Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Digoxin 250 mcg. 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 Digoxin 250 mcg. Digoxin 250 mcg is requested for treatment atrial flutter with a fast ventricular response. The prescriber states that the enrollee has been unable to tolerate beta blockers and calcium channel blockers. The plan indicated in their denial letter that atrial flutter is not a medically accepted indication for the use of the requested drug.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition.The following information is stated in American Hospital Formulary Services Drug Information (AHFSDI) regarding Digoxin: 1) Concomitant use of digoxin and adrenergic blocking agents (blockers) can have additive negative effects on AV conduction, which can result in complete heart block. Although such combined therapy may be useful in controlling ventricular rate in patient with atrial fibrillation and/or flutter, digoxin dosage in patients receiving such therapy should be carefully individualized given the considerable variability of these interactions. 2) regarding the concomitant use of Verapamil and Digoxin, the patient should be monitored closely for clinical response and digoxin toxicity. Combined therapy with the drugs (e.g., for control of ventricular rate in patients with atrial fibrillation and/or flutter) usually is well tolerated if dosage of digoxin is properly adjusted, 3) in the Pharmacology section: Digoxin decreases conduction velocity through the atrioventricular (AV) node and prolongs the effective refractory period (ERP) of the AV node by increasing vagal activity, by a direct effect on the AV node, and by a sympatholytic effect. The effects of the drug on the AV node are not apparent clinically when the atrial rate is slow enough to allow time for the AV node to recover between each beat, but in patients with supraventricular tachyarrhythmias such as atrial flutter or atrial fibrillation, the number of waves of depolarization reaching the ventricles is decreased.As noted, the enrollee is not a candidate for beta blockers or Verapamil. The citations support the use of Digoxin for treatment of atrial flutter with a rapid ventricular response. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Digoxin 250 mcg for the diagnosed condition. As a result, Digoxin 250 mcg is being prescribed for a medically accepted indication as defined by Medicare law. Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Digoxin 250 mcg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.