DEA Continues to Step Up Enforcement Efforts in Response to Opioid Crisis

Most practitioners and businesses that handle controlled substances are required to hold a controlled substances registration with the Drug Enforcement Administration. This includes physicians, pharmacies, dentists, hospitals, manufacturers, reverse-distributors, nurse practitioners, and virtually everyone else who possesses, prescribes, manufactures, or dispenses controlled substances.  Depending on the state, the practitioner or entity may also be required to hold a state-level registration issued by the applicable state entity. For example, until 2016 practitioners and entities in Texas were required to hold a state controlled substances registration issued by the Department of Public Safety before they could even apply for a DEA registration.
 
Any practitioner or business holding a controlled substances registration is required to comply with federal law including the Controlled Substances Act and the applicable rules in the Code of Federal Regulations. While many of these rules are fairly easily understood there are many more that are grey and open ended. Violation of these rules can subject a registration holder to both civil and criminal liability. On the civil side this can involve very large fines and/or the revocation of the holder’s controlled substances registration through a show cause hearing. Criminal penalties can be severe and include incarceration. 
 
The DEA is charged with enforcement of these laws and often works in concert with the United States Attorney’s Office, state law enforcement, and state-level regulators. The DEA’s self-stated mission is to ensure the closed circle of distribution for controlled substances remains intact. This means making sure controlled substance stay within the lawful possession and control of legitimate users from its initial manufacture to final use by a patient. Diversion occurs when a controlled substance leaves the closed circle of distribution through theft, illicit use by the registration holder or their employee, non-therapeutic prescribing by a practitioner or other event that involves in the drug being diverted from legitimate channels. 
 
In my experience the DEA is very aggressive in its investigations and enforcement actions. This has only increased in recent years as it responds to the national opioid crisis. This has led to an increased emphasis on policing controlled substances registration holders as opposed to the DEA’s historical focus on illegal drug trafficking. 
 
Oftentimes a registration holder does not receive notice they are being investigated by the DEA until the local DEA field office suddenly arrives at their business or home accompanied by local law enforcement and state regulators. This is usually done in the context of serving a warrant to seize records, cash, and other property that is suspected to be the proceeds of illegal activity. The DEA will also typically try to conduct on-the-spot interviews with the registration holder and their employees before they have an opportunity to consult with an attorney. This is often accompanied by a demand that the practitioner or entity immediately surrender their controlled substances registration, again without having the benefit of discussing this with a lawyer.
 
In other cases a practitioner or business entity will first become aware they are the subject of DEA scrutiny during or after a routine DEA audit. If the auditor finds discrepancies or other problems the registration holder will typically be notified in writing of the suspected violations. This can often be accompanied by a civil penalty demand and/or request for surrender of the registration accompanied by a threat the DEA will otherwise pursue revocation of the registration through a show cause hearing. The civil penalty demands can be quite massive as federal law allows each violation to be counted as a separate occurrence worth thousands of dollars in penalties. While these penalties can often be negotiated by an attorney the total can still be financially crippling to the registration holder.
 
Any practitioner, pharmacy, or other business that has been contacted by the DEA should promptly consult with a defense attorney. If the DEA suddenly shows up at your doorstep it may be advisable to politely refuse an interview or statement until you can obtain legal advice. Additionally, it is likely best to decline to surrender a controlled substances registration prior to speaking with a lawyer. Giving a statement or surrendering a controlled substances registration can cause irreparable harm to an individual’s case that even an experienced defense attorney might later find it difficult to overcome. 

Change to Texas State Board of Pharmacy's Informal Conference Process

Most pharmacies and pharmacists targeted for an investigation by the Texas State Board of Pharmacy can expect to receive an invitation to an informal conference at some point during their case. At the informal conference, the license holder and their attorney meet with a Board panel to answer questions and present their defense to any alleged violations of the Texas Pharmacy Act.

From the perspective of the pharmacy or pharmacist, the goal of the informal conference is to either convince the panel to recommend dismissal of the case to the full Board or, if this is not possible, persuade the panel to recommend an otherwise favorable settlement. While the pharmacy or pharmacist is not bound to the panel’s recommendation and is still entitled to the full hearing process and possible mediation through the State Office of Administrative Hearings, in my experience most cases with the Pharmacy Board resolve through the informal conference process.

Previously, licensees attending an informal conference with the Pharmacy Board appeared before a panel consisting of a single Board member, the Board’s executive director, the Board’s director of enforcement, and the Board’s general counsel. The single Board member could be a pharmacist or a public (non-pharmacist) member. With only a single Board member present—who may or may not be a pharmacist—most of the licensee’s and their attorney’s interactions with the Panel occurred with the three high-level Staff members: the executive director, director of enforcement, and general counsel. This varied according to the individual personality of the Board member and whether they had a solid background in pharmacy and the specific issues at hand.

The Pharmacy Board recently changed their informal conference format so that there are always two Board members present, at least one of whom is a licensed pharmacist. The Board’s director of enforcement is no longer part of the informal conference while the executive director and general counsel remain participants. This seemingly small change alters the dynamics of the informal conference as the Board members are now much more front and center in the process. More of the questions come from the Board members and interactions with them tend to occupy the majority of the conference. The addition of a second Board member also guarantees a licensee will appear before at least one pharmacist who should have some familiarity with any practice issues important to the case.

In my opinion, the presence of two, as opposed to one, Board members in the informal conference results in a better process. From the perspective of the pharmacy or pharmacist, it increases the likelihood of a dismissal or recommendation individually tailored to the facts of the case and the licensee’s specific circumstances. As a defense attorney I favor this change as it largely leads to better outcomes and is more likely to give clients the feeling they have received a fair opportunity to present their case. In contrast, informal conference processes that are primarily or exclusively Staff driven have a more rigid set of pre-determined results as Staff understandably believe their job is to faithfully implement broad Board disciplinary policies that are aimed at general categories of violations rather than specific facts or circumstances. In contrast, Board members possess more leeway to recommend dismissal or a non-standard result. They are also better positioned to advocate for their recommendation when it is considered by the full Board.

Any pharmacist or pharmacy who has been invited to an informal conference with the Texas State Board of Pharmacy should promptly consult with an attorney. Because most cases resolve though an informal conference process it is important to not put off speaking with an attorney until after the conference. By this time the client may have already unknowingly damaged their case or made it more difficult to obtain a better result without the time and expense of going to trial.

 

The New Face of Telemedicine in Texas

One of the most important healthcare bills to come out of the 85th regular Texas legislative session is Senate Bill 1107. This bill, which has been signed by Governor Abbott, resets the playing field for telemedicine and brings Texas law more in line with other states.

Previously, the scope of telemedicine in Texas had been restricted by statutes and Texas Medical Board rules which required a practitioner who wanted to treat a patient via telemedicine to first establish a valid practitioner-patient relationship through a face-to-face encounter. There were provisions allowing a practitioner to avoid an initial face-to-face meeting through the use of a presenter who was onsite with the patient, however, in practice this exemption was unwieldy at best and an insurmountable barrier for many telemedicine providers. These restrictions were contentious and the source of repeated litigation, most notably the series of successful state and federal lawsuits filed by Teladoc against the Texas Medical Board.

Senate Bill 1107 bars the Texas Medical Board and other state agencies from requiring a face-to-face encounter in order to establish a valid practitioner-patient relationship. Instead, it provides a valid practitioner-patient relationship exists if:

·         The practitioner has a preexisting practitioner-patient relationship;

·         The practitioner is communicating with the patient pursuant to a call coverage agreement; or

·         The practitioner provides telemedicine services through one of the acceptable methods set out elsewhere in the bill.

To be acceptable, a practitioner treating a patient through telemedicine must have access to “relevant clinical information,” such as relevant medical records or test results, and must send the patient’s primary care provider a report on the encounter within seventy-two hours. The law also makes clear the same standard of care applies to a telemedicine encounter as it would to a traditional face-to-face visit. Conversely, state agencies cannot adopt rules creating a higher standard of care for telemedicine.

One of main limitations of the prior law were the restrictions on a practitioner’s ability to prescribe medications through telemedicine. The new law directs the Texas Medical Board, Texas Board of Nursing, Texas Physician Assistant Board, and Texas State Board of Pharmacy to jointly adopt rules on what constitutes a valid prescription in the context of telemedicine. Importantly, it also ties these agencies hands by stating such rules must still permit the establishment of a valid practitioner-patient relationship as provided by the rest of the bill. It is still to be seen how this is implemented by the Medical Board and other agencies and whether the forthcoming rules will create unnecessary burdens to prescribing through telemedicine.

With twenty-eight million residents, many of which are in rural communities far from specialist or even regular primary care, Texas has always been a promising environment for telemedicine. Senate Bill 1007 should go a long way to opening Texas to telemedicine and its touted benefits of greater access to care and lower costs. Still, practitioners should remain aware the full landscape for telemedicine in Texas will not become apparent until the Texas Medical Board and other state agencies adopt rules outlining specific requirements, particularly on prescribing. Additionally, federal law, such as the Ryan-Haight Act, can apply as can another state’s law if the telemedicine encounter is occurring across state lines. Speaking with experienced legal counsel from early date is always prudent.

Governor Abbott Appoints Six New Members to the Texas Medical Board

Since the start of the new year, Governor Abbott has appointed six new members to the Texas Medical Board. The new members, whose terms are set to expire in April 2021, include five physicians and one public member. One of the new appointees, Sherif Zaafran, M.D., has also been named the Board’s new president. Dr. Zaafran, an anesthesiologist, takes over from Michael Arambula, M.D., Pharm.D., who has severed as the Board’s president for the last several years.

With such a sizable influx of new members and the appointment of a new Board president, it will be interesting to see whether there are any shifts in Board policy or disciplinary priorities. Some of the Medical Board’s most prominent initiatives over the last several years have been its ongoing legal battle over telemedicine, the regulation of medspas and non-surgical cosmetic procedures, and the continued crackdown on what the Board views as the non-therapeutic prescribing of pain medications. Whether these will continue to be a primary focus waits to be seen.

On a more individual level, the new Board members have been regularly appearing at informal settlement conferences. Our firm’s experience with the new appointees has been largely positive in this respect as the new members have been generally receptive to the responding physician’s arguments and attentive to the details of each case even if they do not always reach the decision we are advocating for on behalf of our clients. I am hopeful this trend continues.

As of the date of this post, the Board is also still searching for a new Executive Director. The prior Executive Director, Mari Robinson, had a lengthy tenure with the Board and always appeared to play a strong role in the development and implementation of Board policy. Since Ms. Robinson’s departure last year, the Board’s General Counsel, Scott Freshour, has served as the Interim Executive Director. I anticipate any changes in the Board’s broader policies will begin to take shape once they have selected Ms. Robinson’s permanent successor. 

Texas Board of Law Examiners: The Importance of Disclosure When Applying

Prior to being admitted to the Texas Bar, applicants must first demonstrate present good moral character. The agency in charge of making this determination, as well as ensuring applicants meet all other eligibility criteria, is the Texas Board of Law Examiners. The Board of Law Examiners, also referred to as the “BLE,” consists of nine attorneys appointed by the Texas Supreme Court. The ultimate decision on whether to admit an applicant to the Texas Bar rests with the Supreme Court, however, the Court places great reliance on whether an applicant has been certified by the BLE.

In determining whether an applicant possesses present good moral character, the Board of Law Examiners will review the individual’s application as a whole. Past criminal offenses or disciplinary actions while an undergraduate or a law student will commonly raise character issues which result in further investigation by the BLE. Questions of moral character can also be raised by a failure to pay child support, taxes, or court judgments. Essentially, any failure to abide by the law or satisfy legal responsibilities can be viewed by the Board of Law Examiners as relevant to an applicant’s moral character.

All of the above will be considered by the BLE as events bearing on an applicant’s good moral character in and of themselves. Just as important, however, is whether the applicant is truthful and forthright in disclosing and describing these occurrences in their application and other communications with the Texas Board of Law Examiners. In fact, in my experience representing clients before the BLE, it is more often the applicant is in trouble not primarily based on their criminal history or other events from their past, but from a failure to disclose these issues or provide a forthright description.

In my experience, the BLE typically does not deny an applicant due to one or more misdemeanors while they were an undergraduate. The BLE may deny an applicant, or issue a public disciplinary order, if the same applicant fails to disclose their criminal history or provides a misleading description of the circumstances. If the same applicant had fully disclosed their criminal history and provided an accurate explanation of the arrests, it is very possible the Board of Law Examiners would have certified them for admission without even holding a fitness hearing.

The BLE’s policy reflects the value the legal profession places on honesty, truthfulness, and candor to the court. The Board of Law Examiners does not want to admit an applicant they believe would be untruthful or less than forthright with their clients, a court, or opposing counsel. Most lawyers will encounter situations in their practice where the easy thing to do (for themselves or for their client) would be to bend the truth or stretch, if not break, the ethical rules and responsibilities every attorney has as an officer of the court and member of the Bar. Because of this, the Texas Board of Law Examiners can be hesitant to certify someone they feel has been dishonest or misleading during the application process.

I would urge any applicant who needs to disclose past history, or who is unsure whether something needs to be revealed, to consult with an attorney prior to submitting anything to the Texas Board of Law Examiners. Many problems can be avoided by obtaining legal consultation or representation at the start of the application process rather than waiting until a preliminary moral character determination has been made. Once made, a negative preliminary moral character determination will almost always lead to a character and fitness hearing before the Board where the applicant could be facing denial of their application or licensure but with conditions and findings they were dishonest to the BLE.

Senate Bill 195 and Changes to DPS Controlled Substances Registration Requirements

 

Some notable legislation came out of the 84th Legislative Session, at least as it relates to the practice of medicine in the state, and specifically the state’s efforts to fight prescription abuse. Senate Bill 195, passed in the most recent legislative session, serves up some significant changes to the Department of Public Safety’s (DPS) role in regulating the prescribing of controlled substances. 

Effective September 1, 2016, a physician or practitioner in the state of Texas will no longer need to hold a Controlled Substances Registration (CSR) through the DPS. I see this as a positive change as requiring a state DPS registration alongside the federal registration already mandated by the federal Drug Enforcement Administration is redundant and unnecessary. Practitioner’s will probably be happy to have one less expiration date to track, and one less fee to pay.         

Senate Bill 195 also moves the Prescription Access Texas (PAT) electronic prescription database from one state agency to another, specifically from the DPS to the Texas State Board of Pharmacy (Pharmacy Board). PAT has been available for wide use since 2012. Most practitioners who might have occasion to use PAT, are probably aware of it at this point. It makes prescribing data more easily accessible to physicians, pharmacists, and law enforcement. The primary utility for practitioners is the ability to access a patient’s full prescribing history and verify that patients are not receiving controlled medication from multiple sources. It is also useful to monitor whether the practitioner’s own prescribing authority has been used without their knowledge.

So, what is going to change now that PAT is moving under the Pharmacy Board’s operation and control? It appears improvements that have been considered include allowing access to prescription data from surrounding states or nationwide, creating a more user-friendly interface with increased functionality, and ensuring reliable access to the program. The legislature decided that the Pharmacy Board, as a healthcare agency, and an agency engaged in the regulation of filling prescriptions, is better equipped than DPS to implement those changes. We shall see.

 

Texas Medical Board Turns Its Attention to Testosterone and Hormone Replacement Therapy

 

It should go without saying given the Texas Medical Board’s recent aggressive regulatory stance on the treatment of chronic pain, Texas physicians involved in the practice of testosterone and hormone replacement therapy should be made aware of a discussion by the Board at a recent Board meeting regarding a U.S. Food and Drug Association (FDA) safety announcement.

On January 31, 2014, the FDA issued a safety announcement alerting the public the FDA was investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA stated that although it had been monitoring risks related to testosterone products and decided to reassess this safety issue based on the recent publication of two separate studies suggesting an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.

To be clear, the FDA safety announcement stressed the FDA had not concluded FDA-approved testosterone products increased the risk of stroke, heart attack, or death or that patients should stop taking prescribed testosterone products. The Texas Medical Board’s discussions on these issues focused on relevant Board rules regarding standards for physicians practicing complementary and alternative medicine, including requirements of patient assessment, disclosure of expected outcomes, risks and benefits of treatment, a documented treatment plan with periodic review, adequate medical records, and therapeutic validity. The Board also discussed potential disciplinary issues with testosterone therapy which could arise with the “off-label” use of testosterone if the physician did not provide and obtain proper informed consent for off-label use or if the physician did not discuss the benefits weighed against possible risks of the therapy.

Because of the Board’s interest in this particular topic, Texas physicians in the field of testosterone or hormone replacement need to be hyper-vigilant in keeping proper consents and documentation, and keeping apprised of the relevant Board rules.   The attorneys at the Leichter Law Firm have aided numerous Texas physicians to implement best practices.  If the attention has shifted to you and you have an investigation or legal case pending before the Texas Medical Board, and want a knowledgeable administrative law attorney with experience working with the Board and its members, please call the attorneys at the Leichter Law Firm for a free consultation at 512-495-9995.

 

Texas Dental Board Offers Proposed Order Without Giving Dentists a Full Opportunity to Respond

 

The processing of complaints filed with the State Board of Dental Examiners (“Board”) is governed by Chapter 255, Title 3, Occupations Code and Rules 107.00 through 107.103 of the Board’s Rules. After deciding that the complaint involves potential violations, Board Staff has the authority to schedule an informal settlement conference, draw up a proposed board order, or file a formal complaint with the State Office of Administrative Hearings. As the informal settlement conference track gives the licensees an opportunity to present their mitigating or exculpatory evidence to a Board member who has the authority to resolve an investigation, such a setting is many times favorable to flesh out the facts and give the licensees a venue to clarify the issues. 

Unfortunately, the more recent trend has pointed to Board Staff presenting proposed board orders to licensees in lieu of scheduling informal settlement conferences to resolve cases. These board orders are prepared and reviewed by Board Staff, including the dental director who is employed by the Board.  In the proposed order Board Staff will make findings of fact and conclusion of law, and list sanctions without any input from the licensee. The proposed orders are sent to the licensees accompanied by a form letter stating the failure to sign the order would result in a formal complaint and a contested case hearing at the State Office of Administrative Hearings. Many times, licensees, without an understanding of the disciplinary process will be coerced to sign the order as the prospects of a formal hearing are daunting. What the dentist often does not know is they still have the right to request an informal conference and obtain a copy of all non-confidential information in Staff’s investigative file. For these reasons, among others, licensees investigated by the Board should seriously consider hiring an attorney.

The attorneys at the Leichter Law Firm have extensive experience in professional licensing and administrative law and will generally help to secure better outcomes than a practitioner facing the Board alone. In the scenario explained above, we would request an informal settlement conference so that we would be better able to marshal evidence and present your case to Board Staff and a representative Board member.  If you have received a proposed board order without having been afforded the opportunity for a face-to-face informal meeting, please call the attorneys at the Leichter Law Firm for a free consultation at 512-495-9995.

 

Recent Changes to the Texas Peer Assistance Program for Nurses

In the past year-and-a-half there have been several changes to the Texas Peer Assistance Program for Nurses (TPAPN). First, the length of participation has been increased from two years to three years for RNs and LVNs and three to five years for nurse practitioners and CRNAs. This change brings TPAPN more in line with the other official peer assistance programs for health care professionals in Texas such as the Texas Physician Health Program and Professional Recovery Network.

Another important change has been the Board’s move towards offering confidential TPAPN orders in certain cases. Previously, the Board had the option to either refer a nurse to TPAPN directly or enter a public order requiring the nurse to enroll. For cases raising moderate to severe public safety concerns or where the nurse had previously participated in TPAPN, the Board was highly unlikely to agree to a TPAPN referral without a public order. Now such cases can be settled through a non-public order accomplishing the same result. This is a good option in many cases as it allows the nurse to avoid a public order which would follow them for the rest of their careers.

More recently, TPAPN has initiated a new program for nurses with marginal mental health issues comparable to the Extended Evaluation Program (EEP) available to nurses who may have misused a mind-altering substance but lack a DSM-V substance abuse or chemical dependency diagnosis. Like EEP, the new mental health track is a one year commitment, confidential, and not considered to be disciplinary. Typically the participant is only required to regularly meet with their mental health provider who is expected to supply periodic status reports to TPAPN. My experience thus far has been that clients with minor mental health issues or diagnoses in long-term remission are most likely to be accepted.

Given these new developments it is more important than ever for a nurse to contact an experienced attorney to discuss their options if they have been asked or are considering participation in TPAPN. The changes outlined above offer new possibilities for resolution which were not previously available. It takes a lawyer familiar with the Board and TPAPN to know what might be available to a nurse and how to navigate the system to achieve the best result. The increased length of the standard TPAPN contract makes it all the more important for a nurse to seek knowledgeable counsel rather than proceed on their own.

Inappropriate Referrals to the Texas Physician Health Program

 

Since its inception several years ago, the Texas Physician Health Program has provided a valuable option for physicians suffering from chemical dependency, serious mental illness, or physical impairment. For appropriate Texas physicians, the Physician Health Program (also known by its acronym “PHP”) can help a practitioner set up a structured recovery or monitoring program based on recommendations by qualified medical and mental health professionals. Additionally, in most instances participation in PHP is confidential and will not be reportable to the National Practitioner Databank, hospitals, insurance networks, or other credentialing entities.

Unfortunately, my firm has observed an increasing number of Texas physicians referred to PHP by the Texas Medical Board for marginal issues. This includes physicians with a single DWI conviction, long stable mental health conditions, and physical conditions unlikely to affect their practice. Such a physician can quickly find themselves asked to sign a long-term participation agreement with PHP that imposes restrictions on their practice and onerous monitoring conditions. This situation is tragic as in many instances it is possible to obtain a dismissal if the physician hires an attorney and allows the Board to review their case.

A common scenario begins with a physician fulfilling their duty to self-report a first-time DWI or Public Intoxication conviction to the Texas Medical Board. As a follow-up, the physician will often receive a letter from the TMB stating the Board is referring their case to the Physician Health Program for evaluation in lieu of an investigation or possible disciplinary action. The physician is then typically contacted by PHP and asked to set up a meeting with the program director, also a physician, at their office in Austin, Texas. Out of an abundance of caution, PHP will then usually ask the physician to sign a participation agreement with or without further evaluation or treatment. At this juncture, many physicians will enter into the agreement out of a fear of Board action even though their case would likely be dismissed by the Board at an informal conference.

My firm has represented many physicians in the same and similar situations and, through skillful representation before the Medical Board, obtained a dismissal at or before an informal conference. If the issue is marginal, not supported by a diagnosis, or is an existing diagnosis in long-term remission, it is often possible to put together appropriate evidence and expert opinion, present this to the TMB, and convince the Board to dismiss the case without taking any action.

The Board’s decision to refer a case to the Physician Health Program is usually reflexive and done prior to any real review of the physician’s case and circumstances. Effective advocacy by an attorney familiar with the Board’s process can allow a physician with a marginal issue to avoid both discipline by the Board or participation in PHP. Any physician finding themselves in this type of situation should contact an attorney to discuss their options. Evaluation and participation in the Texas Physician Health Program may be inappropriate and unnecessary.