Appeal type: unknown
Decision: unknown

Part D vaccines may be dispensed and administered in different settings (e.g., by pharmacists in pharmacies, by physicians in physician offices) depending on factors such as state laws regarding the administration of vaccines and product administration complexity. While access to Part D vaccines via a network pharmacy is likely the best method for improving enrollees access to Part D vaccines, Part D sponsors must ensure that enrollees have adequate access to Part D vaccines in physician offices when those Part D vaccines are appropriately dispensed and administered in physician offices. Such access is considered out-of-network access because sponsor networks are defined as pharmacy networks only. [42 Code of Federal Regulations Sections 423.100, 423.120(a), and 423.124; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Sections 60.1 and 60.2]Since January 1, 2008, the Part D program covers vaccine administration costs associated with Part D vaccines. The Centers for Medicare & Medicaid Services interprets this statutory requirement to mean that the Part D vaccine administration costs are a component of the negotiated price for a Part D-covered vaccine. In other words, the negotiated price for a Part D vaccine will be comprised of the vaccine ingredient cost, a dispensing fee (if applicable), and a vaccine administration fee. This interpretation recognizes the intrinsic linkage that exists between the vaccine and its corresponding administration, since a beneficiary would never purchase a vaccine without the expectation that it would be administered. In general, the Centers for Medicare & Medicaid Services believes that Part D vaccines, including the associated administration costs, should be billed on one claim for both in- and out-of-network situations. For example, if an in-network pharmacy dispenses and administers the vaccine in accordance with state law, the pharmacy would process a single claim to the Part D sponsor and collect from the enrollee any applicable cost-sharing on the vaccine and its administration. Alternatively, if a vaccine is administered outside of the plans Part D pharmacy network, the provider would supply the vaccine, administer it, and then bill the beneficiary for the entire charge, including all components. The beneficiary would, in turn, submit a paper claim to the Part D sponsor for reimbursement for both the vaccine ingredient cost and administration fee. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.14]Part D sponsors may implement drug utilization management tools to determine if a vaccine is necessary; however, in the absence of any information showing previous immunization (i.e., claims data), the Part D sponsor should make payment available for a vaccine and its administration consistent with Advisory Committee on Immunization Practices recommendations. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.14.3]