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.