End the Patient limits on Care
Why this current rationing policy must end
Background: In 2000 Congress passed DATA-2000, a law that allows physicians, to become eligible to prescribe specially approved opioid-based medications specifically for the treatment of opioid addiction. Buprenorphine/naloxone (Suboxone®) and buprenorphine (Subutex®) became the first medications to be approved and affected by this law. If physicians take and pass an 8 hour course and meet other qualifications, they become eligible to apply for a special waiver which allows them to treat addiction with above mentioned medications in an office-based setting. This same law, void of any supporting science, arbitrarily caps the number of addicted patients a physician can treat at any one time to 30 through the first year following certification, expandable to 100 patients thereafter. No other medications have such restrictions, including the prescription drugs people get addicted to and die from. Like many well-intentioned laws, the unintended consequences are significant. Read Full Text of Law
Update 7/2016: In 2016 HHS amended the regulation to allow qualifying physicians to apply for permission to help up to 275 patients concurrently. Physicians must reapply every 3 years. The 26,000 word rule change can be found here.
Update 7/2016: On 7/22/2016 the Comprehensive Addiction and Recovery Act of 2016 was signed into law. One of its provisions is to allow Nurse Practitioners and Physician Assistants to obtain a DATA-2000 waiver and prescribe buprenorphine for the treatment of Opioid Use Disorder. See summary of new law here.
Reasons to End the Patient Limits on Buprenorphine Treatment
91 people a day die -According to the CDC, 91 people per day die from
opioid overdose. While this epidemic is tearing apart families, an effective treatment exists. The medication buprenorphine when combined with therapy is proven effective and is considered the standard of care. It is unconscionable to ration this lifesaving treatment while so many who need it die daily. This reason alone should be enough to lift the
government-mandated limits on this lifesaving treatment.
Limits access to treatment -Despite over 15 years of recruitment efforts, only 35,894 providers are currently
eligible to prescribe buprenorphine for addiction. Of those 35,894 only about 1/3 actively prescribe the treatment; and these few are further limited by the patient caps. This results in no access at all within reasonable driving distance for many patients.
Forces patients into less effective treatments -Many potential patients who are unable to find a provider able to treat them are
forced to remain in active addiction, seek inferior treatment options, or worse, fall victim to expensive and potentially dangerous options such as ultra-rapid detox.
The limit disproportionately affects the poor -Supply/demand distortions from the limit affect cost and insurance acceptance. Artificially restricting supply of treatment (through the limit and burdensome regulation) in the current demand-rich environment drives up prices of office visits. High demand and low supply [of treatment] enables some physicians to
refuse private insurance and Medicaid, and demand cash only. That, in effect amounts to offering treatment to the highest cash bidders. $500 cash (not including medication) monthly office visits are not uncommon in some high demand parts of the country.
Prohibits evolution of experts -The 30/100/275 patient limit
discourages physicians from devoting their entire practice to treating addiction, specializing in this treatment and thus becoming experts in the field. Amazingly, this is actually one of the intents of the limit. Proponents of limited treatment cite fears of "doctors loading up on patients" as a reason to support rationing of care. Instead,
the needs of communities go under-servedcontributing to the 91/day death rate.
Premature discontinuation of treatment -Stable patients, some in long-term addiction remission, are sometimes
forced off treatment prematurelyto make room for someone in more urgent need of addiction treatment, despite overwhelming evidence showing
longer treatments result in higher survival rates. Patients are horrified to find out the new life they have created is now at risk for no reason other than
arbitrary government limits on how many patients a doctor is allowed to help concurrently.
Fosters diversion market-In order to save their lives, some patients (or loved ones of patients) are
forced into the diversion market to self-medicatewhile waiting for a treatment opening.
The rationing policy promotes unsupervised self-medicationby those who prefer to get it legally, but can't. It
promotes sharing of medication among friendsor family who either can't afford the high cash prices of office visits or are unable to get treatment at any price. Sadly, this type of diversion is being mistaken for abuse and cited as reasons to enact even more restrictions. Patient surveys reveal 85-95% of diverted buprenorphine is used therapeutically, not abused.
Waiting lists -The evidence is clear that treatment is more effective when provided at the time the patient first seeks help. But once a physician first reaches his
government-mandated patient capand must then establish a waiting list, all patients thereafter are not provided treatment when they first seek it and tragically some die while waiting. Imagine a loved one dying, not because treatment didn't exist but because the
government arbitrarily limited how many lives could be saved by any one physician, regardless of the need in the community. Of the National Institute on Drug Abuse's 13 "Principles of Drug Addiction Treatment", number two is "Treatment needs to be readily available... and readily available treatment is crucial."
Cost of compliance -
275 patients is not enoughfor some physicians to recoup the cost of the extra staff and cost of compliance with the regulatory burden (at least while charging reasonable office visit rates). As a result some physicians never become certified, which further prevents access in the community.
Recouping costs with only 30 patients is even more difficult, causing some physicians to wait out the first year until they can treat 100 patients, all the while allowing their newly acquired skills to erode.
Buprenorphine is safer than the drugs the limit forces patients to remain on -The opioid drugs people get addicted to can kill, while
buprenorphine is self-limiting making an accidental overdose of buprenorphine alone, almost impossiblein an otherwise healthy adult.
Buprenorphine's effects have a ceilingbeyond which taking more has no perceivable added effect.
It also can block other, more dangerous opioids for days, further reducing the chance of overdose.
Patients unable to get buprenorphine, due to the limit, are forced to remain addicted to the more dangerous drugs of which 91 people a day die from.
Depot buprenorphine -In the pipeline are
injectable and implantable (Probuphine FDA approved May 2016) buprenorphine productswhich last for months, and are very
difficult to remove and divert. Even if you accept the contested argument that buprenorphine is an exceptionally desired street drug with a high potential of abuse, you will agree that
depot buprenorphine is much less likely to be diverted. Without fear of diversion, misuse, or noncompliance, what possible reason is there to ration this lifesaving treatment to the arbitrary limit of 30, 100 or 275 patients when so many in the community desperately need it?
Patient choice -In some parts of the country there might only be
one provider available to treat addiction with buprenorphine, within reasonable driving distance. But ability to treat is just one factor in choosing a doctor. Does the doctor take insurance? Can he/she treat other co-occurring issues I may have? Do I trust or get along with this doctor? Is the staff helpful or rude? Is the office located in a safe area? Does he/she speak English clearly? There are many factors that go into the decision.
The limit robs this choice from patientsand forces them to go to a doctor who he or she may not have selected given a choice.
Methadone clinics -can now control their own
dispensing schedule for buprenorphine. This means they can allow take-home doses with more discretion than they can with methadone. A counselor at a methadone clinic may have 500 clients or more, yet physicians who have completed special training in addiction medicine are
limited to only 30 or 100 or 275 buprenorphine patients.
Economies of scale -Once providers can distribute the
fixed costs of a medication assisted addiction treatmentpractice over a much larger patient base, economies of scale will reduce the prices they charge for everyone.
Greater risk to children-Untreated opioid addiction can put children of the addicted at much greater risk than the buprenorphine rationing is meant to reduce. Beyond the risk of accidental exposure to the drug, intoxicated, distracted, desperate, or panicked parents can present different but enormous risk to the children they care for.
Cost to society-According to the World Health Organization treated opioid addiction saves society $12 for every $1 spent on treatment. We cannot afford the costs of purposefully withholding evidence-based treatment from those who want and need it.
Reduce the spread of infectious diseases-HIV, HEP-C, and Ebola can be spread through shared needles. Studies have shown MAT with buprenorphine significantly reduces this transmission path.
Pro bono help -With only 30, 100, or 275 patients to divide the additional costs of providing MAT, physicians cannot afford to forfeit one or more of these spots to patients who can't contribute to the cost burden, while charging a reasonable rate to the remaining patients. The result is less pro bono help to patients than would be.
Distorted clinical feedback -It is not uncommon for an addicted married couple to share buprenorphine, as they can only afford the high-priced cash-only office visit for one of them, if they can find treatment at all. This could lead the physician to conclude that patients require twice as much medication as they really do. Likewise, as some patients appear do well at ½ the dose of other patients, the physician could develop an inaccurate view of the range of effective dosing. Such distortions of clinical feedback could lead to over-prescribing or a compromised understanding of buprenorphine's efficacy.
It's unethical -
Arbitrary rationing of lifesaving medical care is unethicalin and of itself. Limiting addiction treatment while not limiting the drugs people get addicted to, is in effect a policy that promotes addiction. For every 100 physicians who can, and do, prescribe the opioid drugs people get addicted to and die from there is only 1 active prescriber of the lifesaving treatment medication. This 1% is further limited to the arbitrary patient caps of 30/100/275. Since an estimated 10% of people prescribed opioid pain relievers become addicted, this policy makes becoming addicted 10 times more likely than obtaining treatment for addiction. The predictable result is the current state... addicted people unable to find or afford the life-saving treatment they need.
- source: Downloaded with permission from: www.naabt.org