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. Healthcare provider organizations and practices face many different types of potential regulatory and liability risks – in this first episode we focus on the risks posed by opioid prescribing. We consider the some of the following issues: 

What are the risks to providers and health care organizations from opioid prescribing? 

1. Policymakers and the healthcare industry are trying to address the opioid crisis in a number of different ways. One of those ways is to focus on the prescribing of opioids, with the goal of significantly reducing the number of people who are prescribed opioids and become addicted or who divert legally prescribed drugs. 
2. Health care providers who engage in inappropriate opioid prescribing are increasingly subject to discipline by professional medical boards. They face restrictions on their licenses to practice, and in certain cases, have had their licenses suspended or revoked. 
3. Where patients are harmed, providers face civil medical malpractice liability.
4. And in the most egregious cases, providers have been prosecuted criminally, either under the federal Controlled Substances Act or state criminal laws. 

What has been the response of the Department of Justice? 

1. The Department of Justice (DOJ), both in Washington and in individual United States Attorney’s Offices, have become more aggressive at identifying providers with problematic or suspicious opioid prescribing records.
2. For example, in 2017, then Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit.In his announcement the Attorney General stated DOJ would use data analytics to identify physicians who are writing opioid prescriptions at a rate that exceeds other physicians, and how many of a doctor’s patients died within 60-days of an opioid prescription.
3. In 2018, US Attorneys in Massachusetts and Georgia sent warning letters to physicians who had relatively high opioid prescribing histories, or physicians who may have had a patient die from an overdose, or who died for any reason within two-months of being prescribed opioids.
4. In the letters in Massachusetts, the US Attorney reminded the physicians that prescribing opioids without a legitimate medical purpose or in excessive amounts is illegal. Of course, this begs the question:  for physicians who genuinely care about their patients and are trying to treat real chronic pain, how do they ensure they are prescribing for a legitimate medical purpose or diagnosis where opioid treatment is both indicated and appropriate?  What dosages or number of pills is “an excessive amount” that could put the physician at legal jeopardy?  

What are legislators and regulators doing to address the opioid crisis? 

1. The crisis has resulted in new laws and regulations addressing hospital staffing, their discharge and treatment processes, limits on the quantity and dosages of opioids that can be prescribed, and mandated use of state Prescription Drug Monitoring Program databases (PDMPs).   
2. Just this February, CMS issued a letter to all Medicare providers with what they call their “roadmap”, focusing on “preventing new cases of opioid-ise disorder,” “treating patients with opioid use disorders,” and “using data to target prevention and treatment activities.” 
3. As a result of this evolving legal environment, individual physicians and physician extenders, group practices, hospitals, and even insurance companies who are increasingly employing physicians, face significant regulatory and liability risks if they are engaging in inappropriate and dangerous opioid prescribing practices, or not complying with the increasingly complex prescribing laws and regulations. 

What is the legal and regulatory framework impacting opioid prescribing?

1. There are a number of federal and state laws impacting opioid prescribing practices. Some of the more recent and significant developments include state laws limiting the quantity and dosage of opioids that can be prescribed and requiring providers to use and check PDMP databases before prescribing certain drugs to a patient.  There are also more sophisticated guidelines for practitioners, including CDC Guidelines, for prescribing opioids, which are becoming the standard of care for prescribers. 
2. For example, just about every state has a PDMP, which is a database that tracks a patient’s history of opioid prescriptions.Increasingly, states require providers to check the PDMP before prescribing opioids.  By checking the PDMP the physician can be informed whether the patient appears to have an addiction problem, may be doctor-shopping for opioid prescriptions, may be diverting drugs, or might be at risk for dangerous drug interactions. 
3. More and more states are passing laws limiting the quantity or dosage of opioids prescribed. For example, Massachusetts, the first state to pass such a law in 2016, set a seven-day limit on initial opioid prescriptions. 
4. The CDC’s Guidelines are targeted to primary care physicians treating adult patients for chronic pain and are designed to improve communications between providers and patients about the benefits and risks of using opioids, and ultimately to reduce opioid addiction and overdoses.  According to the CDC, the three main principles behind the Guidelines are:
5. Non-opioid therapy is preferred for chronic pain in most circumstances;
6. The lowest possible effective dosage should be prescribed; and
7. Clinicians should always exercise caution when prescribing opioids and should closely monitor their patients who have been prescribed opioids.
8. The CDC then offers 12 separate recommendations addressing each of these principles.

What should be the primary compliance concerns for healthcare organizations in connection with the opioid crisis?

1. The big questions for healthcare organizations are:
2. Do you have policies and procedures in place to ensure that your staff, and particularly your physicians, are aware of all the new requirements for opioid prescribing?
3. Have your providers and staff been educated in those policies and procedures?
4. And are they actually following appropriate opioid prescribing practices, and all relevant laws and regulations, including the organization’s own prescribing polices? 

Join us for Episode 2, where we discuss how healthcare organizations can identify and mitigate the risks from opioid prescribing.
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