A hospital peer review has the potential to seriously disrupt a physician’s medical practice, often bringing with it a cascade of legal consequences that can devastate a health professional's practice and reputation. If you are a physician facing the prospect of a peer review due to allegations of unprofessional behavior or a standard of care complaint, the earlier you seek help from an experienced healthcare law attorney familiar with the peer review process, the better positioned you will be to protect yourself against these consequences.
An understanding of the process and its possible sequela is important for any physician faced with the prospect of a peer review. There is much more at stake for the physician than whether he or she will retain their ability to work at a particular hospital and many pitfalls which can catch the doctor unawares.
For example, if a physician resigns his privileges during the course of a hospital investigation, the resignation will likely result in a report to the National Practitioner Databank ("Databank" or "NPDB") , a national clearinghouse of information regarding physician misconduct. A report will also be forwarded to the Texas Medical Board which will then open an investigation leading to potential disciplinary action. The NPDB report, and possible Board order, will be visible to other hospitals where the physician holds privileges, and may result in yet further investigations. Any attempt to move on and gain new privileges will require an explanation of the report. Finally, the NPDB report will raise questions with insurance carriers, whom may attempt to remove the physician from their provider network.
The Investigation Stage:
Broadly speaking, the peer review process takes place in two stages: an investigation followed by a fair hearing. The specifics of this process will be governed by the hospital's medical staff bylaws which outline any right of the physician to participate in the investigation and the procedural details of the subsequent fair hearing.
Investigations are typically initiated by the hospital's Medical Executive Committee ("MEC") following a poor patient outcome or complaints about a physician's behavior or professional conduct. In some instances the hospital administration will also have the authority to open an investigation which will then be passed on to the MEC.
In cases where there is a perceived threat the physician's continued practice would pose an imminent threat to the hospital's patients or staff, the MEC may decide to immediately suspend the physician’s privileges pending further investigation. In addition to the severe damage such a temporary suspension inflicts on a physician's practice and reputation, should such a suspension continue for more than thirty days, the hospital is required to file a report with the NPDB and Medical Board.
If the MEC proceeds without temporarily suspending the physician's privileges, the formal investigation process will begin and the physician will receive official written notice of the allegations. If the investigation is related to medical care, the MEC will likely send the relevant medical records out for external peer review by medical professionals in the same field as the physician. After these reviews are complete, the MEC or an investigative panel, made up of other physicians, will then interview the physician.
During the hospital’s investigation, the physician’s ability to actively defend against the allegations is usually limited. For example, the physician may be given little to no access to the relevant medical records. Likewise, the physician may not be allowed to speak with staff members who are potential witnesses to the issue under review. Additionally, the hospital will often restrict the participation of the physician's lawyer during the MEC's investigative meeting(s) even though the physician is typically asked to attend and answer questions.
When the investigation is concluded, the MEC will consider the evidence and make a recommendation. If the recommendation is to drop the allegations, the peer review ends. If, however, the MEC decides to modify, suspend, or revoke a physician's privileges, the physician must be timely notified in writing of the proposed action, the reasons for this recommendation, and informed their right to a fair hearing. In Texas, physicians also have the right to attempt to mediate the dispute with the MEC and hospital.
The Fair Hearing Stage:
If the physician does not agree to the MEC’s recommendation, they may request a fair hearing. A fair hearing is usually conducted at the hospital before a panel of physicians who are also on the medical staff. Ideally, the panel should include one or more physicians in the same specialty. The panel should not include any doctor in direct economic competition with the physician being peer reviewed.
A hearing officer, normally a lawyer, will be appointed to oversee the hearing. The hearing officer's role is to resolve disputes between the physician and the hospital regarding the admissibility of evidence and hearing procedure and advise the hearing panel on other legal issues. A hearing officer should also ensure that the hearing is conducted in compliance with provisions of the Federal Health Care Quality Improvement Act ("HCQIA"). The HCQIA requires the hospital to provide a physician certain due process rights, and a failure on the hospital’s part to provide these rights could result in the hospital and MEC losing its statutorily granted immunity from certain types of lawsuits.
These due process rights include:
· Allowing representation by an attorney or other person of the physician's choice;
· Having a record made of the proceedings;
· Permitting the physician to call, examine, and cross-examine witnesses;
· Giving the physician an opportunity to present evidence determined to be relevant by the hearing officer, regardless of admissibility in a court of law; and
· Allowing the physician to submit a statement at the close of the hearing
The medical staff bylaws may provide other procedural rights for the physician, such as limited discovery. After the hearing, the panel will provide its recommendation to the MEC, who can either uphold or modify the panel's recommendation. If after the fair hearing the MEC decides to proceed with a recommendation adverse to the physician's privileges, medical staff bylaws usually allow the physician to appeal the MEC’s decision to the hospital's governing board. It is only after the governing board upholds the recommendation that the adverse action becomes final and a Databank report containing the MEC's recommendation is generated.
Contact a Professional:
It is important that a physician involved in a peer review quickly retain legal counsel with both experience in this process and knowledge of applicable state and federal peer review laws. Even during the preliminary investigative phase, an attorney can guide and assist the physician in his interactions with the hospital, with an eye toward a subsequent fair hearing or law suit. An attorney is also necessary to ensure the hospital conducts the process in accordance with state and federal laws, and preserve evidence of any infringement of the physician's rights or illegal motives behind the peer review.
Despite being called a fair hearing, this process is anything but. The medical staff bylaws are typically drafted to provide maximum advantage to the hospital and any subsequent lawsuit or appeal claiming the hospital made the wrong decision is unlikely to succeed. Texas courts have consistently held the due process rights which must be provided to a physician are minimal and the hospital's decision will not be second guessed by the judicial system. Peer review is often used as a sword in a political fight involving the medical staff and/or hospital administration with odds stacked against the physician. Even if the physician does not wish to continue practicing at the hospital, it is vital that an exit strategy be crafted protective of the doctor's interests.
The consequences of an adverse action on a physician's privileges will follow the physician for the rest of their career, regardless of where he or she practices. If you believe you are about to be the subject of a peer review, it is imperative that you contact an experienced health care law attorney immediately.
Possible Secondary Effects of a Temporary Suspension on a Physician's Medicare Billing Privileges and DEA Controlled Substances Registration
Given the Texas Medical Board's increasing use of temporary suspension hearings it would be helpful to understand what repercussions those hearings entail. As we shall see, a temporary suspension not only affects a physician's medical license it may also affect his Medicare billing privileges and DEA controlled substances registration. A temporary suspension hearing may have been preceded by a temporary suspension without notice. A temporary suspension without notice is essentially a shoot first ask questions later proceeding. The Texas Medical Board first suspends the MD or DO and then later schedules a hearing pending which the physician remains unable to practice. While we strongly recommend that physicians always have legal representation during temporary suspension proceedings, we believe even physicians who are currently temporarily suspended may benefit from legal representation to mitigate the secondary effects.
Consequences to a physician's Medicare billing privileges and DEA registration as a result of a without notice temporary suspension proceeding:
As a result of a temporary suspension hearing without notice, the physician's license will be suspended leaving the physician unable to practice medicine. However, this suspension will only be in effect until a temporary suspension with notice hearing. At this subsequent hearing a panel of the Texas Medical Board may vote to reinstate the physician's license finding that the evidence is not sufficient to continue the suspension. In the meanwhile, however, the practitioner may still lose his Medicare billing privileges or DEA registration because of the suspension.
A provider is required under the Medicare regulations to report "any adverse legal action" within 30 days. However, there is a good faith argument to be made that the legal action to be reported must be final and unappealable. A temporary suspension without notice is certainly not a final determination as there must be a subsequent temporary suspension with notice hearing. Additionally it should be noted that the suspension of a medical license is only a "permissive" ground for Medicare exclusion. The physician is not mandatorily excluded from Medicare. An administrative lawyer well versed in Medicare regulations would be helpful in avoiding this undue exclusion during a temporary suspension.
The DEA is likewise entitled to revoke a person's DEA controlled substances registration if their medical license has been suspended or revoked. But, as described above, the temporary suspension without notice is short in duration because of the required temporary suspension with notice hearing. An administrative lawyer can similarly forestall the suspension or revocation of a physician's registration based on a thorough understanding of the Medical Practice Act's temporary suspension proceedings.
Repercussions on a physician's Medicare billing privileges and DEA registration as a result of a suspension with notice hearing.
After a with-notice hearing the temporary suspension can remain in place for an extended period of time, sometimes over a year. At this point, both Medicare and the DEA may exercise their statutory discretion and rescind the physician's privileges. However, because the revocation of the physician's privileges is still not mandatory, a skilled administrative attorney can find a legal basis to maintain the practitioner's privileges.
For instance, the physician may appeal the temporary suspension to a Texas district court. This would prevent the temporary suspension from becoming final as it would still be subject to possible reversal. If a physician's case is particularly strong, he may even move to enjoin the Texas Medical Board from enforcing the temporary suspension pending a final decision. This means that the temporary suspension would no longer have effect and the physician could continue to practice medicine in the interim. If the physician is thus "unsuspended," Medicare and the DEA lose their ability to revoke the physician's privileges on the grounds that his medical license is suspended. However, these agencies may still institute their own separate investigations and disciplinary proceedings against the physician to independently find grounds to revoke or refuse to renew his privileges.
A temporary suspension by the Texas Medical Board can have grave consequences for the physician's Medicare and DEA privileges. Physicians should retain legal representation for the temporary suspension proceedings; However, even after a temporary suspension, a physician should seek legal help from an administrative lawyer to mitigate the secondary damage such as the revocation of Medicare privileges and DEA registration. The lawyer must be familiar with both the Texas Medical Practice Act and the federal statutes and regulations governing Medicare and DEA privileges.
Our Leichter Law Firm physician licensing defense lawyers have exactly such experience and have been successful in obtaining injunctions against temporary suspensions and forestalling Medicare and DEA revocations. If you are facing temporary suspension or are suffering its aftermath please contact us at (512) 495-9995 to schedule your initial consultation.
Important Update for Texas Nurses on a Board Order: Texas Board of Nursing Starts Screening for EtG and EtS
During the last month my firm has experienced an influx of calls from nurses who have tested positive for alcohol while on an Order with the Texas Board of Nursing. The consequences of testing positive for a prohibited substance, including alcohol, while under a Board Order can be quite severe. This includes an automatic temporary suspension of the nurse's license and a high likelihood that this suspension will be continued until the nurse has subsequently obtained twelve consecutive months of sobriety verified by additional random drug and alcohol testing. Moreover, from a legal perspective it is very difficult to mount an effective defense in the face of a positive test and avoid these harsh consequences.
The reason for the sudden increase in nurses testing positive for alcohol appears to be the Texas Board of Nursing's new decision to include testing for ethyl glucuronide (EtS) and ethly sulfate (EtS) in their screening panel. Previously, the screening company used by the Texas Board of Nursing only tested for ethanol, however, the Board recently signed a contract with a new vendor that includes both EtG and EtS screening in their panel. This is crucial as the sensitivity and detection window of EtG and EtS testing is much higher than a traditional urine ethanol screen.
Ethanol, or alcohol, is the primary intoxicating ingredient in alcoholic beverages. Accordingly, a person who has ingested alcohol will only test positive for ethanol as long as the alcohol remains in their system. Once it has been fully metabolized by the liver, the person will no longer test positive. Given this is a relatively quick process ethanol testing will generally only provide a 10-12 hour window in which to detect if a person has ingested alcohol. If the person has only had one or two drinks, the detection window is even shorter.
In contrast, EtG and EtS testing can detect even light alcohol use over a period of several days. Additionally, these tests, and the low cut-off levels used by the Board, are highly sensitive to even a small amount of alcohol ingetsion. It is also well documented that inadvertent, casual exposure to alcohol in the environment can cause a person to test positive. Sources of incidental exposure to alcohol that can cause positive results include:
- hand sanitizers containing alcohol;
- foods containing trace amounts of alcohol;
- non-alcoholic beers such as O'Doul's;
- colognes and perfumes;
- sustained exposure to gasoline and other chemical agents containing alcohol;
- mouthwashes containing alcohol such as Listerine and Scope;
- over-the-counter medications containing alcohol;
- certain natural and herbal medications.
I am unaware whether the Board has provided nurses testing pursuant to a Board Order with information concerning this new testing panel. Ideally, nurses should also be provided with a list of different substances which can inadvertently cause a positive result. For many years, nurses in the Texas Peer Assistance Program for Nurses been given this information prior to their enrollment in testing and hopefully the Board is doing or will soon be doing the same. This is also the standard of practice for the Texas Physician Health Program and the Professional Recovery Network.
Texas nurses testing through the Board need to be made aware that they are now being tested for EtG and EtS and receive education on how to avoid an inadvertent positive. Whether a nurse who has already tested positive can mount a legal defense is largely dependent on their test level and whether they were positive for both EtG and EtS. A low positive can be an indication of only inadvertent exposure to alcohol while a test that is positive for EtG but negative for EtS strongly suggests either a contaminated sample or the spontaneous production of ethyl glucuronide in the specimen container. In District Court actions, my firm has previously successfully challenged on these bases two automatic suspension orders entered against physicians by the Texas Medical Board.
If you have tested positive for EtG or EtS, it is prudent to contact an attorney with Board experience immediately to explore your legal options. The Board is likely to move quickly to temporarily suspend your license and time is of the essence. Even if a suspension is inevitable, oftentimes an attorney can be useful in negotiating a subsequent Order with the Board that minimizes the amount of time the nurse will be unable to practice.
Texas Medical Board Schedules Wave of Temporary Suspension Hearings Targeting Pain Management Physicians and Physician Assistants
As we reported earlier this month, the Drug Enforcement Administration (DEA) along with several state agencies, including the Texas Medical Board (TMB) and Texas State Board of Pharmacy (TSBP), has been increasingly active in Houston over the past few months. More than ever before, the joint state and federal taskforce has taken a scorched earth approach to the battle against alleged “pill mills.” The taskforce has generally shown up at clinics and pharmacies unannounced, seizing records and equipment, and demanding surrender of the practitioner’s DEA prescribing registration. The practitioners targeted by this task force and these methods are not just notorious “pill mill” doctors and pharmacies, but also a large number of legitimate pain management physicians, physician assistants, nurse practitioners, pharmacists and pharmacies that just happen to be operating at ground zero of the war on prescription drugs. The net has been cast wide, and many practitioners are finding themselves in need of competent and experienced legal representation.
A Surge in Temporary Suspensions on the Horizon:
Many of the physicians or physician assistants that have any present or past association with these raided clinics are finding themselves the target of Temporary Suspension proceedings by the Texas Medical Board, based solely on their association with an alleged “pill mill”. We have received numerous calls over the last few weeks from physicians and physician assistants who have received notice of Temporary Suspension proceedings and are seeking the services of professional license defense lawyers. The Texas Secretary of State’s website currently lists eight Temporary Suspension hearings to be heard by the Medical Board just next week.
Temporary Suspension proceedings are initiated when Medical Board staff believes they have evidence sufficient to prove that the licensee’s continued practice constitutes a continuing threat to the public welfare (See Occupations Code, Section 164.059(b)). If after a Temporary Suspension hearing, the Disciplinary Panel, made up of Medical Board members, decides that Medical Board staff has indeed presented evidence sufficient to prove that the licensee constitutes a continuing threat, then that licensee’s license is suspended that very day. As such, there is a great deal at stake for any licensee that finds themselves in that position, and the benefit of hiring an attorney well-versed in medical license defense should be clear.
The Board’s Temporary Suspension remedy has traditionally been used sparingly, due to its severe impact on a licensee’s career, and due to the sizeable burden that Medical Board staff shoulders in proving that a licensee is a continuing threat to public welfare. The wave of Temporary Suspensions that the Board currently has scheduled represents a significant departure from that thinking. The commonalities in these cases are that the practitioners have some connection, either present or past, with a pain management clinic that has been targeted by the DEA taskforce. The licensee may be a physician who was serving as a part-time supervising physician or medical director. The licensee may be a physician assistant that worked in the clinic on a contract basis. Whatever the association, Medical Board staff’s theory of prosecution equates any association with an alleged “pill mill” to a continuing threat to the public, and often the evidence that they are using to show a continuing threat is equally as thin. However, if a licensee is not equipped to challenge Medical Board staff’s evidence and legal theories, it is likely that the Medical Board panel will find with Board staff.
What should you do if you receive notice of a Temporary Suspension hearing?
You should hire an attorney immediately upon being noticed of a Temporary Suspension hearing in front of the Texas Medical Board for several reasons.
First, you are most likely not equipped to represent yourself in a contested hearing in front of the Texas Medical Board. The disciplinary process at the Board is not intuitive and Temporary Suspension proceedings are particularly quirky. It is to your benefit to hire someone that is capable of putting on a cohesive defense that will include preparing and presenting documentary evidence, putting on witness testimony, cross-examining Board staff’s witnesses, and zealously advocating on your behalf.
Second, the Medical Board is only required to give you 10-days notice by Board rule (Texas Administrative Code, Title 22, Chapter 187.60(2)). This is a very limited amount of time to put together a strong and comprehensive defense. The best way to combat this challenge is to hire a lawyer that is capable of preparing a defense under these conditions, and to hire them immediately, so as to not waste time.
Third and finally, you should seek legal counsel and potentially hire an attorney because there is a great deal at stake with a Temporary Suspension hearing. It is nothing to be taken lightly. Your ability to practice under your license in the short term is in jeopardy, as is your future practice. A temporary suspension is on your public record forever, and its existence will definitely require explanation, and could potentially cost you opportunities in the future.
If you receive a visit from the DEA taskforce or you are given notice of a Temporary Suspension hearing from the Texas Medical Board or Texas State Board of Pharmacy, please do not hesitate to contact the professional medical license defense attorneys at the Leichter Law Firm. You need the guidance of an attorney that is experienced in medical licensing law, including cases dealing with allegations of non-therapeutic prescribing and prescription drug diversion, as well as the potential criminal ramifications. The Leichter Law Firm’s attorneys have represented clients in similar circumstances and have gained positive results for our clients. Give us a call at (512) 495-9995 or submit an inquiry through our website at http://www.leichterlaw.com/ for a free consultation.
Over the past month, the Federal Drug Enforcement Administration has drastically increased their activity in the Houston area. This includes a dramatic upswing in the number of unannounced raids targeting pain management physicians, physician assistants, nurse practitioner, and pharmacies. At this juncture, most every pain management clinic and pharmacy in the Houston should be aware of the coordinated campaign being conducted against pain management medicine by the DEA, local law enforcement, the Texas Medical Board, and the Texas State Board of Pharmacy. For background information please refer to the numerous posts concerning this topic on this blog.
To date, the government's strategy has largely focused on identifying the largest prescribers and dispensers of the most commonly prescribed medications for pain management— hydrocodone and some type of muscle relaxer, usually Soma— and then targeting these facilities as well as the associated physicians and pharmacists. Oftentimes, the physician, mid-level practitioner, or pharmacist will only first learn they have been targeted when the DEA and associated agencies suddenly appear at their place of business brandishing badges and search warrants. This will be closely followed by a temporary suspension hearing before the Texas Medical Board or Texas State Board of Pharmacy intended to immediately suspend the practitioner's license.
Based on the number of phone calls to my law firm in the last month, it is clear the government's tactics have shifted away from selectively targeting the highest prescribers and dispensers of pain management medications. The DEA is now engaging in a much wider, almost indiscriminate, operation of raiding pain management clinics and the pharmacies that fill their scripts. Many of these raids appear focused merely on seizing records and equipment.
Traditionally, virtually every search and seizure has included a demand by the DEA that the physician or pharmacy owner immediately surrender their controlled substances registration. This is accompanied by vague threats of criminal and/or administrative prosecution if the licensee declines. During the most recent set of raids, the DEA has not consistently requested the surrender of the physician or pharmacy owner's registration. In some instances, the DEA has even specifically told the client they are free to reopen.
This emerging pattern of practice likely indicates the DEA and local law enforcement are amassing documents and information to later be used for mass indictments in federal and state criminal courts. The Houston District Attorney's office has recently suffered several setbacks in their prosecution of pain management / non-therapeutic prescribing cases. These loses probably heralded the current shift of tactics and more careful preparation of cases prior to filing. The DEA may also be looking to pursue more widespread administrative revocation of perceived wrong-doers' controlled substances registrations.
Regardless of the meaning or implications of this change, any physician or pharmacist who is raided by the DEA should immediately contact an attorney with experience representing clients accused of non-therapeutic prescribing/dispensing in both the criminal and administrative arenas. These cases are pursued zealously by the applicable agencies and usually involve a multi-front assault criminally through state or federal court and administratively through the person's controlled substances registration and applicable state licensing board.
Moreover, a physician, pharmacist, or mid-level practitioner should not surrender their controlled substances registration prior to consulting with an attorney. The DEA's raids are designed to intimidate and many practitioners make the mistake of buckling to the government's threats and surrender their certificates. This is a reflexive request on the part of the DEA and does not actually mean the person has done anything wrong or that the government has a good case. Additionally, even though my firm has been very successful in obtaining the reissuance of clients' surrendered controlled substances registrations, the reinstatement process is onerous and time-consuming and the intervening damage to the client's medical practice or pharmacy can be devastating.
Any physician or pharmacy who has been raided by the DEA should immediately contact an attorney, preferably during the actual raid. You have the right to speak to attorney prior to providing a statement or making any decision concerning your certificate. The stakes are very high in these cases and a successful outcome is often dependent on securing competent counsel at the earliest possible stage.
Several months ago I began a series of posts focused on the combined State and Federal taskforce sweeping the Houston metropolitan area targeting physicians and pharmacists viewed as engaged in the non-therapeutic prescribing and dispensing of narcotics, particularly for the treatment of pain. This process continues to develop and generate new sets of licensees' criminally indicted and/or scheduled for temporary suspension hearings before their respective licensing boards.
With respect to the Texas State Board of Pharmacy, the TSBP has been setting an average of at least two pharmacies, along with the employed pharmacists, every month for temporary suspension hearings. A temporary suspension hearing is an extraordinary remedy designed to immediately remove from operation a pharmacy or pharmacist whose continued practice represents an ongoing threat to the public welfare. A temporary suspension bypasses the normal disciplinary procedure by allowing the Pharmacy Board to immediately remove a licensee from practice pending a final resolution by the Board.
Such hearings can be held with little or no notice to the licensee and are decided by a three-member panel of the Board rather than an independent administrative law judge. For a number of reasons, these hearings are almost always difficult for the licensee. As the Board panel is generally comprised of lay persons without a legal background, the rules of evidence are usually only loosely followed if at all. The short notice given to the pharmacist or pharmacy, oftentimes less than two weeks, permits little preparation time especially given it typically takes the licensee a few days even to locate an attorney. Most importantly, as the panel is comprised of Board members, the hearing's decision-makers are usually very sympathetic and receptive to the arguments and evidence presented by Board Staff. A licensee often, and not without good reason, has the impression that the deck has been stacked against them.
If the Board panel does vote to temporarily suspend the licensee's certificate, the only recourse is to appeal this order to District Court in Travis County. This is also an expensive and time-consuming process and the review provided is limited to determining whether or not the agency abused its discretion, not a full re-weighing of the merits. Moreover, in the interim, the pharmacist and/or pharmacy remains suspended.
My office recently represented two pharmacists, and their respective pharmacies, at a temporary suspension hearing before the Pharmacy Board. The allegations were that the pharmacist had over a period of time dispensed thousands of units of hydrocodone, alprazolam, and carisprodal which they know or should have known were non-therapeutic. The evidence presented by Board Staff at the temporary suspension hearing primarily consisted of a patient list of what they considered the thirty "top-offenders." Notably, the Board investigator, who has no medical background, had never even reviewed these individuals' medical records prior to reaching this conclusion. My firm was able to present evidence and testimony that every one of these patients was receiving appropriate care for their illnesses which for most involved a large array of comorbities. In fact, one of the alleged "top-offenders" was the pharmacist's own elderly mother who was receiving appropriate care from several specialists.
My firm was also able to present evidence that virtually every one of these patients had filled scripts at several other pharmacies, including big chains such as Walgreens, CVS, Wal-Mart, and HEB. Not surprisingly not one of the corporate pharmacies had been prosecuted or disciplined by the Texas Pharmacy Board for filling the exact same prescriptions for the same patients.
Currently, there is no sign that the Pharmacy Board intends to slow down its prosecution of independent Houston pharmacies for the non-therapeutic dispensing of pain medications. Unfortunately, oftentimes the Pharmacy Board appears to schedule licensees for temporary suspension hearing with little to no investigation as to whether they are actually inappropriately dispensing prescriptions, a trend which I believe the case discussed above amply illustrates. A temporary suspension hearing can be completely devastating to an independent pharmacist and make the difference between continuing as an ongoing concern and going out of business even if the licensee is later vindicated. Any Texas pharmacist or pharmacy who receives notice of a temporary suspension hearing should immediately contact an attorney familiar with the Texas Pharmacy Board and its processes.
Over the past several weeks there has been an onslaught of temporary suspensions by the Texas Medical Board and Texas State Board of Pharmacy targeting Houston area physicians and pharmacists. These emergency suspensions have all stemmed from the joint state and federal task force combing Harris County for the non-therapeutic prescribing and dispensing of medications commonly used to treat chronic pain: primarily hydrocodone, soma, xanax, and klonopin. Presently, there is no sign that this barrage of suspensions will let up.
Most of the physicians, pharmacists, and pharmacies which have been temporarily suspended seem to have been selected because they have already been arrested or otherwise targeted by the Harris County task force. Moreover, many of these individuals have appeared in local media coverage of the crackdown. Temporary suspensions by the Medical and Pharmacy Board only allow for short notice to the affected practitioner meaning the licensee has little chance to prepare their defense.
Moreover, it has been my firm's experience with such suspensions that the licensee faces an uphill battle as the deciding panel is made up of three Board members, not an independent judge unaffiliated with the prosecuting agency. Generally speaking, such Board panels accept Board Staff's claims and evidence at face value particularly when the practitioner has been arrested or the subject of media attention. The evidence presented in such hearings is usually the testimony of DEA agents or local law enforcement who have been involved in the case. Oftentimes, this involves testimony from an undercover officer who received pain medication from a physician after falsely telling the practitioner they suffer from chronic pain and undergoing an assessment in conformance with the Medical Board's rules on pain management. It is unclear how this constitutes non-therapeutic prescribing as the physician is essentially being lied to by the undercover agent. A Houston pharmacist was likewise recently suspended based merely on the number of pain prescriptions dispensed by their pharmacy as well as the accidental early filling of a single prescription presented by an undercover officer.
Again, the evidence presented is often flimsy at best and likely would not result in an emergency suspension were the matter before an independent administrative law judge. Simply because a licensee has been arrested does not mean the unproven charges will result in a criminal conviction. The unfortunate result of the current approach by the Medical and Pharmacy Board is the suspension of innocent pharmacists and physicians along with those knowingly engaged in the provision of illegitimate pain medication.
A temporary suspension will dramatically impact a practitioner's career and remain a part of their permanent licensure record. Additionally, if the licensee is a physician a report will be generated with the National Practitioner Data Bank and remain there indefinitely. Once a physician or pharmacist is temporarily suspended their only recourse to overturn the suspension is to appeal the case to District Court in Travis County, a process which is neither timely nor inexpensive.
Legally speaking, the temporary suspension of a physician's or pharmacist's license is meant to be an extraordinary remedy designed to immediately remove such individuals from practice due to an imminent danger to the public were they allowed to continue working. Regrettably, it appears as though many of the persons who have been temporarily suspended in the past few weeks have legitimate defenses to the charges levied by their respective Boards. Any physician or pharmacist who receives notice of a temporary suspension hearing should contact an attorney immediately as there will be little time to prepare and a negative result could cause irreparable harm to their career and reputation.
Over the last few years substantial momentum has been steadily building on both the administrative and criminal fronts against physicians whose practice primarily or substantially involves pain management and the pharmacists who file their prescriptions. In many instances, this governmental clamp down is fully justified as every pharmacist and physician familiar with this practice area is well aware of the significant problem associated with the non-therapeutic prescribing of powerful narcotics and other controlled substances. Tragically, many physicians and pharmacies who provide legitimate pain control have also been captured in this ever-widening net. The consequences can be severe and can include the loss, restriction, or temporary suspension of the individual/entity's state license, loss of a physician's DEA and DPS controlled substances registrations, substantial monetary fines, and even criminal prosecution.
As an attorney who has defended numerous physicians, pharmacists, and pharmacies in both state and federal administrative and criminal actions, it has been my impression that the pace of this clamp-down has only increased. I hope to write a series of articles detailing different aspects of non-therapeutic prescribing/dispensing cases and what practitioners and pharmacists can expect should they be unfortunate enough to be targeted under this or a related claim. This article will focus on the combined state-federal task force presently sweeping Texas to shut-down so-called "pill mills."
The Pill-Mill Taskforce:
The expression “pill-mill” is becoming an increasingly recognizable term to the general public due to investigative journalistic pieces done by national news outlets like 20/20 and CBS News. A true pill-mill is typically comprised of a network of dubious physicians and pharmacists that dole out controlled substance prescriptions to individuals, based not on medical necessity, but on their cash value on the street.
Along with growing media exposure came the realization by government regulators and law enforcement officials that much of the pill-mill activity in Texas is based in Harris County. In response, a taskforce of interested state and federal agencies and law enforcement entities was formed to combat non-therapeutic prescribing in the Houston area. The taskforce includes members of the federal Drug Enforcement Agency (DEA), the Texas Medical Board (TMB), the Texas State Board of Pharmacy (TSBP), and local law enforcement. The taskforce has been very aggressive in pursuing and sanctioning Houston pain management clinics and pharmacies. As discussed above, the consequences can be severe and extend all the way to convictions for serious felony offenses.
Targeted Physicians and Pharmacies:
The joint task force uses several different methods to select targeted practitioners and dispensing pharmacies. These include utilizing databanks maintained by the DEA to pull down the largest prescribers and dispensers of certain medications within a given county. The task force also refers to the list of pain clinics which were required to register with the Texas Medical Board following the last Legislative session. Other red flags include all-cash transactions, high numbers of daily patients, large or atypical numbers of narcotics and other targeted medications, frequent use of the pain cocktail of Soma, Xanax, and Hydrocodone.
Once targeted, a physician or pharmacy is immediately placed on the defensive as they face a coordinated assault by law enforcement officials, the DEA and DPS, as well as the applicable state licensing agencies. These investigations are accusatory in nature and generally proceed on the presumption that the individual/entity is engaged or participating in non-therapeutic prescribing. Oftentimes the first indication that an individual has been targeted will be an armed raid of the person's practice or pharmacy and the seizing of their prescription or dispensing records. The physician or pharmacist may be asked on the spot to sign a statement or affidavit connected with the allegations or asked by the DEA or DPS to surrender their controlled substances registration.
Again, it bears reminding that the sudden arrival of the task force may only be because the targeted entity showed up high on the DEA's records on the volume of narcotics prescribed/dispensed or some other such indication which, by itself, has little bearing on whether or not such prescriptions are for a legitimate therapeutic need. I have represented several physicians targeted by the task force despite their having in place rigorous safeguards and practices designed to ensure that all prescriptions are for legitimate medical conditions and taken only at a therapeutic dose.
This task force represents the leading edge of regulatory pushback at what has increasingly been identified as a widespread problem: physicians and pharmacies who fuel prescription drug abuse by persons who lack a legitimate medical need. The problem is that this combined dragnet continues to ensnare numerous physicians and pharmacists who provide genuine and legitimate pain relief to Texas patients.
Any physician or pharmacist contacted or raided by the joint task force or any of its individual members should seek legal representation immediately. If you are raided by the task force you should contact an attorney on the spot and refrain from giving any oral or written statement, signing any documents, surrendering your license or controlled substance registration, or acquiescing to any demand without first seeking legal counsel. The stakes are very high and a mistake could permanently prejudice your ability to defend yourself.
Recent months have seen a sharp upswing in the Board of Nursing’s use of temporary suspension as a disciplinary measure against licensees including RN’s LVN’s, APN’s and CRNA’s. This is likely due to an influx of new attorneys, investigators, and other staff at the Nursing Board. Temporary suspension is authorized by the Nursing Practice Act (The Act), Section 301 of the Occupations Code. Tex. Occ. Code § 301. The Texas Legislature has carved out two specific areas in which temporary suspension is mandated: continuing and imminent threats to the public welfare, and “intemperate use” cases. Tex. Occ. Code § 301.455 and 4551.
First, temporary suspension is required by the Act “on a determination by a majority of the board or a three-member committee of board members designated by the board that, from the evidence or information presented, the continued practice of the nurse would constitute a continuing and imminent threat to the public welfare.” Tex. Occ. Code § 301.455(a). The Texas Legislature has also authorized the Board of Nursing to suspend or restrict a license without notice or a hearing, provided that two conditions are met. Tex. Occ. Code § 301.455(a). First, institution of proceedings for a hearing before SOAH must be initiated simultaneously with the suspension, and second, a hearing must be held “as soon as possible under this chapter and Chapter 2001, Government Code.” Tex. Occ. Code § 301.455(b)(1) and (2).Our lawyers have seen a number of cases in which a temporary suspension on this basis resulted from allegations of egregious sexual misconduct, serious criminal charges, and violence.
Second, Section 301.4551 mandates temporary suspension of a license for so-called “intemperate use” cases. These cases concern nurses who are subject to a board order prohibiting the use of alcohol and nonprescribed drugs or requiring participation in a peer assistance program. Tex. Occ. Code § 301.4551. The Board may temporarily suspend the license of such a nurse if the nurse in question tests positive for alcohol or a prohibited drug, refuses to comply with a board order to submit to a drug or alcohol test, or fails to participate in the peer assistance program and the program issues a letter of dismissal and referral to the board for noncompliance. Tex. Occ. Code § 301.4551. Our law firm has seen numerous cases in which a nurse is placed on temporary suspension if that nurse shows a pattern of repeatedly engaging in intemperate use of alcohol or other prohibited drugs, especially while at work.
Once an order of temporary suspension has been issued, the Board must hold a hearing to determine probable cause within fourteen days of the issuance of the order. Following that, a hearing on the merits must be held within sixty days. The probable cause hearing is in reality the first opportunity the nurse may get to explain their side of the story and why their nursing license should not be subject to an on-going order of temporary suspension. The hearing is held in accordance with the Administrative Procedures Act and the administrative rules governing the State Office of Administrative Hearings (SOAH). The Board’s case is prosecuted by one of its staff attorneys and is ruled upon by an Administrative Law Judge (ALJ) from SOAH.
Recent Amendments to the Nursing Practice Act and the Subsequent Granting of Power to the Texas Board of Nursing
The statutory amendments to the Texas Nursing Practice Act as proposed by House Bill 3961 came into effect on September 1, 2009. The Amendments were largely suggested by the Texas Board of Nursing’s executive staff and attorneys in an effort to circumvent difficulties they were experiencing prosecuting disciplinary and licensure cases involving the nursing practice of Registered Nurses (RN’s), Licensed Vocational Nurses (LVN’s) and Advanced Practice Nurses (APN’s) such as CRNA’s or Clinical Nurse Specialists (CNS).
The lawyers and staff of the Texas Board of Nursing (TBON) proposed these legislative changes to the Nursing Practice Act in response to challenges they were encountering when experienced administrative law and professional license defense attorneys opposed the abuses and tactics that Nursing Board Staff employed in license investigation(s) and contested case hearings.
While it is unclear how Staff of the Board will try to utilize its new regulatory authority the House Research Organization Bill Analysis does help to explain the bill and does confer what the legislature interpreted the provisions / amendments to mean. The changes also require the Board to adopt rules relating to the practice and procedure surrounding its new ability to request / require forensic psychological evaluations and the questionable polygraph report. This procedure is to be accomplished through a probable cause hearing at the State Office of Administrative Hearings (SOAH) and will be the topic of an independent and subsequent blog article.
The changes that will affect the way that license defense / disciplinary cases are handled involve Board Staff’s ability to request and potentially order a chemical dependency analysis or forensic psychological evaluation of a nurse. The Nursing Practice Act now also mandates that the Board utilize its Temporary Suspension Authority when a nurse tests positive for drugs or alcohol while under a Board Order or while participating in the activities of the Texas Peer Assistance Program for Nurses (TPAPN). The statute also requires the Temporary Suspension of a Nurse who is deemed non-compliant with TPAPN. This is especially troubling (as it has been my experience in handling over 500 nursing license defense cases) that oftentimes a nurse ends up in TPAPN due to routine practices by Nursing Board Staff despite the fact that the nurse is neither appropriate nor eligible for TPAPN per TPAPN’s own standards. Oftentimes TPAPN deems a person non-compliant for a cause that does not relate to drugs or alcohol such as the inability to find employment or disqualification to an ongoing medical condition. Unfortunately these nurses may find themselves temporarily suspended without good cause.
Fortunately the new statute appears to require the agency to demonstrate that probable cause exists that the nurse through their continued practice would pose an imminent danger or threat to the public health & welfare.
While reading the House Bill Analysis it is clear that Board Staff lobbied the legislature and attempted to legitimize its use of polygraph tests as a tool in the forensic psychological evaluations. Nurses however should take note that this tactic is still illegal and inappropriate under Texas Case Law and the Supreme Court’s rulings on the admissibility of polygraph test results in a Court of Law.
Any Nurse who falls prey to Staff of the Texas Board of Nursing’s new use of its authority with respect to mandated psychological evaluations or a temporary suspension should contact an experienced administrative law and professional license defense attorney immediately. The Statutes changes clearly allow for defense and rights relevant to these changes and it is best to assert them before Staff of the Board and its lawyers gain an unfair advantage a nurses license / ability to practice.
The Texas Medical Board (TMB) pursuant to the Medical Practice Act section 164.059 has the authority to temporarily suspend a physician's license to practice medicine with or without notice if the physician poses a real and imminent threat to the public through his/her continuation in practice. Although the evidentiary threshold is more stringent than in disciplinary matters, the panel who decides the physician's fate is comprised of three members of the Texas Medical Board and not an independent and neutral Administrative Law Judge. Needless to say, Staff of the Board rarely loses when it decides to remove a physician from practice through the utilization of its emergency suspension powers. Generally, the Board will invoke this authority for the following types of violations and acts:
- Excessive or intemperate use of drugs or alcohol that in the Board's opinion could endanger a patient's life;
- Non-Therapeutic precribing practices;
- Untreated mental illness;
- Repeated standard of care violations;
- Repeated and dramatic boundary violations.
What is not apparent to most physicians who are faced with this process or loss, are the ramifications which follow the entry of an order temporarily removing the physician from practice. When the hearing is with notice or a noticed hearing is waived in an effort to remedy the problem and settle the case for an Agreed Disciplinary Order at a later date the following consequences will ensue:
- The return of the physician's Drug Enforcement Adminstration & Department of Public Safety Controlled Substances Registrations and the potential long term loss of such privileges;
- The suspension of the doctor's hospital privileges at whatever hospital he/she may be a member of the medical staff;
- The disqualification from the individuals Certifying Medical Specialty Board -Board Certification;
- The termination and exclusion from participation as a preferred provider by insurance companies such as Blue Cross Blue Shield & Aetna;
- Exclusion by the Office of the Inspector General from particpating in Federal reimbursement programs such as Medicare & Medicaid;
- Removal from the Approved Doctor's List of the Department of Insurance's Workers Compensation Commission;
- A swarm of negative press as the TMB issues press releases to the physician's local paper and television networks and such stories often make front page headlines;
- The filing of new and otherwise unremarkeable law suits as a result of the now publicly disclosed negative information regarding the physician's character or practice;
- A wave of new Complaints & Investigations to and by the TMB as patients who were otherwise unknowing or on the fence now feel justified in coming forward.