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CMS Issues 2008 Part D Vaccine Guidance Summary


Email Alert

May 15, 2007

As promised in the Final 2008 Call Letter, CMS released guidance on May 14, 2007, to Part D Plans regarding the issue of vaccine administration under Part D in 2008. A summary of the guidance is below.

  • Part D vaccine administration costs are a component of the negotiated price for a Part D vaccine (e.g. the negotiated price for a vaccine will be comprised of the vaccine ingredient cost, a dispensing fee if applicable, and a vaccine administration fee).

  • As such, beneficiaries should only be charged one cost-sharing amount that includes costs for the vaccine itself and for its dispensing and/or administration.

  • Sponsors must allow any provider so authorized by State law to administer a vaccine.

  • Out-of-network vaccines administered in a physician office or by other non-network providers may be covered under out-of network access rules where a Part D enrollee may self-pay for the vaccine cost and its administration and submit a paper claim for reimbursement to his or her plan.

  • One claim should be used for billing for a vaccine and its administration (in both in and out of network situations). However, CMS recognizes there are circumstances that might require vaccine administration to be billed and reimbursed separately from the vaccine ingredient cost. For instance, in an instance where a pharmacy dispenses a vaccine to a physician office and the physician administers it, Part D sponsors should be able to separately reimburse the pharmacy for the vaccine ingredient cost and dispensing fee and the beneficiary for the physician's administration charge. In instances of separate billing, Part D sponsors are encouraged to scrutinize the separate claims to identify and prevent duplicate billing and to ensure beneficiaries are reimbursed for administration fees paid to physicians.

  • Part D plans should negotiate with pharmacies to set administration fees and should take into account elements reflected in existing 2007 Part B administration fees.

  • Sponsors may set either a single administration fee for all vaccines or multiple fees based on type of vaccine, variance in provider type, and product administration complexity. CMS will retrospectively review fees to look for outliers and potentially discriminatory practices.

  • Sponsors may use UM tools; however, in the absence of information showing previous immunization, they should make payment available in consideration with ACIP recommendations.

  • When one claim is submitted reflecting both the ingredient cost and dispensing fee/administration fee, billing should be conducted using the NCPDP 5.1 standard for both the vaccine and its administration. CMS is looking to NCPDP to issue formal guidance about the standardized field to be used for vaccine administration in the billing transaction.

  • A new unique vaccine administration field will be added to the PDE in 2008 for Part D sponsors' submission of vaccine administration. The format will be published shortly at

The Life Sciences Practice Group would like to thank Susan Ingargiola, Esquire, and Wendy Krasner, Esquire, (Manatt Phelps & Phillips LLP, Washington, DC) for writing this email alert.

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