Medicare Compliance & Reimbursement

Formulary clarifications warrant close watch.

The feds' final call letter notes two other formulary-related changes that could affect patients' ability to receive the drugs they need:

1. Six classes of clinical concern. In 2008, formularies must include all or substantially all drugs in these six classes that were available on April 16, 2007--the deadline by which prescription drug plans (PDPs) had to submit their formularies to the Centers for Medicare & Medicaid Services (CMS).

New for 2008: New drugs or newly approved uses for established drugs within the six classes that come on the market after the above date will be subject to an expedited review, notes CMS' Abby Block.

2. Vaccines. CMS will review formularies to ensure they contain all commercially available vaccines (excluding influenza and pneumococcal vaccines, which are reimbursed under Part B).

Still ahead: CMS decided not to address within the call letter policy the new policy of reimbursement for the administration of vaccines under Part D. In response to the many comments addressing vaccine administration reimbursement, CMS is taking time to finalize its operational guidance, says Anne Hance, attorney with McDermott Will & Emery in Washington, DC. The agency has said it will release a final guidance in May 2007.