Peach State Health Plan Blog

Frequently asked questions on use of influenza A(H1N1) 2009 monovalent vaccines (2009 H1N1 monovalent influenza vaccines): Practical considerations for immunization programs and providers

Two different influenza vaccines are available this influenza season, and many people will be recommended to receive both the seasonal influenza vaccine and the 2009 influenza A (H1N1) 2009 monovalent vaccine (referred to in this document as 2009 H1N1 monovalent influenza vaccine). Below are some practical considerations for use of influenza vaccines. This information is only intended to address the current flu season and might change as the situation unfolds. This information is not intended to be applied to routine use during future seasonal influenza vaccination efforts.

1. Children ages 6 months through 8 years receiving seasonal influenza vaccination for the first time are recommended to receive 2 doses. However, in the prescribing information (package inserts) for 2009 H1N1 monovalent influenza vaccines, children ages 6 months through 9 years are recommended to receive 2 doses. Does CDC recommend that clinicians follow the recommendation in the 2009 H1N1 monovalent vaccine package inserts or use the standard seasonal vaccine recommendations?

The recommendations for use of seasonal vaccine are unchanged – children 6 months through 8 years receiving seasonal influenza for the first time are recommended to receive 2 doses. Other children just need one dose of seasonal influenza vaccine.
Using the 2009 H1N1 monovalent influenza vaccine schedule presented in the prescribing information is recommended (6 months through 9 years receive 2 doses regardless of earlier vaccination with seasonal influenza vaccine).

2. The interval between doses stated in the 2009 H1N1 monovalent influenza vaccine prescribing information is “approximately 1 month”. What does “approximately 1 month” mean?

CDC recommends that the two doses of 2009 H1N1 monovalent vaccines be separated by 28 days (4 weeks).

3. The 2009 H1N1 monovalent influenza vaccine trials that are currently underway have often used a 21 day (3 week) interval between doses. Is a 21 day interval acceptable for inactivated 2009 H1N1 monovalent vaccines?

CDC recommends that the two doses of 2009 H1N1 monovalent influenza vaccines be separated by 28 or more days (4 weeks). However, trials of the inactivated 2009 H1N1 vaccines have often used a 21 day interval. Administering the two doses of a 2009 H1N1 monovalent inactivated influenza vaccine at least 21 days apart is safe and acceptable. Therefore, if the second dose of an inactivated 2009 H1N1 monovalent vaccine is separated from the first dose by at least 21 days, the second dose can be considered valid. If the interval separating the doses is less than 21 days, the second dose should be repeated 28 or more days after the invalid (second) dose (≥ 21 days is acceptable for this interval also).

4. Can the seasonal inactivated vaccine (trivalent inactivated vaccine or TIV) and the 2009 H1N1 monovalent inactivated vaccine be given at the same visit?

Yes.

5. If seasonal LAIV and 2009 H1N1 monovalent LAIV are inadvertently given at the same visit, do either or both doses need to be repeated, and if so, when?

Seasonal LAIV and 2009 H1N1 monovalent LAIV should not be administered at the same visit. While use of the 2 types of LAIV at the same visit could result in reduced immunogenicity for one vaccine, according to some experts, there are no data describing what happens with the vaccine response following simultaneous administration of LAIV vaccines. However, if both types of LAIV are inadvertently administered at the same visit neither vaccine, needs to be repeated.

6. What is the minimum interval between doses of seasonal LAIV and 2009 H1N1 monovalent LAIV?

There are no data on sequential administration of seasonal and 2009 H1N1 monovalent LAIV. The ACIP recommends a minimum interval of 28 days (4 weeks) between use of a seasonal LAIV and a 2009 H1N1 monovalent LAIV because these are considered to be 2 different vaccines. The ACIP recommendations were developed based on data from studies using attenuated injectable live virus vaccines such as the measles, mumps and rubella vaccine. Trials of 2009 H1N1 live attenuated vaccines have used a 28 day interval between doses and therefore, 28 days is the recommended interval between 2 doses of LAIV (seasonal and H1N1 monovalent LAIV). However, based on previous studies of LAIV replication and immune response, as little as 14 days (2 weeks) might be sufficient to allow for an appropriate immune response to both vaccines. Therefore, an interval between the two types of LAIV of 2 weeks or more may be acceptable, although an interval of 28 days is preferred.

7. If seasonal LAIV and 2009 H1N1 monovalent LAIV are not administered on the same day, but are separated by less than 14 days (2 weeks), do either or both doses need to be repeated, and if so, when?

Seasonal LAIV and 2009 H1N1 monovalent LAIV should not be administered at the same visit, and should be separated by at least 28 days (14 days acceptable based on previous studies of attenuated influenza vaccine virus replication and immune response). If accidentally given at the same visit, neither dose needs to be repeated. If given 1-13 days apart, the second dose should be repeated 28 days (14 days acceptable) from the invalid (second) dose.

8. Can a live attenuated vaccine be given at the same visit as an inactivated influenza vaccine (e.g., seasonal LAIV and 2009 H1N1 monovalent inactivated vaccine, or 2009 H1N1 monovalent LAIV and seasonal trivalent inactivated influenza vaccine [TIV])?

Yes, based upon ACIP’s recommendations, these two types of vaccines can be given at the same visit.

9. Can a child who requires 2 doses of a 2009 H1N1 monovalent influenza vaccine and who received the first dose with an inactivated 2009 H1N1 monovalent vaccine complete the series with the 2009 H1N1 monovalent LAIV, or vice versa?

There are limited data describing the immune response to mixed schedules. Therefore, when feasible, the same type of vaccine (live attenuated or inactivated) should be used in a two-dose schedule. Mixed schedules however, are preferable to not completing the series. A 28 day interval between doses is recommended, but 21 days is acceptable. If vaccines are separated by 1-20 days, repeat the invalid (second) dose 28 days (21 days acceptable) from the invalid second dose.

10. Should we set aside doses of 2009 H1N1 monovalent vaccine to administer as second doses to children 6 months through 9 years?

No. 2009 H1N1 monovalent influenza vaccine availability is expected to increase during the next several weeks, so vaccine should not be held in reserve for patients who already have received 1 dose but might require a second dose.

 Source: http://www.cdc.gov/H1N1flu/vaccination/top10_faq.htm

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Dear Peach State Provider:

This letter is to advise you that effective November 28, 2009, Grady Health System (Grady) will no longer be participating in the Peach State Health Plan (Peach State) network. However, members may continue to receive services at Grady and with their Grady PCP through December 31, 2009. After several months of negotiations with Grady, we have been unable to reach an agreement regarding certain contractual provisions.

Our members and your patients are our first priority. Therefore, to ensure a smooth transition, Peach State and Grady are working closely to coordinate care for members that are in active treatment. Over the next two weeks, Peach State will contact those patients to develop transition of care plans. Please assist us by contacting our Case Management Department at 1-800-704-1483, if you have a patient(s) that you believe will need assistance with coordination of care.

Even though your Peach State patients may use Grady through December 31, 2009, we ask that you begin immediately referring your patients to alternative participating hospitals. Effective January 1, 2010, all Peach State patients must be admitted to alternative participating hospitals (refer to our Provider Directory at www.pshp.com) for a list of hospitals in our network). Additionally, you must obtain authorizations for any services performed at Grady except emergency room care, which does not require authorization (refer to your Provider Manual for guidance regarding notification of admission requirements).

 If you have questions regarding this change, please contact the Provider Solutions department at 1-866-874-0633.

 Sincerely,

Kevin Sears

Vice President, Network Management

Peach State Health Plan

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November 25, 2009

Dear Member:

As of November 28, 2009, Grady Health System (Grady) will no longer be a part of the Peach State Health Plan (Peach State) network. You may continue to receive services at Grady and with your Grady primary care physician (PCP) through December 31, 2009.

Important: You must choose a new PCP for you and your child/children.

To choose another PCP, please review the enclosed list of PCPs that are accepting new patients. You can also check your Peach State provider directory or the directory on our website at www.pshp.com. If you need help choosing a new PCP, call our Member Services Department at 1-866-229-2892 or TDD/TTY 1-800-659-7487. 

If you do not choose a new PCP by December 15, 2009, you will be assigned to a new PCP near your home. You will receive new ID cards in the mail with the name of your new PCP.

 We will contact you:

• If you are currently receiving care from a hospital stay.
• If you are scheduled to go into the hospital.
• If you are in your second or third trimester of pregnancy.
• If you are scheduled for an outpatient procedure.

Peach State will work with you to coordinate your care. We will cover services that we have already approved. We will also cover care you or your child/children receive in Grady’s emergency room. The hospital does not need to be in our network for you to receive emergency services. Emergency services do not require approval.

We care about our members and will work with you to help you stay healthy.  Please call us at 1-866-229-2892 (TDD/TTY 1-800-659-7487) if you have questions. 

Sincerely,

Member Services Department

Peach State Health Plan 

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Dear Peach State Hospital Provider:

This letter serves as notice of a revision to our process for completing Emergency Department (ED) claim reviews. Effective September 1, 2009, Peach State Health Plan(Peach State) will be implementing a new review process that is more aligned with the Georgia Fee For Service Medicaid program and the other Care Management Organizations contracted to provide services to members covered by the Georgia Families program. Peach State adopted the definition for an emergency medical condition as defined in the contract agreement between the Georgia Department of Community Health and Peach State. We continue to support the “Prudent Layperson” policy as set forth in the Balanced Budget Act of 1997, the Medicaid Care Management Organizations Act, and as required by Georgia law. 

ED claims coded with a diagnosis that represents a disease or condition that is recognized as a medical emergency will result in the claims being treated and reimbursed as an emergency service based on the rate negotiated with the hospital.  Claims for emergency services submitted with a diagnosis that represents a disease or condition that is not recognized as an emergency situation will be paid at the ED triage rate, the hospital’s contracted rate, which ever is applicable. The explanation of payment (EOP) will indicate the triage payment and include options to request a reconsideration of the claim in writing within three (3) months of the month of payment. An ED reconsideration request received outside the three (3) month time frame will be denied as untimely.

All requests for reconsideration of an ED claim paid at the triage rate must be submitted in writing to the following address along with the medical records and other clinical rationale (i.e., presenting symptoms, patient age, date, and time of arrival) that supports overturning the triage rate. A Medical Director or his designee will review the information. 

 Peach State Health Plan

ATTN: Peach State Health Plan PLP Appeal

PO Box 3000

Farmington, MO 63640-3800

Peach State will automatically reprocess the claim at the contracted rate, if the decision is made to overturn the triage rate. If the decision is made to uphold the triage rate, you may request a formal appeal by submitting the claim and any additional documentation for consideration under the appeals process. You will receive written notification of the decision once the final appeal determination has been made. Please contact the Provider Solutions department at 866-874-0633 if you have questions or if you need additional information regarding the ED claim review process.

 Sincerely,

 Peach State Health Plan

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October 10, 2009

Dear Peach State Provider:

Peach State Health Plan (Peach State) gives a thirty (30) day notice prior to all policy changes to ensure that our providers have adequate time to comply with changes requested by the plan. We also want you to know that we listen to your feedback.

In September 2009, we sent a communication to you about our specialty drug policy. We informed you that we were changing our policy on October 1, 2009 to require all specialty drugs (with the exception of chemotherapy agents, Mirena, and ParaGard) to be obtained through Caremark.

Your valued feedback allowed us to understand potential challenges associated with this policy change. Some of these challenges were related to internal office procedures, especially when hospital based infusion centers were administering medications.

At this time, we are retracting our previous communication. We are asking that you continue to obtain specialty drugs and dispense them as you have done historically. We are making no changes to our list of drugs requiring prior authorization, only to the procedure for dispensing the drugs.

The Specialty Drug Prior Authorization Request Forms are available on the Peach State website, www.pshp.com, under the Provider Forms section. These forms should be completed and faxed with appropriate clinical information to Caremark at 1-800-323-2445 if you need Caremark to ship the drug to your office. You can fax the form directly to Peach State at 1-866-374-1579 if you would like to supply the drug out of your office stock.

If you have any questions about this information, please contact the Peach State Health Plan Pharmacy Department at 1-800-514-0083 option 2.

Thank you,

Wendy D. Bailey, RPh.            Robyn A. Lorys, Pharm. D.

Director of Pharmacy               Director of Clinical Pharmacy

Peach State Health Plan           Peach State Health Plan

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