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Replies to post #202504 on Biotech Values
Who can prescribe Buprenorphine?
Any physician with a special "X" number issued by the DEA. The way the law is written, any doctor can prescribe Suboxone for treating pain, however the FDA has not granted approval for Suboxone to be used for pain, so it would be an off-label prescription. However there exists other restrictions for those who want to prescribe it for opioid addiction treatment (what the FDA approved it for). Doctors must take an 8-hour class on addiction treatment, or already possess such credentials, and then apply for a special DEA#. Once they obtain their # they are limited to treating only 30 patients at a time. (see our 30 patient limit page)
A Doctor Explains How Buprenorphine Is a "Stealth Medicine" for Both Addiction and Chronic Pain
As a family physician, I am in the trenches with patients battling chronic pain... Sometimes people are referred to me for help after limping along on opioids for years. Buprenorphine is often the best choice...
...Buprenorphine is often, in my experience, like a magical key that frees people from their seemingly inescapable dungeon. It is an opioid medication with a unique profile that fits the lock precisely. It blocks withdrawal symptoms and craving. There is no drug “high.” Patients trade sluggishness for a fresh energy. Best of all, the hovering risk of overdose death vanishes.
Buprenorphine was developed decades ago and approved by the FDA in 2002. Yet it remains nearly invisible, despite its potency against a fiendish trio of adversaries: withdrawal symptoms, craving and overdose death. That’s why I call it the Stealth Medicine. It is hidden behind the term “medication-assisted treatment,” which also includes methadone and naloxone. Buprenorphine is the only one doctors can use to treat opioid use disorder in their patients with chronic pain.
Any doctor can prescribe buprenorphine for opioid use disorder, after undergoing a brief training required for authorization, known as a “waiver,” from the Drug Enforcement Agency. Only a tiny minority obtain the waiver, however. Due to federal rules, the number of patients each one can treat is strictly limited—to 100, although President Obama’s plan will increase that to 200—and other prescribers (nurse practitioners and physicians’ assistants) are not eligible for a waiver.
Ironically, there is no such bottleneck on access to the opioid pain pills involved in the deaths of 19,000 people in the US in 2014.
There are strict rules constraining use of the waiver. For one thing, the patient has to have a diagnosis of opioid use disorder. This diagnosis implies a stark but false distinction between “legitimate pain patients” like Marshall and “drug abusers” like Luke. The same dreadful craving afflicted Marshall, who lost his struggle to use pills as prescribed, and Luke, who never had a prescription. Buprenorphine brought relief to both.
“Off-label” prescribing for chronic pain is perfectly legal without a waiver. The limited research available supports this practice: It shows that a switch to buprenorphine improves pain and quality of life.
But here’s the catch: Without a diagnosis of opioid use disorder, buprenorphine is rarely covered by insurance. With the diagnosis, it usually is. Under Obamacare, insurance companies must provide coverage for treatment of substance use disorders. Luke pays roughly $10 per month for this otherwise pricey drug, which can run to hundreds of dollars without insurance...
...Since starting buprenorphine for opioid use disorder [instead of oxycodone for arthritis], Lily had begun walking two miles a day. For two years, she often had no pain at all. Insurance coverage was in place.
Then the insurance company discovered she was not enrolled in a chemical dependency program. She was thus deemed noncompliant with their requirements for buprenorphine coverage. Payment for the next refill was denied.
A formal treatment program would be overkill even for a patient like Luke, the convenience store employee, although he could certainly benefit from having a counselor. But what about Lily? Such a program would be an irrelevant intrusion.
I re-prescribed buprenorphine for Lily, this time using a diagnosis of pain. Coverage was denied. I appealed. Ultimately I talked with the medical director. He politely informed me, “Buprenorphine is not a good medicine for chronic pain, so it is not an option for your patient. But we will cover oxycodone.” Lily has since switched to a more flexible insurance company.
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