Appeal type: unknown
Decision: unknown

A drug management program must meet all requirements. A sponsor must document its drug management program in written policies and procedures that are approved by the applicable Pharmacy and Therapeutics Committee and reviewed and updated as appropriate. These policies and procedures must address all aspects of the sponsor's drug management program, including but not limited to the following: 1) The appropriate credentials of the clinical staff conducting case management, including that the staff must have a current and unrestricted license to practice within the scope of his or her profession in a state, territory, commonwealth of the United States (that is, Puerto Rico), or the District of Columbia; 2) The necessary and appropriate contents of files for case management, which must include documentation of the substance of prescriber and beneficiary contacts; 3) Monitoring reports and notifications about incoming enrollees who meet the definition of an at-risk beneficiary or a potential at-risk beneficiary in Section 423.100 of the Code of Federal Regulations and responding to requests from other sponsors for information about at-risk beneficiaries and potential at-risk beneficiaries who recently disenrolled from the sponsor's prescription drug benefit plan.The sponsor's clinical staff must conduct case management for each potential at-risk beneficiary for the purpose of engaging in clinical contact with the prescribers of frequently abused drugs and verifying whether a potential at-risk beneficiary is an at-risk beneficiary. The sponsor must do all of the following: A) Send written information to the beneficiary's prescribers that the beneficiary met the clinical guidelines and is a potential at risk beneficiary; B) Elicit information from the prescribers about any factors in the beneficiary's treatment that are relevant to a determination that the beneficiary is an at-risk beneficiary, including whether prescribed medications are appropriate for the beneficiary's medical conditions or the beneficiary is an exempted beneficiary; C) In cases where prescribers have not responded to the inquiry, make reasonable attempts to communicate with the prescribers telephonically and/or by another effective communication method designed to elicit a response from the prescribers within a reasonable period after sending the written information.If a beneficiary was identified as a potential at-risk or an at-risk beneficiary by his or her most recent prior plan and such identification has not been, the sponsor meets the requirements outlined above, so long as the sponsor obtains case management information from the previous sponsor and such information is still clinically adequate and up to date.A Part D plan sponsor may do any or all of the following: 1) Implement a point-of-sale claim edit for frequently abused drugs that is specific to an at-risk beneficiary; 2) Limit an at-risk beneficiary's access to coverage for frequently abused drugs to those that are prescribed for the beneficiary by one or more prescribers, dispensed to the beneficiary by one or more network pharmacies, or both.If the sponsor implements an edit as specified above, the sponsor must not cover frequently abused drugs for the beneficiary in excess of the edit, unless the edit is terminated or revised based on a subsequent determination, including a successful appeal.If the sponsor limits the at-risk beneficiary's access to coverage, the sponsor must cover frequently abused drugs for the beneficiary only when they are obtained from the selected pharmacy(ies) or prescriber(s) or both, as applicable: 1) In accordance with all other coverage requirements of the beneficiary's prescription drug benefit plan, unless the limit is terminated or revised based on a subsequent determination, including a successful appeal; and 2) Except as necessary to provide reasonable access. [42 Code of Federal Regulations Sections 423.153(f)(1)-(4)]