the waivers expire.

Now, other states are also gradually rolling back these telehealth emergency waivers afforded to out-of-state healthcare providers during the early stages of the pandemic in favor of more permanent changes to regulate interstate telehealth delivery. In particular, Florida has been a first mover in establishing a permanent registration telehealth policy. During the 2019 legislative session, Florida lawmakers passed section 456.47, Florida Statutes, which authorized out-of-state healthcare providers to furnish telehealth services to patients residing in Florida and established standards of practice for telehealth services. After Governor DeSantis signed the law on June 25, 2019, the law took effect on July 1, 2019. Under section 456.47, all out-of-state healthcare providers are required to register with the Florida Department of Health in order to furnish telehealth services and may not provide in-person services to Florida patients.

More recently, Governor DeSantis signed a new law amending Chapter 456.47 to remove prior restrictions on the prescription of controlled substances via telehealth on April 6, 2022. Under the new law, telehealth providers may prescribe Florida patients all controlled substances except for Schedule II substances. While this amendment does permit out-of-state healthcare providers to prescribe controlled substances to Florida patients via telehealth, providers should also be aware of federal law that also governs the prescription of controlled substances. Under the Ryan Haight Online Pharmacy Consumer Protection Act, a controlled substance may not be prescribed by means of the internet without a valid prescription. Providers are required to conduct at least one in-person medical examination of a patient before prescribing a controlled substance to patients. The Ryan Haight Act law does provide seven exceptions to the in-person requirement, but these exceptions are narrow and apply only to providers in an institutional setting.

Another approach to telehealth licensing that has started to gain traction involves the adoption of an interstate compact, such as the Interstate Medical Licensure Compact. The compact was created to allow medical professionals an expedited alternative to obtain additional state medical licensure to qualify to practice medicine among IMLC member states. To date, the IMLC is composed of 33 states, the District of Colombia, and Guam. Other states such as Massachusetts, New York, and North Carolina have passed legislation to be admitted to the IMLC. Under the current administration, Florida is unlikely to join the IMLC as admission to the compact would require the Florida Legislature to overhaul the state’s health care policy and pass new stand-alone bills which would be a significant commitment.

Looking forward to 2023, two key issues to keep an eye out for includes potential legislation surrounding telehealth payment parity and the increase of telehealth fraud.

Payment Parity

In April 2022, the Federation of State Medical Boards (FSMB) released an updated telemedicine policy for the first time since 2014. The FSMB acknowledged that rapid growth and utilization of telemedicine technologies have dramatically transformed conventional healthcare delivery. As such, the FMSB intends to advise state medical boards on proper procedures to regulate the use of telemedicine technologies in medical practice for the benefit of the public. The FMSB observed that limiting insurance coverage for healthcare services delivered via telehealth may increase inequities in the access to healthcare. The FMSB recommends that health insurance plans should provide the same coverage extended for the cost of healthcare services delivered in-person on the same basis as those delivered through telemedicine.

Coronavirus (Covid-19) Creates Opportunities for Use of Telehealth in Florida

I. Introduction

For several years, we have discussed the practical benefits of using Telehealth or Telemedicine as a supplement to traditional medical care and not as a replacement. However, we are facing a moment in history where Emergency Rooms are becoming increasingly overwhelmed and don’t have the staff, resources, healthcare professionals, respirators, ventilators and other equipment necessary to adequately and expeditiously treat patients.  Telemedicine is becoming more essential now that countries around the world are paralyzed due to the spread of the Coronavirus which has resulted in a pandemic.

Telemedicine is useful for those individuals who are unable or unwilling to travel to their healthcare provider while allowing them to receive the same level of care and treatment through the use of medical technology. Telemedicine is particularly useful during times like this when individuals have to self-quarantine and when a State of Emergency has been issued as a measure to minimize the spread of the virus. Telemedicine may have the ability to assist healthcare professionals by remotely diagnosing conditions, such as the Coronavirus without putting the health of others in jeopardy. The Coronavirus can cause respiratory problems, among others, and the elderly and those with pre-existing conditions regardless of age are particularly susceptible to the effects of contracting the virus, including death.

II. Florida Law

Now is as good a time as any for those who are interested in incorporating Telehealth into their practice to become familiar with the Florida laws that govern its use. Prior to the passage of House Bill 23 (Chapter 2019 – 137), the Standards for Telemedicine practice were governed by Florida Administrative Code 64B8-9.0141 (for Medical Doctors) and 64B15-14.0081, which have since been repealed and replaced by this House Bill and Florida Statute §456.47.

          A. What is Telehealth under H.B. 23

“Telehealth” is defined as the use of synchronous or asynchronous telecommunications technology by a telehealth provider to provide healthcare services, including, but not limited to, assessment, diagnosis, consultation, treatment, and monitoring of a patient; transfer of medical data; patient and professional health-related education; public health services; and health administration. The term does not include audio-only telephone calls, email messages, or facsimile transmissions. A “Telehealth Provider” means any individual who provides healthcare and related services using telehealth and who is licensed or certified under the appropriate Florida Statute or who is licensed under a multi-state health care licensure compact of which Florida is a member state or is a registered out-of-state telehealth provider. A telehealth provider and a patient may be in separate locations when telehealth is used to provide healthcare services to a patient. It should be noted that it is not a violation for a non-physician telehealth provider using telehealth and acting within his or her relevant scope of practice.

          B. Telehealth Prescribing and Recordkeeping

A telehealth provider may not use telehealth to prescribe a controlled substance unless the controlled substance is prescribed for the following: (1) the treatment of a psychiatric disorder; (2) inpatient treatment at a hospital; (3) the treatment of a patient receiving hospice services: or (4) the treatment of a resident of a nursing home facility.

A telehealth provider must document in the patient’s medical record the healthcare services rendered using telehealth according to the same standard as used for in-person services. Medical records, including video, audio, electronic, or other records generated as a result of providing such services are confidential and must comply with HIPAA requirements.

          C. Out-Of-State Telehealth Providers

                1. Registration of Out-Of-State Telehealth Providers

A healthcare professional not licensed in Florida may provide healthcare services to a patient located in this state using telehealth if the healthcare professional registers with the applicable board and provides those healthcare services within the applicable scope of practice established by Florida law. In order for an out-of-state healthcare professional to be registered they have to prove or complete the following: (1) complete an application to provide telehealth services as an out-of-state provider; (2) have an unencumbered occupational license that was issued by another state, the District of Columbia, or a possession or territory of the United States and that is substantially similar to the license issued to a Florida-licensed provider. Foreign trained providers without a valid Florida-professional license are ineligible to register to provide telehealth services in Florida; (3) has not been the subject of disciplinary action relating to his or her license during the 5-year period immediately preceding the submission of their application; (4) designates a duly appointed registered agent for service of process in this state; and (5) demonstrates to the board that he or she maintains professional liability coverage or financial responsibility.

A healthcare professional may not register if his or her license to provide healthcare services is subject to a pending disciplinary investigation or action, or has been revoked in any state or jurisdiction. If you are a duly registered healthcare professional, you must notify the appropriate board of any restrictions placed on your license to practice, or any disciplinary action taken or pending against you, from any state or jurisdiction within 5 days after the restriction is placed or disciplinary action is initiated or taken.

               2. Insurance Coverage

As noted above, a registered provider must maintain professional liability coverage or proof of financial responsibility, that includes coverage or financial responsibility for telehealth services provided to patients not located in the provider’s home state.

               3. Physical Presence

An out-of-state healthcare professional may not open an office in Florida and may not provide in-person healthcare services to patients located in this state.

               4. Disciplinary Action Against Out-Of-State Telehealth Provider

The board may take disciplinary action against an out-of-state telehealth provider if the registrant: (1) fails to notify the applicable board of any adverse actions taken against his or her license; (2) has restrictions placed on or disciplinary action taken against his or her license in any state or jurisdiction; (3) violates any of the requirements of this section; or (4) commits any act that constitutes grounds for disciplinary action under the applicable practice act for Florida-licensed providers. Disciplinary action may include suspension or revocation of the provider’s registration or the issuance of a reprimand or letter of concern. A suspension may be accompanied by a corrective action plan the completion of which may lead to the suspended registration being reinstated according to the rules adopted by the board.

          D. Venue

Any act that constitutes the delivery of health are services is deemed to occur at the place where the patient is physically located at the time the act is performed or in the patient’s county of residence.

          E. Exemptions

A healthcare professional who is not licensed to provide healthcare services in this state but who holds an active license to provide healthcare services in another state or jurisdiction, and who provides healthcare services using telehealth to a patient located in this state, is not subject to the registration requirement if the services are provided: (1) in response to an emergency medical condition; or (2) in consultation with a healthcare professional licensed in this state who has ultimate authority over the diagnosis and care of the patient.

          F. Reimbursement for Telehealth Services

A contract between a health insurer issuing major medical comprehensive coverage through an individual or group policy and a telehealth provider must be voluntary between the insurer and the provider and must establish mutually acceptable payment rates or payment methodologies for services provided through telehealth. Any contract provision that distinguishes between payment rates or payment methodologies for services provided through telehealth and the same services provided without the use of telehealth must be initialed by the telehealth provider.

 

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Can I become a Federally Qualified Health Center?

Federally Qualified Health Centers (“FQHC”) are community-based healthcare providers that receive money for providing primary care services to under-served populations or areas. FQHCs were enacted under Section 1861(aa) of the Social Security Act and was amended by Section 4161 of the Omnibus Budget Reconciliation Act of 1990.

FQHCs are required to adhere to certain criteria, including, but not limited to, providing comprehensive healthcare services (either on-site or by arrangement with another provider) on a sliding fee scale based on ability to pay and operating under a governing board that includes patients. These comprehensive services may include: (1) preventive health services; (2) dental services; (3) mental health and substance abuse services; (4) Transportation services necessary for adequate patient care; and (5) hospital and specialty care. FQHCs must also implement an ongoing quality assurance program.

 

FQHC Certification

To be certified as an FQHC, a healthcare provider must meet one of the following requirements:

  • Receive a grant under Section 330 of the Public Health Service Act (“PHS Act”) or receive funding from such a grant and meets other requirements.
  • Is not receiving a grant under Section 330 of the PHS Act but is determined by the Secretary of the Department of Health & Human Services to meet the requirements for receiving such a grant based on the recommendation of the Health Resources and Services Administration (“HRSA”).
  • Was treated by the Secretary of HHS for purposes of Medicare Part B as a comprehensive Federally-funded health center as of January 1, 1990.
  • Is operating as an outpatient health program or facility of a tribe or tribal organization under the Indian Self-Determination Act or as an urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act as of October 1991.

 

For certification as an FQHC, the entity must meet all of these requirements:

  • Provide comprehensive services and have an ongoing quality assurance program
  • Meet other health and safety requirements
  • Not be concurrently approved as a Rural Health Clinic.

 

FQHC Eligibility

Once eligible, FQHCs will qualify for funding under Section 330 of the Public Health Service Act, as well as, enhanced reimbursement form Medicare and Medicaid. FQHCs are paid based on the FQHC Prospective Payment System (“PPS”) for medically-necessary primary health services and qualified preventive health services furnished by a FQHC practitioner.

 

Examples of FQHC

A FQHC visit is medically-necessary face-to-face medical or mental health visit or a qualified preventive health visit between the patient and a physician, NP, PA, CNM, CP, or CSW during which time one or more qualified FQHC services are furnished.  FQHCs include:

  • Community health centers
  • Migrant health centers
  • Healthcare for the homeless health centers
  • Health centers for residents of public housing
  • Health center program “look-alikes”

 

Telehealth Services

FQHCs are authorized to serve as an originating site for telehealth services if the FQHC is located in a qualifying area. An originating site is the location of an eligible Medicare patient at the time the service being furnished via a telecommunications system occurs. FQHCs that serve as an originating site for telehealth services are paid an originating site facility fee.

FQHCs are not authorized to serve as a distant site for telehealth consultations. A distant site is the location of the practitioner at the time the telehealth service is furnished. The cost of a visit may not be billed or included on the cost report.

 

FQHC Reimbursements

FQHCs set their own charges for the services they provide and determine which services to include in the bundle of services associated with each FQHC code. Charges must be uniform for all patients.

Payment is for professional services only. Laboratory tests and the technical component of billable visits are paid separately. Procedures are included int eh payment of an otherwise qualified visit and are not separately billable. If a procedure is associated with a qualified visit, include the charges for the procedure on the claim with the visit.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services please contact me using the information listed above.

All of the information and references made to laws, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Jamaal R. Jones, Esq. Presents a Webinar to the Florida Department of Health

On April 19, 2018, Jamaal R. Jones, Esq. made a presentation to the Florida Department of Health Attorneys for Continuing Legal Education credit. The name of the CLE Presentation was “mHealth and Wearable Technology Issues in Remote Medicine”. This presentation was listened to by 80+ attorneys who work directly for the Florida Department of Health.

Contact us to find out more information about this presentation.

Jamaal Jones, Esq. speaks at 9th Annual Interdisciplinary Conference

On February 21, 2018, Jamaal R. Jones, Esq. spoke in front of an audience of Health Professionals at Nova Southeastern University’s 9th Annual Interdisciplinary Conference.

Mr. Jones discussed “Telemedicine and its Intersection with mHealth an Innovation of Things”.

Some attendees included Anesthesiology Assistants, athletic trainers, behavioral scientists, dental hygienists, nurse practitioners, physicians, physician assistants, and physical therapists to name a few. 

Jamaal Jones Presents at Master Class on Telemedicine

On December 8, 2017, Jamaal Jones, Esq. discussed his presentation called “Health and Wearable Technology Issues in Remote Medicine” in front of other Healthcare Attorneys and Professionals at the Rosen Centre in Orlando, Florida.

If you would like to find out more information about Mr. Jones and his presentation please email him at jrj@joneshealthlaw.com or call him at (305)877-5054.

Florida Senate Bill 8-A’s Effect on Physicians’ Medical Marijuana Practices

Background

President Trump he has not taken a firm stance publicly in favor of or opposed to the use of medical marijuana. Currently, he intends to leave the medical marijuana issue up to the individual states. The 2016 fiscal year  omnibus appropriations bill appears to be in line with Trump as it contains language prohibiting the Department of Justice from meddling in state medical marijuana laws.

According to a Department of Health report, the state registry now has 16,614 patients. A recent state revenue impact study projects that by 2022 there will be approximately 472,000 medical marijuana patients and $542 million in sales.

Many activists expect that there will be several lawsuits related to SB8A. Legislators anticipated this and have added language that divides SB8A so that if certain parts are held unconstitutional the court would only invalidate those parts without invalidating the entire law.

Qualified Physician

Under SB8A, a “qualified physician” is a person who holds an active and unrestricted license to practice medicine in compliance with the physician education requirements. In order to be approved as a qualified physician, the physician must successfully complete a 2-hour course and exam by either the Florida Medical Association or the Florida Osteopathic Medical Association. The exam will not cost more than $500. This requirement also applies to those seeking to become Medical Directors in medical marijuana treatment centers (“MMTC”).

A “Medical Marijuana Treatment Center” means an entity that acquires, cultivates, possesses, processes (including development of related products such as food, tinctures, aerosols, oils, or ointments), transfers, transports, sells, distributes, dispenses, or administers marijuana, products containing marijuana, related supplies, or educational materials to qualifying patients or their caregivers and is registered by the Department. As you can see, the definition of an MMTC is very broad and includes virtually every type of business in the medical marijuana industry.

A qualified physician may not be employed by, or have any direct or indirect economic interest in, a medical marijuana treatment center or marijuana testing laboratory. This sentence is important because it means that not every physician is bound by this rule. If you are a physician and you have not taken the course and exam to become certified so that you can certify marijuana to your terminally ill patients then this law doesn’t apply to you. For example, if you are a dermatologist who does not treat any terminally ill patients and you are not a “qualified physician” for purposes of providing marijuana to terminally ill patients then you are not prohibited from being employed by or having an economic interest in an MMTC or marijuana testing laboratory (“MTL”). An MTL or “Independent testing laboratory” means a laboratory, including the managers, employees, or contractors of the laboratory, which has no direct or indirect interest in a dispensing organization.

This aforementioned provision of SB8A places broad limits on the types of marijuana facilities and businesses that a qualified physician is permitted to have a financial interest in. MMTCs and MTLs are off-limits to qualified providers. Non-Qualified providers are thus able to work for or have a financial interest in medical marijuana retailers, medical marijuana delivery devices, and medical marijuana delivery companies to name a few.

A qualified physician may not authorize a patient to receive more than three 70-day supply limits of marijuana. However, a physician may request an exception to the daily dose amount limit electronically. Further, a physician must evaluate an existing patient at least once every 30 weeks prior to issuing a new physician certification.

Physician Certification

Physician’s Certification means that a physician may authorize a qualified patient to receive marijuana and a marijuana delivery device (i.e. vape pen) from a MMTC. A physician may certify that a patient is in need of medical marijuana only after she has:

  • Conducted a physical examination while physically present in the same room as that patient (Telemedicine is not permissible) and recorded a full assessment of the medical history of the patient.
  • Diagnosed the patient with at least one qualifying medical condition.
  • Determined that the use of medical marijuana would likely outweigh the potential health risks for the patient and it is documented as such in the patient’s medical record. If a patient is under 18 years old, a second physician must concur with this determination, and it too must be documented in the patient’s medical record.
  • Determined that the patient is pregnant. A pregnant patient may only receive low-THC cannabis.
  • Reviewed the patient’s controlled drug prescription history in the prescription drug monitoring program database.
  • Reviewed the medical marijuana use registry and confirmed that the patient is not currently receiving medical marijuana from another qualified physician.
  • Registers as the issuer of the certification to the patient on the medical marijuana use registry.
  • Obtains the voluntary and written consent of the patient, or their parent or legal guardian if they are a minor, only after the physician has sufficiently explained its content, for the medical use of marijuana each time the physician issues the certification to the patient.

A physician certifying the use of medical marijuana for their patient must use a standardized informed consent form adopted by the Board of Medicine or Board of Osteopathic Medicine, which must include, at a minimum the following:

  1. The Federal Government’s classification of marijuana as a Schedule I controlled Substance.
  2. The approval and oversight status of marijuana by the Food and Drug Administration.
  3. The current state of research on the efficacy of marijuana to treat the qualifying conditions.
  4. The potential for addiction.
  5. The potential effect that marijuana may have on a patient’s coordination, motor skills, and cognition, including a warning against operating heavy machinery, operating a motor vehicle, or engaging in activities that require a person to be alert or respond quickly.
  6. The potential side effects of marijuana use.
  7. The risks, benefits, and drug interactions of marijuana.

That the patient’s de-identified health information contained in the physician certification and medical marijuana use registry may be used for research purposes.

Medical Marijuana Use Registry

Physicians should be aware that a review panel will be created by their respective Boards to review all physician certifications submitted to the medical marijuana use registry. The panel will track and report the number of physician certifications and the qualifying medical conditions, dosage, supply amount, and form of marijuana certified. The panel will report the data by individual physician and in aggregate formats by county and statewide. On the surface, it appears that the Board is just collecting data from those who certify patients to receive medical marijuana. However, it also appears that the Board is analyzing patterns and potential abuse by physicians who over prescribe or prescribe at a much higher rate than other qualified physicians that are similarly situated. At this time, I am not sure what action the Board would take if any, if they determine that there is some irregularity with the prescribing pattern of a particular physician.

The medical marijuana use registry must be accessible to qualified physicians and MMTCs to verify the authorization of a qualified patient or a caregiver to possess marijuana or a marijuana delivery device and record the marijuana or marijuana delivery device dispensed. The goal of the registry is to prevent an active registration of a patient by multiple physicians who can then receive and possess an amount of marijuana that exceeds the legal limits. The fear is that this will lead to an abuse of the Schedule I drug.

Penalties

SB8A doesn’t contain many penalties for physicians apart from the other laws and Board rules that currently exist to which physicians are bound by. However, I’m confident that with the proliferation of medical marijuana use by terminal patients and the tracking of prescribing patterns by the Board that there will be additional penalties for physician-owners and qualified physicians on the horizon. A qualified physician who issues a physician certification for marijuana or a marijuana delivery device and receives compensation from a MMTC related to the issuance of the physician certification for marijuana or a marijuana delivery device is subject to disciplinary action under the applicable practice act and Fla. Statute. 456.072(1)(n).

 

***This blog post does not constitute legal advice and is only intended for educational purposes only. You should consult a licensed attorney in the State of Florida that specializes in healthcare law.***

Telemedicine and its intersection with Mobile Health Apps and Wearable Tech

There was a time when you could receive a home visit from your primary care physician when you were feeling ill. Well those days are long gone…or are they? Much like many other aspects of our lives, the delivery of medicine has evolved throughout the years and we are now being ushered back to the days when we didn’t have to travel to our physician’s office to receive medical treatment. This time around when the nurse says “The doctor will see you now” the “visit” will be very different.

The proliferation of Telemedicine has made the delivery of medical services more accessible to those who are unable or unwilling to travel to their physician’s office. Our busy schedules or physical disabilities resulting in immobility have increased our demands and usage of Telemedicine. Now more than ever, physicians and their patients are utilizing mobile health applications and wearable technology devices that collect, store, and transmit our protected health information (“PHI”) to our physician or any other health care provider or entity that the patient designates.

When the physician receives the patient’s PHI through the app the physician can interpret that information to provide her with a more accurate examination during the next Telemedicine appointment. In other words, Telemedicine and mobile health apps/devices when used in tandem allow a physician to provide a more precise diagnosis.

Technology is meant to simplify our lives, but at what cost? We’ve all seen and received advertisements that state “Stay focused this holiday season with the latest in wearable tech”, “Get real-time heart rate & calorie burn stats”. To the average consumer, wearing a smart watch or using a health tracker app on your phone seems harmless, but what happens when your PHI gets into the wrong hands? What if there is a data security breach and millions of PHI, including yours is stolen by hackers? What if a provider discloses your PHI to someone that you did not authorize them to disclose it to? The reality is that this occurs more often than we’d like to admit, and with the increase in the usage of Telemedicine and mobile health apps and wearable tech we are more susceptible to our PHI getting into the wrong hands.

The popularity of Telemedicine for health care providers is increasing rapidly because it allows providers to connect with and treat a larger population of patients that it otherwise wouldn’t have access to, and the result is an in increase profits. New laws are being enacted and existing laws are being revised or amended to facilitate the surge of Telemedicine.

Telemedicine

Generally, telemedicine involves the use of interactive telecommunications for the delivery of health care services when a health care provider and patient are not in the same physical location. Engaging in this practice of remote health care allows providers to reach more patients and grow their businesses by providing health care services, such as primary and specialty care and remote patient monitoring, via videoconference rather than requiring patients to travel to an office or hospital. Although the use of telemedicine is utilized sparingly compared to face-to-face treatment by a health care provider its use is on the rise and laws and regulations are being enacted across the nation to govern the provision of telemedicine by health care practitioners.

  1. Telemedicine in Florida

    Telemedicine policies regarding reimbursement, licensure requirements, online prescribing, scope of coverage, and other issues vary greatly from state to state. Several states have or are in the process of enacting legislation that addresses several of these issues. Florida, like many other states has been slow to enact new laws or evolve existing laws and statutes to deal with the proliferation of telemedicine. On March 12, 2014, the Florida Administrative Code established standards for telemedicine practice. This Rule was adopted by the Florida Board of Medicine and the Florida Board of Osteopathic Medicine.

    The Rule defines “telemedicine” as the practice of medicine by a licensed Florida physician or physician assistant where patient care, treatment, or services are provided through the use of medical information exchanged from one site to another via electronic communications. Florida does not have specific language within its statute, nor its administrative regulations, granting out-of-state physicians a limited license to enter the state remotely to practice medicine, but that may change if proposed legislation is passed. For example, an insurer using a provider that’s in-network in another state would also be allowed to treat a Florida patient if passed. The Rule prohibits the use of Telemedicine to administer health care services by using solely an audio only telephone, email messages, text messages, facsimile transmission, U.S. Mail or other parcel service, or any combination thereof. The Rule also states that the standard of care must remain the same regardless of whether a Florida licensed physician or physician assistant provides health care services in person or via telemedicine.

    Florida licensed physicians and physician assistants providing health care services via telemedicine are responsible for the quality of the equipment and technologies employed and are responsible for their safe use. The Rule did not include a list of technologies that it deemed safe for use in telemedicine. This was done on purpose to allow the rule to be broad enough to permit the practitioner to use available technology sufficiently encrypted and compliant with HIPAA.

    Physicians may not prescribe controlled substances through the use of telemedicine unless the patient is in a hospital facility. According to the Rule, prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice medicine with the level of care, skill, and treatment which is recognized by reasonably prudent physicians as being acceptable under similar conditions and circumstances, as well as prescribing legend drugs other than in the course of a physician’s professional practice.

    Under the Rule, physicians and physician assistants cannot provide treatment recommendations, including issuing a prescription via electronic or other means, unless: (a) a documented patient evaluation, including history and physical examination to establish the diagnosis for which any legend drug is prescribed; (b) there has been a discussion between the physician or the physician assistant and the patient regarding treatment options and the risks and benefits of treatment; and (c) there exists proper maintenance of contemporaneous medical records.

    Patient confidentiality obligations and recordkeeping requirements of physicians and physician assistants are not altered by the provision of health care services via telemedicine. In fact, a physician-patient relationship may be established through telemedicine.

    This rule does not apply to emergency medical services provided by emergency physicians, emergency medical technicians (“EMTs”), paramedics, and emergency dispatchers. Additionally, the rule doesn’t apply where a physician or physician assistant is treating a patient with an emergency medical condition that requires immediate medical care.

  2. Reimbursement

    While this rule accomplished a lot for establishing standards of care, listing licensure requirements, and online prescription prohibitions it did not mandate insurance coverage or reimbursement for telemedicine services provided in Florida. There are many factors that states use to determine the scope of coverage for telemedicine applications, such as the quality of equipment, type of services to be provided, and location of providers (e.g. remote rural sites). The American Telemedicine Association tracks recent changes to State telemedicine legislation, including those states that have enacted legislation mandating private insurance coverage for telemedicine services. While there are several bills before the Senate and House in Florida, there remains some skepticism by various parties in interpreting and expanding upon current telemedicine regulations. In Florida, if passed, there is a Senate bill which would require public and private insurers to reimburse for telemedicine services allowing doctors to negotiate payment rates with insurers. Supporters of this bill and others believe that in the long term, telemedicine will save money by reducing hospital and emergency room admissions.

Medicaid

According to Medicaid’s website, telemedicine includes such technologies as telephones, fax machines, and emails, which are used to collect and transmit patient data for monitoring and interpretation. Even though such technologies are not considered “telemedicine,” they may nevertheless be covered and reimbursed as part of a Medicaid coverable service, such as laboratory service, x-ray service or physician service. For a provider to be reimbursed for the delivery Medicaid covered services via telemedicine those services must meet federal requirements of efficiency, economy, and quality of care. Federal law affords Florida the flexibility to develop novel payment methodologies for telemedicine services. For example, states may reimburse the physician or other licensed practitioner at the distant site and reimburse a facility fee to the originating site. States are permitted to reimburse for technical support, transmission charges, and equipment. These add-on costs can be incorporated into the fee-for-service rates or separately reimbursed as an administrative cost by the state. If they are separately billed and reimbursed, the costs must be linked to a covered Medicaid service.

Medicaid guidelines require all providers to practice within the scope of their state practice requirements. Some states have enacted legislation that requires providers using telemedicine technology across state lines to have a valid state license in the state where the patient is located. A provider must have a Florida license to conduct telemedicine across state lines into Florida. The provision of health care services is generally held to be where the patient is located, so the standard of care in the patient’s community should, but may not always apply. Existing state malpractice case law, tort law and civil procedure will govern telemedicine issues in the absence of telemedicine specific statutes.

Medicare

On July 7, 2015, the House introduced the Medicare Telehealth Parity Act of 2015, which if enacted, would increase the scope of telemedicine services covered by Medicare. Specifically, this bill would (a) lessen the “originating site” requirements for certain services; (b) expand the types of services that are covered to include services like respiratory services, audiology and outpatient therapy services; (c) expand the types of providers whose services are covered; (d) expand the geographic locations in which telemedicine services are covered; and (e) establish coverage for remote patient monitoring for certain chronic conditions. The bill would allow reimbursement under Medicare for certain services provided in a beneficiary’s home, regardless of locale.

As it stands today, Medicare Part B pays for office or other outpatient visits, subsequent hospital care services (with the limitation of one telemedicine visit every 3 days); subsequent nursing facility care services (not including the Federally-mandated periodic visits under §483.40(c) and with the limitation of one telemedicine visit every 30 days); professional consultations, psychiatric diagnostic interview examination, neurobehavioral status exam, individual psychotherapy, pharmacologic management, end-stage renal disease-related services included in the monthly capitation payment (except for one “hands on” visit per month to examine the access site); individual and group medical nutrition therapy services, individual and group kidney disease education services, individual and group diabetes self-management (“DSMT”) training services (except for one hour of in-person services to be furnished in the year following the initial DSMT service to ensure effective injection training); and individual and group health and behavior assessment and intervention services, and smoking cessation services furnished by an interactive telecommunications system if the following conditions are met:

  1. The physician or practitioner at the distant site must be licensed to furnish the service under State law. The physician or practitioner at the distant site who is licensed under State law to furnish a covered telemedicine service described in this section may bill, and receive payment for, the service when it is delivered via a telecommunication system.
    • The practitioner at the distant site is a physician, physician assistant, nurse practitioner, etc. as defined in the appropriate section of the CFR.
    • The services furnished to a beneficiary at an originating site, such as a physician’s or practitioner’s office, critical access hospital, rural health clinic, Federally qualified health center, hospital, skilled nursing facility, community mental health center, or critical access hospital-based renal dialysis center.
    • Originating sites must be located in either a rural health professional shortage area or in a county that is not included in a Metropolitan Statistical Area.
    • The medical examination of the patient is under the control of the physician or practitioner at the distant site.

Private Payors

Many private payor insurance plans do reimburse for telemedicine-delivered services; however, federal law does not require these payors to provide coverage for any type of telemedicine-delivered service. Some states have passed their own private payor laws, affecting private payor plans that operate in those states. Currently, twenty-eight states and D.C. have some private payor-related reimbursement laws. An additional four states have telemedicine private payor laws that have passed, but are not yet effective. Some states mandates some sort of reimbursement, while other mandate reimbursement at the same level as in-person care under certain conditions.

Mobile Health and Fitness Apps and Wearable Tech

Not all mobile health apps and wearable tech are created equally. If the health app or wearable tech electronically collects, stores, and shares PHI with covered entities (i.e. physicians) or business associates in connection with a transaction for which the Department of Health and Human Services (“HHS”) has adopted a standard, it must be HIPAA compliant. HIPAA privacy and security regulations extensively regulate the use and disclosure of individually identifiable health information and require certain covered entities, including most health app developers, and their business associates to implement administrative, physical, and technical safeguards to protect the security of such information. The HITECH Act promotes the adoption of meaningful use of health information technology. HITECH provides HHS with the authority to establish programs to improve health care quality, safety, and efficiency through the promotion of health IT. HITECH addresses the privacy and security concerns associated with the electronic transmission of health information, partly through several provisions that strengthen the civil and criminal enforcement of the HIPAA rules. Additionally, there are several federal agencies, including the Federal Communications Commission (“FCC”) that regulates the use of wearable tech.

PHI is any information in a medical record that can be used to identify an individual, and that was created, used, or disclosed in the course of providing a health care service, such as a diagnosis or treatment. Examples of PHI includes billing information, test results, doctor’s appointment scheduling, etc. HIPAA was drafted in an age when health apps and wearable tech were non-existent and therefore protecting PHI in health apps was not a consideration in drafters’ minds. As a result, it is difficult to determine which apps must be HIPAA compliant and which are exempt based on the current drafting of the law.

Mobile health apps are not required to be HIPAA compliant if they are only used for tracking or informational purposes, such as those that: (i) track daily diets; (ii) allow the user to covertly research various illnesses; (iii) provide access to medical reference materials; and (iv) permit users to record their weight and exercise routines. To determine whether an app falls under HIPAA, the developer should determine whether the user will be covered entity and if it will include PHI. If the app doesn’t involve PHI or involve a covered entity it doesn’t have to be HIPAA compliant.

Implementing the HIPAA Privacy and Security Rules are indispensable to operating these apps because they are highly susceptible to data theft and other security breaches. When we consider the frequency with which wearable tech and cell phones are lost and stolen we understand why it is so important to be HIPAA compliant. App developers who believe that their apps must be HIPAA compliant can protect and secure PHI by incorporating the following safety mechanisms into their apps: (i) require a password or other user authentication; (ii) allow users to enable built-in encryption capabilities; (iii) allow for remote wiping and/or remote disabling; (iv) restrict file sharing applications; (vi) enable security software to protect against viruses, malware, and spyware attacks; and (vii) make sure that security software is up to date. This is not an exhaustive list, but just some of the security measures that an app developer should consider when adopting policies and procedures to protect PHI on wearable tech.

App developers should require that all of their business associates to agree to sign a Business Associate Agreement. A business associate is a person or covered entity that performs certain functions or activities that involve the use or disclosure of PHI on behalf of, or provides services to, a covered entity. This is true even if the app was not intended to be used in a manner that stores and transmits PHI. If an app collects and stores PHI intentionally or unintentionally, it must be HIPAA compliant. Stating that the app was not intended to collect or store PHI is not an adequate defense during a HIPAA audit.

Healthcare providers are increasingly incorporating wearable tech and mobile health apps into their telemedicine practice. They should not access unsecured or unknown Wi-Fi networks when using this tech if it contains PHI. Securing wearable tech that stores and transmits electronic PHI is required by the law.

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