In this special five-part podcast series, sponsored by Affiliated Monitors, Inc., I visit with AMI Managing Director Jesse Caplan on emerging issues in healthcare compliance and monitoring. In Episode 1, Jesse Caplan discussed the many different types of potential regulatory and liability risks healthcare provider organizations and practices face in connection with the prescribing of opioids.  In this Episode 2, we discuss how healthcare organizations can identify and mitigate the risks from opioid prescribing by their practitioners.

Some of the issues considered are:
What can healthcare organizations and their compliance departments do to identify and mitigate the risks from opioid prescribing?

1. Healthcare organizations and medical practices can be proactive in making sure they have an opioid compliance program or plan, that the program incorporates all relevant federal and state laws and regulations, CDC prescribing guidelines and relevant standards of practice, that prescribers have been educated on the opioid prescribing program, and that the organization is assessing actual prescribing in order to flag potentially risky practices.
2. An effective opioid prescribing program will incorporate policies and procedures that inform prescribers what they need to do before they prescribe opioids, and what needs to be documented. For example, 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 database (or PDMP) 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?
3. The program should also inform on the limitations on prescribing – quantity and dosages, and what combinations of drugs are counter-indicated.
4. And the program should address what follow-up the physician should engage in with the patient after prescribing opioids – like what needs to be done before renewing a prescription – for example should blood or urine screening be required?
5. 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 MCLEs that are relevant to their practice.
6. And finally, is physician prescribing being audited or monitored to identify potentially risky practices.

What are some examples of deficient opioid prescribing practices by, otherwise, experienced and caring physicians?

1. Affiliated Monitors, working with physicians with expertise in opioid prescribing and pain management, have assessed the prescribing practices of many physicians who are legitimately trying to address the needs of their patients. In many cases, these physicians are not following evolving best practices, state and federal regulations, or CDC guidelines.  And as a result, 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.

2. Some of the most common deficiencies we see in opioid prescribing include:
3. 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, like physical therapy. We see physicians prescribing opioids for conditions where opioid treatment is not the appropriate first line treatment, or not indicated as a treatment at all.
4. Physicians not documenting sufficient medical, social or family histories, or considering those factors that could raise red flags for potential addiction or substance misuse.
5. Not checking the state’s PDMP to see whether the patient is being prescribed controlled substances by other physicians.This is very important to see whether the patient may be doctor shopping, abusing medications, or taking combinations of medications that may be very dangerous.  
6. Prescribing opioids in dosages, or numbers of pills, or in combinations with other drugs, that are inconsistent with guidelines or state laws and regulations.
7. Not closely following patients on chronic opioid treatment programs and re-evaluating their pain diagnosis, and the efficacy of the opioid treatment, on a regular basis. Many 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 tox screen is negative for the medications prescribed, that could be a sign that the patient is diverting those medications.  If the tox screen is positive for controlled substance that have not been prescribed, that could be a sign that the patient has an addiction and is abusing medications. 
8. Patients on chronic opioid treatment often should be followed with 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 Agreement will not only provide valuable information for the patients, but it also gives the physician a basis for discontinuing opioid treatment if the patient violates the Agreement.   
9. Finally, the CDC recommends that naloxone be considered for many at-risk patients receiving 50 or greater Medical Morphine Equivalents of opioid medication.

What help is available to healthcare organizations to address these risks?

1. Healthcare organizations can take a proactive approach by having experienced and expert clinicians in pain management and opioid prescribing assess the organization’s opioid program and policies, and review samplings of patient charts where patients have been prescribed opioids.Such an 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. 

Do monitoring firms like AMI provide these types of proactive assessments of opioid prescribing programs and practices?

1. We have been engaged by hospital systems and physician practices to assess opioid prescribing programs and practices. We have relationships with experienced physicians who are experts in pain management and opioid prescribing who work with us to assess the programs, review patient charts, and make recommendations for improvement. 

2. The bottom-line is 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.

Join us for Episode 3, where we discuss the expanding use of independent monitors by health regulators.
For more information on Affiliated Monitors, check out their website here.