CMS Pub. 100-18, ch. 6, § 30.4.10

A successful transition process is contingent upon informing enrollees and their health care

provider about their options for ensuring that enrollees’ medical needs are safely accommodated

within a Part D sponsor’s formulary. An enrollee who receives a temporary supply of a non-formulary Part D drug at a network pharmacy might simply assume that, by virtue of filling his

or her prescription, that the plan will cover that drug for the remainder of the contract year. For

this reason, sponsors must provide enrollees with appropriate notice regarding their transition

process within a reasonable amount of time after providing a temporary supply of non-formulary

Part D drugs (including Part D drugs that are on a sponsor’s formulary but require prior

authorization or step therapy under a sponsor’s utilization management rules).

Part D sponsors will be required to send a written notice, via U.S. First Class mail, to each

enrollee who receives a transition fill. This standard is consistent with CMS’ requirement that

other beneficiary communications, including formulary change notices and explanations of

benefits, be sent via U.S. First Class mail. In addition, this notice must be sent to each affected

enrollee within 3 business days of adjudication of the temporary transition fill. If the enrollee

completes his or her transition supply in several fills, the sponsor is required to send notice with

the first transition fill only. CMS believes this turnaround is necessary in order to provide an

affected enrollee with sufficient time -- especially in light of CMS’ 30-day transition fill policy

in the retail setting -- to work with his or her prescriber to switch to a therapeutically equivalent

drug that is on the plan’s formulary or to process an exceptions request.

The notice must include the following elements:

• That the transition supply provided is temporary;

• That the enrollee should work with the sponsor as well as his or her health care provider

to satisfy utilization management requirements or to identify appropriate therapeutic

alternatives that are on the sponsor’s formulary;

• That the member has the right to request a formulary exception, the timeframes for

processing the exception, and the member's right to request an appeal if the sponsor

issues an unfavorable decision; and

• The sponsor’s procedures for requesting a formulary exception.

CMS provides Part D sponsors with a model transition letter. CMS expects that sponsors will

make prior authorization or exception request forms available upon request to both enrollees and

prescribing physicians and via a variety of mechanisms -- including by mail, fax, email, and on

sponsor Web sites. To the extent that sponsors have the capacity, CMS encourages them to

provide any prior authorization or exception request forms a beneficiary will need to effectuate a

transition with the transition notice.

CMS strongly encourages point-of-sale notification to enrollees about transition supplies by

pharmacists. CMS has worked with the pharmacy and drug benefit industry, including the

National Council for Prescription Drug Programs (NCPDP), to incorporate a work-around

process for using structured payment coding in the message field of billing transaction responses

indicating that a particular fill is a transition supply. This process is consistent with the current

NCPDP standard. For more information about Standardized Claims Messaging see chapter 14,

section 50.5.