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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were governed by Florida Administrative Code 64B8-9.0141 (for Medical Doctors) and 64B15-14.0081, which have since been repealed and replaced by this House Bill and Florida Statute §456.47.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.

Florida Pharmacists Must Use E-FORCSE To Combat Opioid Abuse

By: Saamia Shaikh, Esq., OMS-III

In 2011, Florida legislator’s enacted the Prescription Drug Monitoring Program, also known as, the Electronic-Florida Online Reporting of Controlled Substances Evaluation (“E-FORCSE”). The program has legally expanded the role of dispensing pharmacists by requiring them to report the distribution of controlled substances.

 

E-FORCSE requires dispensers of controlled substances to report, within seven days, information regarding the prescriber and the patient for any prescription filled for controlled substances. Specifically, a patient’s demographic information, DOB, gender, as well as the prescriber’s demographic information, DEA number, NPI number, and license number must be reported. Additionally, dispensing information such as the dispenser’s DEA number, Rx number, date written, date filled, refill number (if applicable), NDC, quantity/strength dispensed, and payment type must also be reported. The failure to report a controlled substance willfully and knowingly as required by section 893.055 Florida Statutes constitutes a first-degree misdemeanor.

 

As of 2014, the Florida Board of Medicine reported opioid-related deaths had decreased by 41%.  Nevertheless, Florida remains a leading state in terms of opioid abuse with an estimated 3,900 deaths arising from opioid abuse and overdose in 2015.

 

On May 3, 2017, Governor Rick Scott declared Florida in a state of emergency due to the opioid epidemic. Pursuant to the Governor’s Executive Order 17-146, Dr. Celeste Philip, the Surgeon General of Florida, declared this matter a public health emergency, statewide, and issued a standing order for naloxone, an opioid antagonist that is commonly used to treat and reverse opioid overdose. The order authorizes pharmacists to dispense naloxone via either an auto-injection delivery system or via intranasal spray to emergency responders such as firefighters, emergency medical technicians, paramedics, and law enforcement officers. As a result, pharmacists do not require a script from physicians to dispense naloxone to emergency responders. Emergency responders are shielded from civil and criminal liability under Florida’s Good Samaritan Act if the life-saving treatment is done in good faith and with the exercise of reasonable care.

 

The current state of emergency in Florida is a tremendous opportunity for pharmacists. In 2015, the Fifth District Court of Appeal in Oleckna v. Daytona Discount Pharmacy held that that pharmacists owe a duty of reasonable care that extends beyond merely filling a script written by a physician; “robotic compliance” would not suffice. Pharmacists are being held to a higher standard of care and thus must independently evaluate every situation before dispending controlled substances to a patient. In their evaluation, E-FORCSE is an additional tool pharmacists can consult before filling a prescription. If a pharmacist suspects “doctor shopping” or determines that a patient is improperly and excessively presenting scripts for controlled substances, he or she may legally refuse to fill such a prescription. Pharmacists also have the option of calling and discussing any issues with the prescribing physician before reaching a conclusion about filling a questionable prescription. In fact, pharmacists are being held increasingly liable for filling scripts without independent investigation and must assess the reasonableness of the prescription including: (1) the reasonableness of the dosage of any medication prescribed by a physician; (2) the frequency by which the respective medication is to be taken; (3) as well as the quantity of pills to be dispensed.

 

While physicians may be aware of E-FORCSE, they do not actively use or reference it. Surprisingly, physicians were reported to be a minority amongst the class of users reported. An article published in the International Journal of Emergency Medicine by Young et. al. in 2017 shed some light on this issue, revealing that emergency room physicians’ use of E-FORSCE was low due to barriers in access and due to a lack of formal training of how to use the program.

 

While the duty of a pharmacist is not clearly defined, recent case law in Florida as well as the expanding role of pharmacists suggests an elevated duty of care owed as well as a greater exposure to liability. Thus, it is imperative that all pharmacists be cognizant of their professional duty of care owed and be familiar with all their options in a dubious situation, especially given the current climate of abuse in the state.

Saamia Shaikh, Esq., OMS-III

My DEA Number was Stolen by an Employee and Used to Buy Controlled Substances

Most doctors have various licenses that provide them with unique identification numbers. If any of these identification numbers find their way into the wrong hands it can be detrimental to the healthcare provider’s practice, their patients, and the public. Doctors hire support staff to run their practice efficiently by perform tasks that they don’t have time to do or don’t have the training to perform. This employer-employee relationship requires a certain level of trust from both parties because a bad act by either party can have a negative impact on the other party’s license, privileges, or reimbursement for services. Some of the support staff working in a doctor’s office may have access to HIPAA-protected information and a doctor’s unique identification numbers, such as his NPI and DEA numbers. What should you do if one of your employees steals your DEA number and uses it to self-prescribe controlled substance through e-prescribing or traditional prescription pads? What if they use your DEA number to order controlled substances for the practice without your knowledge or consent? Doctors should also be concerned with their potential liability for the unauthorized use of their DEA number.

My DEA Number Was Stolen by an Employee and Used to Self-Prescribe Controlled Substances

Most doctors have various licenses that provide them with unique identification numbers. If any of these identification numbers find their way into the wrong hands it can be detrimental to the healthcare provider’s practice, their patients, and the public. Doctors hire support staff to run their practice efficiently by perform tasks that they don’t have time to do or don’t have the training to perform. This employer-employee relationship requires a certain level of trust from both parties because a bad act by either party can have a negative impact on the other party’s license, privileges, or reimbursement for services. Some of the support staff working in a doctor’s office may have access to HIPAA-protected information and a doctor’s unique identification numbers, such as his NPI and DEA numbers. What should you do if one of your employees steals your DEA number and uses it to self-prescribe controlled substance through e-prescribing or traditional prescription pads? What if they use your DEA number to order controlled substances for the practice without your knowledge or consent? Doctors should also be concerned with their potential liability for the unauthorized use of their DEA number.

Reporting Requirement

According to Florida Statute §893.07(5)(b), if your DEA number has been stolen and used to divert controlled substances you must file a police report with the local sheriff of that county within 24 hours after discovery. A person who fails to report a theft or significant loss of a controlled substance commits a misdemeanor of the second degree. It is not required that you press charges against the perpetrator of the theft, but I always recommend that my clients do so for several reasons. First, it shows authorities that you were not complicit in the theft. Second, it becomes part of the employee’s record and prospective future employers will be able to see this information on their criminal history during background checks. Third, as punishment for the emotional despair you will endure, negative impact on your practice, and the cost to hire an attorney to represent you in this matter.

You must also notify the Drug Enforcement Agency (“DEA”) within one business day upon discovery of a theft or significant loss of controlled substances. “Upon discovery” means that a report should be filed once the doctor has made a good-faith effort to determine whether a theft has in fact occurred. To determine whether a loss is significant the DEA provided the following factors in 21 C.F.R. § 1301.74(c):

1) The actual quantity of controlled substances lost in relation to the type of business;
2) The specific controlled substances lost;
3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
5) Whether the specific controlled substances are likely candidates for diversion; and
6) Local trends and other indicators of the diversion potential of the missing controlled substance.

The six factors mentioned above are not exhaustive and should be taken into account with other factors where appropriate.

According to 21 C.F.R. § 1301.76(b), the DEA’s implementing regulations for the Controlled Substance Act, all DEA registrants must complete DEA Form 106 and submit it to the DEA electronically or by mail. Once submitted, the DEA will begin the investigatory process and contact you to obtain additional information.

Additionally, you should contact the board or association that grants you your license to practice (i.e. Florida Board of Osteopathic Medicine) to see what reporting requirements they may have. For example, although I could not find a clearly defined rule requiring so, the Florida Board of Osteopathic Medicine (“FDOM”) strongly suggests that the doctor file a complaint with the Florida Department of Health (“DOH”) against the perpetrator of the crime so that they may conduct their own investigation into the matter. The complaint should be sent to the Consumer Services Section of the DOH. You will typically receive a response from the DOH within ten business days at which point in time they may schedule a phone call or an in person meeting as part of their ongoing investigation. This investigation may include interviewing parties in your practice about the perpetrator or the crime and facts and events that gave rise to the incident.

During all stages of the investigation, whether talking to the DEA, local police authorities, or the DOH you must be candid with the investigating authorities so that there isn’t any indication of impropriety on your part.

Steps To Prevent A Theft From Occurring Again

To limit the occurrence of future thefts or significant loss, providers should do the following:

  • Conduct employee background checks for all employees, including those employees with access to controlled substances. This background check should be performed in any local, state jurisdiction where the employee has worked and resided. Federal background checks should also be performed.
  • Schedule I and II drugs must be stored separately from other drugs in an approved safe. Schedule III and IV drugs must also be kept under lock and key but the security measures are more relaxed than their counterparts.
  • Utilize tracking software that records specific employee’s removal of controlled substances from locked cabinets together with an associated patient identifier. The software is designed to flag and alert the doctor of suspicious or unusual employee activity.
  • Providers should also conduct periodic internal audits to ensure that the inventory of controlled substances is accurate.
  • Providers may also want to consider a adopting a policy into their practice which requires employees to be periodically drug tested and suspicion-based drug testing. Drug testing should be performed prior to employment; the offer of employment should be conditional on a clean drug test.
  • Sparingly share you DEA number and e-prescribing log-in information only with trusted employees.
  • Make sure that your prescription pads are locked up in a secure area. Utilize watermarks on your prescription pads because it makes it more difficult to replicate.
  • Monitor remittance advice, claims and reimbursements to verify billed services match your income.
  • Observe and takes notes of erratic or unusual behavior by an employee (i.e. lying and mood swings) and physical abnormalities, such as “track marks”, excessive sweating, pale skin, red face with red eyes, etc.
  • Implement a training program to educate staff on controlled substance diversion.

 

Conclusion

If you are unable to determine whether a theft of controlled substances did in fact occur within one business day, you should err on the side of caution and file a report with the DEA and other appropriate authorities. It may also be necessary to notify the Center for Medicare and Medicaid Services If you fail to timely report a theft or significant loss you may face penalties and fines or any other remedial actions that the authorities deem are necessary. If any patients were affected by the theft you must determine how to appropriately notify your patients. Make sure to gather any documents or evidence that can be useful for authorities during their investigation. Any theft of prescribing pads should be reported to the Board of Pharmacy.

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This post was authored by Jamaal R. Jones, Esquire of Jones Health Law, P.A. for more information contact me at (305) 877-5054; email us at JRJ@JonesHealthLaw.com, or visit our website at www.JonesHealthLaw.com.

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.