Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Oxycodone HCL 10 mg, 240 per 30 days. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Oxycodone HCL 10 mg, 240 per 30 days. Oxycodone HCL 10 mg every 3 hours as needed, 240 per 30 days is requested for ongoing treatment of chronic pain. The Plan limits the amount of Oxycodone 10 mg to 180 per 30 days; the Plan also has a quantity limit of 180 per 60 days for the 15 mg, 20 mg, 30 mg strengths, and also has extended release Oxycodone as Xtampza on their formulary. You have indicated to the Plan that the current treatment was started December 8, 2018, the enrollee is stable on this medication at the requested dose/quantity, and that it could be detrimental for the patient to stop taking the medication. You further stated that the requested dosing schedule for Oxycodone 10 mg is how the enrollee likes taking the medication. There is discrepant information regarding trials of lower doses - it is stated that the enrollee has not failed lower doses, but also stated that the enrollee has tried and failed the requested medication at the quantity limit available. Regardless of whether there has been a trial of lower quantities of Oxycodone 10 mg, the documentation indicates that the enrollee has not tried and failed other medications for treatment of the noted diagnosis, and that the prescribed dose can be achieved with a lower quantity of a higher strength that does not exceed the plan's quantity limit.Based on the documentation provided, although it is unclear whether lower doses of Oxycodone 10 mg have been tried and failed, there is insufficient documentation that a lesser quantity of a higher strength tablet of Oxycodone (which would be within the Plan's quantity limit) would not be an appropriate option for this enrollee. You have not indicated that the number of doses of the Oxycodone (higher strength) allowed by the Plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met. Of note, there is also an option for extended release Oxycodone. In addition, the Plan also brought up safety concerns regarding the issue of concomitant use of Oxycodone with a benzodiazepine which will need to be addressed by you before Plan consideration of approval of Oxycodone.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Oxycodone HCL 10 mg, 240 per 30 days.