Yesterday I begin a two-part blog post series on how compliance can be a part of the solution to the opioid crisis. In Part I, I considered the many different types of potential regulatory and liability risks health care provider (HCP) organizations and practices face in connection with the prescribing of opioids. Today, Jesse Caplan, Managing Director of Corporate Oversight at Affiliated Monitors, Inc. (AMI), relates how healthcare organizations can identify and mitigate the risks from opioid prescribing by their practitioners by implementing a compliance program and how an independent third party is well suited to ensure that compliance. Finally, this approach allows regulatory oversight through the transparency brought by an independent integrity monitor. I call it the “Opioid Prescription Compliance Program”.

Risk Assessments

Healthcare organizations and medical practices can be proactive by putting an Opioid Prescription Compliance Program in place, which incorporates all relevant federal and state laws and regulations, Center for Disease Control (CDC) prescribing guidelines and relevant standards of practice, for example that physician-prescribers have been educated on the Opioid Prescription Compliance Program; the organization is assessing actual opioid prescriptions in order to flag potentially risky practices; and, finally, is monitoring all of this on an ongoing basis.

An effective program begins with policies and procedures that inform prescribers about what they need to do before they prescribe opioids and what needs to be documented. Caplan cited the following examples, “What needs to be asked as part of the medical history of the patient? Has the physician checked the state’s Prescription Drug Monitoring Program (PDMP) database for that patient’s prescribing history? Has the physician counseled the patient on alternatives as well as the risks of using opioids? Does the patient have a “pain contract”? And is all of this documented in the medical record?”

The program should also inform on the limitations of prescribing quantity and dosage and what combinations of drugs are counter-indicated. The opioid prescribing program should address what follow-up the physician should engage in with the patient after prescribing opioids and what needs to be done before renewing a prescription, for example should blood or urine screening be required?

The organization should also make sure that prescribers are being adequately educated on all appropriate prescribing policies, procedures, laws and regulations – both by the organization and whether the physician is taking continuing educational credits which are relevant to their practice. Finally, in the area of ongoing monitoring, Caplan said an Opioid Prescription Compliance Program should include both auditing and monitoring of physicians to identify potentially risky practices.

Examples of deficient opioid prescription practices

Caplan has assessed the prescribing practices of many physicians who are legitimately trying to address the needs of their patients. He noted that in many cases, these physicians are not following evolving best practices, state and federal regulations, or CDC guidelines. Due to this, they are putting not just their patients at risk of harm, but they are also putting themselves and their organizations at risk of legal jeopardy.

I asked Caplan to list some of the most common deficiencies he has seen in opioid prescribing. He provided the following examples: “Physicians not conducting sufficient examinations to truly determine the cause of the patient’s pain that would warrant treatment with opioids, as opposed to other medications or non-medication treatments, such as physical therapy; Physicians prescribing opioids for conditions where opioid treatment is not the appropriate first line treatment, or not indicated as a treatment at all; Physicians not documenting sufficient medical, social or family histories, or considering those factors that could raise red flags for potential addiction or substance misuse; Physicians not checking a state’s PDMP to see whether the patient is being prescribed controlled substances by other physicians; Physicians prescribing opioids in dosages, large numbers of pills or in combinations with other drugs, that are inconsistent with guidelines or state laws and regulations; finally, physicians not following patients closely on chronic opioid treatment programs and re-evaluating their pain diagnosis and the efficacy of the opioid treatment, on a regular basis.”

Caplan said that often patients on chronic opioid treatment programs should be subject to toxicology screens to help inform the physician whether the patient is taking the prescribed medications and whether they are taking controlled substances that they have not been prescribed. If a toxicology screen is negative for the medications prescribed, that could be a sign that the patient is diverting those medications. If the toxicology screen is positive for controlled substances that have not been prescribed, that could be a sign that the patient has an addiction and is abusing medications.

Interestingly, patients who are on chronic opioid treatment also have a role in an Opioid Prescription Compliance Program. Here he suggested patients should be provided a “Pain Contract” – an agreement that the patient signs with the physician that explains the risks of opioid treatment and that sets out the ground rules for what the patient is and is not permitted to do with the medications being prescribed. This Pain Contract will not only provide valuable information for the patient, but it also gives the physician a basis for discontinuing opioid treatment if the patient violates the agreement.

Ongoing Assessments

As with any best practices compliance program, ongoing assessments are a critical feature. Caplan said, “Healthcare organizations can take a proactive approach by having experienced and expert clinicians in pain management and opioid prescribing assess the organization’s Opioid Prescription Compliance Program by reviewing samplings of patient charts where patients have been prescribed opioids. Such an ongoing assessment can help identify gaps in the program, flag physicians who may be engaging in risky prescribing practices, and most important, offer recommendations for improving the program and physician prescribing practices. This information can be used to mitigate risk to the organization, physicians and patients.”

Caplan ended by stating that the goal of these proactive assessments is to identify areas for improved practices, provide clear guidance, and recommend relevant medical education to help physicians provide better and safer treatments for their patients, while also protecting them and their organizations from legal risks. If HCPs adopt something like the Opioid Prescribing Compliance Program described in this series, it would represent a healthcare-based solution to the opioid healthcare crisis and a legal framework which has been developed in response to the crisis.

This publication contains general information only and is based on the experiences and research of the author. The author is not, by means of this publication, rendering business, legal advice, or other professional advice or services. This publication is not a substitute for such legal advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified legal advisor. The author, his affiliates, and related entities shall not be responsible for any loss sustained by any person or entity that relies on this publication. The Author gives his permission to link, post, distribute, or reference this article for any lawful purpose, provided attribution is made to the author. The author can be reached at tfox@tfoxlaw.com.

© Thomas R. Fox, 2019

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