Suboxone denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for (1) admission to a residential treatment center (RTC) (ASAM Level 3.5) and (2) prescription Suboxone. Per American Society of Addiction Medicine (ASAM) criteria, this patient meets Level 3.5 criteria for RTC services. ASAM criteria focuses on six dimensions to determine the appropriate level of care, which includes: (1) intoxication and withdrawal potential; (2) biomedical conditions; (3) emotional, behavioral and cognitive conditions; (4) readiness to change; (5) relapse, continued use, or continued problem potential; and (6) recovery environment. For dimension 1, the patient has a history of addiction since age 15. He was stable on Suboxone for four and a half years until a breakup with his girlfriend.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested reimbursement and prospective authorization and coverage for brand name medication Suboxone. Suboxone is well documented to reduce morbidity and mortality associated with opioid use disorder. Abrupt cessation of this medication places an individual at very high risk for relapse and unintentional overdose. While generic medications are required by the U.S. Food and Drug Administration (FDA) to be bioequivalent to branded medications, they may contain inactive ingredients that differ from the branded formulations. This includes differences in fillers, dyes, or flavorings that may cause adverse reactions for certain patients.

Where the denial was upheld

The enrollee is requesting authorization and coverage for the medication, Suboxone. The enrollee has a history of complex regional pain syndrome (CPS) type 2 and mood difficulties that have been responsive to psychotropic medications. The enrollee has been on pain medications for about five years and was on a high dose of opioids prior to her enrollment in the pain management program, Opioid Safety Program (OSP), in order to taper-off from her opioid medications. The enrollee is highly motivated to get-off of her opioid medications completely. According to the OSP note, the starting daily Morphine Milligram Equivalent (MME) was 210. The providers’ notes indicate the enrollee has been tolerating the tapering well, until she reached her daily MME of 165.

A 25-year-old female enrollee has requested Suboxone for treatment of her back pain. Findings: The physician reviewer found that review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the requested medication. Buprenorphine is a long-acting semisynthetic opioid that has partial mu receptor agonist and kappa receptor antagonist activities. Its clinical effects at low doses are similar to morphine. At higher doses, its effects are less than those of full opiate receptor agonists (Wesson). Buprenorphine, nonetheless, is a widely-abused drug (Yokell, et al). Suboxone is a combination drug that contains buprenorphine and naloxone, an opioid antagonist.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Suboxone, then check the rights and deadlines that apply to your plan.