By Jay K. Joshi, MD & Ron Chapman II, JD, LLM

Opioids remain a medical and regulatory black sheep in healthcare because we see their clinical value through overdose and mortality statistics.

Limiting death due to opioids seems simple enough: Cast out this black sheep entirely or learn to work with it, within reason. Cue the educational courses, endless guidelines, and the overzealous cautiousness a prescriber might rely upon to stay out of sight, out of mind when the government's stern glare gets a little too close for comfort.

So where do education and well-intentioned guidelines go wrong? How can an entire industry mired in the artful caretaking of debilitating pain fail so often to capture all that contributes to the decision to prescribe opioids? Pain, after all, is as subjective as the art of its elimination. Failure, then, should very well be the expectation when asking the government, the medical community, and pain patients alike to agree on the most important question when the decision to prescribe an opioid is made:

What is pain, and when is it enough?

The answer to this seems to be all about optimizing clinical decisions -- but it's something hardly ever discussed.

Lynn Webster, MD, a senior fellow at the Center for U.S. Policy, explains:

Webster: There are many reasons why best clinical decisions are not utilized -- lack of knowledge, biases, and lack of consensus around what is optimal care, limited care options, short-term rather than long-term decision-making, and fear of regulatory sanctions.

The Mainstreaming Addiction Treatment (MAT) Act, released through the same legislation that lifted the X-waiver restriction, supports Webster's observations: Designed to encourage more physicians to prescribe medications for opioid use disorder, and also to educate them on the risks and benefits of those medications, the legislation did little of either because it addresses only part of what contributes to a clinical decision, as Webster indicates.

Webster: First and foremost is that opioid prescribing recommendations and policies lack solid evidence. Beyond that, there is bias among policymakers who fear contributing to the opioid crisis but refuse to look at the needs of people in pain to the same extent. Both considerations stymie good clinical decision-making.

The latest standard of care is important, but clinical acumen is far from the only factor driving clinical decisions. The bigger motivator for many prescribing physicians is actually in their perceived capacity to handle the inherent litigiousness of helping their patients.

Webster: Policymakers and regulators sometimes misunderstand what is appropriate versus inappropriate opioid prescribing, with the result being that most practitioners must first think about protecting themselves. This dynamic prevents providers from putting patients first and can even place a provider in conflict with the needs of patients.

Worse yet, the forced relationship between physicians and the law leaves many chronic pain patients feeling abandoned by their physicians -- outright cut off from their pain medications or forcefully tapered to inappropriately low doses.

In this vein, we revisit our formative question: "What is pain, and when is it enough pain?" We can now assert that the answer is not about pain. The answer was never about pain or the medication used to treat it.

The answer is compliance.

In order to protect clinically sound decision-making, to protect patients, and, most importantly, to protect the Hippocratic Oath, medical professionals and communities must develop a compliance plan that protects the best standard of healthcare from undue legal liability.

Webster: Ensuring that a provider understands the rules of prescribing and billing is crucial. Most providers do not have adequate knowledge to protect their practices from regulatory interventions. It is challenging for most providers to keep up with oft-changing legal trends, just as it is difficult to understand evolving tax laws. Providers should consult with legal firms to provide the structure and policies that help protect them.

The benefits of a compliance plan, ostensibly, are to standardize clinical decisions and to provide a legal foundation to justify those decisions. More personal to the compliant physician or clinic, the benefits go well beyond perfunctory documentation. An ironclad healthcare compliance program assuages the most visceral of fears: the fear that comes with looking over one's shoulder for weeks, months, and even years; and the fear that hard work and artful medical consideration could be painted with the harsh brush of endless court proceedings and testimony from those who vow to stop only when licenses and freedoms are revoked to the satisfaction of third-party detractors.

Webster: Providers should make better decisions if they have a good compliance plan and follow it. It should then follow that they will be able to defend their decisions.

Physicians with a robust regulatory compliance plan are less likely to make decisions out of fear of legal liability and more likely to make decisions for the benefit of patients. Compliance plans act as a safeguard against a mountain of potential risk -- and this is no big secret in healthcare law. In fact, behavioral economists have known about it for decades. People make decisions differently when the perceived risk changes. Put simply, when someone feels protected from the legitimate downside risk, they value the potential upside -- the art of maintaining the best standard of care -- more.

For physicians tasked with making tough clinical decisions, having a compliance plan in place provides much-needed relief from knowing the law as well as knowing the medicine.

Webster: Monitoring medication adherence and thoroughly documenting decision-making rationales provide affirmative litigation protection. Therefore, it would make sense that a well-designed compliance plan, which includes close monitoring of patients and documenting clinical decisions, would have a positive impact on patient outcomes by facilitating dedication to best practices and preventing disruption of care.

Ultimately, a documented trail of good decision-making is the goal of a compliance plan: a truly well-designed plan provides a framework that oversees and reports on all aspects of clinical decision-making, which leads to better clinical outcomes. While many may perceive compliance as nothing more than a system of recording and reporting patient care, or see it as a hassle with its requiring physicians to document information assumed to be extraneous (such as pricing, treatment options, and socioeconomic considerations), those physicians who welcome streamlined accountability systems are confident, focused on patient care outcomes, and are better decision-makers.

More importantly, physicians and staff who adhere to compliance programs are far less likely to one day sit in a prison cell, away from loved ones and their life's work, wondering about a more troubling question:

"What is healthcare compliance, and why didn't I have it?"

Jay K. Joshi, MD, is a practicing physician and entrepreneur in Northwest Indiana. He is also an advocate for physicians to ensure they receive proper due diligence in civil and criminal litigation. Ron Chapman II, JD, LLM, is a federal criminal defense attorney and president of Chapman Consulting Group.