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Understanding the Intervention Project for Nurses Monitoring Contract

If you are a nurse (i.e. LPN, RN, APRN, etc) and have decided to participate in the Intervention Project for Nurses (“IPN”) you will first have to undergo an evaluation, which will include an interview with an IPN approved doctor and a toxicology test. After this evaluation has been completed, IPN may suggest no monitoring or require that you enter into a monitoring contract.

Typically, you have roughly two weeks to sign the monitoring contract. Prior to signing the contract, you should thoroughly review the IPN Participant Manual so that you understand the requirements for participation. The last thing you want is to comply with the monitoring contract only to have your contract extended or have your case referred to the Board of Nursing because you failed to adhere to the Participant Manual’s requirements.

You will also receive a contract packet, which will include: (1) Progress Evaluation for Therapy Form; (2) Work Performance Evaluation Form; (3) Notice of Address/Employer Change; (4) IPN Medication Management Evaluation Form and (5) Medication Report. Depending on your situation you many not be required to complete all of these forms.

Requirements

Contract lengths typically vary from 2 – 5 years and you are required to keep your contact information updated throughout the term of the contract. IPN will review your participation after one year of active monitoring. If you comply with the terms of the contract they will grant you early completion and suspend your contract. For example, if you are have a 2 year contract term and you pass all of your toxicology testing and other requirements under the contract IPN may suspend the second year of your contract so that you can return to practice without any further obligations under the contract.

During the contract period you will be required to undergo random toxicology testing. This is an abstinence contract which means that you are prohibited from using mood altering, controlled or addictive substances including alcohol or alcohol-based products or THC/cannabis products (i.e. CBD, Hemp, etc.). This is true even if you are not participating in the IPN program for any of these specific products.

Periodically, you will need to check in with the Affinity eHealth/Spectrum Compliance App for your toxicology testing notification Monday through Friday. Again, to ensure the accuracy of your testing, you must adhere to the recommendations in the Random Toxicology Testing section of your Participation Manual.

You are required to complete and submit a quarterly self-report online via the Spectrum Compliance App. Quarterly reports are due in January, April, July and October. The App will have a complete list of reports due each quarter some of which can be downloaded from the available reports page by clicking on the PDF link.

Employment Expectations

Prior to accepting a position (paid or volunteer) and/or beginning nursing school clinicals, you are required to inform your immediate supervisor you are an IPN participant. Your position must include direct supervision by another licensed healthcare professional who is: (1) aware of your IPN participation; (2) working on the premises or same unit with periodic observation; (3) readily available to provide assistance and intervention; (4) willing to complete required employer report each quarter.

RNs must be supervised by another RN or APRN and LPNs must be supervised by RNs. LPNs may only be supervised by LPNs in nursing home facilities. You must immediately notify and/or obtain approval from IPN prior to starting or making any changes in any health care related position (i.e. resignation/termination, new employment, supervisor change, etc.) You are also required to work in nursing a minimum of twelve (12), eight (8) hour shifts per quarter while employed, to meet completion criteria.

Unless you have special approval from IPN you may not: (1) be self-employed or work for multiple employers; (2) work for more than 40 hours per week and/or more than 84 hours bi-weekly, if not working 12-hour shifts; (3) work for an agency, home hospice, home health, or float outside the areas supervised by your manager.

Current Status

Your Contract will also state your employment status. Depending on the severity of your condition you may be approved for employment in a supervised nursing position. You are required to provide your immediate supervisor with a copy of the Monitoring Contract and provide your supervisor’s email address to IPN for completion of your quarterly reports. You also need to provide IPN with the contact information for your current place of employment as well as the name of your immediate supervisor. If you fail to relay this information to IPN you may face immediate termination from the IPN program.

Review for Early Completing

As stated above, you may have your contract reviewed for early completion. However, it is contingent upon: (1) compliance with all terms of the Monitoring Contract; (2) negative toxicology tests; (3) minimum of six (6) consecutive months of negative toxicology tests preceding the contract completion date; (4) satisfactory work performance in a clinical nursing position for a minimum of one year; (5) if applicable, recommendation for completion form your Support Group Facilitator, employment supervisor, and treatment provider; and (6) if applicable, work successfully for six (6) months in a clinical nursing capacity subsequent to controlled substance restriction being lifted. For Board of Nursing participants, a readiness-to-complete evaluation is mandatory.

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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

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.***

Seeing Through the Smoke of Florida’s Medical Marijuana Industry

As you may be aware, On November 8, 2016, Florida voters approved the use of Medical Marijuana in a constitutional ballot initiative called Amendment 2. This Amendment approved the use of Medical Marijuana in treatment for patients who suffer from specific debilitating medical conditions. These debilitating medical conditions include, but, are not limited to, cancer, AIDS, PTSD, glaucoma, Parkinson’s Disease, epilepsy, and Crohn’s disease. Physicians may also prescribe Medical Marijuana for “other debilitating medical conditions of the same kind or class” as those mentioned above and “for which a physician believes that the medical use of marijuana would likely outweigh the potential health risks for a patient.” Those looking to do business in the medical marijuana industry must proceed with some caution because even with the passage of Amendment 2 marijuana is still considered a controlled substance consumption of which is illegal under federal law.

Who Can Prescribe Medical Marijuana

Believe it or not, medical marijuana is a Schedule I drug and is regulated by the Florida Department of Health’s Office of Compassionate Use. In order to prescribe Medical Marijuana to a patient a physician must be licensed to practice medicine in Florida and certified by the Department of Health (“DOH”). Further, the physician must complete an 8-hour course and exam offered by either the Florida Medical Association (“FMA”) or Florida Osteopathic Medical Association (“FMOA”). Additionally, if the physician is a medical director of a Medical Marijuana Treatment Centers (“MMTC”) they are required to take a 2-hour course.

Restrictions on Use

Currently, Marijuana is only supposed to be used for the treatment of medical conditions and any recreational use is prohibited. Medical Marijuana may only be consumed in the form of food, tinctures, aerosols, oils, ointments, or related products. Notably missing is the permissibility to consume or use Medical Marijuana in a plant form that can be smoked.

Further, medical marijuana may only be prescribed to eligible patients as defined in Fla. Stat. §499.0295 as having a “terminal condition”. Patients will be classified as terminally ill only if two physicians designate them as such.

Additionally, Amendment 2 makes no accommodations for the use of medical marijuana at the workplace, public places, or school settings. Currently, federal and private program payors are not required to reimburse patients for medical marijuana treatment.

The DOH must register and regulate MMTCs that produce and distribute medical marijuana. Identification cards must be issued to patients and caregivers. In order to receive medical marijuana a patient must be: (1) a permanent Florida resident; (2) a patient of the ordering physician for at least three months; and (3) diagnosed with a debilitating medical condition.

Reaction to the Legalization of Medical Marijuana

The Trump Administration has stated that it intends to enforce federal law that prohibits the use of recreational marijuana, but they are unlikely to prohibit the legitimate use of medical marijuana for treatment purposes.

However, in some cities and counties throughout Florida, legislators and local officials are still trying to determine whether medical marijuana is even legal despite its overwhelming support by voters in Amendment 2. Throughout Florida, many cities are ill-prepared to regulate various aspects of the medical marijuana industry prior to the September deadline requiring its statewide availability. Even after the Trump Administration has made a public statement regarding medical marijuana officials are weary about implementing regulations because it is still federally prohibited. However, at least twenty-eight states have operated without significant intervention from the federal government after they have legalized either recreational or medical marijuana.

Many physicians welcome Amendment 2 and feel that it’s long overdue. Physicians are educating themselves on administering medical marijuana to their patients. For example, they are learning about the various strains of Cannabis and how certain illnesses may respond differently to a particularly strain and dosage. Many doctors prefer to prescribe medical marijuana rather than narcotics, which can be highly addictive to the patient. As a country, we are facing an opioid epidemic and by using medical marijuana as an alternative when appropriate may help to curb the addiction.

Medical Marijuana is Big Business

According to reports, there might be as many as 450,000 patients throughout Florida who may be eligible to receive medical marijuana treatment. That number is expected to rise as the types of illnesses that are treatable by marijuana becomes less narrow and not limited to debilitating medical conditions or terminal conditions. According to New Frontier’s projections, medical marijuana users in Florida will spend an estimated $200 million annually, and by 2020 Florida will account for 14% of the permissible marijuana use in the country.

There will likely be an expansion of dispensing organizations but it will not be easy. Currently, there are seven approved dispensing organizations in Florida. The following is a non-exhaustive list that the DOH considers when dispensing organizations apply:

  • The technical and technological ability to cultivate, process, and dispense low-THC cannabis;
  • The ability to secure the premises, resources, and personnel necessary to operate as a Dispensing Organization;
  • The ability to maintain accountability of all raw materials, finished products, and any byproducts to prevent diversion or unlawful access to or possession of these substances;
  • The financial ability to maintain operations for the duration of the 2-year approval cycle;
  • Passing a background check; and
  • Posting a performance bond.

Individuals seeking to enter the medical marijuana industry face several challenges due to federal laws that prohibit its manufacture, distribution, and use. Banks, insurance companies, and real estate brokers are hesitant to contract with medical marijuana companies due to the existing federal laws. Since it is illegal to operate a medical marijuana company on the federal level banks can’t or are unwilling to loan them money out of fear that there will be retribution  for funding an illicit enterprise. This will only change if Congress passes a measure to legalize the medical marijuana industry.

Conclusion

Legislators must quickly determine the ongoing medical marijuana education requirements for physicians and how it will be regulated. Providers will increasingly enter into the business because the law effectively shields them from civil or criminal actions that arise from their prescribing of medical marijuana. However, physicians may face discipline for wrongfully prescribing low-THC marijuana or medical marijuana. Physicians must ensure that they receive the requisite informed consent prior to prescribing medical marijuana. It’s still uncertain if Amendment 2 will expand the number of dispensaries and by how many. Also, if you are a non-physician looking to enter into the medical marijuana business it is not clear what role one can legally play in the medical marijuana industry other than owning a dispensing organization.

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.

 

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