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.
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.
The advent of telemedicine has made it possible to provide high quality medical care for underserved areas of Texas. Patients in rural areas now have the opportunity to receive care from the state’s best physicians when before travel costs would have made it impossible. Because of the new nature of telemedicine, state and federal laws and regulations have remained in flux. It is important for any telemedicine provider to be aware of these changes to ensure they remain compliant.
One of the most significant changes to telemedicine was the passage of the Ryan Haight Act in 2008. The Act places a number of restrictions on the practice of online pharmacies and the ability of practitioner's to prescribe medications through the internet. It was named after Ryan Haight, a teenager who died of a drug overdose in 2001 from controlled substances he bought from an online pharmacy. Mr. Haight was able to procure a prescription for Vicodin online without ever meeting a doctor.
The Act regulates anyone who delivers, distributes, or dispenses medication by means of the internet. The Drug Enforcement Agency treats a practitioner who prescribes medication following a telemedicine evaluation as covered under the Act. Generally a practitioner is in violation of the act if he or she does not perform at least one in-person assessment of the patient before prescribing medication.
The Act does exempt practitioners from this requirement as long as a practitioner meets the federal definition of practicing telemedicine. A physician practicing telemedicine may prescribe controlled substances without an in-person evaluation if: (1) The patient is treated by, and physically located in a hospital or clinic which has a valid DEA registration; and (2) the telemedicine practitioner is treating the patient in the usual course of professional practice, in accordance with state law, and with a valid DEA registration. 21 USC 802(54)(A). The most important thing to note for a practitioner is that the location where the patient is being treated must be a hospital or clinic that is itself registered with the DEA.
The requirement that the patient be in a hospital or clinic with a DEA registration is more stringent than Texas Medical Board requirements. Under Board rules, a physical, in-person evaluation is not necessarily required to prescribe medication and there is no requirement that the hospital or clinic have a DEA registration. A physician may treat a patient solely through telemedicine as long as the physician creates a physician-patient relationship, the patient is being treated at an “established medical” site, e.g., a clinic or hospital, and all additional requirements are met, including the use of a qualified presenter to examine the patient. Texas law also mandates that a telemedicine provider create and maintain detailed written protocols aimed at preventing fraud and abuse as well as separate policies covering the protection of patient privacy.
There are a number of other special types of telemedicine that under federal law allow a practitioner to prescribe medication without an in person visit, such as practicing telemedicine while working for the Veterans Administration, or receiving a special exemption from the Attorney General. The interaction between federal law and state law in this field is complicated and changing, and made all the more complicated by the piecemeal construction of the Controlled Substances Act.
If you are a physician who is thinking of beginning a telemedicine practice, it is important to seek the advice of experienced counsel to ensure your practice meets all federal and state law requirements. The applicable law can be complex and involve overlapping mandates on both the state and federal level. In Texas the rules regarding telemedicine continue to evolve as the Texas Medical Board frequently revisits this issue, often with an eye towards making more stringent regulation. The attorneys at the Leichter Law Firm have aided numerous physicians and other providers navigate both state and federal telemedicine law and implement best practices to help avoid the most common problems endemic to this field. In our experience, telemedicine is a complaint rich area where seeking the advice of a qualified attorney prior to being subjected to state or federal scrutiny makes all the difference.
Given the current aggressive regulatory climate surrounding the treatment of chronic pain, it is worthwhile to look back and understand how the applicable law developed prior to the Legislature's empowerment of the Texas Medical Board to oversee registered pain clinics in 2011. This prior law, including the Intractable Pain Treatment Act, was designed to safeguard physicians who treat chronic pain while remaining within the standard of care. It has been my experience as an attorney representing numerous physicians, mid-level providers, and pharmacies, that this prior law has largely been either forgotten or eroded to the point it no longer provides real protection to medical professionals.
The Intractable Pain Treatment Act (IPTA), separate from the Medical Practice Act, is codified at Chapter 107, Texas Occupation Code, and was intended to provide physicians with a safe harbor in prescribing controlled substances and dangerous drugs to treat pain. In this post we provide a background of this Act and its current relevance, or lack thereof, in the practice of medicine.
The Intractable Pain Treatment Act was passed in 1989 to deal with the problem that physicians were being disciplined by the Texas Medical Board because the Board refused to distinguish habitual users of narcotic drugs from patients with genuine medical needs. Prior to the passage of the IPTA, the Medical Practice Act allowed the Texas Medical Board, known at that time as the Texas Board of Medical Examiners, to discipline physicians for prescribing controlled substances or dangerous drugs to a person "known to be habitual users of narcotic drugs, controlled substances, or dangerous drugs or to a person who the physician should have known was a habitual user of the drugs." This phrasing of the Medical Practice Act made patients taking opioids to alleviate genuine suffering "habitual users." Accordingly, physicians prescribing pain medication to cancer patients were subject to disciplinary action by the Board. Such was the effect that physicians refused to prescribe these therapeutic drugs and hospitals refused to let physicians prescribe them on the premises.
The Intractable Pain Act of 1989 sought to rectify this basic problem by protecting physicians from Texas Medical Board discipline if they prescribed the medication for "intractable pain." Intractable pain is defined as pain the cause of which cannot be removed, treated, or cured. The IPTA also prohibited hospitals from restricting credentialed physicians from prescribing pain medications for intractable pain.
In 1993 the Legislature modified the Medical Practice Act to prohibit doctors from prescribing to a person who was a known "abuser" of controlled medications. In 1996 the Legislature amended the Intractable Pain Act to allow physicians to prescribe controlled medication even to such abusers as long as the medication was strictly for the management of their diagnosed pain which the physician had a duty to monitor. The physician was also required to document the understanding between the doctor and the patient and to consult with an addiction specialist as appropriate. These restrictions were only required when dealing with patients who were drug abusers or had a history of drug abuse.
In its final form the IPTA was meant to provide a safe harbor for Texas doctors who treated long-term pain provided the controlled medications they prescribed were actually for an underlying pain condition. This safe harbor protects physicians who treat known drug abusers for intractable pain provided they monitor the patient and consult with the appropriate mental health expert. Yet the protections of the safe harbor are slight; by the Act's own terms, the Texas Medical Board can still discipline physicians if they prescribe non-therapeutically or prescribe in a manner inconsistent with the public welfare.
The safe harbor provision provided by the Intractable Pain Treatment Act has been recognized, albeit modified, by the Board in its pain management rules codified at Chapter 170, Title 22 Texas Administrative Code. The rules recognize that pain treatment is a vital and integral part of the practice of medicine and that doctors should be able to treat pain using sound clinical judgment without the fear of disciplinary action from the Texas Medical Board. Yet, the rules go on to list several actions that should be involved in the treatment of chronic pain including the formulation of a pain management contract requiring random drug screening.
From the rules it is apparent that whereas the Intractable Pain Treatment Act required heightened monitoring and more rigorous documentation merely for known drug abusers, the Board's most recent rules make that standard applicable to all long-term pain management patients. While the rules do call themselves "guidelines" it should be noted that the Texas Medical Board will allow deviation from the guidelines only if the physician's rational for treatment indicates sound clinical judgment documented in the medical records.
To conclude, the Intractable Pain Treatment Act has largely been subsumed by the Board's pain management rules codified at Title 22, Chapter 170, Texas Administrative Code. Whereas the IPTA was enacted to provide safe harbor to physicians prescribing long-term pain medications, the Board's rules make prescribing harder by requiring extensive documentation from physicians. Whereas the IPTA required monitoring and more rigorous documentation only for known drug users, the Board rules holds all patients to that standard. All that is left from the Intractable Treatment Act is the prohibition against hospitals from restricting the ability of a credentialed physician to prescribe and treat intractable pain.
The rule's emphasis on documentation is important as in my experience most of the chronic pain cases pursued by the Texas Medical Board in the last few years rely heavily on a strongly biased reading of the physician's medical records. When the records are sent out to the Board's confidential expert panel for examination prior to an informal conference, the reviewers invariably apply an unworkable standard of documentation and then conclude, without further evidence, that the absence of certain items means the physician is engaged in non-therapeutic prescribing of medications. Through this process what is at worst a documentation issue is transformed by the Board into a physician who practices outside the standard of care and may even be operating a "pill mill."
The story of the IPTA is indicative of the back and forth history of the treatment of chronic pain in Texas. It demonstrates how the regulatory climate has consistently shifted back and forth between those in favor of broadening access to chronic pain treatment and those who view this ready availability as too broad and prone to abuse by both physicians and patients. Hopefully, the current campaign being waged by the Texas Medical Board, Drug Enforcement Administration, Texas State Board of Pharmacy and local task force will soon face substantial popular or legislative pushback. As it stands, I feel substantial damage is being done to the availability of chronic pain treatment, particularly for patients who are uninsured and not covered by Medicare, as legitimate physicians are pressured to leave this specialty by an out-of-control Texas Medical Board and Drug Enforcement Administration.
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.
A combination of increased competition from large chain brick-and-mortar pharmacies, mail-order refills, and the rise of the internet as a medium for both legal and illegal activity have driven many unsuspecting pharmacists into the dangerous world of “internet pharmacy.” Since at least 1999, various federal agencies led by the Drug Enforcement Agency and the FDA have combined efforts with state law enforcement and state licensing boards to crackdown on internet pharmacies. The result has been the revocation of professional licenses, stiff fines, and long prison sentences. Many of the pharmacists victimized by this legal dragnet have been severely prosecuted simply because they failed to exercise enough caution when entering the minefield of internet pharmacy.
The target of these law enforcement and regulatory efforts follows a typical pattern of organization and prescription/dispensing process. Oftentimes pharmacists and physicians will be approached by a “facilitator”, which may be in the form of a corporation or other entity who are seeking licensed medical personnel to participate. Fees are often paid on a per prescription basis and can be supplemented with generous handling fees for the pharmacists and consulting fees for the doctors. Such facilitators will point to doctors and pharmacists who have already signed on to give their business plan a deeper air of legitimacy and better induce the medical professional(s) to join.
Once the internet pharmacy contracts the necessary professionals, the prescription and dispensing of controlled substances begins. The patient, who may or may not be legitimate, first tries to order a drug online and is then asked to fill out a preliminary questionnaire which will be viewed by a physician. This doctor, who usually never sees the patient and often lives in a different state, reviews the questionnaire and prescribes the requested medication. The prescription is then transmitted to the pharmacist, who can be in yet another state, who fills it and ships it to the patient. Unfortunately, this process, especially the absence of a proper examination and diagnosis, violates most States’ regulatory rules and exposes all participants to administrative and criminal action.
In addition some patients are not legitimate recipients of medical drugs. Many are actually drug dependent or even drug dealers who like the quick and anonymous access to controlled substances provided by the internet and Cash on Demand delivery. It is not uncommon for such unscrupulous individuals to sell their ill-begotten medication for double the price paid.
The potential danger presented by these prescribing practices has led law enforcement and administrative agencies to zealously prosecute internet pharmacies which follow the above pattern. For example, in 2003 ten individuals and three companies were prosecuted under a 108-count indictment for illegally selling prescription drugs over the internet to patients who had never seen a doctor. The defendants included six physicians and two pharmacists who were charged with violations of the Federal Drug and Cosmetics Act for improperly placing into interstate commerce mislabeled drugs and controlled substances. One pharmacist admitted to dispensing at least 9,055 prescriptions for non-controlled substances, and 43,066 prescriptions for Schedule III and IV controlled substances. He was sentenced to sixty months incarceration and was ordered to pay a $140,318.
A 2003 case focused on the website Kwikmed.com and its affiliates. The website allowed a consumer to purchase prescription drugs after filling out a health and symptom questionnaire which were supposedly being reviewed by a physician. The indictment alleged that in fact the majority of cases involved no such review, let alone an actual physical examination. One of the physicians associated with the website plead guilty to five felony counts including conspiracy, introduction of misbranded drugs into interstate commerce, failure to register as a drug manufacturer, mail fraud, and conspiracy to commit money laundering. This indictment was the result of investigations by the FDA and U.S. Postal Service.
These cases are the result of stepped up efforts of federal and state agencies and law enforcement to eliminate certain internet pharmacies and punish those involved with them. The Department of Justice has made clear since 2001 that their focus has been on web sites that involve a questionnaire without any physical examination or any confirmation of the patient-supplied answers. In 2004, the Office of National Drug Control and Policy announced the President’s National Drug Control Strategy for 2004. The policy included increased efforts and budgeting directed towards a crackdown on internet pharmacy including the authorization of such hi-tech police techniques as web crawlers and data mining to locate and prosecute illegal “pill mills.” The Policy also called for better cooperation between the FDA, DEA, FBI, IRS, various other federal agencies, and state agencies and law enforcement in finding and shutting down such illegal activity.
State agencies have also made it clear that they will not tolerate this form of internet pharmacy. For example, the Texas State Board of Pharmacy has explicitly stated that internet pharmacy which is based on either an online or telephonic consultation, such as a questionnaire, without a valid patient-physician relationship is illegal and can subject a pharmacist or physician to discipline and possible criminal action. The statutory and regulatory basis for their conclusion begins with Section 483.021(a) of the Texas Dangerous Drug Act which mandates that a pharmacist determine prior to dispensing a prescription that, in their professional opinion, the prescription is valid. Further, Section 291.34(b)(1)(B) of the Texas Pharmacy Rules holds that for a prescription to be valid it must be based on a valid patient-physician relationship. Finally, according to the rules of the Texas State Board of Medical Examiners, physicians who use the internet “must establish a proper physician-patient relationship, which at a minimum includes:
- establishing that the person requesting the treatment is in fact who the person claims to be;
- establishing a diagnosis through the use of acceptable medical practices such as patient history, mental status exam, physical examination, and appropriate diagnostic and laboratory testing to establish diagnoses and identify underlying conditions and/or contraindications to treatment recommended/provided;
- discussing with the patient the diagnosis and the evidence for it, the risks and benefits of various treatment options; and
- ensuring the availability of the physician or coverage of the patient for appropriate follow-up care.
The mere use of a physician review questionnaire completed under the honor-system cannot meet this standard and can imperil both a pharmacist and physicians’ license, not to mention expose them to criminal sanctions.
The condemnation of “questionnaire” prescribing is not limited to Texas. In 2000, a special committee on conduct and ethics of the Federation of State Medical Boards noted that the “prescribing of medications by physicians based solely on an electronic medical questionnaire clearly fails to meet an acceptable standard of care and is outside the bounds of professional conduct.” The American Medical Association has concurred with this statement stating that such practice does not meet the requisite standard of medical care. In 2001, the California State Board of Pharmacy fined Total Remedy and Prescription Center $88 million and charged two of its pharmacists with filling prescriptions in violation of that state’s rule requiring a prior good faith examination by a doctor with a California license.
Many of the targets of this war on internet pharmacy are simply everyday professionals who were simply looking for a new source of business without a proper awareness of the very real legal traps present in internet pharmacy. If a doctor or pharmacist enters online pharmacy and only later does it come out that his or her partners have not been following the rules, the authorities will still try and hold the otherwise innocent practitioners liable for their partners’ malfeasance. A claim of ignorance, even if genuine, will not stop a prosecution or disciplinary action from being initiated. In fact, my law office has represented individuals who have gone so far as consulting an attorney and hiring a private investigator to determine the legality of the online pharmacy with which they were doing business.
The world of internet pharmacy can be a dangerous place for all those involved. The current crackdown on internet pharmacy and its participants shows every sign of continuing. Any physician or pharmacist considering entering such a venture or who already practices in one should exercise extreme caution. An informed professional can better protect themselves by requiring such assurances as VIPPS or SquareTrade Licensed Pharmacy Program certification of all websites before entering into a business arrangement. Developed by the National Association of the Boards of Pharmacy and the National Community Pharmacists Association respectively, these certifications mandate that internet pharmacies conform to certain practice guidelines. Further, a doctor or pharmacist would be wise to consult with an attorney knowledgeable with the fast developing law affecting internet practice. The worst course a professional could take is to ignore any warning signs such as inconsistent prescriptions or suspect practices, as deliberate ignorance of possible violations of state and federal law will not provide a defense to later investigation(s) or prosecution(s). The consequences of doing so amid the current regulatory climate are simply too dire.