Petition Asks FDA to Take NarxCare Off the Market

By Pat Anson, PNN Editor

A citizen’s petition filed with the U.S. Food and Drug Administration is asking that controversial software used by Bamboo Health to analyze health data and give patients “risk scores” be declared a misbranded medical device and taken off the market.

The petition by the Center for U.S. Policy (CUSP) says the software “has fundamentally altered the practice of medicine in the U.S. to the detriment of patients” by depriving many of them of access to opioids and other controlled drugs.

(Update: On July 21, the CUSP petition was rejected by FDA on procedural grounds because it was “not within the scope” of the agency’s petition process.)

The clinical decision support (CDS) software – known as NarxCare -- uses proprietary algorithms to gather and analyze prescription drug and other health information for millions of patients, creating risk scores for them based on their potential for misuse. The risk scores are widely used by hospitals, pharmacies, insurers and other healthcare providers to decide whether to prescribe and dispense controlled substances to patients.

Patient advocates have long said the Narxcare scores are inaccurate and being abused, depriving legitimate patients of medications to treat pain, anxiety, depression and opioid use disorder (OUD). Some also believe the scores are being used by law enforcement to identify and take action against doctors writing high-dose prescriptions.

“There are a lot of cases of people being harmed,” says Lynn Webster, MD, a pain management expert and Senior Fellow at CUSP. “What tipped the scale for me was when I was asked to look at records for a doctor who had been accused of prescribing inappropriately, totally based on a risk score. And his records did not justify being investigated or asking that his DEA license to be forfeited.

‘There is actually no validity to the scores that they provide. Too many people are being harmed from a lot of different perspectives. It’s only hurting people, not helping.”  

Having NarxCare declared a misbranded medical device is a novel approach, but Webster says the software is no different than any other device used to diagnose and treat a patient. Medical devices need prior approval from the FDA, which the agency has not given to NarxCare. Bamboo Health closely guards what data is used to create its risk scores.

“If you’re going to have a decision support tool for physicians, they have to have enough information to take a look at the content of what goes into developing that score, so they can override it and make their own judgements. But there is no information about what has really gone into it that’s publicly available that I can find,” Webster told PNN.

The petition asks the FDA to issue a warning letter to Bamboo Health, start a mandatory recall, and inform healthcare providers not to use the NarxCare risk scores.

Bamboo Health did not respond to requests for comment. In the past, the company has defended its software as an important clinical tool to help providers identify patients at risk of abusing opioids, antidepressants, sedatives and stimulants. Much of the data is collected from state-run Prescription Drug Monitoring Programs (PDMPs), which gather information on virtually every patient in the country who has been prescribed a controlled substance.

A 2021 clinical study looked at NarxCare scores for nearly 1,500 patients who were prescribed opioids in Ohio and Indiana. Researchers concluded that their risk scores were a “useful initial screening tool” for prescribers. The scores were deemed 86.5% accurate in identifying patients who are at low risk of opioid misuse.  

But prescribers are not the only gatekeepers in the process. If a physician decides to go ahead and write a prescription for a “high risk” patient, a pharmacy or insurer could still refuse to dispense or pay for the medication, based on their NarxCare score.

“When patients with pain, OUD, anxiety, or insomnia, for example, have inadequate access to controlled medications their health care providers deem necessary, the resultant harms can include relegation to the illicit drug market, exposure to substances adulterated with illegal fentanyl, prosecution and incarceration, drug poisoning, suicide, and death,” Michael Barnes, CUSP’s chairman, said in a statement.  

What Every Patient Should Know About NarxCare

By Rochelle Odell, Columnist

Walmart and Sam’s Club recently announced that by the end of August their pharmacists will start using NarxCare, a prescription tracking tool that analyzes real-time data about opioids and other controlled substances from Prescription Drug Monitoring Programs (PDMP’s).

Recent studies question the value of PDMP’s, but 49 states have implemented them so that physicians, pharmacists and insurers can see a patient's medication history. Granted, there is a need for monitoring the select few who doctor shop and/or abuse their medications, albeit that number is only in the 2 percent range.

What is NarxCare? Appriss Health developed NarxCare as a “robust analytics tool” to help “care teams” (doctors, pharmacists, etc.) identify patients with substance use disorders. Each patient is evaluated and given a “risk score” based on their prescription drug history. According to Appriss, a patient is much more willing to discuss their substance abuse issues once they are red flagged as a possible abuser.

“NarxCare automatically analyzes PDMP data and a patient’s health history and provides patient risk scores and an interactive visualization of usage patterns to help identify potential risk factors,” the company says on its website.

“NarxCare aids care teams in clinical decision making, provides support to help prevent or manage substance use disorder, and empowers states with the comprehensive platform they need to take to the next step in the battle against prescription drug addiction."

Sounds great doesn't it? Except prescription drugs are not the problem and never really have been. Illicit drug use has, is, and will continue to be the main cause of the addiction and overdose crisis. 

Even the name NarxCare has a negative connotation. “Narx” stands for narcotics. And in today's environment, narcotics is a very negative word. NarxCare makes me feel like a narcotics police officer is just around the corner.

Each patient evaluated by NarxCare gets a “Narx Report” that includes their NarxScores, Overdose Risk Score, Rx Graph, PDMP Data and my favorite, the Red Flags. The scores are based on the past two years of a patient’s prescription history, as well as their medical claims, electronic health records and even their criminal history.

Ohio, Michigan, Indiana, Iowa, and several other states are using NarxCare to supplement their own PDMPs. And Walmart isn’t the only big retail company to adopt it. Kroger, Ralphs, Kmart, CVS, Rite Aid and Walgreens are already using NarxCare. There’s a good chance your prescriptions are already being tracked by NarxCare and you don’t even know it.

But NarxCare doesn’t just analyze opioid prescriptions. It also tracks other controlled substances, such as antidepressants, sedatives and stimulants. If a patient is on any combination of those drugs, their risk scores and their chances of being red flagged will be higher – even if they’ve been safely taking the medications for years.

There are several other ways a patient can be red flagged, such as having multiple doctors or pharmacies. But what if you moved and changed physicians? What if you had the same physician for many years and he/she retired or moved away? What if your pharmacy refused to fill your prescription and you had to go pharmacy hunting every month? What if you had dental surgery and your dentist placed you on a short-term pain medication?

Unfortunately, the NarxCare scores do not reflect any of that. How can raw data on prescription medications be an indicator of abuse? I believe there is some merit in tracking and weeding out the rare abuser, but NarxCare doesn't factor in all the “what if’s” that can happen to law-abiding and responsible patients. 

As pain patients, we need to be acutely aware of the negative impact this analytics tool can have. Many of us have already been required to sign pain contracts, take drugs tests, and undergo pill counts. In 2019, Medicare will adopt policies making it even harder for patients to get high doses of opioid medication. Some insurers are already doing it. We're already being policed enough as it is.

I intend to ask my physician, pharmacist and case manager if they utilize NarxCare. So should you. If they say yes, ask them why. Ask your doctor if they believe you are at risk for substance use disorder. Why is their judgement and treatment of you being second guessed by anyone?

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.