Monthly Archives: March 2021

A Call for Rational Reform of IPN and PRN Laws and Regulations

As the COVID-19 pandemic has reminded everyone, healthcare workers perform critical jobs under significant amounts of stress every day. While everyone else was sheltering in place, healthcare workers went to the frontlines and put their lives at risk to save others.

Unfortunately, many of these healthcare workers have been taken advantage of by the very programs that were set up to protect and help them. When a healthcare worker has issues with drugs or alcohol, they can seek treatment through an impaired practitioner program. These programs serve dual, laudable goals: 1) to protect the public from impaired healthcare workers, and 2) to provide treatment to these practitioners to ensure that they can practice their craft safety.

Despite these laudable goals, and as discussed in more detail here, these programs have become a trap for health care professionals. While these programs were established by Florida law, they are administered by private corporations with little guidance or oversight. This has led to serious concerns that these programs are over-recommending courses of treatment to make more money, knowing that the professionals subject to their programs must comply or lose their professional license and their career. This ABC investigative report discusses the claims of over-recommendations here.

The time for reform is now. As discussed in detail in this article, if you are healthcare professional who is being unfairly treated by an impaired practitioner program (e.g., IPN or PRN), it is time to band to together to challenge the legality of the current impaired practitioner programs and to lobby for legislative change to address the unaccountable nature of these programs.

Overview of the Impaired Practitioner Programs

The impaired practitioner programs were created by Florida Statute § 456.076 with the stated purpose of protecting “the health, safety, and welfare of the public.” § 456.076(3), Fla. Stat. While no reasonable person would disagree with that goal, the statute itself does very little in the way of ensuring that this goal is being met.

The majority of the statute is devoted to setting forth the structure and organization of these programs. Specifically, the statute creates “consultants” which means the “individual or entity who operates an approved impaired practitioner program pursuant to a contract with the [Department of Health].” § 456.076(1), Fla. Stat.

The Department of Health has entered into two consultant contracts 1) The Impaired Practitioners Network (“IPN”), which exclusively handles issues with nursing practitioners and 2) The Professional Resources Network (“PRN”) which handles all other professionals subject to the impaired practitioner programs statute. See 64B31-10.001, F.A.C.

The statute also creates evaluators. An evaluator is a “state-licensed or nationally certified individual who has been approved by a consultant or the department, who has completed an evaluator training program established by the consultant, and who is therefore authorized to evaluate practitioners as part of an impaired practitioner program.” § 456.076(1), Fla. Stat. Importantly, the statute provides that the consultants themselves (IPN and PRN) cannot evaluate practitioners – only independent evaluators can do that.

The statute further provides for the process for how a practitioner is admitted to an impaired practitioner program. Specifically, the statute provides that PRN or IPN “shall enter into a participant contract with an impaired practitioner and shall establish the terms of monitoring and shall include the terms in a participant contract. In establishing the terms of monitoring, the consultant may consider the recommendations of one or more approved evaluators, treatment programs, or treatment providers. A consultant may modify the terms of monitoring if the consultant concludes, through the course of monitoring, that extended, additional, or amended terms of monitoring are required for the protection of the health, safety, and welfare of the public.” Fla. Stat. § 456.076(5).

There is no additional guidance, either through statute or rule, as to what can be contained in a monitoring contract, what monitoring needs to include, what standards the consultants or the evaluators need to apply when monitoring a practitioner, or any maximum length of time for the monitoring contract. IPN and PRN are left to their own discretion to set the terms of the contract. Moreover, there are no standards set for the evaluators. Evaluators are free to recommend whatever course of treatment they see fit and have no guidance as to when certain treatments should be recommended. For example, there is no statutory guidance to set forth the conditions as to when inpatient treatment is needed versus when a less invasive form of treatment could be given.

What this means from a practical perspective is that when a practitioner is referred to IPN or PRN, either by their employer or by the Department of Health, that person is stuck with whatever contract IPN or PRN sees fit based upon the recommendations of an evaluator who is free to make any recommendation he or she sees fit. There is little-to-no statutory or regulatory oversight as to how these consultants or evaluators deal with the practitioners that have been referred to them.

Once a practitioner has signed a contract with IPN or PRN, these consultants now have significant control over the practitioner and his or her license. Specifically, Florida Statutes provide that the following is grounds for discipline, including revocation or suspension of the practitioner’s license:

Being terminated from an impaired practitioner program that is overseen by a consultant as described in s. 456.076, for failure to comply, without good cause, with the terms of the monitoring or participant contract entered into by the licensee, or for not successfully completing any drug treatment or alcohol treatment program.

§ 456.072(1)(hh), Fla. Stat. (emphasis added).

It is notable that “good cause” is not defined in the statute or any applicable rule. That is discussed in more detail below.

Thus, once a practitioner is in an impaired practitioner program, he must comply with all the terms imposed by that program, otherwise, he will be terminated and subject to licensure discipline.

The Good Cause Exception

One might believe that the “good cause” exception to being terminated would provide a check on IPN and PRN – keeping them from making recommendations that are, for example, not medically necessary or that are too cost prohibitive or onerous for the practitioner to complete. In reality though, the Department of Health has limited the definition of “good cause” so narrowly that it has been rendered meaningless.

While the Department of Health has not undergone any rulemaking to officially define “good cause” when a practitioner is facing discipline for being terminated from IPN or PRN, it has stated that “good cause” is limited to “serious and unavoidable events in the life of a practitioner; such as the return to active military duty, the acute appearance of a disabling medical condition, or death of the practitioner.” DOH v. Adebiyi, DOAH Case No. 18-4813PL, DOH’s Proposed Recommended Order (DOAH 2018). The issues with this definition should be readily apparent and none of those examples would include an example that would allow the practitioner to continue practicing.

Administrative law judges (“ALJs”) have agreed with DOH’s definition. For example, DOH v. Adebiyi, DOAH Case Number 18-4813PL, Recommended Order (DOAH 2018) involved a practitioner who suffered from mental health issues but had no diagnosed issues with drugs or alcohol. As a condition of her licensure, she was required to enroll in IPN. Despite not having any issues with drugs or alcohol, she was required to refrain from mood altering substances and submit to toxicology screening. Due to the costs of the toxicology Respondent missed numerous tests. The ALJ found the following:

  • “[T]he cost of the monitoring program created a financial hardship on [respondent]”;
  • “It has never been shown that [respondent] uses drugs”; and
  • “There was no showing in the record that Ms. Adebiyi has ever caused actual damage, physical or otherwise, to a patient under her care, or that her violations of IPN procedures caused such damage.”

Even with all of this, the ALJ found that good cause did not exist for respondent to terminate her IPN contract and recommended that her license be suspended until she complied with IPN requirements.

Thus, despite no allegations of alcohol or drug use and no allegation that the practitioner was unable to practice safely, the fact that she could not afford drug testing did not constitute good cause for her to terminate her IPN contract.
This unabated definition of “good cause” creates a real issue for practitioners who are facing unnecessary, costly recommendations from IPN or PRN. They must either comply or face having their license suspended or revoked until they comply.

Potential Legal Challenges and Opportunities for Change

One option is to challenge DOH’s definition of “good cause” as an improper, unadopted rule. In fact, Smith & Associates has recently filed an unadopted rule challenge to this definition, arguing that DOH’s definition of “good cause” serves as a rule, as defined by Florida Statutes, but that has never been formally adopted as a rule. Moreover, this challenge argues that this definition constitutes an invalid exercise of delegated legal authority – essentially that DOH is exceeding the authority given to it by the Legislature by adopting this limited, unsupported definition of “good cause.” The case has been assigned case number 21-0866 and its progress can be monitored here: https://www.doah.state.fl.us/ALJ/searchDOAH/.

Additionally, there is an argument that impaired practitioner programs themselves violate the Florida Constitution. Article II, Section 3 of the Florida Constitution provides:

The powers of the state government shall be divided into legislative, executive and judicial branches. No person belonging to one branch shall exercise any powers appertaining to either of the other branches unless expressly provided herein.

Interpreting this, the Court has held that, while power can be delegated to other branches, the Legislature must define clear guidelines and limitations in the statute. Specifically, the Court has held, that “statutes granting power to the executive branch must clearly announce adequate standards to guide … in the execution of the powers delegated. The statute must so clearly define the power delegated that the [executive] is precluded from acting through whim, showing favoritism, or exercising unbridled discretion.” Florida Dept. of State, Div. of Elections v. Martin, 916 So. 2d 763, 770 (Fla. 2005).

Here, the Legislature establishes the Impaired Practitioner Programs in Florida Statute § 456.076. That statute provides no limits or guidance as to what can be contained in the participant contract, the limits on the treatments these programs can require, or any way for a participant to appeal or seek a second opinion. Further, as described above, Florida Statute § 456.072(1)(hh) allows DOH to revoke a participant’s license if they are terminated from a program, but provides no direction or guidance as to what grounds constitute good cause for a program to terminate a participant. In short, the Legislature has improperly delegated its authority to a third-party.

In addition to legal action, there is also the opportunity to lobby for a change in the statute and in the rules related to these programs and their administration. While no one wants to allow impaired health care professionals to be able to practice on patients, guidance needs to be given to these programs to protect the healthcare professionals that protect us. Putting protections in place to prevent these programs from taking advantage of healthcare workers should be a bipartisan goal.

The Need to Organize and Band Together

Legal challenges, lawsuits, lobbying, etc. are all expensive propositions. If each professional stuck in the IPN/PRN trap attempts to fight this alone, they are unlikely to have the resources or the sway to mount an effective challenge against these large, government backed institutions.

However, if they were to band together to form an association to fight for their interests, the collective costs to each practitioner would be minimal, but the collective effect would be significant. These programs affect thousands of practitioners every year. If even a small percentage of them banded together to form an association, it could launch significant legal challenges to these programs as well as lobby for common-sense legislative and regulatory reform.
If you are a practitioner affected by IPN or PRN and need help determining your options or if you are interested in forming an association to challenge these programs, please contact an attorney at Smith & Associates to discuss your rights.

COVID-19 FACILITY SURVEYS

During this challenging and uncertain time in the fight against COVID-19, the Agency for Health Care Administration (“AHCA”) has been working closely with the Florida Department of Health (“DOH”) and health care providers on COVID-19 prevention and response efforts to ensure that facilities across Florida have the knowledge and training to take every precaution to ensure the health and safety of patients, residents and health care staff. AHCA shares key guidance from the Centers for Disease Control and Prevention (“CDC”) and DOH on the importance of restricting visitors, infection control protocols, and hygiene best practices. All licensees need to be vigilant in the protection against the spread of COVID-19 at their facilities. In facilities such as Assisted Living Facilities (“ALFs”) and Skilled Nursing Facilities (“SNFs”), it is extremely important to follow prevention guidelines because once COVID-19 appears in a facility it is a quick battle to isolate it and prevent others from being infected. Unfortunately, sometimes the battle is not quickly won, and the good guy suffers despite following detailed recommendations released by the CDC and the DOH.

Although AHCA and the DOH provide information on training, prevention, and response efforts, it must be noted that they are the policing agencies that are responsible for making sure that the Florida facilities protect their residents. Alerts released through AHCA require that facilities must report the positive COVID-19 cases in their facilities on a daily basis through the Emergency Status System (“ESS”). The ESS is the approved database for all licensees providing residential or inpatient services to report their emergency status. The number of COVID-19 cases in a facility is considered emergency status and must be reported daily.

AHCA and other state survey agencies are under extreme pressure to survey facilities to ensure compliance with COVID-19 directives. In fact, on January 4, 2021, the Centers for Medicare and Medicaid (“CMS”) issued a revised memorandum detailing new triggers for focused infection control surveys. The original CMS memorandum from June 1, 2020 identified two triggers for an infection control survey: nursing homes that report three or more new COVID-19 cases in the past week or one new resident case in a nursing home that was previously COVID-free as reported to National Healthcare Safety Network (“NHSN”). These surveys must be initiated by the state survey agency within three to five days of identification.

The January 4, 2021 update has outlined five more triggers for a focused infection control survey which went into effect immediately. Now nursing homes must meet one of the original case criterion plus at least one of the following new criteria: multiple weeks with new COVID-19 cases, low staffing, selection as a Special Focus Facility (a facility identified by CMS to have a documented pattern of providing poor care), concerns related to conducting outbreak testing per CMS requirements, or allegations or complaints that pose a risk of harm or immediate jeopardy to the health or safety or that are related to certain areas such as abuse or quality of care (e.g., pressure ulcers, weight loss, depression, decline in functioning). A survey may not be necessary for nursing homes meeting the above criteria if the nursing home received an onsite focused infection control survey in the three weeks prior to meeting the criteria, either as a stand-alone survey or as part of a recertification survey. However, in the event that a nursing home continues to meet the above criteria in the fourth week following the prior focused infection control survey, a new survey should be initiated. It must be noted that the original June 1, 2020 memorandum directed that state survey agencies must conduct a focused infection control survey of a minimum of 20% of the nursing homes in the state during the fiscal year 2021. Additionally, to meet this minimum of 20% of state nursing homes surveyed, only stand-alone focused infection control surveys may be counted.

In February 2021, AHCA issued its most recent emergency rules regarding mandatory entry for testing: 59AER21-3 Mandatory Entry for Testing and Infection Control for Nursing Homes and 59AER21-2 Mandatory Entry for Testing and Infection Control for Assisted Living Facilities. These rules provide updated DOH infection control directives and infection control duties concerning staff and resident testing, including making off-shift staff available at the facility for testing.

AHCA’s Field Operations Offices are responsible for conducting facility surveys. When deficiencies are found, a report called a Statement of Deficiencies (“SOD”), is generated to the facility for corrective action. The SOD issued to the facility will specify which rules or statutes the facility is deficient in following. In a situation where a facility is the subject of a focused COVID survey, the SOD may contain a deficiency for Resident Care – Rights & Facility Procedures pursuant to F.A.C. 59A-36.007(6) and F.S. 429.27 and F.S. 429.28 for failure to adhere to recognized standards from the CDC. Such failure may be in the form of failing to ensure social distancing and/or, failure to ensure residents and staff wore personal protective equipment (“PPE”) to prevent the spread of COVID-19. Additionally, it may include facility’s failure to ensure that the staff were knowledgeable about the prevention of the spread of COVID-19 and failure to screen staff and residents appropriately.

Another potential violation of the above rule and statutes that the SOD may contain is for failure to properly abide by the Division of Emergency Management (“DEM”) Order No. 20-011 (signed October 20, 2020) regarding the prohibition of entry of individuals to the facility except in certain circumstances as follows:

1. Every facility must continue to prohibit the entry of any individual to the facility, except in the following circumstances:
…
K. General visitors, i.e. individuals other than compassionate care visitors, under the criteria detailed below:
…
iii. Before allowing general visitors, the facility shall:
1. Set a policy to prohibit visitation if the resident receiving general visitors is quarantined, positive for COVID-19 and not recovered (as defined by most recent CDC guidance), or symptomatic for COVID-19;
2. Screen general visitors to prevent possible introduction of COVID-19;
3. Establish limits on the total number of visitors allowed in the facility, or with a resident at one time based on the ability of staff to safely screen and monitor visitation;
4. Establish limits on the length of visits, days, hours, and number of visits allowed per week;
5. Schedule visitors by appointment only;
6. Maintain a visitor log for signing in and out;
7. Immediately cease general visitation if a resident—other than in a dedicated wing or unit that accepts COVID-19 cases from the community—tests positive for COVID-19, or is exhibiting symptoms indicating that he or she is presumptively positive for COVID-19, or a staff person who was in the facility in the prior ten (10) days tests positive for COVID-19;
8. Monitor visitor adherence to appropriate use of masks, PPE, and social distancing;
9. Notify and inform residents and their representatives of any changes in the facility’s visitation policy;
10. Clean and disinfect visiting areas between visitors and maintain handwashing or sanitation stations; and
11. Designate staff to support infection-prevention and control education of visitors on use of PPE, use of masks, hand sanitation, and social distancing.

2. Individuals seeking entry to the facility, under the above section 1, will not be allowed to enter if they meet any of the screening criteria listed below:
A. Any person infected with COVID-19 who does not meet the most recent criteria from the CDC to end isolation.
B. Any person showing, presenting signs or symptoms of, or disclosing the presence of a respiratory infection, including cough, fever, shortness of breath, sore throat, chills, headache, muscle pain, repeated shaking with chills, new loss of taste or smell, or any other COVID-19 symptoms identified by the CDC.
C. Any person who has been in close contact with any person(s) known to be infected with COVID-19, who does not meet the most recent criteria from the CDC to end quarantine.

Clearly, this Order is very detailed on when and how a facility can admit visitors into the facility and it can easily be found that a facility failed to follow it precisely.

Another possible deficiency that a facility may be cited for is failure to follow the Comprehensive Emergency Plan that is required by F.S. 408.821. This statute requires that any licensee providing residential or inpatient services must utilize an online database approved by AHCA to report information to AHCA regarding the provider’s emergency status, planning, or operations. As stated above, all facilities are required to report their COVID-19 positive cases through the ESS on a daily basis. If a facility fails to report a positive case on any day, it can be cited for failure to follow the Comprehensive Emergency Plan violating the statute.

AHCA imposes administrative fines for violations according to a classification system in statute, based on the nature of the violation and the gravity of its probable effect on facility residents. ALFs’ (governed by Chapter 429, Part I, Florida Statutes, in addition to Chapter 408, Florida Statutes) deficiencies are classified as a Class I, Class II, Class III, or Class IV violation. The core licensing statutes for the facility type determine the Class and the fine that AHCA is authorized to charge the provider. SNFs are governed by Chapter 400, Part II, Florida Statutes, as well as Chapter 408, Part II, Florida Statutes. The “classification” system and applicable penalties for SNFs are found in section 400.23(8), Florida Statutes, and while similar to those of ALFs have striking differences. Specifically, the SNF statute provides for different levels of fines depending on whether the deficiency was isolated, patterned, or widespread. Additionally, for Class I, II, and III deficiencies, section 400.23(8), Florida Statutes, provides that “The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more class I or class II deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection.” (emphasis added).

As part of a survey that results in deficiencies due to COVID-19, AHCA may request a facility to enter a Voluntary Limitation on Admissions in order to help control the spread of COVID-19 in the facility. Many facilities will agree to the voluntary limitation in the best interests of their residents. Unfortunately, the facility cannot begin readmitting former residents or admitting new residents until AHCA issues a letter lifting the voluntary limitation. When the facility finally gets the green light on admissions it is possible that they will have lost numerous readmissions and initial admissions and therefore face a steep financial challenge.

Additionally, even though a facility agrees to a voluntary limitation and then quickly contains the COVID-19 outbreak, they are still at risk for being the subject of an Administrative Complaint. The Administrative Complaint will seek administrative fines, a survey fee, and will sometimes seek to take action against the facility license (e.g., license suspension or revocation). Once served with an Administrative Complaint, the facility has the option to file a Petition for Formal Administrative Hearing to challenge the validity of AHCA’s action or proposed action on the license. Hearings on license proceedings are held before an independent administrative law judge at the Division of Administrative Hearings. Such hearings are an opportunity to prove that the true facts do not support the sought fines, and suspension or revocation of the facility license.

If your facility has received an Administrative Complaint resulting from COVID-19 issues, we can help. Contact an attorney at Smith & Associates today to discuss your rights and options. For additional information on challenging a statement of deficiency or on classification of violations, please see our article Defending Alleged Survey Deficiencies At Assisted Living Facilities (ALFs) and Skilled Nursing Facilities (SNFs).

The Importance of Legal Counsel When Filing for a Trademark Registration

Registering a trademark with the United States Patent and Trademark Office (“USPTO”) is an important process that can confer significant rights on the holder of the registered trademark. Despite the importance and gravity of this registration process, many people seek to perform this task themselves or with the help of a non-attorney service like Legal Zoom. While the process of filing for a registration is deceptively simple (it is an online form accessible to the public), the implications to your brand are significant. Failure to properly research and file your application can lead to consequences ranging from the rejection of the application all the way to a trademark infringement lawsuit by a senior user. This is not a process that should be taken lightly.

The requirement to register a mark have been discussed here. However, while that article discusses the general legal principles for registration, it does not discuss the practicalities of the registration process. Importantly, before filing an applicant will want to do a trademark search to ensure that the new mark will not cause any consumer confusion with an existing mark. While not required by the online form, this step is critical before making any registration application. Failure to ensure that there are no prior, similar registered marks can lead to the application being rejected by the examiner. Worse, by filing the application, you are admitting to using the mark in commerce. This means that if there is any senior user of the mark, you have now opened yourself up to a trademark infringement lawsuit. This simple online form that you have submitted to the USPTO can now become evidence against you in a federal lawsuit – an admission that you were infringing on the mark in question, including the dates you started your infringement.

Further, failure to properly fill out each of the items on the form can lead to office actions from the examiner. Some of the issues in an office action can be fixed and the application can proceed. However, significant changes are not allowed. Failure to properly fill out the application form can lead to the complete rejection of the application. If an application is rejected, your will lose your priority date and, should someone else register a similar mark in the meantime, you may lose your ability register completely.

At Smith & Associates, we take steps to help find potential senior users of the mark and to help prevent the rejection of the application. Prior to filing any application, we provide our clients with an analysis letter that details potential senior marks that have already been registered and which may pose an issue to the registration of your mark. Further, the letter contains an analysis on the strength of your mark and the likelihood that the examiner will allow it to be added to the principal register. This way, prior to filing any registration or making any public admissions, you can have a clear view of any potential issues your registration may face. Additionally, your registration application will be filed by an experienced attorney, someone who understands the underlying legal principles and the legal significance of each of the questions posed in the application. Finally, we do all of this on a flat-fee basis – charging you a single, affordable fee for of our services.

Registering your mark with the USPTO is an important step in growing and protecting your brand. Trying to do this step yourself or without legal counsel can have severe and costly legal consequences in the future. If you are considering filing a trademark registration with the USPTO, you should contact an attorney at Smith & Associates for a free consultation to discuss your rights and options.

Administrative Law Judge Rejects Claim of Sexual Misconduct by Physician

In a recent article, I discussed the ruling by an Administrative Law Judge (ALJ) in the case of Department of Health v. VanBuskirk, which rejected revocation of a physician’s license based on alleged sexual misconduct. See “Physician Discipline Rejected by Judge.” In another Recommended Order entered on March 1, 2020, an ALJ rejected the Department of Health’s claims seeking disciplinary action against a physician based upon allegations of sexual misconduct. See Department of Health v. Khan, DOAH Case No. 20-4079 PL. Unlike the prior case, this most recent decision did not involve a factual dispute over whether a sexual encounter occurred. The physician conceded that a sexual encounter did indeed occur. However, the ALJ found that there was no “physician-patient relationship” because the physician had previously severed the patient relationship months prior to the date of the encounter. The physician previously was the patients’ primary care physician for 13-14 years. However, the patient ended her patient relationship five months prior to the sexual encounter, when she became unhappy with the care and treatment she had received, and her feeling that the physician had committed a major medical error when he ordered the wrong procedure for her. The former patient retained a new primary care provider. She had contacted the physician again by Facebook and asked to see him as a friend. On the day of the encounter, she did not sign in as a patient, was not seen as a patient by staff in a patient room and met with the physician in his private office area. There was no doubt an aggressive and unwelcome sexual advance was made by the physician, but the judge ruled that because there was not an existing physician-patient relationship the actions could not be the basis for a license disciplinary proceeding.

It remains to be seen whether the Department of Health will accept the ALJ’s Recommended Order or will reject the ALJ’s reasoning as to the existence and termination of the physician-patient relationship. (The Agency could reject the conclusion of law interpreting disciplinary rules as being as reasonable or more reasonable than the ALJ conclusion. See 120.57(1(l), Fla. Stat.) Moreover, the physician could still potentially be subject to criminal prosecution, with a conviction supplying a new independent basis for license disciplinary action.