Every healthcare practitioner who prescribes or administers opioid-based medications should, at this point, be aware that the legal and regulatory landscape has evolved considerably in recent years. Currently one of the most hot-button issues in the medical field, opioid prescribing practices have factored prominently into an increase in investigations and prosecutions by both state and federal law enforcement and state medical licensing authorities.
Beginning around the turn of the millennium, both medical and nonmedical use of opioids began to increase substantially, precipitating what has now been commonly acknowledged as a public health crisis or “opioid epidemic.” As an unintended – if predictable – consequence, use of illicit opioids (mainly heroin, but more recently fentanyl) have skyrocketed. From 1999 to 2011, overdose mortality in opioid use increased fourfold, and the trend has shown no signs of abating. These trends cut across all demographic and socioeconomic classes, with the effects seen most notably in young adults between 18 and 25. Indeed, despite rising steadily for decades, there are reports that the average life expectancy in the United States actually began to decrease starting in 2016, due to the toll taken by the opioid crisis.
Not surprisingly, government scrutiny and regulatory enforcement of opioid prescribing has increased dramatically. In New York, the Office of Professional Medical Conduct (“OPMC”), has sharply focused its resources on investigation and prosecution of cases involving improper prescribing and diversion of opioid medications by physicians. Despite this, and extensive media coverage of the opioid crisis in general, many physicians have been slow to change with the times. Perhaps accustomed to prescribing medications in a certain manner over the course of many years, physicians have not kept abreast of relevant regulatory changes, nor have they adjusted their behavior accordingly. As a result, in many cases, adverse consequences have followed.
Accordingly, it is imperative that practitioners implement a vigorous compliance program for dealing with patients to whom they are prescribing opioid medications, and zealously adhere to that program. The compliance policy should be in writing, and should encompass all required steps to be taken when dealing with opioid patients. This policy should be distributed to every member of a physician’s staff, if applicable, who might be involved in examination and treatment of patients, documenting treatment in the patient’s medical record, and writing or transmitting prescriptions to pharmacies. The physician should also ensure that all employees are familiar with the steps to be taken.
It is a safe assumption that regulatory authorities such as OPMC will focus on several key factors when deciding where to conduct their investigations. One such factor would be individual patients being prescribed high quantities of opioids. A second is a large number of patients receiving opioid prescriptions at any given practice. Finally, regulators are constantly on the lookout for patients who are “doctor shopping” (obtaining concurrent narcotics prescriptions from more than one physician).
Logically, these red flags combine to make doctors who treat chronic pain the most likely targets of investigation and enforcement. This makes a compliance program, especially for these practices, all the more essential. While a comprehensive compliance program is unique to each practice, it would most likely include:
Consult the I-STOP/Prescription Monitoring Program (“PMP”) Database
As of August 27, 2013, New York requires that, generally speaking, all prescribers consult the PMP before writing any Schedule II, III, or IV controlled substances. This includes all prescription opioid medications, as well as most benzodiazepines (including Xanax, Valium, Klonopin or Ativan). This mandate was brought about, in part, due to the fact that when New York had a voluntary prescription database, virtually no practitioners chose to use it regularly. The PMP logs every inquiry into the database, so it is easily apparent when a physician has written a narcotics prescription but has not consulted the PMP. Therefore, every physician must check the PMP on every occasion when a covered prescription is written. The fact that the PMP was checked should be simultaneously and conspicuously documented in the patient’s medical record.
Attempt Alternative Treatments
Governmental investigators typically scrutinize whether patients are treated with opioids as a first-line treatment, even in cases of chronic pain. Doctors should attempt alternative treatment methodologies, and document these treatments and their efficacy in the patient’s medical record. If opioid treatment is deemed necessary, the decision should be accompanied by realistic goals for pain and functioning (for example, the ability to do light exercise). This should also be noted in the medical record. Additionally, dosages should be closely monitored to ensure patients are receiving the appropriate amount of medication for effective pain management and no more. Physicians should also require new patients to fill out risk assessment surveys (such as the SOAPP survey), whereby their answers result in a score which quantifies their prospective risk of addiction and abuse.
Advise Patients of the Risks and Benefits
Steps should also be taken to educate and explain to the patient both the risks and benefits of opioid treatment, including addiction and overdose, and prescribers should document those steps. To that end, the practice should develop and utilize a form opioid contract explaining those risks, which all patients must review and sign to indicate that they have been duly informed. A copy of the contract, along with a note that it was discussed, should be placed in the patient’s medical record.
Conduct Toxicology Screens
All patients –especially new patients – should be subjected to random substance abuse screening. Initially, testing should be conducted on a more frequent and no less than monthly basis. However, assuming continued compliance, a lack of any positive results for illicit and non-prescribed substances, and indications that the patient is taking their own prescribed medication, testing frequency may be reduced over time. That said, compliant patients should still be tested at least a few times every year.
Note All Changes in Medication and the Basis for the Change
The patient’s medical record should reflect an informed medical decision each time a dose is altered. This will help protect physicians if they are questioned by regulatory authorities regarding such changes, and deflect possible accusations that dosage increases were made arbitrarily, or reflect dosages that were not medically necessary. Notwithstanding any dosage changes, medical records should reflect initial evaluations, periodic evaluations, objective measures to determine the efficacy of treatment, and any coordination of care between the prescribing physician and other clinicians treating the patient.
Terminate Patients for Noncompliance
If a PMP check reveals that a patient is doctor shopping, or a toxicology screen shows that a patient is either not using their prescribed medication or is using illegal substances, a physician could consider reasonable short-term efforts to correct non-compliance. Should those efforts fail, however, physicians should seriously consider terminating treatment of the patient in an appropriate manner, and transition care to another provider or rehabilitation facility. With due consideration for continuity-of-care issues related to the patient’s underlying ailment, a physician discharging a patient should provide him or her with a referral for substance abuse or mental health services to address the cause of non-compliance. Of course, all such decisions and their reasons should be noted in the medical record.
Obtain Documented Education on Drug Abuse and Treatment
Despite the fact that physicians have received a full medical education, many are unschooled in the practical aspects of drug abuse and treatment when that particular knowledge falls outside their medical specialty. Therefore, every physician who regularly prescribes opioid-based medications should regularly participate in continuing medical education on the subject. Attendance at trainings or programs related to this education should be documented, so that regulatory authorities can see that the physician has taken affirmative steps to remain informed of risk factors and warning signs of possible abuse.
Some states also mandate certain levels of provider education. New York, for instance, requires that prescribers with a DEA registration number licensed to prescribe controlled substances must complete at least three hours or coursework every three years on the topic of pain management, palliative care, and addiction. In seeking out such education, whether to satisfy this requirement or on a voluntary basis, a good place to look is in a state medical society or professional practice organization. Provider education may also be offered by insurance companies or other institutions.
Monitor Changing Policies
One of the greatest challenges in a rapidly changing regulatory environment is keeping abreast of continuously updated policies, and this is particularly true of opioid prescribing practices. Whereas the general rules of prescribing remained relatively stagnant for a long period prior to the opioid crisis, at present there seems to be an endless cascade of new guidance being rolled out on a constant basis. Fortunately, physicians have many different sources for keeping current and adjusting their prescribing practices accordingly. New guidance is continually highlighted in publications by state licensing boards, medical societies, and professional practice organizations. Doctors may also refer to hospitals, pharmacies and payors for general information regarding updated guidelines. Physicians employed in hospitals might also be able to take advantage of intra-facility guidance that is distributed by their employers. Naturally, all new laws, rules and regulations should be incorporated into the physician’s compliance plan.
In a climate where many view the current opioid crisis as a natural consequence of the liberal prescribing practices of the past, the extent and aggressiveness to which regulatory and enforcement agencies have taken an interest in physicians who dispense opioids cannot be overemphasized.
While the effort required to keep on top of ongoing changes might seem daunting or at least bothersome to busy practitioners, this inconvenience pales in comparison to the time and expense required to address an investigation by a regulatory authority such as OPMC or the DEA. As such, it is imperative that every practitioner who prescribes opioid medications adhere to a compliance policy, take proactive steps to eliminate the risk of diversion and misuse, and thoroughly document all interactions and risk-mitigation efforts in a patient’s medical record.
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