The Texas Medical Board's Stricter Chronic Pain Management Rules Prompt Physician Concerns About Liability
Law Feature — September 2015
Tex Med. 2015;111(9):51-55.
By Joey Berlin
How big is the difference between "should" and "must"? Texas physicians treating patients for chronic pain may soon find out.
The Texas Medical Board (TMB) has adopted amendments to clarify just how set in stone the board's chronic pain treatment rules are and to ensure patients receive treatment that matches the evolving standard of care. The changes, as TMB stated in its rule proposal last spring, "are more clearly delineated as minimum requirements that a physician must do in every case when treating pain."
Although TMB downplays the regulatory change from chronic pain treatment "guidelines" to "minimum requirements" as a semantic one, others say the rule changes are a much more significant shift. The Texas Pain Society (TPS) applauds the board's efforts in written comments and believes the amendments will help crack down on the unsavory, overprescribing practices of so-called "pill mill" clinics.
But Houston anesthesiologist Jaideep Mehta, MD, chair of the Texas Medical Association's Committee on Patient-Physician Advocacy, says the rule amendments go too far, particularly with regard to the information they require physicians to document. The rule changes adjust numerous chronic pain guidelines from something physicians "should" do to something they "must" do. During the comment period before the rule's adoption, TMA expressed other concerns with the rule language.
"I think it's going to be a very big burden on the individual [with] the change of practice, and [a burden on] the ability to run a practice effectively for many people," Dr. Mehta said.
The board published the adopted rule in the July 31 edition of the Texas Register, and the rule took effect Aug. 4.
Requirements, Not Guidelines
The adopted rule specifies "Minimum Requirements for the Treatment of Chronic Pain." A new opening subsection further states TMB will evaluate a physician's treatment of a patient's pain by considering whether the treatment met the accepted standard of care and whether the physician met the listed minimum requirements. The rules go on to change the language accordingly, amending numerous instances of "should" to "must."
TMB Executive Director Mari Robinson says the new, stricter language doesn't change the nature of the rule. She says the rules in the section were always requirements, and the board always enforced them as such. TMB does not compile statistics on violations of a particular rule section.
"The physician has always been held to these standards under [Chapter] 170, and we added a couple," Ms. Robinson said. "But the ones that were there, they've always been held to those."
Others see more of an impact in the board's should-to-must language shift.
Dr. Mehta, who reviewed the rules for the Committee on Patient-Physician Advocacy, says one example is the way the amendments affect the interpretation of a rule that now states, "The physician must refer a patient with chronic pain for further evaluation and treatment as necessary."
Dr. Mehta says that amendment is the most alarming change for primary care physicians. He notes many counties in Texas don't have access to certain specialists, and he adds the rule doesn't leave enough flexibility for doctors who believe they're already doing an adequate and appropriate job of pain management.
"That's a pretty big push to say that you've got to send somebody off to a specialist when there may not even be a specialist available," Dr. Mehta said.
The word "must" also tightens a physician's requirements for documenting the patient's history and the doctor's rationale for treatment. The rule now says a doctor must, rather than "should," document a six-part list of information pertaining to the patient's case. That list includes the nature and intensity of the pain, the effect of the pain on the patient's physical and psychological function, and any history of and potential for substance abuse. The amendment also requires the physician to include a patient's history of and potential for substance diversion.
Dr. Mehta says the documentation burden the new rules impose not only is too heavy but also leaves physicians open to potential liability. As an example, he points to the amendment on informed consent. That rule now requires a physician's discussion of risks and benefits for a treatment plan to include an explanation of seven items, including anticipated therapeutic results, therapies available other than drug therapy, and potential side effects and how to manage them.
Dr. Mehta worries that a patient who overdoses or becomes addicted to a drug could sue a physician if the record doesn't document that the doctor discussed every single side effect listed for every opioid prescribed.
The rule tightens documentation requirements some more. It stipulates that in documenting the physician's rationale for the patient's treatment plan and prescriptions, the patient's medical record "must" include a list of 10 items. (See "Pain Management 'Musts.'").
"The rules no longer would say they must simply demonstrate sound clinical judgment and rationale … now you've got to be very detailed, and the rules almost dictate the nature of how you're going to practice that pain management and how you're going to use specifically that class of medication," Dr. Mehta said. "That's where it becomes fairly alarming — that the rules would get that prescriptive … as to what must be documented in the record and minimum requirements.
"[Those are] things that would open us as physicians up to lot of legal challenges or legal concerns with respect to licensure or risk of loss of license if you're in violation of that for any one record. Because there are so many items that they specify in the case of chronic pain," he added.
Austin attorney Michael Sharp agrees that changing the guidelines to requirements opens physicians up to potential liability.
"I think that making it required — a failure to do it would first of all be a violation [with] the board," he said. "And, secondly, now that it is a rule, I think a plaintiff could try to make a case against a doctor who had not completed all the required actions, and that's scary."
But Garland pain management specialist C.M. Schade, MD, a past president and current director emeritus for TPS, says the rule changes were necessary to negate the arguments pill mills have used to defend their prescribing practices: that the rule presented only guidelines, not requirements, for pain treatment.
"The Texas Pain Society is never in favor of more mandates, but it's one of the necessary evils when dealing with something that has street value, which narcotics have," Dr. Schade said. "So it really ups the game because now it says that you 'must' do a history, physical exam, diagnosis, treatment plan, and other requirements in the rule. That means that if you don't, without proper documentation, you're in violation of a rule."
Not all of the rule changes amounted to merely changing a word or two. One new section requires a physician to "consider" reviewing the patient's prescription data and history through the state's prescription monitoring database, Prescription Access in Texas (PAT), before prescribing dangerous drugs or controlled substances. A physician must also consider obtaining a baseline toxicology screen to determine the patient's drug levels before prescribing controlled substances.
How will the board know whether a physician actually considered those steps? Rather than hook doctors up to a mind-reading machine, TMB requires them to prove they considered it by documenting in the medical record why they didn't review the patient's prescription data and history or why they didn't obtain the baseline toxicology screen.
"If you are going to be prescribing chronic pain drugs to somebody, part of what the board believes you should do is check the prescription monitoring program or at least consider doing that," Ms. Robinson said.
During the comment period, TMA expressed concern about the proposed rule language on a couple of fronts. The original proposal didn't explicitly say the language would apply only to the treatment of chronic pain, so TMA suggested including a specific reference to chronic pain treatment. The board took that suggestion, inserting the words "for the treatment of chronic pain" in the rule.
But the board didn't make any changes based on TMA's larger concerns. One such concern was that the responsibility for PAT would change hands. In June, Gov. Greg Abbott signed a bill transferring responsibility for PAT from the Texas Department of Public Safety to the Texas State Board of Pharmacy (TSBP).
In written comments, TMA asked the board to delay the requirement until TSBP had taken control of the prescription database and could implement anticipated improvements to the system. Once the transition was complete, TMA recommended a "stakeholder process should be undertaken jointly and the TSBP invited to participate, with the goal of improving the system's utility and any related rules."
TMB addressed that concern by writing in the Texas Register, "The board has learned that there will be little interruption to the information system's operation, if any."
TMA asked whether the rule should "apply to inpatient acute episodes of care, where there is not the same level of concern regarding diversion. … Can this obligation be delegated under appropriate supervision? TMA believes that these questions, among others, warrant further discussion and consideration by the TMB," the association wrote.
TMA had the same concerns with another section of the rules that requires physicians to periodically review a patient's compliance with the prescribed treatment plan and reevaluate the patient for any potential substance abuse or diversion. The doctor would again have to consider reviewing PAT and/or obtaining a baseline toxicology screen, and if the physician didn't do so, document the reason. (See "Pain Management Course From TMA
Although almost every state has a prescription monitoring database like PAT, a minority of states, including Massachusetts and Kentucky, require doctors to check the state database before prescribing dangerous controlled substances. Ms. Robinson says TMB doesn't see the requirement to consider checking PAT as an incremental step toward requiring physicians to check the database outright. She says the board will continue examining other parts of the rule to ensure it reflects the desired standard of care.
"The only thing the board is currently considering is cases of chronic pain treatment only, and they were very clear at the board meeting that they had no intention of opening this up beyond chronic pain," Ms. Robinson said.
Another rule change applies to patient pharmacy choice. The old rule stipulated that a patient can fill prescriptions only at one particular pharmacy. Updates to the rule now give the patient the choice to designate the pharmacy and add an exception to the one-pharmacy rule if the designated pharmacy is out of stock of the drug the physician prescribes.
Plano occupational and sports medicine physician James Cable, MD, was the only physician to submit written comment as an individual on TMB's rule proposal. Dr. Cable's comments echoed some of Dr. Mehta's concerns.
"It says that the intent of the board is not to impose regulatory burdens on the practice of medicine, but that is exactly what these rules do," Dr. Cable wrote. "Many of the rules proposed are already implemented in my own practice. On the other hand, I fear that even a minor oversight on my part could bring the wrath of [TMB] down on my colleagues and me."
Mr. Sharp says the board is tightening its documentation requirements as a reaction to more sophisticated documentation practices by the pill mills.
"Yet, what does it do? It has a likely potential to net the innocent people who were doing good therapy because they didn't document everything," he said. "So you've got potentially a good doctor who's treating … pain management, who doesn't document very well and gets punished and a doctor who's a charlatan or doing less of a good job, who is falsely documenting everything, who skates."
Dr. Schade says TMB's attorneys maintain that the new rules will strengthen cases against pill mills, keeping them from hiding behind the seemingly looser nature of the old rule language.
"The good doctors are not going to have a problem with this because the TMB investigations are complaint-driven," Dr. Schade said. "The only people who are going to have a problem with this are the people who are on the fringe, who are operating illegally, in my opinion."
But Dr. Mehta says the majority of physicians treating patients for chronic pain won't be well-versed in the board's amended rules. Most are primary care physicians, he said, and the burden of the new requirements is "probably going to dissuade them from wanting to treat that aspect of their care, to make sure they're complying with all of these new rules."
"[The board was] very focused on the challenge on the issues they were seeing with pill mills and overprescribing controlled substances," he said, "but not leaving enough flexibility for people to take care of patients in the fashion that we've been doing, not recognizing the good job we have been doing up to this point."
Joey Berlin can be reached by phone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email.
Pain Management "Musts"
Newly adopted changes to the Texas Medical Board's pain management rules turn numerous chronic pain treatment guidelines into minimum requirements. The rules previously provided guidelines for what a physician should include in the medical record to document the rationale for the patient's treatment plan. Now, the medical record must include:
- Medical history and physical examination;
- Diagnostic, therapeutic, and laboratory results;
- Evaluations and consultations;
- Treatment objectives;
- Discussion of risks and benefits;
- Informed consent;
- Medications prescribed (including date, type, dosage, and quantity);
- Instructions and agreements; and
- Periodic reviews.
Pain Management Course From TMA
Learn how to bridge the ambiguity gap between under-prescribing and overprescribing medications while earning 1 AMA PRA Category 1 Credit™ with help from TMA's Education Center. Ethics and Regulation of Pain Management teaches physicians to discuss ethical challenges in treating pain patients, identify the difference between substance use disorders and physiological dependence, and more.