2009 Influenza (H1N1) Monovalent Vaccine: Vaccine Provider Agreement Q & A

October 27, 2009, 12:30 PM ET

Purpose and Target Audience

The purpose of this document is to answer questions pertaining to the 2009 Influenza (H1N1) monovalent vaccine Vaccine Provider Agreement. The provider agreement is an agreement between providers and public health at the Project Area level and indicates the minimum federal requirements for providers to participate in the H1N1 influenza vaccination effort.

Purpose and target audience
The purpose of this document is to answer questions pertaining to the 2009 Influenza (H1N1) monovalent vaccine Vaccine Provider Agreement. The provider agreement is an agreement between providers and public health at the Project Area level and indicates the minimum federal requirements for providers to participate in the 2009 H1N1 monovalent influenza vaccination effort.

Does the language from the CDC Provider Agreement need to be used verbatim?

The agreement must be used verbatim.  However, as stated in item 12, Project Areas have the option of inserting additional requirements, as long as those requirements are not contrary to the federal requirements listed in items 1-11 (Please see additional information on Project Area requirements in the responses below).

In addition, in lieu of listing all providers and their license numbers, Project Areas may elect to remove this language from the provider agreement and instead require only the name and license number of the practice/facility/organization Medical Director Pharmacy Manager, or Corporate Representative.  Project Areas can also require listing of state licensure numbers of participating licensed medical facilities.

By whom must the Provider Agreement be signed?

The Provider Agreement must be signed by an individual who can bind the organization.  This person must ensure all vaccine providers employed by, or associated with, the organization are informed of their obligations under the Provider Agreement.

In the retail pharmacy setting there may not be a Medical Director. Can a pharmacist sign the Provider Agreement?

Yes, the Pharmacy Manager (or Corporate Representative) can sign the Provider Agreement.

When the Provider Agreement is signed by an individual who is not a Medical Director, is a medical license number necessary?

The name and license number of the Medical Director, Pharmacy Manager, or Corporate Representative must be provided whether or not that individual signs the agreement on behalf of the practice/facility/organization.

Can Project Areas include requirements (e.g. reporting to the state registry) in addition to those required by CDC?

Yes, states are allowed to add requirements that are necessary for compliance with state laws.  Additional requirements beyond those required for compliance with state law are also allowed, but should be used sparingly to avoid adding additional barriers to enrollment and participation in the 2009 H1N1 monovalent influenza vaccination campaign and must not be contrary to the minimum federal requirements listed in items 1-11. Additional requirements that preclude participation of some providers - for example a requirement for which it is necessary to have computer capacity that some providers do not possess - cannot be used to exclude providers who could otherwise meet the federal minimum requirement.

What is the approval process for Project Areas to modify the Provider Agreement so that it conforms to specific state needs?

Project Areas are permitted to modify the agreement as needed on the condition that they provide assurance to CDC that modifications to the agreement are not contrary to items 1-11 and will not interfere with compliance with such CDC minimum requirements.  There is no need for CDC to specifically approve the modifications to the provider agreement.

How do Project Areas provide assurance to CDC that their Provider Agreement is in compliance with CDC minimum requirements?

Project Areas have signed an Assurance of Conformance which was provided by CDC and returned it to CDC

Who will need to sign off on the Provider Agreement: all vaccinators, or authorized prescribers under whose authority vaccinations are given?

Only a single individual needs to sign the Provider Agreement. Project Areas must require the facility/practice/organization Medical Director, Pharmacy Manager, Corporate Representative or other individual authorized to bind the facility/practice/organization to sign the Provider Agreement and inform all providers in the practice of their obligations under the agreement.  Regardless of who signs the Agreement, the name and license number of the Medical Director, Pharmacy Manager, or Corporate Representative must be included.

When a commercial system redistributes vaccine to their participating sites, will each need to sign a provider agreement?

States may allow a single individual (i.e., the facility/practice/organization Medical Director, Pharmacy Manager, Corporate Representative or other individual authorized to bind all participating sites to sign for all sites.  Such person must ensure all participating providers are informed of their obligations under the agreement.  Regardless of who signs the Agreement, the name and license number of the Medical Director, Pharmacy Manager, or Corporate Representative must be included.

Are Project Areas required to obtain and store signed copies of the Provider Agreement?

No, it is not necessary for states to obtain signatures for the Provider Agreement when registration takes place through a website, so long as the electronic registration process includes steps that confirm that the registrant accepts all conditions of the agreement (e.g. by clicking a button or checkbox that electronically stores the confirmation).

Can the CDC agreement be combined with other 2009 H1N1 provider agreements, for example for antiviral drugs?

Yes, as long as conditions described above are met.

How can we address the fact that in some settings, such as retail pharmacies, vaccinations are not recorded in the patient’s medical record or in an office log, as required according to the Provider Agreement?

The terms of the Provider Agreement are met as long as the vaccinating entity keeps a record of the 2009 H1N1 monovalent vaccination in a document equivalent to a patient medical record or office log.