Health Resources and Services Administration
Friday, October 15, 2010
HHS sets regulations to implement Countermeasures Injury Compensation Program
Federal program provides compensation for certain countermeasure injuries
The Department of Health and Human Services (HHS) has established Administrative Regulations for implementing the Countermeasures Injury Compensation Program (CICP).
The program, administered by HHS’ Health Resources and Services Administration (HRSA), provides compensation for medical expenses, lost employment income, and/or death benefits for certain individuals (including military and uniformed service personnel and their dependents), injured as a result of receiving covered countermeasures against certain pandemic, bioterrorism, or security threats as specified in a declaration by the HHS Secretary.
Secretarial declarations currently cover certain pandemic influenza countermeasures used to prevent, treat, or diagnose pandemic influenza such as 2009 H1N1 monovalent vaccine, other pandemic influenza vaccines (e.g., avian H5N1 influenza vaccine), Tamiflu ®, Relenza ®, peramivir, N 95 masks, mechanical ventilators, and pandemic influenza diagnostics.
In addition, declarations also currently cover certain vaccines, antimicrobials, antitoxins, drugs, diagnostics or devices used to identify, prevent, or treat smallpox, anthrax, botulism, or acute radiation syndrome.
Although CICP does not cover countermeasures used against seasonal influenza, HRSA’s National Vaccine Injury Compensation Program may provide coverage for adverse events caused by the trivalent seasonal influenza vaccine.
To be considered for compensation, individuals (or their representatives) must file a Request for Benefits Form within one year of the administration or use of the covered countermeasure they believe may have caused their serious physical injury (prior to this, a Letter of Intent had been accepted to satisfy the one-year filing deadline).
The regulations were established through an interim final rule and published in the October 15 Federal Register. Although this became effective upon publication, HRSA is seeking public comment on the regulations and may revise them based on comments received. Comments should be sent within 60 days of the publication date to: Health Resources and Services Administration, Department of Health and Human Services, Attention: HRSA regulations Officer, Parklawn Building, Room 14A-11, 5600 Fishers Lane, Rockville, MD 20857. Electronic comments may be sent to CICP@HRSA.gov.
For more information about the CICP and to obtain a copy of the interim rule, visit the CICP website at www.hrsa.gov/countermeasurescomp or call 1-888-275-4772.
The Health Resources and Services Administration is part of the U.S. Department of Health and Human Services. HRSA is the primary Federal agency responsible for improving access to health care services for people who are uninsured, isolated, or medically vulnerable. For more information about HRSA and its programs, visit www.hrsa.gov.