Pain Rules, Part 3
In its rules, the Board tries to paint with a broad brush on attempting to define what may constitute sound clinical judgment. The Board writes “[s]ound clinical judgment results from evidence-based medicine and/or the use of generally accepted standards.”[1] The method to show sound clinic judgment is “…recording the physician’s rationale for the treatment plan and maintaining medical records that are legible, complete, accurate and current for each patient.”[2] This seemingly insignificant statement is critical. For the Board, medical records are insufficient to merely provide basic SOAP information. The medical records, particularly for the treatment of chronic pain, must clearly demonstrate what the physician was thinking when he or she determined a particular course of action for a patient. All relevant factors should be included in these records, based on the author’s actual experiences with the Board. This should include, but is not limited to family histories, the patient’s medical history, prior treatments, especially if more conservative treatments were not attempted, consults to other specialists, whether non-narcotics treatments were utilized or even considered, and other factors that fully and comprehensively detail why this course of action was taken and evidence to support that decision. Failure to do so has lead many physicians into disciplinary action by the Board.
The rule for the Board is chiefly based on the medical record itself. The rule states that sound medical judgment can be shown through medical records that are “…legible, complete, accurate and current for each patient.”[3] The Board further suggests that “[t]he extent of medical records should be reasonable for each case.”[4] Suggestions of what to include in this “complete” and “reasonable” record are justification for narcotics, especially when it is difficult to relate the pain to objective findings and to ensure the use of the drugs are closely monitored.[5] Yet, for all the warnings and suggestions presented, there are so many wiggle words that much of what is asked is in the eye of the beholder. For better or worse, if a complaint is filed against a doctor, the Board is the beholder.
Are There Treatment Limits?
The Legislature did place limits on prescribing for chronic pain. These limits are somewhat obvious. The doctor cannot prescribe for an illegitimate purpose.[6] That seems perfectly acceptable. The second limit can be a little more problematic in actual practice. The doctor cannot prescribe to someone he knows or should know is improperly using the medications.[7] From experience, if a patient admits non-therapeutic use of drugs, then the doctor needs to immediately cease prescribing drugs. However, “should” know that someone is abusing drugs is a more difficult situation. Should know is typically a product circumstantial information that would lead a common person to believe a patient is abusing drugs. The problem again is the issue of the subjective nature of pain and the trust involved between the patient and the doctor. Should that trust be violated, then it is a factor that may lead to termination of the prescribing of controlled substances. Information from other physicians, pharmacies, law enforcement, family members, and obvious signs of drug seeking behavior could all be factors to consider in whether one “should have known” about non-therapeutic use of medications. The Board does prosecute physicians who failed to adequately look into their crystal ball. It is often easy to see a drug abuser in retrospect. It is often more challenging before the abuse is actually discovered. It is the doctor’s role to be suspect of any action out of the norm. The problem is the “norm” for treating pain is not always obvious.
The law directs if a physician does treat patients with chronic pain, that doctor is under an affirmative obligation to monitor the patient. The monitoring ensures the medications are used to treat the pain condition.[8] More importantly, the law mandates that the doctor take certain and specific steps to ensure the proper use of controlled substances by patients. The doctor is legally required to document an “understanding between the physician and patient about the patient's prescribed treatment.”[9] In the past, this could have been done by merely documenting patient education. Of late, the Board has found that insufficient. Any patient education needs to be specific and direct. The preferred method of documenting this understanding is through a pain contract. The Board has rules on pain contracts, which the Board rules refers to as “agreements.” This will be discussed later in the paper.
The Legislature also requires strict documentation on the drugs prescribed and administered. Requiring:
1. The name of the drug[10];
2. The dosage of the drug and the method of taking the drug (i.e. IM, oral, etc.)[11];
3. The number of dose units prescribed[12];
4. The frequency of prescribing and dispensing of the drug[13]; and
5. Consult with psychologist, psychiatrist, expert in the treatment of addictions, or other health care professional, as appropriate.[14]
The first four requirements appear basic on its face. Naming the drug clearly and legibly is critical. It is equally important to document if one is providing the drug as a sample. Be familiar with the Board rules on documenting the use of sample medications.[15] Denoting the proper dosage is also critical. Be careful with decimal points. Rarely do people list the method of taking the drug, so it is important to double check and add that to your list of requirements when documenting. Just because it appears self-evident based on the type of medication prescribed, it is still critical to list the method of ingestion or administration.
Frequency of prescribing or dispensing controlled substances is a huge issue. “The board will not look solely at the quantity or duration of drug therapy.”[16] The operative word is “solely.” The fact is quantity and duration has always been at the heart of the investigations by the Board. Pill counts and graphs indicating the drugs the patients received over a given time period are part and parcel of the Board’s prosecution of a chronic pain case. The defense, again, is a clearly documented medical argument for the course and nature of the treatment.
An ironic problem that has been seen in the author’s defense in such cases is the discrepancy that exists on the issue of quantity prescribed and frequency of visits with the doctor. Prescribing less than thirty days is often seen as insufficient, while prescribing more than sixty days is excessive. Providing refills without in person follow-ups is often seen as excessive. Seeing patients more frequently than thirty days can been seen as excessive, especially if this is a long-term patient; whereas seeing patients less than quarterly is viewed as too infrequent. Providing refills over the phone is often seen as inadequate care, even for patients that have been stable for a long period of time. Obviously, mailing a prescription to a patient is seen as very poor judgment. Based on the actions of the Board in disciplining doctors, they have created, in the author’s opinion, a thin tight rope for Texas physicians to walk.
The fifth factor is often seen as a question of evaluating the judgment of the doctor’s sound clinical judgment. The Board will question why someone was not referred to consultants. This can be a critical factor for the Board, especially if there is no evidence that more conservative measures or alternatives were not attempted prior to the use of controlled substances. If the patient has history for substance abuse, failing to obtain a psychiatric evaluation to judge the risks and benefits of using controlled substances to control the pain will result in action by the Board.
Despite the statute stating a doctor cannot be disciplined for prescribing or administering a narcotic in the treatment of chronic pain, the Legislature placed in several exceptions. The chief and most frequently used is the prescription was not for a legitimate medical purpose and therefore, non-therapeutic in nature.[17] In order to provide guidance to both the statute and the rules, the Board enacted several specific “guidelines,” which the Board actually uses as rules. These guidelines are critical to know and should be made part of one’s practice if they deal with chronic pain patients.
These so-called guidelines are used by the Board during both its investigations and prosecutions of complaints. Further, these guidelines are used by the Board’s consultants and others to determine whether the doctor operated within the standard of care and exhibited sound clinical judgment. Prior to exploring the rules in detail, the Board states “[i]t is not the board’s policy to take disciplinary action against a physician solely for not adhering strictly to these guidelines if the physician’s rationale for the treatment indicates sound clinical judgment documented in the medical records. Each case of prescribing for pain will be evaluated on an individual basis.”[18] Although this is a part of the Board’s guidelines, through the author’s actual experience before the Board, failure to follow these guidelines makes defending the care rendered extremely difficult. The vast majority of investigations of those who do not follow the process set by the Board go on to prosecution and the majority of those receive some form of discipline.
The practice guidelines established by the Board are dramatic and complex. It is critical to review one’s practice and make sure one is in-line with these processes to ensure compliance. Again, this is the best defense against prosecution. Moreover, even if a physician only treats one chronic pain patient and has thousands of other patients, that singular patient is covered by these guidelines and the doctor is subject to discipline for failure to adhere to them.
Part 4 soon