Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and authorization and coverage for the requested medication, Belbuca (600Mcg film, 60 per month).The Medical Board of Californias Guidelines for Prescribing Controlled Substances for Pain state that continuation, modification or termination of opioid therapy for pain should be contingent on the providers evaluation of evidence of the patients progress toward treatment objectives and the absence of substantial risks or adverse events. The guidelines recommend that providers consider the 5-As method for chronic pain management assessment. The 5-As method takes the following into consideration: Analgesia (the patient is experiencing a reduction in pain); Activity (the patient is demonstrating an improvement in level of function); Adverse (the patient is not experiencing side effects); Aberrance (the patient is complying with the pain management agreement and there are no signs of medication abuse or diversion) and Affect (the patients behavior and mood are appropriate). The Board recommends that physicians proceed cautiously (yellow flag warning) once the MED reaches 80 mg/day. Referral to an appropriate specialist should be considered when higher doses are contemplated.Similarly, Centers for Disease Control and Prevention (CDC) guidelines on opioid prescribing suggest comprehensive steps at all stages of opioid initiation, monitoring, continuation, and discontinuation. CDC guidelines state that opioids should only be considered when non-opioid and non- pharmacologic interventions have been ineffective, and when selected, they 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 compliance, as well as urine toxicology screening. An opioid use contract is recommended between the provider and the patient. CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care state that clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. CDC recommendations state that clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months. The recommendations also state that when prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.In this case, within the submitted documentation, the requesting provider did not adequately document fulfillment of the above aspects of opioid pain management. The submitted records do not adequately document improvement in function in an objective manner to warrant continuation of the requested opioid medication. There was no clear documentation that the use of Belbuca resulted in an improvement in functional outcomes. In addition, records do not reflect that the CURES database was queried to monitor for 'doctor shopping' behavior at the interval recommended by the CDC (from every prescription to every 3 months). Finally, periodic urine drug screening at the recommended interval (at least annually for those at low risk) was not noted. Under these circumstances, the requested medication, Belbuca (600Mcg film, 60 per month), was not, and is not, medically necessary for the patients medical condition.Final Result: The reviewer determined that the requested medication was not, and is not, medically necessary for 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 subspecialty 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.