2. Disclosures
The authors report no relevant financial interests regarding the work presented in this talk
This talk will not include any reference to products not licensed by the Food and Drug Administration

3. Acknowledgments
A collaborative effort among the following individuals and institutions:
Denver Public Health
Judith C. Shlay, MD, MSPH (PI)
Kelly Busch, BSN, MSN
Denver Health and Hospitals
Deborah Rinehart, MA
Nicole Morgan, MHA
Simon J. Hambidge, PhD, MD
Mette Riis, RN
Anne Hammer, RN
Sarah Rodgers
U. Colorado/Children’s Hospital
Allison Kempe, MD, MPH
Jennifer Pyrzanowski, MSPH
Hai Fang, PhD, MPH
Fran Dong, MS
Karen Albright, PhD
Denver Public Schools
Donna Shocks, MSN, CNS, RN
Jean Lyons, BSN, RN
Scott Romero, MS
Linda Parker-Long, RN
Bridget Beatty, MPH
Elizabeth Cooper, RN
Kaiser Permanente Colorado
Matthew F. Daley, MD
Community Benefits Program
Centers for Disease Control and Prevention
Tara Vogt, PhD
Emily McCormick, MPH

4. Vaccines for Adolescents
New vaccines, new opportunities for prevention:
Routinely recommended vaccines: Tdap, meningococcal, HPV (females), influenza
“Adolescent immunization platform:” coordinate delivery of vaccines with delivery of preventive care
Barriers to reaching the platform:
Infrequent visits to primary care settings
Visits predominantly for acute care
Lack of insurance or lack of medical home for some
Transition to vaccination in schools needed.
Ref: McCauley et al: Pediatrics 2008;121 Supp
Broder et al: Pediatrics 2008;121 Supp.

5. Vaccination in Schools
Extensive school-based vaccination programs in other countries (Australia, Canada, Belgium), in other decades (polio, U.S., 1960s)
More current U.S. examples:
Knox County, TN, in 2005: donated influenza vaccine, no billing
Carroll County, MD, in 2005: donated influenza vaccine, staffed by volunteers, no billing
Ref: Carpenter et al: Pediatrics 2007;120; Davis et al: Pediatrics 2008:122

6. Vaccination in Schools: Additional Considerations
Viewed favorably by parents
Schools already involved in immunizations, through tracking and enforcing mandates
Generally supported by physicians, but concerns:
Could lose a “hook” for well-adolescent visits
Could lead to scattered immunization records
Challenges with school-based delivery:
No delivery or billing infrastructure
FERPA regulations limit information disclosure
Ref: Middleman and Tung: Vaccine 2010;28; Schaffer et al: Arch Pediatr Adolesc Med 2001;155

7. Study Objectives
To assess feasibility of a school-based vaccination program which is
open to all students regardless of insurance status,
capable of billing insurance companies, and
bills for both vaccine costs and administration fees
To assess vaccination and billing outcomes of the program 7

8. Study Methods Setting: urban public school district
Time period: vaccination clinic was in April 2009
Targeted school:
Large, socio-economically diverse middle school
Enrollment n=909 students
67% eligible for free/reduced lunch
Focused on Tdap vaccination: required for school entry, but mandate not aggressively enforced 8

9. Planning Meetings with School District
Met with school district research committee, district administration, nursing services
Supportive, but concerns included:
Burden on school personnel
Student confidentiality (FERPA)
Whether parents would receive bill for denied claims; important to school district that parents perceive education as “free and fair” 9

10. Preparing for Tdap Clinic
School nurse determined which students needed Tdap, based on school paper/electronic records
Parents of students without documentation of Tdap mailed consent forms from school, twice
Health insurance/billing information requested on consent
Once parents consented, community vaccinator could contact, confirm insurance 10

11. Running the Tdap Clinic
A local community vaccinator conducted clinic on school grounds
Staffed by RNs, other personnel
Students recalled by grade to clinic; out of class for roughly 20 to 45 minutes
Immunization data entered into local immunization registry, which downloads to state registry 11

12. Billing Processes Community vaccinator managed billing:
Existing contracts examined
Attempts to expand existing contracts limited due to time constraints
Bills resubmitted multiple times if necessary
Reasons for denial captured
Parents not billed if claim denied 12

13. Billing by Insurance Category
Vaccine
Cost
Administration Fee
Private 
S-CHIP
Medicaid (VFC) No
Uninsured (VFC)

14. Analytic Methods
Descriptive frequencies of consent, immunization outcomes
Costs estimated by microcosting approach:
Collected time and cost data on every immunization-related activity
Included cost of immunization-related supplies
Included costs of billing for services
Analyzed costs for each participating entity
Ref: Glazner et al: Pediatrics 2004;113
Glazner et al: Pediatrics 2009;124 Supp

15. Results: Flow of Participants
Total school enrollment (n=909)
History of prior Tdap (n=415)
46%
No documented Tdap at school (n=494)
54%
Consent returned:
later learned had
history of
Tdap (n=9) 2%
Vaccine record
returned: prior
Tdap (n=36) 7%
No consent
or vaccine record
returned (n=294)
60%
Consent returned:
no history of
Tdap (n=155)
32%

16. Immunization Outcomes
Tdap vaccination clinic lasted 2.5 hours:
Immunized: 151 of 155 eligible consented students
Not immunized: 3 absent; 1 with contraindication (allergy)
Over-immunization:
An additional 6 students over-immunized
Received Tdap, later records showed had prior Tdap
School-wide Tdap immunization rate increased from 46% to 67% (p<0.01)
446 students identified as up to date prior to March 13th using IC Iz data
151 students were vaccinated at the clinic
6 students were up to date and over vaccinated
1 student was determined to have already had Tdap the day of the clinic and was not vaccinated (one of three represented in our data)
5 students received the vaccine between March 13th and April 9th (day of the clinic)
= 609; 609/909 = 67%
This number is different that what was in the abstract 68% (614/909). The difference of 5 students include 4 students who had Td within last 24 months of clinic, and one student who received Tdap before licensure.
Need to update p value. 16

17. Insurance Status of Students Vaccinated at Clinic (n=151)17

18. Vaccine Costs n Unit cost Total cost Private 45 $35.31 $1589 S-CHIP 8
$282
Medicaid (VFC) 38
$0.00 $0
Uninsured (VFC) 60
Total
151
$1872
We purchased Adacel - Sanofi Pasteur. The CDC cost for this is $30.75.  The DH cost was $35.31, which is a 340B price.  The wholesale price for the vaccine we used is xx. (Deb is looking into this).
The 340B Drug Pricing Program resulted from enactment of Public Law , the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act. Section 340B limits the cost of covered outpatient drugs to certain federal grantees, federally-qualified health center look-alikes and qualified disproportionate share hospitals. Significant savings on pharmaceuticals may be seen by those entities that participate in this program. 18

19. Costs to Administer Clinic
Entity
Description
Total cost
Community vaccinator
Pre-clinic (compiling, sending, and reviewing consents); mailings; day of clinic (RN hours, clerical, transportation)
$3180
Billing department
Registering patients; billing, with follow-up of denied claims
$576
School
Pre-clinic and day of clinic nursing and clerical support
$1461
Updating immunization information for entire school enrollment (n=909)
$4487 19

20. Costs to Administer Clinic
Entity
Description
Total cost
Community vaccinator
Pre-clinic (compiling, sending, and reviewing consents); mailings; day of clinic (RN hours, clerical, transportation)
$3180
Billing department
Registering patients; billing, with follow-up of denied claims
$576
School
Pre-clinic and day of clinic nursing and clerical support
$1461
Updating immunization information for entire school enrollment (n=909)
$4487 20

21. Costs to Administer Clinic
Entity
Description
Total cost
Community vaccinator
Pre-clinic (compiling, sending, and reviewing consents); mailings; day of clinic (RN hours, clerical, transportation)
$3180
Billing department
Registering patients; billing, with follow-up of denied claims
$576
School
Pre-clinic and day of clinic nursing and clerical support
$1461
Administrative costs, per student immunized = $ 34.55
Prior studies, private practices = $ 7.57 to $11.51
Ref: Glazner et al: Pediatrics 2004;113
Glazner et al: Pediatrics 2009;124 Supp 21 21

22. Reimbursement for Vaccine Costs: Billed $36.25 Per Dose
Reimbursed
(> $0), n
Denied
(= $0), n
Total, $
Private 23 22
$808
S-CHIP 8
$290
Medicaid (VFC) NA $0
Uninsured (VFC)
Total
$1098
Are you sure you want the last column to be $ per dose rather than a total? I put a total, otherwise down the column you will basically have $7.00 repeated.
What about reasons for denial for administration fee?
missing 17; CO97 6; CO16 5; CO165 3; PR1 3; PR204 2; CO04 1; PR200 1; PR38 1; PR49 1
NA=Not applicable 22

23. Reimbursement for Administration Fees: Billed $7 Per Dose
Reimbursed
(> $0), n
Denied
(= $0), n
Total, $
Private 13 32
$87
S-CHIP 5 3
$35
Medicaid (VFC) 33
$231
Uninsured (VFC) NA $0
Total
$353
Are you sure you want the last column to be $ per dose rather than a total? I put a total, otherwise down the column you will basically have $7.00 repeated.
What about reasons for denial for administration fee?
missing 17; CO97 6; CO16 5; CO165 3; PR1 3; PR204 2; CO04 1; PR200 1; PR38 1; PR49 1
NA=Not applicable 23

24. Summary of Costs and Reimbursements
Total Costs: Vaccine + Administration
Total Reimbursement
Dollars Reimbursed, %
Private
$3144
$895
28%
S-CHIP
$559
$325
58%
Medicaid (VFC)
$1313*
$231
18%
Uninsured (VFC)
$2073* $0 0%
Total
$7089
$1451
20%
We purchased Adacel - Sanofi Pasteur. The CDC cost for this is $30.75.  The DH cost was $35.31, which is a 340B price.  The wholesale price for the vaccine we used is xx. (Deb is looking into this).
The 340B Drug Pricing Program resulted from enactment of Public Law , the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act. Section 340B limits the cost of covered outpatient drugs to certain federal grantees, federally-qualified health center look-alikes and qualified disproportionate share hospitals. Significant savings on pharmaceuticals may be seen by those entities that participate in this program.
*Administration costs only 24

25. Reasons for Denial of Claims (n=22)
Patient responsibility
Deductible (n=6)
Not covered by plan (n=1)
Not covered outside of physical (n=1)
Contractual obligation
Missing information (n=3)
Absence of/exceeded referral (n=3)
Pending further review (n=1)
No response from insurer (n = 7)
CO – Contractual Obligations: This group code should be used when a contractual agreement between the pay and the payee, or a regulatory reguirement, resulted in a an adjustment. Generally, these adjustments are considred a write off for the provider and are not billed to the patient.
PR – Patient Responsability: This group should be used when the adustment respresents an amount that should be billed to the patient or insured. This group would typically be used for deductible and copay adjustment.
CO133 n= 1; CO16 n = 3; CO165 n = 3; missing n = 7; PR1 n = 6; PR204 n = 1; PR49 n = 1
Total n = 22 25

26. Limitations Pilot study Not known why some parents didn’t consent
1 school, 1 vaccine, no comparison school
For : 7 schools, all vaccines, compared to a group of 8 comparison schools
Not known why some parents didn’t consent
Up-to-date?
Perceived cost?
Preferred vaccination with PCP?
May not be generalizable to other regions 26

27. Additional Limitations
Limited time prior to Tdap clinic to examine and renegotiate contracts with private insurers
Administrative cost estimates sensitive to model assumptions
Did not include parental lost time from work as a potential cost-saving of project

28. Conclusions
School Tdap vaccination clinic significantly increased school-wide rates
Students of all insurance types participated
Denied claims relatively common, for both vaccine costs and administration fees
High administrative costs for school-based clinic, compared with estimates from private practices 28

29. Implications
As a pilot study, demonstrated feasibility, but not necessarily financial sustainability
Sustainability = ↑ efficiency plus ↓ denials
↑ efficiency: no mailings, streamline consent process, improve documentation of school vaccination records
↓ denials: building relationships and revising contracts with insurers
Perspective is important
Community vaccinator: good service; limit financial loss
School: educational mission paramount; what is burden?
Societal: reduce disparities; prevent disease
So Stay Tuned! 29

30. Thank You! Denver Public Health Judith C. Shlay, MD, MSPH (PI)
Kelly Busch, BSN, MSN
Denver Health and Hospitals
Deborah Rinehart, MA
Nicole Morgan, MHA
Simon J. Hambidge, PhD, MD
Mette Riis, RN
Anne Hammer, RN
Sarah Rodgers
U. Colorado/Children’s Hospital
Allison Kempe, MD, MPH
Jennifer Pyrzanowski, MSPH
Hai Fang, PhD, MPH
Fran Dong, MS
Karen Albright, PhD
Denver Public Schools
Donna Shocks, MSN, CNS, RN
Jean Lyons, BSN, RN
Scott Romero, MS
Linda Parker-Long, RN
Bridget Beatty, MPH
Elizabeth Cooper, RN
Kaiser Permanente Colorado
Matthew F. Daley, MD
Community Benefits Program
Centers for Disease Control and Prevention
Tara Vogt, PhD
Emily McCormick, MPH 30

31. Consent Vs. No Consent Consent n =155 No consent n = 299 p value
Gender M, % 51 58
0.14
11 years old, % 19 15
12 years old, % 42 35
>12 years old, % 39 50
0.08
Grade 6, % 53 44
Grade 7, % 21 25
Grade 8, % 26 31
0.17 31