Countermeasures Injury Compensation Program

1. Countermeasures Injury Compensation Program Program Update Department of Health and Human Services Health Resources and Services Administration Health Systems Bureau National Vaccine Advisory Committee February 4, 2010

2. Authorizing LegislationPREP Act (42 U.S.C. Secs. 247d-6d, 247d-6e) • Authorizes the Secretary to issue PREP Act Declarations that provide tort liability immunity • For claims relating to the administration or use of countermeasures to diseases or threats determined by the Secretary to be a present public health emergency or could in the future constitute a public health emergency • In order to encourage the development, manufacture, testing, distribution, administration and use of such countermeasures.

3. PREP Act • Provides broad liability protections to covered persons • Persons involved in the development, manufacture, testing, distribution, administration and use of a covered countermeasure including clinic administrators, providers, public officials & others • Provides compensation to eligible individuals • Who sustain a serious physical injury or death • Resulting from administration or use of covered countermeasure • In accordance with a Declaration issued by the Secretary in response to an actual or potential public health emergency • Or in a good faith belief the countermeasure was so administered or used

4. Diseases or Threats Currently Covered by PREP Act Declarations • H1N1 pandemic Influenza A (also H5N1, H2, H6, H7, H9 that may potentially evolve into a pandemic strain) • Countermeasures currently include • Antiviral drugs--Tamiflu, Relenza, & peramivir (only H1N1) • Devices--Mechanical ventilators, N95 masks, diagnostic kits • Vaccines--pandemic intranasal & injectable forms • Anthrax, Smallpox (or other orthopoxvirus), Radiation Syndrome, Botulism • Countermeasures currently include any vaccine, antimicrobial/antibiotic, other drug or antitoxin, or diagnostic or device to identify, prevent or treat the disease or adverse events from such countermeasures

5. Benefits Available • Types of Benefits Available • Unreimbursed reasonable medical expenses • Lost employment income • Death benefits • Benefits are secondary to benefits from all other third party payers in almost all cases

6. Determining Medical Eligibility • One year filing deadline • A covered injury may be established by: • Meeting the requirements of a “Table Injury” • Rebuttable presumption of causation OR • Presenting compelling, reliable & valid scientific evidence that demonstrates causation • Reconsideration of the Secretary’s eligibility and/or benefits determination • Process is administrative

7. CICP Administrative rules, policies, and procedures • PREP Act directs the Secretary to follow the Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), with limited exceptions • The interim final rule for CICP outlining administrative rules, policies, and procedures follows the SEPPA. • CICP interim final rule is currently in the clearance process.

8. Current Status of the CICP • Can not accept or process Requests for Benefits until interim final rule completes the clearance process and it is published in Federal Register • Letters of Intent to file • Allows people to meet filing deadline • Program has received 54 letters of intent as of January 27, 2010 for 2009 H1N1 pandemic influenza vaccine

9. Outreach • Presentations to state immunizers, immunization officials, and groups such as ASTHO • VAERS Letters • H1N1 Vaccine Information Statement • Anthrax vaccine • Smallpox vaccine • Website • E-mail and phone contact points

10. CICP Contact Information • CICP@hrsa.gov • 1-888-275-4772 • www.hrsa.gov/countermeasurescomp • Staff: • Vito Caserta, Director, 301-443-5287 • Tamara Overby, Senior Advisor, 301-443-3766 • Nasrin Sorock, Medical Officer, 301-443-8848 • Judy Ceresa, Program Analyst, 301-443-4769