Misguided federal regulations are likely to cause more pain in people already living with it

Hidden in the shadows of the Covid-19 pandemic is the U.S.’s drug epidemic, which is getting worse. One group that is paying the price for it, but shouldn’t be, are people who live with chronic pain conditions.

The opioid epidemic was initially fueled by the misuse of prescription opioids that were often obtained illegally. In recent years, though, the majority of overdose deaths have been caused by illegal or “street” drugs such as illicit fentanyl and its analogs, heroin, cocaine, and methamphetamines.

About a decade ago, in an effort to address the increase in opioid-related overdose deaths, government agencies at both the state and federal levels clamped down on prescription opioids in a misguided effort to tackle the crisis. The result? Numerous pain patients who were legitimate users of opioids were forced to stop taking these effective painkillers and left to fend for themselves. As a result, some of them turned to the black market, leading to far more overdose deaths.

Data from the Centers for Disease Control and Prevention depict a disheartening trend. Overdose deaths have been rising steadily since 1999. Although there was an encouraging decline in 2018, in 2019 a record number of deaths were recorded.

Worse still, the Covid-19 pandemic has increased social isolation causing widespread mental health issues, especially anxiety and depression. Not surprisingly, this has led to an increase in illegal drug consumption. Indeed, preliminary data from the CDC indicate that 2020 will see a record number of overdose deaths.

Chronic pain can result from a multitude of conditions that cause severe neurologic symptoms leaving patients suffering and threatening their ability to function. This can lead to job loss, financial devastation, social isolation, chronic anxiety and depression, and suicide. In the U.S., approximately 50 million patients live with chronic pain caused by conditions such as injury, neck and back issues, multiple sclerosis, Parkinson’s disease, arthritis, autoimmune diseases, and more. Of these, 19.6 million live with what’s known as high-impact chronic pain, which affects their ability to work.

When I was the chief medical officer at the Department of Health and Human Services, I had the opportunity to chair the national Pain Management Best Practices Inter-Agency Task Force, a joint effort by HHS, the Department of Veterans Affairs, and the Department of Defense. The task force included pain experts, primary care doctors, surgeons, mental health experts, pharmacists, patients, veterans, and many others.

The seminal report from the task force, published in 2019, recommended a multimodal approach for patients in pain after an injury or operation, as well as for those with chronic pain and various underlying pain conditions. Recommended treatments include medications — non-opioid as well as opioid medications (while emphasizing safe opioid stewardship), interventional approaches, restorative therapies, behavioral health interventions, and complementary and integrative approaches. An underlying theme was that treatment must be individualized, and one size does not fit all.

The publication of best practices and the development of sound policies can ensure that health care providers have the knowledge and tools they need to help manage and provide treatment for those living daily with painful conditions.

But policymakers have lately been erecting roadblocks to treatment, such as prior authorization, that threaten some of these innovative approaches. If we do not act quickly to counter these actions, people who are already suffering from pain will suffer even more. By limiting access to these treatments, it affects their ability to perform activities of daily living including work, sleep, and other routines. Some will require additional medical care and hospital admissions, both of which will worsen their quality of life. Furthermore, these counterproductive actions will have a negative economic impact on our health care system, already severely strained by the pandemic.

Many pain specialists, including me, are concerned that recent announcements from the Centers for Medicare and Medicaid Services aimed at slowing the “overutilization” of safe and effective pain treatments will prevent Medicare patients from being able to access these non-pharmacologic treatments.

For example, CMS recently required prior authorization for therapies like Botox injections for people with chronic migraine who are being treated in outpatient settings. Even more concerning is CMS’s proposal to require prior authorization for neuromodulation treatments such as spinal cord stimulators in the outpatient setting. The effectiveness of neuromodulation — the electrical or pharmaceutical alteration of nerve activity — is backed by strong clinical evidence. It can reduce nerve-related pain and improve function among people with high impact chronic pain.

Prior authorization is a bureaucratic hurdle that delays access to safe and effective treatments for patients living with chronic pain, such as physical therapy, movement therapy, medications that help patients maintain functionality, and others. This is exactly what pain patients don’t need.

One of the many consequences of our nation’s response to Covid-19 has been the cancellation of nonessential procedures, which has limited access to non-Covid-19-related medical care. It has affected millions of Americans, and made matters worse for patients with painful debilitating conditions leading to worsening of pain, increased suffering, and poorer outcomes. Many of my patients who had been getting better have suffered severe setbacks. As recent data show, the improvement in the care of patients with Covid-19 has been countered by the negative impact of the pandemic on mental health, which has been caused by the unprecedented isolation that affected more than 310 million Americans at the height of lockdown restrictions.

Worse still, people who has been taking opioids safely for years to treat chronic pain continue to be subjected to forced tapering, meaning they are weaned off of opioids against their will, depriving them of a medication that can be lifesaving for those with complex neurological pain. Forced tapering can worsen medical conditions and some patients who legitimately and safely use opioids have been abandoned by their physicians. Add on the proposed CMS restrictions and we will inevitably see more suffering and more preventable deaths.

CMS must put a stop to this dangerous practice of limiting patient and provider access to therapies that they need and deserve.

Congress and several presidential administrations have made it clear that the health care community must use all of its resources to confront the opioid epidemic. To do so, clinicians need access to all of the safe and effective therapies that have been created by our nation’s innovators. Federal policies must not take us backward at this critical junction.

Instead, science and compassion are needed to address dueling public health crises: millions of people living with chronic pain and overdose deaths from the use of illicit drugs. This can be addressed by solutions that are right in front of us — if patients and their doctors can access them.

Vanila M. Singh is an anesthesiologist and pain management specialist at Stanford University School of Medicine, clinical associate professor of anesthesiology, pain, and peri-operative medicine at Stanford University, former chief medical officer at the Department of Health and Human Services Office of the Assistant Secretary of Health, and chair of the Pain Management Best Practices Inter-Agency Task Force.