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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the purchase of Xtampza ER and future authorization and coverage of Xtampza ER. 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 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. Moreover, a study indicates urine drug monitoring is suggested to be performed at baseline for most patients prescribed opioids for chronic pain and at least annually for those at low risk, two or more times per year for those at moderate risk, and three or more times per year for those at high risk. Additional urine drug monitoring (UDM) should be performed as needed on the basis of clinical judgment. In this case, the requesting provider did not adequately document fulfillment of all the above aspects of opioid pain management. Records state the pain relief obtained from the Xtampza trial is good and the patient denies any side effects thus far. However, the provider did not adequately document improvement in function in an objective manner. There is no clear documentation that the use of Xtampza results in improvement of functional outcomes. Additionally, opioid risk stratification is not evident in the record, and periodic urine drug testing at the interval recommended by guidelines was not noted. Based upon the above considerations, the purchased Xtampza ER was not medically necessary for the treatment of the patients medical condition. Further, the requested Xtampza ER is not medically necessary for the treatment of the patients medical condition. Final Result: The reviewer determined the medication at issue 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.