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The Litigious Nature of What We Do: A Necessary Conversation During PAIN 2021

Op-Med is a collection of original articles contributed by Doximity members.

As clinicians, we all understand the responsibility of taking care of patients. When a patient enters our care, the liability is on us to stay up-to-date with current practice guidelines and innovations that can dictate the care we provide to our patients. As pain specialists, this responsibility is magnified with the current government stance on controlled substances, the opioid epidemic, and recent litigation against opioid manufacturers and prescribers.

During Pain Week 2021, several presentations highlighted the importance of government policies and medicolegal factors that influence the field of pain medicine. With the recent uptick in drug overdose cases, behavioral health needs, and decreased access to pain management solutions during the COVID-19 pandemic, it has become increasingly challenging to be a pain specialist. Courtroom battles over the standards of care applicable to frontline physicians and allied clinicians who prescribe controlled medications continue to play out nationwide. It is clear — now more than ever — that there are significant differences in perspective between government and medicine when it comes to pain management. 

In 2016, the CDC released guidelines for prescribing opioids for chronic pain. However, many primary care providers, insurance companies, and government entities view these guidelines as the law. The Institute of Medicine defines clinical practice guidelines as "statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options." So, the question becomes, if you go against recommendations included in the prescribing guidelines, is it malpractice or criminal? The government seems to believe it is the latter. 

This misappropriation is further realized when the CDC published a pivotal article in the New England Journal of Medicine on April 24, 2019, specifically reiterating that the CDC Guideline has been, in some instances, misinterpreted or misapplied. The authors highlight that the guideline does not address or suggest the discontinuation of opioids prescribed at higher dosages. Educating stakeholders about the intent of the guidelines, reemphasizing the core benefits of the guideline, and encouraging optimal applications of the said guideline are essential to pain management and government entities.

As clinicians, we are responsible for treating each patient individually. We understand that treatment modalities can differ significantly between two patients, regardless of how similar those patients may appear to be. While some patients require more procedural interventions, others may require more medication management to improve their quality of life.  We must keep in mind that medication management remains a cornerstone of patient treatment and is both a legitimate and necessary treatment modality for many patients. As clinicians, at what point do we need to worry that prescription guidelines may begin to influence our treatment decisions?

As the government's oversight increases, payers are becoming more complex and significantly less risk-tolerant in their approach to performing opioid prescribing surveillance. Payers often reach out to prescriber practices when they perceive excessive risk, and this may be brought to a clinician without any notice at all. Government insurance providers have recently obtained the power to revoke Medicare, Medicaid, and Tricare privileges from clinicians with suspicion of malpractice, overbilling, or late responses to Medicare requests, which could result in permanent exclusion from programs for 10 years with little to no appeal — career-ending. Clinicians may be encouraged to make changes or face costly remediation or network termination, while the data used to make these decisions is not always clear. Unfortunately, it seems to not only be medications that are facing increased scrutiny, but also many procedural interventions that may be regarded as being unnecessary. While the government seeks to enforce its vision of pain care, clinicians face another obstacle where insurance companies, including Medicare/Medicaid, are enforcing policies limiting access to alternative medications. 

The presentations on this topic during Pain Week 2021 resonated with me because I have seen, firsthand, so many times how government involvement can be a double-edged sword when it comes to patient care. Just last week, I took care of a patient who has been receiving a non-opioid patch for 20 years to manage her pain condition. She recently received an abrupt denial of coverage by her insurance company, stating that the particular medication was no longer approved for her pain condition, despite the patch providing her decades of pain relief. And, although this patient no longer has coverage for a rather benign treatment, her insurance approval for opioids was hassle-free. Unfortunately, these scenarios are frequent and only seem to be increasing.

If the government wants to regulate the treatment of patients, there needs to be a shift in approach from accusations to conversations. Government agencies are monitoring clinicians and hoping to curb practices when they should focus on the bigger picture. The oversight would be better served shifted to discussions with practices and insurance companies, including government programs, and establishing policies to limit medication approvals of controlled substances. 

Medical education is vital to understanding disease processes, choices of treatments, and patient’s comprehensive health. However, I’m beginning to wonder if the knowledge of these disease states is even worth it with government policies that question every decision beyond malpractice. Perhaps more consensus-driven policies discussed with prominent pain medicine societies on an ongoing basis would be the next best thing. With government agencies dictating how to practice, and insurance companies allowing coverage for certain therapies but not others, clinicians have to learn to navigate this arduous maze of approvals, denials, timely responses, declining reimbursements, and sanctions to relieve the pain of one patient; only to do it all over again for the next one.

Dr. Mukhdomi is employed by New York Presbyterian - Weill Cornell Medical Center. They have no conflicts of interest to report.

Illustration by April Brust

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