The opioid epidemic is in the news every day. State and federal regulators and law enforcement regularly investigate cases of drug diversion, ‘pill mills’, opioid over-prescribing, and even deaths from overdoses. Although most of those cases involve deliberate and knowing actions by providers, patients, drug companies, and other bad actors, the enforcement landscape has created a worrisome reality for physicians and other prescribers who are trying to take care of patients with chronic pain.

Pain management is a big challenge for prescribers in the current environment who regularly read stories of physicians and other providers who lose their license or even go to jail for cases related to opioid prescribing. This creates a conundrum where the provider needs to weigh the patient’s needs against the risks of being flagged by a health plan or government agency for over-prescribing. Although there are varying laws and regulations across state lines, there are some steps prescribers can take to protect themselves, and their patients, from the risks associated with opioid prescribing.

  1. Prescription Drug Monitoring Programs (PDMPs). PDMPs exist at the state level, and include databases of drugs containing controlled dangerous substances (CDS) prescribed and dispensed to the patients in that state. The PDMPs are not structured on a common platform, and the reporting and monitoring requirements vary across states, so there are limitations to the data. The various states have laws outlining the requirements relating to the use and access of the PDMP, with the goal of providing prescribing and dispensing information to providers, pharmacists, law enforcement, and others who have an interest in monitoring these activities. The data included in the database will typically include information on the patient, drug being prescribed or dispensed, the prescriber and the dispenser or pharmacy.

      Prescribers need to understand their state laws relating to the PDMP in order to  ensure they are meeting the legal requirements around monitoring and reporting. In addition, even in the absence of reporting requirements, providers should review the PDMP for any patients where they have concerns about possible drug-seeking behavior or opioid abuse. It is a good idea to develop a policy and procedure related to these activities, and make sure that all the providers in the practice or department/facility are trained on these requirements and follow them. Lastly, be sure to document the actual PDMP monitoring activities in order to demonstrate diligence around opioid prescribing.

2. Pharmaceutical Sales Representatives. The huge-dollar front-page settlements related to prescription drugs inevitably involve the interactions between drug companies(“Industry”) and health care providers. Those cases typically include drug companies marketing their drugs for purposes not approved by the FDA, also known as off-label marketing. Off-label marketing implicates prescribers when money or other benefits are offered to prescribers for prescribing the drugs for the off-label purpose, or, even worse, for the physicians to do the marketing themselves. In those cases, settlements under the Anti-Kickback statute have in some cases exceeded tens of millions of dollars in penalties for the drug companies, as well as penalties for the physician involved. These cases are certainly not limited to opioids, but there are off-label opioid cases that have been prosecuted under the Anti-Kickback Statute. In one case, a drug called Subsys, which was approved for cancer break-through pain, was marketed and prescribed for other chronic pain. This case was not only about fraud and abuse, but also quality of care, as the drug’s addictive properties were downplayed in order to increase prescribing and sales. The government has a huge interest in these cases not only because of the potential harm to patients but also due to the significant cost impact to government health care programs. It’s also important to remember that, under the Anti-Kickback Statute, both parties to the transaction can be found culpable, and there is no ‘de minimis’ protection. Prescribers need to be wary of drug companies offering speaking engagements or other ‘marketing’ activities that are being promoted as education or research. The government views many of these arrangements as ‘shams’ that are designed merely to increase sales of drugs for unapproved uses.

The pharmaceutical industry has taken steps, as a result of these cases, to establish appropriate standards for providing remuneration to physicians and other prescribers. The published guidance, PhRMA Code on Interactions with Healthcare Professionals, is a valuable resource for providers to review and to use to develop internal policies and procedures around gifts from Industry. In addition to creating internal policies and procedures, it’s critical to provide education to all providers who write prescriptions. Not only does there need to be education related to the policy, but also education on the fraud and abuse laws and consequences for providers who have violated those laws. Inappropriate financial arrangements with Industry have been at the root of the largest healthcare fraud cases in recent history, and a review of those cases should convince any sceptics.

3. Patient Care Documentation. There are an abundance of clinical guidelines that describe specific recommendations for managing and documenting care for chronic pain patients. The Centers for Disease Control (CDC) and other government agencies have developed clinical guidelines, as have many specific healthcare organizations or specialty groups. State-specific organizations also have created similar guidance. In fact, there are so many different guidance documents available it can be overwhelming. There are, however, certain steps that can be taken to minimize risks.

  • Try non-opioid therapies first, and document those treatments and failure of those therapies prior to prescribing opioids
  • Discuss options, goals, risks and benefits with patients, and document that conversation
  • Check PDMP to verify patient’s prescription history, document results
  • Run a urine drug screen
  • Assess and document pain levels (Pain scale, 1-10)
  • Schedule routine reassessment
  • Prescribe lowest dose and short-acting opioids initially
  • Have patient enter into a pain management contract to hold patient accountable for compliance with the regimen and instructions

The above steps are only a very high-level snapshot of risk mitigation strategies available to manage a very visible and high-risk practice issue, but hopefully this provides an overview of issues and activities to undertake to not only reduce risk to patients but also to protect prescribers of opioids against regulatory exposure.