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VFC-AFIX Quarterly Conference Call Minutes
October 2008

Grantee Roll Call

The following grantees were on the conference call:
Alabama, Arkansas, Arizona, Colorado, Connecticut, DC, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York City, New York State, Ohio, Oregon, Pennsylvania, Philadelphia, San Antonio, Texas, Utah, Washington, West Virginia, Wyoming

(Note: A large number of grantees were unable to participate in this call due to lack of capacity on the call-in line. This problem will be corrected in future calls by significantly increasing call-in capacity.)

Summary

VFC Updates

• Updated Q&A document
• 2009 site visit questionnaire
• Non-Compliance with VFC Program Requirements Protocol/Algorithm
• Grantee Comments/Questions

AFIX Updates

• Adolescent changes to VFC Management Survey for March 2009
• AFIX Feedback training: April 2009
• AFIX Policies and Procedures Manual
• AFIX contacts updates at website

CoCASA v4.0 Updates

• Adolescent changes
• VFC changes
• Algorithm updates
  • HepB (Pediarix)
  • Hib and PCV
  • HPV
• Report changes Misc changes
• Timeline for testing and release

2009 schedule for VFC/AFIX Quarterly Calls

Minutes

VFC Updates (Nancy Felon)

• Updated Q&A document
  
  This is to remind everyone that there is a new Q&A document available and the most up-to-date version has a revision date of September 15, 2008. It was sent out as an all-grantee message on September 15^th and was posted to the VFC website that same week. There several new questions in the document. Three questions are located under the Section titled VFC and Record Keeping. Two relate to screening for VFC eligibility. The first one provides guidance on the number and how to select records for review for screening of VFC-eligibility. The second one is related to how to follow-up with a provider who is not screening all patients for VFC-eligibility. The third question defines the word "waive" in the context of the statement if a parent or guardian cannot afford the administration fee the fee must be waived. The final new question is in the "VFC Eligibility Section" and is the last question in the section and address children who have health insurance that covers only a portion of the cost of a vaccine. There are no plans to release any further updates to the Q&A document in 2008.
  

• 2009 site visit questionnaire
  
  Originally, the 2009 VFC Site Visit Questionnaire and the High Priority Questions Answer Key was sent out as an All-grantee message and posted on the VFC website on September 15, 2008. Three days later, on September 18^th there was a VIS update and a date change was made on one of the statements which required a revision to the 2009 Site Visit Questionnaire and the updated version was reposted to the VFC website. On September 30^th another revision to the 2009 questionnaire was required due to a question that came up related to the programming of the next version CoCASA (4.0) specifically on questions #17 and #18 where an additional answer option was added. So, now the most recent version of the 2009 VFC Site Visit Questionnaire and High Priority Answer Key which is available on the VFC website has a revision date in the footer of September 30, 2008.
  
  If further changes are required to the word & the pdf files to make them identical to the version in CoCASA 4.0, the changes will be posted on the VFC website. It is advisable for the VFC Coordinators to check the website on weekly basis for further updates until the CoCASA 4.0 is released.
  
  I would like to briefly discuss another topic related to CDC’s Site Visit Questionnaire. CDC is requesting grantees that alter Section One in anyway in their VFC Site Visit Questionnaire or plan to alter the 2009 VFC Site Visit Questionnaire to submit their questionnaire to CDC by October 24^th, 2008 for review. Your project officer’s should have made contact requesting this information last week or early this week. CDC would like a copy of the Site Visit Questionnaire even if the only change is to place the questionnaire on state letterhead.
  
  The reason for the request is that in 2008, CDC learned of some grantees who were not administering all high priority questions from Section One in their grantee-specific questionnaire. Since these questions monitor the provider’s compliance with the nine federal requirements and the results are reported in the VFC Management Survey it necessary to make sure that the questions in Section One are asked as written in the questionnaire.
  
  It is equally important to make sure appropriate follow-up plans are developed, implemented and documented for providers that answered a high priority question incorrectly.
• Non-Compliance with VFC Program Requirements Protocol/Algorithm
  (The concerns expressed by grantees on the call regarding the algorithm are being taken to ISD administration, and grantees will receive an update following those meetings.
  
  The Non-Compliance with VFC Program Requirements Algorithm was sent out as an All-Grantee message on September 15, 2008 and was posted on the VFC website that same week. The implementation date for using this algorithm is January 1, 2009.
  

  

  Background on the Algorithm development
  CDC required that all grantees submit by December 31, 2007 - their Fraud & Abuse policies that incorporated the requirements outlined in Module 10 of the VFC Operations Guide. After reviewing the policies it was determined not approve or disapprove any of the submitted policies but advise the grantees to finalize their fraud & abuse policies through their normal policy development process.
  
  Many policies focused on education to correct situations of non-compliance that could possibly develop into a fraud and abuse situation. Using this information and the requirements in Module 10 CDC developed a detailed algorithm of steps to follow from the identification of compliance issues to final resolution of the compliance issue. To test the practicality of the algorithm, 4 grantees were asked to review the algorithm. The grantees felt that using the algorithm would assist them in determining how to deal with VFC non-compliance situations and help them to determine when to refer a situation for fraud and abuse investigation. The algorithm is designed to be used in day to day situations with oversight by the fraud and abuse coordinator to determine how non-compliant situations should be addressed.
  
  The algorithm was first unveiled at Vaccine University in May 2008 with the request that grantees review and use the tool over the summer and provide questions and comments to CDC by August 31^st. Several grantees provided questions and comments. The questions and comments were reviewed by CDC and based those questions and comments the "Key Instruction Guide" was developed.
  
  I would like to go over a few of the grantees comments in today’s call. First, I would like to make sure that everyone has a clear idea of why the Non-compliance algorithm is important. Three fundamental components of the VFC program work together to make sure that the VFC program is being implemented appropriately at the provider level, these components are the Nine Federal VFC Provider Requirements, the Provider Enrollment Form and the VFC Site Visit Questionnaire. The Provider Enrollment Form outlines the 9 federal requirements and any additional state specific requirements that the enrolling providers agrees to maintain to participate in the VFC program. CDC’s VFC Site Questionnaire monitors how well a provider is complying with the federal requirements that he/she agreed to uphold when signing the provider enrollment form. If grantees have added any additional requirements to the provider enrollment form- the grantees should have processes in place to monitor the compliance with the state specific requirements. The non-compliance algorithm closes the circle and provides a road map for grantees on how to address provider non-compliance with VFC program requirements.
  If the non-compliant behavior cannot be change, the algorithm provides steps to work through to determine if the behavior may be creating a situation that needs to be referred to an outside agency for investigation of possible fraud or abuse against the VFC program and/or if the provider should be removed from the program.

  

  Grantee Comments/Questions
  

1. The first grantee comment I would like to address is that the algorithm is too confusing.

I want to acknowledge that the 7 slides that represent the algorithm are very overwhelming and can be daunting when someone is starting to use the algorithm. There is a solution to make the slides less overwhelming and the task less daunting. Take another sheet of paper and cover all the boxes except for the first box on the top of each page then uncover each action box or line of boxes separately as you move through algorithm until a decision is reached on how the non-compliance will be addressed.

Another key is in Slides # 2 and 3 and the critical box is the first box. This box will tell you if you need to work through the steps on that slide or if you need to go to another slide. If the non-compliance is discovered by an external source- slide #2 is the algorithm that should be used. When the algorithm on that slide is followed through, the last action box on that slide will determine if you need to proceed to another slide or issue has been resolved. In a hypothetical situation after working through the steps in slide #2, the decision is to enroll the provider in tertiary education - you should next proceed to the slide #5. On slide #5, the first action box states "tertiary education" and then follow the steps in the action boxes on that slide. At the end of the tertiary education process if the educational intervention was successful – the provider is returned to routine follow-up. If the decision is to refer to external agency for further investigation of fraud and abuse then you would proceed to slide #6 with the first action box that states "Referral to external agency for further fraud and abuse investigation" and follow through action boxes on that slide. This process would continue until the provider is returned to routine follow-up or terminated from the program.

2. Another grantee requested guidance on what questions from CDC’s Site Visit Questionnaire could be corrected during the site visit and closed without further follow-up and what questions when answered incorrectly should the provider be enrolled into secondary or tertiary education.

Those questions are listed in the instructions document under bullets #5 and #6. One comment- I need to make is that the wording of those two points will be change to start with "In general," because as the points are written now – they appear black and white when the best course of action may be some shade of gray. At some point, there will be a situation that will not follow the exact instructions in bullets #5 and #6, the wording change will allow the grantees more flexibility in determining the best course of action for follow-up.

3. Clarify one of the questions in the instructions used to determine if a provider should be enrolled in secondary or tertiary education. The question was specifically regarding Question #2: Is the behavior placing the VFC program in danger if the behavior is not stopped immediately?

This question overlaps both questions #1 and #3 but it goes beyond just vaccine loss through storage and handling issues and financial gain. It was included to address other non-compliant practice situations that place the VFC program in danger of fraud and abuse. The term danger should be used in terms of determining if the action is placing the program at risk for unintentional fraud or abuse. Or are the provider actions placing VFC children at risk. Finally, if a grantee has reason to believe that the actions represent intentional fraud and/or abuse of the VFC program the appropriate course of action must be immediate referral for investigation of possible fraud and abuse.

4. The last comment/question I would like to clarify is using the algorithm for non-compliance with best practice recommendations.
he algorithm should be used for non-compliance with VFC Program requirements and not non-compliance or failure to implement recommended best practices since failing to implement a recommendation would not result in referral for investigation of possible fraud and abuse or discussion about termination of the provider from program.

This guidance changes if the best practice is include as requirement on the provider enrollment form. For example:
If during a site visit you recommend storing filled water bottles in the door of storage unit to help maintain a stable temperature - the provider is not non-compliance with any of the Nine Federal VFC requirements.

However, if your provider enrollment form includes a requirement regarding following all storage and handling practices listed in the grantee’s provider manual and this practice is listed then the provider is out of compliance with a state specific requirement and the algorithm should be followed. However, it is unlikely that any grantee would refer this type of non-compliant behavior for investigation of fraud and abuse. The program must be ready to discuss the status of the provider in the VFC program if the non-compliant behavior is unchanged after the completion of the educational intervention.

Finally, I want to point out some information about the minimum follow-up schedule and documenting the follow-up once a provider is entered into an educational intervention.

The VFC Management Survey beginning in 2010 will ask for information on the number of providers enrolled in non-compliant education follow-up. CoCASA is being programmed to capture this follow-up information. At this time, the focused VFC site visit that occurs after the educational intervention is compete, CDC is requiring that grantees re-administer only the high priority VFC Site Visit questions that the provider answered in-correctly. At this time this abbreviated questionnaire will not be able to be entered as a VFC site visit questionnaire in CoCASA. Further guidance will be provided on how to document the focused site visit results in CoCASA once we are closer to the release date of 4.0.

AFIX Updates (Nathan Crawford)

• Adolescent changes to VFC Management Survey for March 2009
  • Definition of "Active Patient" will be required
  • Adolescent vaccines assessed will be required
• AFIX Feedback training: April 2 (afternoon) – April 3 (ending at noon), 2009
  • The vast majority of responses to the grantee survey conducted a couple weeks ago were overwhelmingly positive regarding scheduling the AFIX Feedback training immediately following NIC on April 3 – 4. Most grantees indicated that this would be preferable over another separate trip to Atlanta.
    
  • Since we want to model face-to-face interactive discussion, we will keep the group small and are only allowing your AFIX coordinator to attend. This is a train-the-trainer meeting, and will not be open to all grantee-attendees of NIC. We understand that many grantees will want to send multiple people to this training, but, both for the sake of space and for the sake of interactive discussion and learning, only the one AFIX coordinator is invited to attend.
  • The purpose of the training is to teach and discuss effective ways to facilitate a clinic’s AFIX feedback. John Fontanessi will help lead some of the training.
    
  • Focus on facilitating an effective feedback: role play, discussion
    Topics: preparation for feedback; anticipating and answering tough questions; common solutions to common problems; helping providers see beyond the number.
  • CDC will provide more information about this training as it approaches and will send a letter to grantees for the purposes of travel approval.
• AFIX Policies and Procedures Manual
  
  • Due March 2009 to CDC
  • The target audience for this manual is grantee AFIX staff, not CDC, thus the purpose of the manual is to provide you the details you need to maintain a strong program. The policies and procedures should be user friendly, easy to read and understand, and should describe the details of how your AFIX program works and operates on a daily basis.
  • CDC wishes to see grantee manuals for the purposes of better understanding how grantees operate their AFIX programs, including how different grantees address various details of their programs. Knowing the details of grantee AFIX programs strengthens Electronic submission of your manual is preferred, but mail is also acceptable.
  • Contact Nathan Crawford at ncrawford2@cdc.gov if you feel that your manual is too large to send or would be too difficult to send.
• AFIX contacts updates at website: (http://www.cdc.gov/vaccines/programs/afix/contacts.htm)
  Please check site for accuracy; note primary and secondary contacts
  

CoCASA Updates

• CoCASA 4.0 (significant changes) Adolescent changes (Nathan) Capture 3 different age groups: 0-3; 4-12; 13-18 Different vaccine combinations will be available depending on the age group you indicate.
  Capture of Feedback type: face-to-face, mail, other
  Capture of 6-month follow-up: "reason" can be stated
• VFC changes (Nancy)
  Added secondary and tertiary educational visit types
  Made changes for unavailable temperature log
  Enhancements to ensure completion of questionnaires
• Algorithm changes (Nathan)
  
  • HepB (Pediarix)
    • 6-month dose (3^rd Pediarix dose) will be valid as long as it is
      1. given at or after 24 weeks of age
      2. given at least 16 weeks after dose 1
      3. the 4^th dose of HepB

      The change removes any minimum spacing between doses 3 and 4 of HepB effectively causing CoCASA to ignore the 3^rd invalid HepB (in the case of Pediarix), which has been a long-standing recommendation of CDC. See example below:
      
      Common "Problem" Scenario in CoCASA (pre v4.0)
      Birth: HepB 1
      2 months: HepB 2 (Pediarix 1) – valid HepB2
      5 months: HepB 3 (Pediarix 2) – invalid HepB3 because given prior to 24 weeks of age.
      6 months: HepB 4 (Pediarix 3) – This dose 4 is viewed by CoCASA as HepB dose 3, which requires an 8 week spacing from the previous dose. Thus, CoCASA calls this dose invalid because there is only a 4 week spacing. Thus, this child still has only 2 valid HepB doses and is not yet UTD.
      
      CoCASA 4.0 will call HepB 4 above valid by ignoring the time since the previous dose.

  • HIB and PCV
    
    • Will allow for 3-dose Hib schedule
      
    • Hib: will show a child as UTD if final dose given after 12 months (with proper spacing)
      
    • PCV will have greater sensitivity to age at previous dose
    • In both cases, will need to assess for 4 dose
      
      Hib algorithm in CoCASA v4.0
      
      For validity:
      
    • Dose 1 must be given at 6 weeks or later.
    • Dose 2 must be given at 10 weeks or later and at least 4 weeks after dose 1.
    • Dose 3 must be given at 14 weeks or later and at least 4 weeks after dose 2.
      
    • Dose 4 must be given at 12 months or later and at least 8 weeks after dose 3.
      
      CoCASA will count a patient as complete and up to date if:
      
    • 4 doses were given and ACIP recommendations are not applied or
    • the patient’s age at compliance date was greater than 59 months or
    • the patient has 4 valid doses or
    • the patient’s first valid dose given after 15 months of age or
    • the patient’s second valid dose was given after 12 months of age and it was given more than 8 weeks after dose 1 or
      
    • the patients third valid dose was given after 12 months of age and it was given more than 8 weeks after dose 2
  • HPV (24 week interval from dose 1 to dose 3)



• Report changes (Nathan)
  
  • New section on missing immunization report (missing any doses) showing the names of kids who received the 4^th DTaP 4-6 months after dose 3. Those same patients will not show as missing immunizations and those doses will not show in the invalid doses report.
    
  • The only DTaP4 doses that will show as invalid are those given before 12 months of age or those with a spacing of less than 4 months since last dose.
    
  • Made the reasons on the invalid doses report more descriptive (e.g.
    "interval of X weeks/months from previous dose not met;" "interval of 2-28 days from other live vaccine not met.")
    
  • New section on missing immunization report (overdue) showing the names of kids who are overdue based on recommended age
• Misc changes (Nathan)
  
  • Removed the AFIX/CoCASA Course (will replace with manual on CDC AFIX site)
    
  • Added a way to deactivate specific users
    
  • Updated CVX/CPT codes and manufacturers
• Timeline for testing and release (Troy Waddington)
  
  • CDC internal testing and rework - Oct 20 – Nov 21 (5 weeks)
    
  • Beta testing (external users/grantees) - Nov 24 - Dec 12 (3 weeks)
    
  • Beta rework - Dec 15 - Dec 26 (2 weeks)
    
  • 4.0 release date - Dec 29
    

Grantee users with the time and interest to beta test both the VFC and AFIX functions of CoCASA v4.0 are encouraged to contact the CoCASA helpdesk (nipcocasa@cdc.gov) or Nathan Crawford (ncrawford2@cdc.gov).

2009 Schedule

2009 Schedule for VFC/AFIX All-Grantee Conference Calls

• January 14, 2:00 – 4:00 pm (eastern)
• April 8, 2:00 – 3:30 pm (eastern)
• July 8, 2:00 – 3:30 pm (eastern)
• October 14, 2:00 – 3:30 pm (eastern)

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