For more information about Medicare Part D, visit www.vaccinesupportservices.com or www.cms.hhs.gov

Vaccines and Medicare Part D

ZOSTAVAX may be reimbursed under the Medicare Prescription Drug Program (Medicare Part D). Reimbursement can vary even for patients with the same Part D insurer, depending on the patient’s coverage status. ZOSTAVAX is not covered under Medicare Part B.

ZOSTAVAX can be reimbursed under 1 of 2 types of Medicare Part D plans:

• Medicare Advantage Prescription Drug Plans (MA-PDs):
  medical and prescription drug benefits.
• Prescription Drug Plans (PDPs): stand-alone prescription drug plans for patients who have Medicare fee-for-service medical coverage.

Medicare Part D plans that have added ZOSTAVAX to their formulary might require the patient to initially pay the physician the full cost of the vaccine. The patient would then submit a paper claim requesting reimbursement from his or her Medicare Part D plan.

Vaccine and Administration Fee Reimbursement

What is the process for reimbursement for a Medicare Part-D–covered vaccine and the administration fee? According to the CMS:

• Part-D–covered vaccines administered in a physician’s office will be processed under the Medicare Part D out-of-network access rules.²¹
• Absent any other process implemented by the Part D plan, a Part D enrollee is required to self-pay the physician for the Part-D–covered vaccine and administration charges and submit a paper claim for reimbursement to his or her Part D plan.²¹
• Some Medicare Part D plans have instituted other processes, such as Web-based billing or specialty pharmacy, to reimburse for Part D vaccines.
• Some Medicare Part D plans require prior authorization approval.
• It is important that you contact—or have the patient contact—the patient’s plan to determine the available processes.

CMS Guidance on Charges for Vaccine Costs

What can an out-of-network pharmacy or physician’s office charge their
customers? According to the CMS²²:

• They can charge the usual-and-customary price (U&C). This is the
  price an out-of-network pharmacy or physician’s office charges a
  customer who does not have any form of prescription drug coverage
  for a covered Part D drug.²²

Select Safety Information

ZOSTAVAX is contraindicated in persons with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; with a history of primary or acquired immunodeficiency states including leukemia; lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; or with AIDS or other clinical manifestations of infection with human immunodeficiency viruses. ZOSTAVAX is a live attenuated varicella-zoster vaccine and administration may result in disseminated disease in individuals who are immunosuppressed. ZOSTAVAX is also contraindicated in persons on immunosuppressive therapy. ZOSTAVAX is not indicated in women of childbearing age and should not be administered to pregnant females.

Vaccine-related, injection-site and systemic adverse events in >1% of individuals in the Adverse Event Monitoring Substudy (AEMS), a subgroup of individuals from the Shingles Prevention Study (SPS) who received ZOSTAVAX (n=3,345), included headache (1.4%) and the following injection-site reactions: erythema (33.7%), pain/tenderness (33.4%), swelling (24.9%), hematoma (1.4%), pruritus (6.6%), and warmth (1.5%). Most of these adverse experiences were reported as mild in intensity.

From Day 0 to 42 postvaccination, in the overall (SPS) study population, serious adverse experiences (SAEs) occurred at a similar rate (1.4%) in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS, the rate of SAEs was increased in the group who received ZOSTAVAX (1.9%) as compared to the placebo group (1.3%) from Day 0 to 42 postvaccination. Over the course of the entire study, in the overall study population, investigator-determined, vaccine-related serious adverse experiences were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).

Among reported serious adverse events in the SPS (Days 0–42 postvaccination), serious cardiovascular events occurred more frequently in subjects who received ZOSTAVAX (20 [0.6%]) than in subjects who received placebo (12 [0.4%]) in the AEMS. The frequencies of serious cardiovascular events were similar in subjects who received ZOSTAVAX (81 [0.4%]) and in subjects who received placebo (72 [0.4%]) in the entire SPS study cohort (Days 0–42 postvaccination).

Transmission of vaccine virus may occur rarely between vaccinees and susceptible contacts.

ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).

Vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.

Before administering ZOSTAVAX, please read the Prescribing Information and Patient Product Information.

ZOSTAVAX is a registered trademark of Merck & Co., Inc.