Why The 100-Patient Limit for Buprenorphine Treatment Should Be Eliminated
By Eve Pearce
In the year 2000, Congress passed the Drug Addiction Treatment Act of 2000 (DATA 2000), an Act permitting qualified, office-based physicians who obtain special waivers to treat opioid addiction with specific, FDA-approved, Schedule III, IV, and V opioid medications. Previously, physicians had to practice in an opioid treatment program, such as a methadone clinic, to provide medication-assisted treatment for addiction. Under DATA 2000, physicians may prescribe buprenorphine to treat addiction in an office-based setting. Unfortunately, the Act also caps the number of patients an addiction practitioner may treat with buprenorphine products to 30 patients the first year following certification, and to 100 patients thereafter. This is an arbitrary limit that has no scientific basis supporting it. Likewise, in some states, there are limits on the maximum dosage a physician may prescribe. No other drugs are bound by such tight restrictions, leading to the absurd situation in which physicians may prescribe unlimited, high doses of Schedule II through V controlled substances that could lead to addiction, yet they are limited when using controlled substances to treat addiction.
Recently, certain Medicaid providers (such as Coventry in Kentucky) informed their members that buprenorphine would no longer be covered after their current prescriptions ended. Following this notification, threats of legal action led Coventry to back down and continue providing coverage for this drug. In nearby West Virginia, patients are limited to a once-per-lifetime 24 mg per day dose for 60 days, after which their maintenance dosage is capped at 16 mg. Medicaid in Maine imposes the same limitations. Dr. Stuart Gitlow, President of the American Society of Addiction Medicine (ASAM), asks a vital question: “Why, when we have a reasonably safe drug which is nearly impossible to overdose on, which has a lower street value than other narcotics, and which is used to deal with the increased fall-out of overprescribed opioids, does this specific drug keep getting beaten on? I can think of only one reason: discrimination against addicts.”
The U.S. Department of Health and Human Services (HHS) should revoke the 100-patient limit on buprenorphine, for the following reasons:
* It leads to long waiting lists: Patients in countries with government-rationed health care might be accustomed to waiting months or longer to access care, but traditionally, an enviable feature of the U.S. health care system has been the general ability to obtain care when it is necessary.
According to Money.co.uk, “One of the major advantages of taking out a private medical insurance plan is that when you require treatment, you will be able to undertake it as soon as it is convenient for you to do so.” The patient cap undermines patients’ contractual expectations under insurance policies that cover detoxification services and outpatient drug treatments.
It is illogical that, in the U.S., many physicians should have waiting lists that are three times as long as their patient lists. The National Alliance of Advocates for Buprenorphine Treatment (NAABT) provides an interesting real-time map of patients seeking buprenorphine treatment; the number of patients who are currently not being treated, owing to the patient cap, is staggering. By the time a physician gets to call new names on the waiting list, many of the telephone numbers have already been disconnected. As one physician says, “Opioid dependence tends to do that to telephone accounts, either through poverty or death.”
The cap directly clashes with one of the 13 principles espoused by the National Institute on Drug Abuse – Principle 2 states: “Readily available treatment is crucial.”
* It leads to the rationing and early termination of care: The 30/100-patient limit skews the chain of supply and demand. Patients who are fortunate enough to receive treatment may be prematurely forced off their physician’s patient list in order to make room for new patients. Evidence suggests that long-term treatment leads to improved success rates; patients should not feel forced to terminate treatment before they are ready.
* Prescription drug-related morbidity rates are already alarmingly high: The U.S. Centers for Disease Control and Prevention (CDC) reports that, since 1990, drug overdose rates have more than tripled; most of these deaths are caused by prescription drugs. Any and every attempt should be made to avoid these untimely deaths, through the provision of prompt and effective addiction treatment.
* It discourages professional specialization: The patient cap indirectly affects patients by discouraging physicians from specializing in addiction medicine. Indeed, many physicians may not become certified in addiction medicine at all, fearing that the cap will not enable them to earn an adequate living. Statistics indicate that of the U.S.’s 800,000 physicians, fewer than 25,000 are currently eligible to prescribe buprenorphine to treat addiction. Of these, only about one third prescribe it, and these prescribers are limited by the 30/100-patient cap.
* It leads to greater expenditure on health: The CDC reports that, in 2009, the misuse and abuse of prescription pain relievers led to over 475,000 emergency visits (this number is double that of five years previous). Again, any and every attempt should be made to avoid substance-related medical emergencies through the provision of prompt and effective addiction treatment.
* It forces patients into inferior treatment options: Patients can be encouraged by less effective treatments, or exposed to the potentially dangerous effects of treatments that have not been validated in science. Treatment can also be inferior because a patient is forced to choose from a smaller selection of doctors, thereby reducing the quality that emanates from market competition.
* It is discriminatory: The 30/100-patient limit enables doctors with long waiting lists to pick and choose their patients, often refusing private insurance or Medicaid patients and accepting cash-only payments. This practice directly affects the poor and often drives the cost of treatment up to several hundreds of dollars a month, an amount even an employed patient could find hard to meet. People with addiction are often unemployed, which makes any service based on cash payments difficult to access. The cap is also discriminatory against office-based physicians, given that prescribers in methadone clinics are allowed to control their own dispensing schedule for buprenorphine and are not subject to a patient limit.
* New forms of buprenorphine reduce risks: To the extent that the 30/100-patient limit may be justified as a means of preventing the diversion and abuse of buprenorphine, new implantable forms of buprenorphine will reduce those risks. The same is the case with accidental exposure.
* The cap negatively affects pricing: A larger patient base using buprenorphine will drive down its price in the long-term through economies of scale.
Proponents for the patient cap are running out of reasons to support their position.