Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for tramadol 50 mg, 60 tablets every 30 days.Tramadol is a controlled substance that has opioid agonist activity and also inhibits the re-uptake of serotonin and norepinephrine. Thiels and colleagues conducted a study to determine the risk of prolonged opioid use in patients receiving tramadol compared with other short acting opioids. The authors noted that patients receiving tramadol alone had a similar or somewhat greater risk of prolonged opioid use after surgery. Per the authors, Although all factors related to the safety of a drug must be considered, from the standpoint of opioid dependence, the Drug Enforcement Administration and U.S. Food and Drug Administration (FDA) should consider rescheduling tramadol to a level that better reflects its risks of prolonged use. (Thiels, C., et al.). The Medical Board of California (MBC) released a policy statement in November 2014 to provide guidance to physicians prescribing controlled substances. This statement recommended the following chronic pain management assessment considerations: pain reduction; improvement in level of function; side effects; whether the patient is complying with the pain management agreement and there are no signs of medication abuse or diversion; and whether the patients behavior and mood are appropriate. Furthermore, the MBC recommended that physicians proceed cautiously once the morphine equivalent dose (MED) reaches 80 mg/day. Similarly, the Centers for Disease Control and Prevention (CDC) guidelines on opioid prescribing suggested comprehensive steps at all stages of opioid initiation, monitoring, continuation, and discontinuation. The 2016 CDC guidelines state opioids should only be considered when non-opioid and non-pharmacologic interventions have been ineffective, and when selected, should be used at the lowest dose that is effective and minimizes opioid-related complications and risks including overdose. In addition, professional opioid management should include consultation with the state prescription drug monitoring program (PDMP) to determine whether the patient is receiving opioid dosages or dangerous combinations that places him or her at high risk for overdose, as well as utilizing urine toxicology screening.In this case, the requesting provider did not adequately document fulfillment of all the above aspects of opioid pain management. There is documentation that shows the patient works 10 hours a day and that one tablet of tramadol is not enough to get the patient through his 10-hour shift. In a progress report, there is documentation that the directions for tramadol were to take one tablet by mouth every 12 hours as needed for pain. Periodic urine drug screens are noted. However, there is no clear documentation that tramadol results in an improvement in pain or functional outcomes. Additionally, opioid risk stratification is not evident in the record. Based upon the above considerations, tramadol 50 mg, 60 tablets every 30 days are not medically necessary for the treatment of the patients medical condition.Final Result: The reviewer determined that the requested medication quantity is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation, with sub-specialty certification in pain medicine, and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.