In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status.
The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.
MEDICALLY NECESSARY
An inpatient admission for the initiation, dose escalation or reinitiation of dofetilide (Tikosyn) is considered medically necessary and, therefore, covered for either of the following indications:
- For conversion of atrial fibrillation (AF) and atrial flutter (AFL) (AF/AFL) to normal sinus rhythm (NSR)
- For the maintenance of NSR (delay in time recurrence of AF/AFL) in individuals with AF/AFL of greater than 1 week's duration who have been converted to NSR
Dofetilide (Tikosyn) should be reserved for individuals in whom AF/AFL is highly symptomatic because the drug can cause life-threatening ventricular arrhythmias.
Therapy with dofetilide (Tikosyn) for initiation, dose escalation, and, if necessary, reinitiation, must be done according to the product
labeling, for a minimum of 3 days in an inpatient setting that provides continuous electrocardiographic (ECG) monitoring in the presence of personnel trained in the management of serious ventricular arrhythmias. Additionally, individuals should not be discharged within 12 hours of electrical or pharmacologic conversion to NSR.
- For information on maintenance therapy with dofetilide (Tikosyn), refer to the Guidelines section of this policy.
NOT MEDICALLY NECESSARY
Dofetilide (Tikosyn) has not been shown to be effective in individuals with paroxysmal atrial fibrillation; therefore, it is considered not medically necessary and is not covered for this condition.
EXPERIMENTAL/INVESTIGATIONAL
All other uses of dofetilide (Tikosyn) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.
REQUIRED DOCUMENTATION
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
