Citing concerns about transparency and timing, on August 13, 2015, CMS issued a memorandum to clarify guidance to Medicare Part D sponsors regarding the any willing pharmacy requirement.
Medicare Part D sponsors are required to contract with any pharmacy that meets the Part D sponsor’s standard terms and conditions. CMS requires that the standard terms and conditions must be “reasonable and relevant.” The sponsor’s standard terms and conditions establish the “floor” of minimum requirements that all similarly situated pharmacies must abide by (e.g., licensure requirements, minimum levels of liability insurance, etc.).
CMS expects Part D sponsors to make the standard contracting terms and conditions “readily available for requesting pharmacies no later than September 15 of each year for the immediately succeeding benefit year,” or 105 days prior to the start of the plan’s benefit year for non-calendar year plans. The CMS guidance also requires that sponsors identify how pharmacies may obtain their standard terms and conditions, and provide the applicable terms and conditions to requesting pharmacies within two business days upon receipt of the request. Part D sponsors must also provide the standard terms and conditions to CMS within two days of CMS’s request.
If the Part D drug plan sponsor requires a pharmacy to execute a confidentiality agreement, the sponsor is to provide the confidentiality agreement within two business days and then provide the standard terms to the pharmacy within two business days following the receipt of the executed confidentiality agreement. CMS repeats that sponsors should not cause “any undue delay in executing” the any willing pharmacy agreement.
The guidance notes that sponsors may still modify some of their standard terms and conditions to encourage participation by particular pharmacies. It does not alter or modify CMS regulations and guidance that permit Part D sponsors to establish networks of “preferred pharmacies.”