By Pat Anson, Editor

The addiction treatment industry is lobbying hard for a proposed rule change to expand the number of patients that doctors can treat for opioid addiction. At stake is hundreds of millions of dollars in potential new business, much of it paid for by taxpayers.

The Obama administration has proposed doubling the maximum number of patients that a doctor can prescribe with buprenorphine from 100 to 200. Buprenorphine is an opioid that can be used to treat both pain and addiction. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse.

For many years the drug was sold exclusively under the brand name Suboxone, but it is now produced by several different drug makers and generates nearly $2 billion in sales annually.

Because buprenorphine is an opioid that can also be abused, prescribers have to register with the Drug Enforcement Administration and undergo special training. Over 33,000 doctors have done so, but most are limited to just 30 patients.

About 10,000 physicians are currently allowed to prescribe buprenorphine to the maximum number of 100 patients.

Many addiction experts say the patient limits have restricted access to a valuable treatment tool, especially in rural areas where fewer doctors are certified to prescribe buprenorphine. According to the Health and Human Services Department (HHS), about 2.3 million people who are dependent on opioid pain medication or heroin could benefit from buprenorphine treatment, but many lack access to the drug because of limits on prescribers.

In a joint letter to HHS Secretary Sylvia Burwell, the American Psychiatric Association, American Academy of Addiction Psychiatry, and the American Osteopathic Academy of Addiction Medicine stated that as “the number of people addicted to these opioids increases, there continues to be a shortage of physicians who are appropriately trained to treat them. The shortage severely complicates and impairs our ability to effectively address the epidemic, particularly in many rural and underserved areas of the nation.”  

While the goal of treating opioid addiction is laudable, little attention has been paid to the diversion of buprenorphine or the financial incentives that doctors have to prescribe it.

“This proposed rule directly expands opportunities for physicians who currently treat or who may treat patients with buprenorphine,” HHS says in an extensive analysis of the rule change. “We believe that this may translate to a financial opportunity for these physicians.”

HHS broadly estimates the added cost of treating new patients at between $43.5 million and $313 million in the first year alone. Many of the patents are low-income and the bills for treating them – about $4,300 annually for each patient – will often be paid by Medicaid. The Obama administration has asked Congress for an additional $1.1 billion to fight opioid abuse, with much of the money earmarked for addiction treatment.

The additional cost to taxpayers for expanding buprenorphine treatment, according to HHS, will be more than offset by the health benefits achieved by getting opioid addicts into treatment, which the agency generously estimates at $1.7 billion in the first year.

But some addiction experts have sounded a note of caution, warning that buprenorphine prescribing has already become a lucrative cash cow for some unscrupulous doctors.

“In northeast Tennessee, I am not aware of any buprenorphine provider that accepts insurance. Here buprenorphine clinics charge $100 cash at the time of service and require weekly visits for refills. This amounts to a cost to patients of over $5,000 yearly for medical services. This is a significant economic barrier for patients who typically have little or no income,” wrote Jack Woodside, MD, a professor at East Tennessee State University College of Medicine, in a public comment on the proposed rule change.

“From the provider's perspective, collecting $5,000 yearly from 100 patients amounts to an annual gross income of $500,000, with low overhead and no costs associated with billing insurance. This economic bonanza is causing many physicians to abandon traditional medical practices. A primary care physician remarked that he earns as much in one day in the buprenorphine clinic as he does the rest of the week in primary care.”

Buprenorphine Abuse

HHS acknowledges there could be “unintended negative consequences” to increased prescribing of buprenorphine – one of them being diversion.  Buprenorphine is a popular street drug, with addicts using it to either get high or to ease their withdrawal pains from illegal opioids like heroin. In 2014, the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. 

Some experts say the drug naltrexone is a better treatment option than buprenorphine. Naltrexone also reduces cravings, but it is not an opioid and is non-addicting.

“As I have been saying for longest time, buprenorphine is a double-edged sword. I contend greatly expanding the access of opioids contributes to the spread of addiction and a major factor in relapse,” said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“We are seeing more and more patients getting exposed to heroin and it is going to get worse. Sadly, the heroin addiction is being sustained by buprenorphine preparations.”

A 2013 study by the Substance Abuse and Mental Health Services Administration (SAMHSA) found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for the "non-medical" use of buprenorphine – meaning many users took the drug to get high.

“It is important to note that studies have found that the motivation to divert buprenorphine is often associated with lack of access to treatment or using the medication to manage withdrawal—as opposed to diversion for the medication's psychoactive effect.  Thus, the overall effect of this rulemaking on diversion is not clear,” HHS says in its analysis.

Clear or not, many of the same government regulators and anti-opioid activists who want to restrict access to opioid pain medication are some of the biggest supporters of expanding access to buprenorphine.

They include Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), a program funded by Phoenix House, which operates a chain of addiction treatment centers in 10 states and the District of Columbia. 

Kolodny, who is Phoenix House’s chief medical officer, has long advocated the use of buprenorphine, calling it “one of the most effective medications for opioid addiction” on C-SPAN last year. During the same interview, Kolodny likened other opioid pain medications to “heroin pills.”

Kolodny declined to comment to Pain News Network for this story.

Patient Limits “Indefensible”

Under the proposed rule change, only doctors who are certified in addiction medicine or addiction psychiatry will be eligible for the expanded limit on buprenorphine prescribing. The rule changes also favor physicians in larger “qualified practices” – excluding many primary care physicians and other doctors who don’t offer additional therapies such as addiction counseling.

HHS is accepting public comment on the rule change until the end of this month. The vast majority of the nearly 300 comments received so far are from doctors, including many who are angry that the restrictions on buprenorphine aren’t being loosened further:

“The current limit is indefensible. There are not enough doctors now who are willing to deal with addicted patients, there is no need to further limit which doctors can treat more patients. The goal should be to get as many doctors as possible treating as many patients as they can comfortably handle,” wrote Jon Robertson, MD.

“We should have an immediate increase in the number of opiate addicts/heroin addicts we can treat with buprenorphine. We should have an unlimited number of patients we can treat,” said Peter Rogers, MD. 

“Why is it that I can give 10,000 patients OxyContin, yet I cannot meet the need in my community to treat addiction? No other specialty of medicine, no other physician, has any limit on any prescribing, especially during an epidemic,” wrote Anne Pylkas, MD.  “I am not a thief, I am not a charlatan or a quack. I am not a pill mill. I take insurance. I do not make millions on the backs of the helpless.”

 “It makes no sense to limit physicians to an arbitrary number of patients that can be treated to get the patients out of opiate addiction,” wrote Raymond Moy, MD. “Instead of making it hard to treat opiate addicts, why don't you make it harder to create opiate addicts? Make all these regulations apply to doctors prescribing opiates.”

“I practice in a rural area with a shortage of physicians to treat opioid addiction. My staff is capable of treating many more than 100 patients, so our contributions to the community's health are hampered by the current limits,” said Nels Kloster, MD, who runs a treatment center in Vermont. “There are many more persons seeking this treatment, but we have to turn them away due to this artificial restriction to our services.”

Only a few commenters warned that buprenorphine is already widely available on the black market and some doctors are likely to abuse the system.

“While it seems logical that increasing the patient limit would increase the ability to get people into the system, it does have some very serious downsides,” wrote Karl Hafner. “Several of these providers (at least in our area) are what most would consider pill mills. This only puts more medication on the street for abuse.

"By increasing the limit you will move physicians from doing this as part of a practice to just doing Suboxone and they will become pill mills. Do not increase the cap unless it is tied to treatment programs. There are plenty of providers.”

In a recent column in the Journal of Psychiatric Practice, one expert also warned of unintended consequences if the cap on buprenorphine prescribing is raised.

“Buprenorphine is an effective treatment for opioid use disorder; however, with increased access and availability, its abuse and diversion may be inevitable,” warned Daryl Shorter, MD, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine.

“This real-world, almost paradoxical, phenomenon demonstrates the complexity inherent in the treatment of addictive disorders -- a medication intended to treat substance use disorder that has its own abuse potential, upon gaining popularity and increased availability, will inevitably be explored by drug abusers for reward and reinforcement purposes.”