Non long-term care enrollees who are:

• New enrollees into prescription drug plans on January 1, 2008, following the 2007 annual coordinated election period
• Newly eligible Medicare beneficiaries from other coverage in 2007 into a Part D plan
• Individuals who switch from one Part D plan to another after January 1, 2008 (also applies to re-assignees and any individual moving to a new plan)

Plans must provide a temporary 30-day fill (unless enrollee presents with a prescription written for less than 30 days) when presenting at a pharmacy to request a refill of a non-formulary drug that patient was taking before enrollment (including Part D drugs that are on a plan’s formulary but that require pre-authorization or step therapy under a plan’s utilization management rules) within the first 90 days of coverage, under the new plan.

New enrollees who are residents of long-term care facilities

Plans must provide a temporary 31-day fill (unless the prescription is written for less than 31 days) of non-formulary Part D drugs—including Part D drugs that are on a plan's formulary but require pre-authorization or step therapy under a plan's utilization management rules. Also, plans must honor multiple fills of non-formulary Part D drugs (including Part D drugs that are on a plan's formulary but require pre-authorization or step therapy under a plan's utilization management rules) during the first 90 days of their coverage, under the new plan.

Enrollees who remain in same plan as in 2007 but experience negative formulary changes in 2008 (eg, taking a drug that was on formulary in 2007 but is not on formulary in 2008, or had an exception granted in 2007 that will not be honored in 2008).

After enrollees receive their Annual Notice of Change on October 31st of a given year, CMS expects plan sponsors to select 1 of the following 2 options for effectuating an appropriate, meaningful transition for enrollees who experience negative formulary changes:

1. Provide a transition process for current enrollees consistent with the transition process required for new enrollees beginning on January 1, 2008.

   To prevent coverage gaps, plans choosing this option are expected to provide a temporary supply of the requested prescription drug (where not medically contraindicated), consistent with the 2008 Formulary Transition Guidance, and provide enrollees with notice that they must either switch to a therapeutically appropriate drug on the plan’s formulary or get an exception to continue taking the requested drug.

2. Effectuate a transition for current enrollees prior to January 1, 2008.

   In effectuating this transition, plans must aggressively work to (1) prospectively transition current enrollees to a therapeutically appropriate formulary alternative; and (2) requests for formulary and tiering exceptions to the new formulary had to be completed before January 1, 2008.

Enrollees who request an exception, but the plan fails to issue a timely decision on the request by the end of the transition period

CMS expects plans to make arrangements to continue providing requested drugs via a case-by-case extension of the transition period to the extent that the individual's exception request or appeal has not been processed by the end of the minimum transition period

Enrollee who remains in same plan as in 2007 and is using a drug as a result of an exception that was granted in 2007

Plans have the option of “honoring” exceptions granted in 2007 beyond the end of the plan year (ie, a plan may choose to honor an exception for as long as the beneficiary remains in the plan)

If a plan is not going to honor an exception beyond the end of the plan year, it must have notified the enrollee in writing at least 60 days before the end of the 2007 plan year and either (1) offer to process a prospective exception request for the 2008 plan year, or (2) provide the enrollee with a temporary supply of the requested prescription drug (if not medically contraindicated) at the beginning of 2008, and notify the enrollee that he/she must either switch to a therapeutically appropriate drug on the plan’s formulary or get an exception to continue taking the requested drug

Enrollee who remains in same plan as in 2007 and is using a drug with a prior authorization requirement that is expiring

Before the beginning of the new plan year, enrollees may attempt to satisfy the pre-authorization requirement by requesting a coverage determination or by requesting a formulary exception if he/she cannot satisfy the pre-authorization requirement

Current enrollees experiencing a level-of-care change

Enrollees who are outside their transition period may experience circumstances that involve level-of-care changes in which a beneficiary is changing from one treatment setting to another. CMS encourages, but does not require, plans to incorporate processes in their transition plans that allow for transition supplies to be provided to current enrollees with level-of-care changes. Thus, beneficiaries and providers must avail themselves of plan exceptions and appeals processes.

Current enrollees entering long-term care settings from other care settings

These enrollees will be provided emergency supplies of non-formulary drugs (including Part D drugs that are on a plan’s formulary but require prior authorization or step therapy under a plan’s utilization management rules). This transition supply is not limited only to initial enrollment.

Current enrollees in a long-term care setting requiring an emergency supply of a nonformulary drug

To the extent that an enrollee in a long-term care setting is outside his/her 90-day transition period, the plan must still provide an emergency supply of nonformulary Part D drugs (including Part D drugs that are on a plan's formulary but require prior authorization or step therapy under a plan's utilization management rules) while an exception is being processed. These emergency supplies must be for at least 31 days of medication, unless the prescription is written by a prescriber for less than 31 days