The Cost of Consent: Can We
Afford It?
Anna C. Dragsbaek, JD
National Immunization
Conference 2008
• Define consent terms
• Case Study of Opt-in
System
• Discussion of Costs
– Financial
– Cost of re-immunizing
– Public Health Preparedness
• Policy Discussion
Definitions
What is “Opt-in” or “Consent”?
A requirement that all parents actively indicate a
willingness to participate in immunization record
data sharing
What is “Opt-out” or “Voluntary Exclusion”?
Consent for inclusion is automatically presumed
unless parent actively excludes child.
Study Design
• Project staff measured the time spent gathering
consent for one child by conducting time studies
at 5 private and 3 public birthing hospitals and
10 private and 10 public provider offices in the
Greater Houston area.
• Time studies were also conducted at ImmTrac to
record the time required to complete procedures
for receiving, verifying and maintaining proof of
consent.
• Cost of Consent calculated by computing salary,
materials and overhead for complete consent
process from beginning to end.
Texas Consent for IIS
Participation
• “The department by rule shall develop guidelines
to…require the written consent of a parent, managing
conservator, or guardian of a patient before any
information relating to the patient is included in the
registry.”
TX Health & Safety Code § 161.007 (d) (2005)
Fact: 96% consent to
inclusion in the IIS if offered
the opportunity!
Consent
Voluntary
Exclusion
Texas 10-step
1. Birth Registrar
completes worksheet
2. Data from worksheet
entered into Texas
Electronic Registrar
(TER)
3. Birth Registrar Prints
4. Parents Sign
5. Birth Registrar faxes
to Vital Statistics Unit
6. Consent form received
by Vital Statistics Unit
7. Data Compiled and
Verified
8. Birth Certificate number
issued
9. Message sent to
ImmTrac regarding
consent status
10. Consent Status Verified
by ImmTrac letter to
parent
Consent Granted!!!
(phew!)
The Cost to Texas
Annual cost to consent
Texas cohort
Annual cost of voluntary
exemptions (estimated)
$1,700,000
($4.81 per child*)
$19,800
($1.30 per child)
* $1.30 at birth and $21 at doctor’s
office
Nationwide Registry Consent Laws
Opt-in (written consent
required)
Idaho, Illinois, Kansas, Massachusetts,
New York, Texas, Virginia
Voluntary Exclusion (consent
is implied)
Alabama, Arizona, Arkansas, Colorado,
Connecticut, Delaware, District of Columbia,
Florida, Georgia, Indiana, Iowa, Kentucky,
Louisiana, Maine, Maryland, Michigan,
Minnesota, Mississippi, Missouri, Montana,
Nebraska, Nevada, New Hampshire, New
Jersey, New Mexico, North Carolina, North
Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, Rhode Island, South Carolina,
South Dakota, Tennessee, Utah, Vermont,
Washington, West Virginia, Wisconsin
Verbal consent only
California
Law is silent about consent
Alaska, Hawaii, Wyoming
What are the True Costs of
Consent?
Financial
Cost of Over-Immunizing
Cost during public health emergencies
Cost of Over-Immunizing
• In Opt-in states, there is a higher risk of
over-immunizing due to incomplete
records.
• Cost of fully immunizing one child =
$1,381*.
• Cost of over-immunization estimated at
$26.5 million**
*VFC price list 3/2008
**Feikema, 2000
Public Health
Emergencies
Cost to Disaster Preparedness
• States with voluntary exclusion have more
robust databases when disaster strikes.
• IISs can be deployed at disaster relief
locations and in private provider offices.
• By the time disaster strikes, it is too late to
build a useful database!
Costs of Vaccines in Retrieved LINKS Records
Sept. 20, 2006 VFC Price List
Vaccine
DTaP
Number
Price
Total-No Admin
Fee
Total with Admin
Fee
22,638
$12.25
$277,316
$613,490
DTaP-Hep B-IPV
544
$43.75
$23,800
$31,878
DTP-Hib
621
$24.94
$15,488
$24,710
Hep A
131
$12.10
$1,585
$3,530
Hep B
13,636
$9.10
$124,088
$326,582
Hib
14,990
$7.92
$118,721
$341,322
Hib-Hep B
2,292
$26.25
$60,165
$94,201
M, R, MMR, Mu, M/R
9,731
$17.28
$168,152
$312,657
Meningococcal
18
$68.00
$1,224
$1,491
Pneumococcal
5,551
$57.59
$319,682
$402,114
Polio
19,841
$10.82
$214,680
$509,318
DT, Td
2,131
$16.62
$35,417
$67,063
Varicella
4,374
$56.90
$248,881
$313,835
$1,609,197
$3,042,192
Total
96,482
Policy Implications
• Consent is costly and should be avoided
• Educate stakeholders, policy makers and
legislators about the different ways that consent
is costly
• Policies should be developed to address the
concerns about privacy to remove it as a barrier
to eliminating consent laws
• If consent cannot be eliminated, develop ways to
streamline the process and to ease
administrative burden to cut costs and make the
process more efficient. (e.g. TX Definition of
verification)
Conclusion
Consent laws are obstructive and
should be eliminated or simplified
in order to avoid the fiscal cost,
the cost of over-immunization and
the cost to disaster preparedness.