FDA Approves 2009-2010 Seasonal Flu Vaccine

The Food and Drug Administration (FDA) announced July 20 that it has approved a vaccine for 2009-2010 seasonal influenza (flu) in the United States.

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.

The vaccine for the 2009-2010 seasonal flu contains:

  • an A/Brisbane/59/2007 (H1N1)-like virus
  • an A/Brisbane/10/2007 (H3N2)-like virus
  • a B/Brisbane/60/2008-like virus

The Centers for Medicare & Medicaid Services (CMS) issued Transmittal 515, Change Request 6539, July 10, to remind providers and suppliers that Medicare Part B pays 100 percent for flu vaccination and administration services provided to beneficiaries annually without a physician’s order. Beneficiaries should not be charged a co-pay and do not require co-insurance.

Medicare providers and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers must enroll using the appropriate CMS 855 provider enrollment form. Information on provider enrollment forms can be found on the CMS Web site.

Suppliers must enroll as a Mass Immunization Roster Biller (specialty provider type 73) with a local Part A/B Medicare Administrative Contractor (A/B MAC) or legacy carrier to provide flu or pneumococcal vaccination services for which they will bill Medicare.

Providers who render only flu/pneumococcal vaccination services must enroll as a Mass Immunization Roster Biller (specialty 73) or Centralized Biller.

Both provider types must also:

  1. Accept assignment of both the vaccine and the administration;
  2. Bill only for flu/pneumococcal vaccinations; and
  3. Submit claims using the roster billing process.

Additionally, mass immunizers must be licensed in the states in which they plan to operate, submit claims to their local Medicare contractor, and attach to the CMS-1500 paper claim form a roster containing the variable claims information regarding the supplier and Medicare beneficiaries.

Centralized billers—those who operate in at least three payment localities, with three different carriers or A/B MACs—must enroll each year and sumbit roster bill claims electronically.

Refer to the Internet Only Manual (IOM) Publication 100-04, Chapter 18, Sections 10-10.5 for more information on billing requirements.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus, warns the FDA. The H1N1 virus vaccine could result in beneficiaries receiving more than one flu vaccine during the upcoming season.

The AAPC will continue to update you with future information regarding the development of the H1N1 virus vaccine and any coding updates.

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