Formulary changes and transition policies

July 23, 2007

Changes to formularies continue to be among the most frustrating aspects of the Medicare prescription drug benefit for pharmacists and physicians, and most confusing to beneficiaries.

Plans can change their formulary during the year as long as they notify CMS and all affected parties 60 days before the proposed change. The change may be posted to the plan's Web site to comply with the notice requirements, but most plans will send a letter to those affected by the change. CMS does not require the plans to wait for approval before making a formulary change. A plan may choose to provide notices to CMS and beneficiaries at the same time. If CMS does not disapprove within 30 days of the notice, approval for the change is automatic.

Occasionally Part D beneficiaries change plans outside the annual renewal period. For example, a person may move out of the coverage area, experience a change in eligibility for a low-income subsidy (LIS), or enter a long-term care facility. Persons who qualify for an LIS may find it necessary to change to a plan that is fully subsidized. Those who are eligible for both Medicare and Medicaid may change plans as well. Beneficiaries who take multiple drugs are unlikely to find all of their medications covered by their new plan even when they make a careful plan selection and are likely to encounter problems with formulary coverage.

For current enrollees, however, CMS encourages plans to provide an effective transition process if there is a change in formulary status. If the beneficiary has received an exception in the past, the plan may rescind the exception with a 60-day notice that allows time for the beneficiary to file an appeal or change the medication regimen. If the Rx is for a new medication that the beneficiary was not taking when enrolled, the beneficiary must comply with the formulary policies for exception requests or contact a physician for a new prescription.

If a claim for a transition supply of medication is denied, the beneficiary can take several courses of action. First, the individual must notify the plan about the problem and get an explanation of plan formulary policy. A request for an exception can be made. If the beneficiary disagrees with the plan determination, he or she can file an appeal that must be processed within seven days-or within 72 hours if an expedited appeal is requested. The plan decision is provided in writing and can be appealed again to an independent review organization. The appeals process varies from plan to plan, but the plan must provide written instructions to the beneficiary for the appeal.

In the event that an appeal is not resolved in 30 days, CMS "expects" a case-by-case assessment but does not necessarily require plans to continue providing the requested drug. A beneficiary may contact his or her local State Health Insurance Assistance Program (SHIP) for help. Referrals to the appropriate SHIP office are available by calling the Elder Care Locator at 1-(800) 677-1116.