Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Interim Final Rule, 63656-63688 [2010-25110]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 199 (Friday, October 15, 2010)]
[Rules and Regulations]
[Pages 63656-63688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25110]



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Part IV





Department of Health and Human Services





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42 CFR Part 110



Countermeasures Injury Compensation Program (CICP): Administrative 
Implementation, Interim Final Rule; Final Rule

Federal Register / Vol. 75 , No. 199 / Friday, October 15, 2010 / 
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 110

RIN 0906-AA83


Countermeasures Injury Compensation Program (CICP): 
Administrative Implementation, Interim Final Rule

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Interim final rule with request for comments.

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SUMMARY: The Public Readiness and Emergency Preparedness Act (PREP Act) 
authorizes the Secretary of Health and Human Services (the Secretary) 
to establish the Countermeasures Injury Compensation Program (CICP or 
Program). The Department of Health and Human Services (HHS) is issuing 
this interim final rule with request for comments in order to establish 
administrative policies, procedures, and requirements for the CICP. 
This Program is designed to provide benefits to certain persons who 
sustain serious physical injuries or death as a direct result of 
administration or use of covered countermeasures identified by the 
Secretary in declarations issued under the PREP Act. In addition, the 
Secretary may provide death benefits to certain survivors of 
individuals who died as the direct result of such covered injuries or 
their health complications. The Secretary is seeking public comments on 
this interim final rule.

DATES: This regulation is effective on October 15, 2010. Written one 
comments must be submitted on or before December 14, 2010. The 
Secretary will consider the comments received and will decide whether 
to amend the current procedures and requirements based on such 
comments.

ADDRESSES: You may submit comments in one of three ways, as listed 
below. The first is the preferred method. Please submit your comments 
in only of these ways, so that no duplicates are received.
    1. Federal eRulemaking Portal. You may submit comments 
electronically to https://www.regulations.gov. Click on the link 
``Submit electronic comments on HRSA regulations with an open comment 
period.'' Submit your actual comments as an attachment to your message 
or cover letter. (Attachments should be in Microsoft Word or 
WordPerfect; however, we prefer Microsoft Word.)
    2. By regular, express or overnight mail. You may mail written 
comments to the following address only: Health Resources and Services 
Administration, Department of Health and Human Services, Attention: 
HRSA Regulations Officer, Parklawn Building Rm. 14A-11, 5600 Fishers 
Lane, Rockville, MD 20857. Please allow sufficient time for mailed 
comments to be received before the close of the comment period.
    3. Delivery by hand (in person or by courier). If you prefer, you 
may deliver your written comments before the close of the comment 
period to the same address: Parklawn Building Room 14A-11, 5600 Fishers 
Lane, Rockville, MD 20857. Please call in advance to schedule your 
arrival with one of our HRSA Regulations Office staff members at 
telephone number (301) 443-1785.
    Because of staffing and resource limitations, and to ensure that no 
comments are misplaced, we cannot accept comments by facsimile (FAX) 
transmission.
    In commenting, please refer to file code [HRSA-2010-0006]. Comments 
received on a timely basis will be available for public inspection as 
they are received, beginning approximately 3 weeks after publication of 
this Notice, in Room 14-05 of the Health Resources and Services 
Administration's offices at 5600 Fishers Lane, Rockville, MD., on 
Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: 
301-443-1785).

FOR FURTHER INFORMATION CONTACT: Dr. Vito Caserta, Director, 
Countermeasures Injury Compensation Program, Healthcare Systems Bureau, 
Health Resources and Services Administration, Parklawn Building, Room 
11C-26, 5600 Fishers Lane, Rockville, MD 20857. Phone calls can be 
directed to (888) ASK-HRSA (275-4772). This is a toll-free number.

SUPPLEMENTARY INFORMATION:

Background

    This regulation administratively establishes the compensation 
program authorized by the Public Readiness and Emergency Preparedness 
Act (the PREP Act) which added new authorities under sections 319F-3 
and 319F-4 of the Public Health Service Act, as amended (PHS Act) (42 
U.S.C. 247d-6d, 247d-6e). The PREP Act, which was enacted as part of 
the Department of Defense, Emergency Supplemental Appropriations to 
Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of 
2006 (Pub. L. 109-148) on December 30, 2005, confers broad liability 
protections to covered persons and authorizes compensation to eligible 
individuals who sustain serious physical injuries or deaths as the 
direct result of the administration or use of a covered countermeasure 
for a disease, condition, or threat that the Secretary of Health and 
Human Services (the Secretary) determines either constitutes a current 
public health emergency, or there is a credible risk that the disease, 
condition, or threat may in the future constitute such an emergency. 
This determination is identified in a declaration issued by the 
Secretary under the PREP Act.
    Both the liability protections and the compensation authorized 
under the PREP Act are invoked by declarations issued by the Secretary 
(hereinafter PREP Act declarations or declarations) (section 319F-3(b) 
of the PHS Act (42 U.S.C. 247d-6d(b)). Through the issuance of such 
PREP Act declarations, the Secretary makes a determination that a 
disease, condition, or other threat to health constitutes a public 
health emergency, or that there is a credible risk that the disease, 
condition, or threat may in the future constitute such an emergency. In 
such declarations, the Secretary recommends targeted liability immunity 
for persons or entities involved in the manufacture, testing, 
development, distribution, dispensing, administration, and/or use of a 
covered countermeasure for the disease, threat, or condition specified. 
Each Secretarial declaration specifies, for each covered countermeasure 
identified in the declaration: (a) The category or categories of 
diseases, health conditions, or threats to health for which the 
Secretary recommends the administration or use of the covered 
countermeasure; (b) the period or periods during which the liability 
protections are in effect (for example, from a certain date through a 
future date, or other descriptions of events that would trigger the 
application of the liability protections); (c) the population or 
populations for whom the Secretary recommends the administration or use 
of the covered countermeasure (for example, the entire population 
during a pandemic period); and (d) the geographic area or areas for 
which the liability protections are in effect (e.g., no geographic 
limitation, a certain region of the United States). In addition, the 
Secretary can provide whether the liability protections are only 
available for specified distribution methods (for example, the 
liability protections shall only be in effect if the countermeasures 
are obtained through a voluntary means of distribution). The Secretary 
may change any component of a declaration by amendment.
    The Secretary publishes all PREP Act declarations, and amendments 
to such declarations, in the Federal Register. In addition, they are 
generally posted on

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the Department's Web site at https://www.hhs.gov/disasters/discussion/planners/prepact/ and on the Program's Web site at https://www.hrsa.gov/countermeasurescomp/. As of April 2010, the Secretary had published 
declarations with respect to the following countermeasures: (1) 
Pandemic influenza vaccines (including, but not limited to the 
influenza A H1N1 2009 monovalent vaccine which will be hereafter 
referred to as the 2009 H1N1 vaccine); (2) anthrax countermeasures; (3) 
botulism countermeasures; (4) the influenza antiviral drugs 
Tamiflu[supreg] and Relenza[supreg] when used for pandemic purposes; 
(5) smallpox countermeasures; (6) acute radiation syndrome 
countermeasures; (7) pandemic influenza diagnostics, personal 
respiratory devices, and respiratory support devices; and (8) the 
influenza antiviral drug peramivir when used to treat pandemic H1N1 
2009 influenza (which will be hereafter referred to as 2009 H1N1). 
Several of these declarations have been amended, some on multiple 
occasions.
    ``Covered countermeasure'' is a term of art defined in the PREP Act 
and includes three categories (section 319F-3(i)(1) of the PHS Act (42 
U.S.C. 247d-6d(i)(1)). The first category, consisting of ``qualified 
pandemic or epidemic product[s],'' is defined in section 319F-3(i)(7) 
of the PHS Act (42 U.S.C. 247d-6d(i)(7)). This category includes 
products (drugs, biological products, and devices) manufactured, used, 
designed, developed, modified, licensed, or procured to diagnose, 
mitigate, prevent, treat, or cure a pandemic or epidemic or to limit 
the harm such pandemic or epidemic might otherwise cause. The category 
also extends to products used to diagnose, mitigate, prevent, treat, or 
cure a serious or life-threatening disease or condition caused by a 
``qualified pandemic or epidemic product.'' In order to qualify, a 
drug, biological product, or device must be: (1) Approved or cleared 
under the Federal Food, Drug, and Cosmetic Act (FFDCA) or licensed 
under the PHS Act; (2) the subject of research for possible use and 
subject to an exemption under sections 505(i) or 520(g) of the FFDCA; 
or (3) covered under an emergency use authorization (in accordance with 
section 564 of the FFDCA).
    The second category includes ``security countermeasure[s].'' A 
security countermeasure, defined in section 319F-2(c)(1)(B) of the PHS 
Act (42 U.S.C. 247d-6b(c)(1)(B), is a drug, biological product, or 
device that the Secretary determines: (1) Is a priority to diagnose, 
mitigate, prevent, or treat harm either from an agent identified as a 
material threat or from a condition that may result in injuries or 
deaths and may be caused by administering a drug, biological product, 
or device against such an agent; (2) is a necessary countermeasure; and 
(3) is approved or cleared under the FFDCA or licensed under the PHS 
Act or will likely be approved, cleared or licensed within eight years 
or is authorized for emergency use under section 564 of the FFDCA.
    The final category consists of products subject to emergency use 
authorizations. This category extends to drugs (as defined in section 
201(g)(1) of the FFDCA, 21 U.S.C. 321(g)(1)), biological products (as 
defined in section 351(i) of the PHS Act (42 U.S.C. 262), or devices 
(as defined in section 201(h) of the FFDCA, 21 U.S.C. 321(h)) that are 
authorized for emergency use in accordance with section 564 of the 
FFDCA.
    In order to be eligible for the liability protections of the PREP 
Act or to receive benefits under the compensation provisions of the 
PREP Act, a covered countermeasure must meet one of these three 
categories and must also be identified by the Secretary in a PREP Act 
declaration. As explained above, the liability protections afforded by 
the PREP Act are tied to Secretarial declarations. The PREP Act's 
liability protections are broad, covering, for example, the 
manufacture, testing, development, distribution, dispensing, 
administration or use of the designated covered countermeasure (absent 
willful misconduct as defined in section 319F-3(c)(1) of the PHS Act 
(42 U.S.C. 247d-6d(c)(1)). The immunity from suit afforded by the PREP 
Act applies to any claim for loss that has a causal relationship with 
the administration to or use by an individual of a covered 
countermeasure, including a causal relationship with the design, 
development, clinical testing or investigation, manufacture, labeling, 
distribution, formulation, packaging, marketing, promotion, sale 
purchase, donation, dispensing, prescribing, administration, licensing, 
or use of such countermeasure[s] (section 319F-3(a)(2)(B) of the PHS 
Act (42 U.S.C. 247d-6d(a)(2)(B)). For more information about the 
liability protections afforded to covered persons under the PREP Act, 
questions and answers are available on the Department's Web site at 
https://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html and https://www.hhs.gov/disasters/discussion/planners/prepact/prepact-h1n1.html.
    In addition to establishing the PREP Act's liability protections 
for covered persons, the PREP Act authorizes the Secretary to establish 
a program to provide compensation to eligible individuals for certain 
covered injuries sustained as the direct result of the administration 
or use of a covered countermeasure identified in a PREP Act 
declaration. The Secretary delegated the authority to operate the 
compensation program described in section 319F-4 of the PHS Act (42 
U.S.C. 247d-6e) to the Administrator of the Health Resources and 
Services Administration (HRSA) on November 8, 2006. Pursuant to this 
delegation of authority, HRSA established and administers the 
Countermeasures Injury Compensation Program (hereinafter CICP or 
Program).
    Under the CICP, certain persons may be eligible for benefits for 
covered injuries, described below, sustained as a direct result of the 
administration or use of covered countermeasures. The PREP Act 
stipulates that the CICP will follow, with very limited exceptions, the 
Smallpox Vaccine Injury Compensation Program (SVICP) for eligibility 
and compensation determinations (section 319F-4(b)(4) of the PHS Act 
(42 U.S.C. 247d-6e(b)(4)). In addition, the elements of compensation 
are almost identical to those available under the SVICP (section 319F-
4(b)(2) of the PHS Act (42 U.S.C. 247d-6e(b)(2)). The SVICP was 
established under the Smallpox Emergency Personnel Protection Act of 
2003 (SEPPA) and its implementing regulations are available at 42 CFR 
part 102. Specifically, the PREP Act provides that (with limited 
exceptions) the CICP is to follow the SEPPA, the SVICP regulations 
implementing the SEPPA, and such additional or alternate regulations as 
the Secretary may promulgate for purposes of this section (section 
319F-4(b)(4) of the PHS Act (42 U.S.C. 247d-6e(b)(4)). The Secretary is 
issuing this interim final rule under that authority.
    As authorized under the PREP Act, the Secretary is herein, at 42 
CFR part 110, establishing the procedures and requirements governing 
the CICP. As explained below, the Secretary is issuing this regulation 
as an interim final rule, to be effective on October 15, 2010. However, 
the Secretary is seeking public comments on these procedures and 
requirements and may change provisions of this regulation upon review 
of the comments received.

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Summary of the Regulation

Summary of Available Benefits (Sec.  110.2)

    The benefits available under this Program are medical benefits, 
benefits for lost employment income, and survivor death benefits. 
Medical benefits are described more fully in Sec.  110.31 and include 
payment or reimbursement for medical services and items that the 
Secretary determines are reasonable and necessary to diagnose or treat 
a covered injury and to diagnose, treat, or prevent its health 
complications. Benefits for lost employment income are described more 
fully in Sec.  110.32 and cover lost employment income incurred as a 
result of a covered injury or its health complications. Death benefits 
are described in Sec.  110.33 and provide payments to survivors if the 
Secretary determines that the death of the injured countermeasure 
recipient was the direct result of a covered injury. As described in 
Sec.  110.33, death benefits are available under standard or 
alternative calculations depending upon the eligible survivors.
    As explained in Sec.  110.2(b), the PREP Act, based upon provisions 
included in the SEPPA, establishes that the government generally is a 
secondary payer for benefits available under the Program. For example, 
death benefits paid under the alternative calculation in Sec.  
110.82(c) are secondary to death and disability benefits under the 
Public Safety Officers' Benefits (PSOB) Program (a program within the 
United States Department of Justice that provides payments to public 
safety officers and their survivors, including death benefits for 
officers killed in the line of duty).
    Benefits under the Program usually will only be paid after the 
requester has in good faith attempted to obtain all other available 
coverage from all third-party payers with an obligation to pay for or 
provide such benefits. Requesters generally must provide the names of 
all other third party payers that have already provided benefits, that 
are expected to do so in the future, or that may have a legal or 
contractual obligation to do so. These payers include, but are not 
limited to: insurance companies, workers' compensation programs, the 
Federal Employees' Compensation Act (FECA) Program, military treatment 
facilities (MTFs), the Department of Veterans Affairs, or the PSOB 
Program. If such a third-party payer has paid for or provided the type 
of benefits requested under this Program, the Secretary will only pay 
such benefits in an amount necessary to supplement the payments already 
provided so that the requester does not have unreimbursed out-of-pocket 
expenses. For example, if a requester determined to be eligible for 
medical benefits incurred $10,000 in reasonable and necessary medical 
expenses resulting from a covered injury and the requester's health 
insurance company (a third-party payer) has paid $5,000 for the covered 
medical benefits and services, the Program would reimburse the 
requester $5,000 (representing the amount the requester is entitled to 
under this Program, reduced by the amount paid or payable by third-
party payers). As explained later, upon payment of benefits under the 
Program, the Secretary will be subrogated to the rights of the 
requester and may assert a claim against any third-party payer with a 
legal or contractual obligation to pay for, or provide, such benefits.

Eligible Requesters (Sec.  110.10)

    There are three categories of eligible requesters under the 
Program: (1) Injured countermeasure recipients; (2) survivors of 
deceased injured countermeasure recipients who died as a direct result 
of the administration or use of a covered countermeasure; and (3) 
executors or administrators on behalf of the estates of deceased 
injured countermeasure recipients (regardless of their cause of death).
Injured Countermeasure Recipients
    The first category of requesters, an ``injured countermeasure 
recipient'' is defined in Sec.  110.3(n) as an individual:
    (1) Who, with respect to administration or use of a covered 
countermeasure pursuant to a Secretarial declaration:
    (A) Meets the specifications of the pertinent declaration; or
    (B) Is administered or uses a covered countermeasure in a good 
faith belief that he or she meets the specifications of the pertinent 
declaration; and
    (2) Sustained a covered injury as defined in Sec.  110.3(g).
    (3) If a covered countermeasure is administered to, or used by, a 
pregnant woman in accordance with paragraphs (1)(A) or (1)(B), any 
child from that pregnancy who survives birth is an injured 
countermeasure recipient if the child is born with, or later sustains, 
a covered injury (as defined in section 110.3(g)) as the direct result 
of the covered countermeasure's administration to, or use by, the 
mother during her pregnancy.
    Thus, the eligibility requirements for injured countermeasure 
recipients may vary based on the terms of the PREP Act declaration 
issued with respect to the particular covered countermeasure. For 
example, all of the declarations issued to date, which are subject to 
change, include specific limitations in Category I, entitled ``Covered 
Countermeasures.'' The amended PREP Act declaration for pandemic 
influenza vaccines specifies that the liability immunity afforded under 
the PREP Act ``shall only be in effect with respect to: (1) Present or 
future Federal contracts, cooperative agreements, grants, interagency 
agreements, or memoranda of understanding for vaccines against pandemic 
influenza A viruses with pandemic potential used and administered in 
accordance with this Declaration, and (2) activities authorized in 
accordance with the public health and medical response of the Authority 
Having Jurisdiction to prescribe, administer, deliver, distribute or 
dispense the pandemic countermeasures following a declaration of an 
emergency, as defined in section IX below'' (74 FR 51153 (Oct. 5, 
2009)). This document defines an Authority Having Jurisdiction as ``the 
public agency or its delegate that has legal responsibility and 
authority for responding to an incident, based on political or 
geographical (e.g., city, county, Tribal, State, or Federal boundary 
lines) or functional (e.g., law enforcement, public health) range or 
sphere or authority.'' Id.
    Thus, the immunity protections (and the benefits available under 
the CICP) are contingent upon either requirement (and not necessarily 
both) being satisfied. With respect to each requester who received a 
covered countermeasure identified in a declaration with such language, 
the Secretary will have to consider whether the administration or use 
of a covered countermeasure met either of the requirements set forth 
above or whether there was a good faith belief of such at the time of 
the administration or use in order to determine whether the person 
identified as an injured countermeasure recipient meets the 
requirements of Sec.  110.3(n)(1). In the case of 2009 H1N1 vaccines, 
this inquiry will generally be simple, given that all such vaccines 
distributed in the United States were purchased under contract by the 
Federal Government (satisfying the first requirement quoted above).
    The amended PREP Act declaration for the influenza antivirals 
Tamiflu[supreg] and Relenza[supreg] contains similar limitations to 
those described above in its section entitled ``Covered 
Countermeasures.'' Specifically, the amended PREP Act declaration 
provides that the liability immunity afforded under the PREP Act 
``shall only be in

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effect with respect to: (1) Present or future Federal contracts, 
cooperative agreements, grants, interagency agreements, or memoranda of 
understanding involving countermeasures that are used and administered 
in accordance with this declaration, and (2) activities authorized in 
accordance with the public health and medical response of the Authority 
Having Jurisdiction to prescribe, administer, deliver, distribute or 
dispense the Covered Countermeasure following a declaration of an 
emergency, as defined in section IX below'' (73 FR 61861 (Oct. 17, 
2008), amended by 74 FR 29213 (June 19, 2009)). The declaration, like 
other PREP Act declarations, goes on to define ``the Authority Having 
Jurisdiction,'' and the ``Declaration of Emergency.'' Many 
administrations or uses of pandemic influenza antivirals in the current 
2009 H1N1 outbreak will certainly meet the first requirement (e.g., 
antivirals from the Strategic National Stockpile are under Federal 
contracts). A more complicated analysis may be required with respect to 
other administrations or uses to determine whether the alternate 
requirement (the Authority Having Jurisdiction requirement) was 
satisfied in particular circumstances. In order for the Authority 
Having Jurisdiction requirement to apply, the authorized activities 
must follow a declaration of emergency, as defined in the applicable 
declaration. With respect to the declaration for Tamiflu[supreg] and 
Relenza[supreg], a ``Declaration of Emergency'' is defined as ``[a] 
declaration by any authorized local, regional, State, or Federal 
official of an emergency specific to events that indicate an immediate 
need to administer and use pandemic countermeasures, with the exception 
of a Federal declaration in support of an emergency use authorization 
under section 564 of the FFDCA unless such declaration specifies 
otherwise'' (73 FR at 61863, section IX (definitions)). The same 
declaration defines the ``Authority Having Jurisdiction'' as ``the 
public agency or its delegate that has legal responsibility and 
authority for responding to an incident, based on political or 
geographical (e.g., city, county, tribal, State, or Federal boundary 
lines) or functional (e.g., law enforcement, public health) range or 
sphere of authority).'' Id. Thus, the Authority Having Jurisdiction can 
vary depending upon the circumstances. The Secretary, in an amendment 
to the PREP Act declaration for the influenza antivirals 
Tamiflu[supreg] and Relenza[supreg] for pandemic use, shared her 
determination that the risk of the spread of 2009 H1N1 viruses and 
resulting disease constitutes a public health emergency (74 FR 29213 
(June 19, 2009), amending 73 FR 61861 (Oct. 17, 2008)). Prior to the 
issuance of the PREP Act Declaration, the Acting Secretary, pursuant to 
the authority vested in him under section 319 of the Public Health 
Service Act, 42 U.S.C. 247d, issued a determination that a public 
health emergency existed nationwide involving H1N1 influenza that 
affected or has significant potential to affect national security. This 
determination was subsequently renewed by the current Secretary. Thus, 
with respect to covered countermeasures used in connection with the 
2009 H1N1 virus, the Secretary has issued a declaration of emergency 
sufficient to invoke the ``Authority Having Jurisdiction'' requirement 
in declarations published to date.
    Although the Authority Having Jurisdiction requirement was 
intentionally worded broadly to account for the complexities of our 
national public health and emergency response systems (in which the 
Federal Government, States, localities, tribes, and the private sector 
play important roles), the Secretary wishes to provide some additional 
guidance to enable individuals who have been administered or used 
covered countermeasures to assess their potential eligibility for CICP 
benefits as injured countermeasure recipients. In the Secretary's view, 
activities authorized in accordance with the public health and medical 
response of the Authority Having Jurisdiction to prescribe, administer, 
deliver, distribute, or dispense the covered countermeasure will apply 
primarily in two contexts. Under the first scenario, authorized 
activities would include activities associated with the administration 
or use of covered countermeasures that were prescribed, administered, 
delivered, distributed, or dispensed by healthcare providers and others 
specifically authorized to do so under an agreement, memorandum of 
understanding, standard operating procedure, or other formal 
arrangement with an Authority Having Jurisdiction following the 
declaration of an emergency. In this way, the Authority Having 
Jurisdiction requirement would extend to individuals receiving medical 
care from private healthcare providers and institutions provided that 
the provider or institution is charged, through some sort of formal 
arrangement, by an Authority Having Jurisdiction with carrying out such 
activities as part of the public sector's response.
    Under the second scenario, activities authorized in accordance with 
the public health and medical response of the Authority Having 
Jurisdiction would include covered countermeasures administered or used 
in accordance with the written recommendations of an Authority Having 
Jurisdiction following the declaration of an emergency. For example, if 
a local public health agency recommends that all persons with a certain 
high-risk condition who contract the 2009 H1N1 virus receive a 
particular course of treatment with an influenza antiviral identified 
in a PREP Act declaration following the declaration of emergency for 
the associated disease, then individuals who use such medications based 
on their doctors' compliance with such recommendations would qualify as 
activities authorized by the Authority Having Jurisdiction. Likewise, 
the Centers for Disease Control and Prevention (CDC) issued interim 
recommendations for the use of influenza antivirals for pandemic 
purposes. See e.g., ``Updated Interim Recommendations for the Use of 
Antiviral Medications in the Treatment and Prevention of Influenza for 
the 2009-2010 Season'' (available at https://www.cdc.gov/H1N1flu/recommendations.htm). If an individual used an influenza antiviral for 
pandemic purposes covered by a PREP Act declaration because his or her 
physician prescribed the covered countermeasure in accordance with the 
CDC's recommendations, then such use would meet the Authority Having 
Jurisdiction requirement because the physician's actions would 
constitute activities authorized by the Authority Having Jurisdiction 
(in this case, the CDC). Given the complexity of the health care 
delivery system and the numerous and diverse products already 
identified as covered countermeasures in PREP Act declarations, an 
analysis of whether particular specifications included in declarations 
will necessarily be declaration-specific and fact-specific. The 
Secretary notes that in certain cases, a patient being administered or 
using a covered countermeasure as a result of a healthcare provider's 
independent medical judgment, and not because the patient necessarily 
falls within a targeted group identified in an Authority Having 
Jurisdiction's recommendations, may qualify as an activity authorized 
by an Authority Having Jurisdiction because recommendations issued by 
such authorities often take into account the need for healthcare 
providers to use independent clinical judgment with

[[Page 63660]]

respect to the use or administration of covered countermeasures with 
respect to each patient. The Secretary does not wish to interfere with 
such independent clinical judgments.
    Although this discussion of the Authority Having Jurisdiction 
requirement used in declarations to date is intended to assist 
potential requesters with the CICP, whether a particular recipient was 
administered or used a covered countermeasure in accordance with a 
particular PREP Act declaration will be dependent on the language 
included in the pertinent declaration, as well as the specific 
circumstances involved.
Administrations and Uses in Pregnant Women
    Section 110.3(n)(3) addresses certain circumstances in which a 
pregnant woman is administered or uses a covered countermeasure. This 
provision applies to women when their administration or use of a 
covered countermeasure satisfies all of the terms of a PREP Act 
declaration (or if there was good faith belief of such). Thus, it 
applies to women who meet the definition of an injured countermeasure 
recipient under Sec.  110.3(n) themselves, except that the pregnant 
women need not suffer a covered injury as required by Sec.  
110.3(n)(2). As provided for in Sec.  110.3(n)(3), a child can qualify 
as an injured countermeasure recipient if the child survives birth, and 
is born with, or later sustains, a covered injury as the direct result 
of the mother's administration or use of a covered countermeasure 
during pregnancy. Such a child's eligibility for compensation under the 
Program is dependent upon the mother being administered, or using, a 
covered countermeasure under the terms of a declaration (or based on a 
good faith belief of such) and upon the child sustaining a covered 
injury as a result (regardless of whether the mother sustained a 
covered injury). Absent such a clarification, and in light of the 
breadth of the PREP Act's liability protections (see e.g., section 
319F-3(a)(1)-(2)), such a child might be barred from pursuing 
litigation against a covered person (e.g., a vaccine manufacturer) for 
an allegedly related injury (absent willful misconduct) without being 
afforded compensation otherwise available under the CICP. This is not 
the Secretary's intention.
    Eligibility of children for compensation under this Program does 
not depend upon whether the covered person (e.g., doctor administering 
the vaccine) or the mother knew that she was pregnant at the time the 
covered countermeasure was administered or used.
Other Requesters
    The second category of requesters, survivors of a deceased injured 
countermeasure recipient, is defined in Sec.  110.3(bb) and described 
in Sec.  110.11. Categories of eligible survivors and the priority of 
such survivors to receive benefits from the Program are discussed below 
in relation to Sec.  110.33, which addresses death benefits (the only 
type of benefit survivors are eligible to receive).
    The third category of requesters encompasses the estates of 
deceased injured countermeasure recipients, through their executors or 
administrators. These are individuals who are authorized to act on 
behalf of the deceased injured countermeasure recipient's estate under 
applicable State law. Estates of deceased injured countermeasure 
recipients are not eligible for death benefits, but they may be able to 
receive the medical and/or lost employment income benefits which the 
injured countermeasure recipient would have been paid by the Program 
prior to death, but had not received in full during his or her 
lifetime.
Members of the Uniformed Services and Eligibility for Benefits Under 
the CICP
    Members of the Uniformed Services may be eligible for benefits 
under the CICP. The term Uniformed Services means the armed forces, the 
Commissioned Corps of the National Oceanic and Atmospheric 
Administration and the Commissioned Corps of the Public Health Service. 
Such individuals are subject to the same eligibility requirements as 
civilians. The fact that they are members of the military or a 
Uniformed Service does not preclude them from receiving benefits under 
the CICP if they are otherwise eligible. However, given that the CICP 
is the payer of last resort (including after any medical care, lost 
wages, or other benefits provided by the United States Government or 
other third-party payers), the amount of benefits available under the 
CICP may be minimal because of the benefits they are entitled to by 
virtue of their status as members of the Uniformed Services.
Territorial Limitations
    Section 319F-4(b)(1) of the PHS Act provides that CICP benefits are 
only available to eligible individuals if their covered injury is 
caused by a covered countermeasure administered or used pursuant to a 
declaration issued by the Secretary under 42 U.S.C. 247d-6d(b) (or in a 
good faith belief of such). One of the provisions that the PREP Act 
directs the Secretary to establish in each declaration is the 
``geographic area or areas'' in which liability immunity under the Act 
is in effect ``with respect to the administration or use of the 
[covered] countermeasure'' (section 319F-3(b)(2)(D) of the PHS Act (42 
U.S.C. 247d-6d(b)(2)(D)). The Secretary has the discretion to specify 
in a declaration that liability immunity applies ``without geographic 
limitation,'' and also to determine ``whether the declaration applies 
only to individuals physically present in such areas or also to 
individuals who have a connection to such areas, which connection is 
described in the declaration.'' Id. Although each declaration is unique 
and all are subject to amendment through publication in the Federal 
Register, the PREP Act declarations published to date provide no 
geographic limitation and generally apply to any populations that use 
or are administered the countermeasures in accordance with the terms of 
the declarations. As long as other eligibility requirements are 
satisfied, CICP benefits may be paid without regard to United States 
citizenship.
    The Secretary's intent is to provide clear guidance to potential 
requesters injured by the administration or use of a covered 
countermeasure. Therefore, she has determined that, solely for the 
purpose of administering the CICP, otherwise eligible individuals at 
American embassies, military installations abroad (such as military 
bases, ships, and camps) or at North Atlantic Treaty Organization 
(NATO) installations (subject to the NATO Status of Forces Agreement) 
where American servicemen and servicewomen are stationed, may be 
considered for CICP benefits. Individuals not in one of these 
categories may not be eligible for benefits under the Program.

Survivors (Sec.  110.11)

    Section 110.11 describes the categories of eligible survivors in 
the event that the injured countermeasure recipient dies. Survivors may 
be eligible to receive death benefits under the Program if the 
Secretary determines that the otherwise eligible injured countermeasure 
recipient sustained a covered injury and died as a direct result of the 
injury. Thus, if the Secretary determines that the injured 
countermeasure recipient died of a cause unrelated to the covered 
injury, survivors are not eligible to receive death benefits 
(regardless of the seriousness of the covered injury).

[[Page 63661]]

    With limited exceptions, the CICP follows the requirements of the 
PSOB Program with respect to the categories of eligible survivors 
(known in the PSOB Program as beneficiaries) and the order of priority 
for payments of death benefits. The order of priority for survivors to 
receive death benefits under the Program is subject to future changes 
made to the PSOB Program concerning eligible survivors and their 
priority to receive death benefits.
    Currently, the categories of eligible survivors under the PSOB 
Program are as follows:
    (1) Surviving spouses;
    (2) Surviving eligible children (as defined in Sec.  110.3(e)). 
This definition is based on the definition of ``child'' within the 
PSOB. Currently, a surviving child is considered eligible under the 
PSOB Program if he or she is an individual who is a natural, 
illegitimate, adopted, or posthumous child, or stepchild, of the 
deceased person and, at the time of that individual's death, is 18 
years of age or younger (i.e., has not reached 19th birthday), or 
between 19 and 22 years of age and a full-time student, or is older 
than 18 years of age and incapable of self-support because of physical 
or mental disability. For clarity, Sec.  110.3(e) defines a stepchild, 
based on the PSOB's definition of a stepchild, and a posthumous child 
(a child born after the death of a parent).
    (3) Individuals designated by the deceased person as the 
beneficiaries under the deceased person's most recently executed life 
insurance policy; or
    (4) Surviving parents (of deceased children or adults).
    Such survivors, as defined under the PSOB Program, are also 
eligible survivors under this Program.
    The PREP Act, following the SEPPA, included two additional 
categories of survivors under this Program who are not eligible 
survivors under the PSOB Program:
    (5) Legal guardians of deceased minors without surviving parents; 
and
    (6) Surviving dependents who are younger than the age of 18 (have 
not reached their 18th birthday). This category could include children 
who also meet the requirements of category 2 above (surviving eligible 
children). However, it also includes persons who would not qualify as 
surviving eligible children (for example, a nephew who was supported by 
the deceased injured countermeasure recipient, but who was not 
adopted). Persons who satisfy both category 6 and category 2 (surviving 
eligible children) may be able to choose between death benefits under 
the standard calculation and death benefits under the alternative 
calculation.
    As discussed below, special criteria apply to the final category of 
eligible survivors. Under current practices, in the event that a 
deceased injured countermeasure recipient is survived by a spouse and 
eligible children, the spouse will receive 50 percent of the death 
benefit and the children will divide the remaining 50 percent equally. 
If there are no surviving eligible children, then the spouse receives 
the entire benefit; if there is no surviving spouse, then the children 
divide the benefit in equal shares. In the event that the deceased 
injured countermeasure recipient is not survived by a spouse or 
children, the individual designated by the deceased injured 
countermeasure recipient as the beneficiary under his or her most 
recently executed life insurance policy receives the death benefit. If 
there is no life insurance policy or no surviving designated 
beneficiary under such a policy, the parents, if living, divide the 
death benefit in equal shares. If none of these categories of survivors 
exists, the legal guardian of a deceased minor (who was an injured 
countermeasure recipient) with no living parent will receive the death 
benefit, if applicable. As explained in Sec.  110.11(b)(5), surviving 
dependents younger than the age of 18 (category 6 above) have the same 
priority as surviving eligible children (category 2 above).
    Only the legal guardians of persons qualifying both as surviving 
eligible children (category 2 above) and as dependents younger than the 
age of 18 (category 6 above) can choose between a proportional death 
benefit under the standard and the alternative methods of payment for 
death benefits, described in detail in Sec.  110.82. Survivors eligible 
under the PSOB Program's categories of survivors (e.g., spouses, 
parents, certain insurance designees, and surviving eligible children) 
who do not qualify as dependent minors are only covered under the 
standard death benefit calculation. Dependents who are minors and who 
do not qualify under another category of eligible survivors (under the 
example given above, a nephew who was supported by the deceased injured 
countermeasure recipient, but never adopted) are only covered by the 
alternative method of payment. In the event that survivors are eligible 
for death benefits under the Program, Program staff will be able to 
assist families concerning the standard and alternative calculation of 
death benefits once a determination is made concerning eligibility.
Serious Physical Injuries
    As set forth in Sec.  110.20(b), and pursuant to section 319F-
4(e)(3) of the PHS Act, only serious physical injuries or deaths are 
covered by the Program (42 U.S.C. 247d-6e(e)(3)). The definition of a 
serious physical injury included in the liability provisions of the 
PREP Act apply only to those provisions and to lawsuits pursuing claims 
of willful misconduct. Congress did not mandate that the same 
definition apply within the CICP. Under the definition pertaining to 
the liability provisions of the PREP Act, a serious physical injury is 
defined as an injury that (a) is life threatening; (b) results in 
permanent impairment of a body function or permanent damage to a body 
structure; or (c) necessitates medical or surgical intervention to 
preclude permanent impairment of a body function or permanent damage to 
a body structure (section 319F-3(i)(10) of the PHS Act (42 U.S.C. 247d-
6d(i)(10)). Under the CICP, Sec.  110.20 clarifies that physical 
biochemical alterations leading to physical changes and serious 
functional abnormalities at the cellular or tissue level in any bodily 
function may, in certain circumstances, be considered serious physical 
injuries. As a general matter, only injuries that warranted 
hospitalization (whether or not the person was actually hospitalized) 
or injuries that led to a significant loss of function or disability 
(whether or not hospitalization was warranted) will be considered 
serious physical injuries. Hereafter serious physical injuries will be 
referred to as serious injuries. This includes instances in which there 
may be no measurable anatomic or structural change in the affected 
tissue or organ, but there is an abnormal functional change. For 
example, many psychiatric conditions are caused by abnormal 
neurotransmitter levels in key portions of the central nervous system. 
Thus, it is possible that certain serious psychiatric conditions may 
qualify as serious physical injuries if the psychiatric conditions are 
a manifestation of a physical biochemical abnormality in 
neurotransmitter level or type caused by a covered countermeasure. One 
way of determining that an abnormal physical change in neurotransmitter 
level is causing the injury would be a clinical challenge that 
demonstrates a positive clinical response to a medication that is 
designed to restore the balance of appropriate neurotransmitters 
necessary for normal function in an injured countermeasure recipient. 
However, minor injuries do not meet this definition. For example, 
covered

[[Page 63662]]

injuries do not include common and expected skin reactions (such as 
localized swelling or warmth that is not of sufficient severity to 
warrant hospitalization and that does not lead to a significant loss of 
function or disability) or expected minor scarring at the vaccination 
site (as occurs commonly with smallpox vaccinations).
    Unlike under the VICP, the effects of an injury need not last for a 
certain period of time (or result in inpatient hospitalization or 
surgical intervention) for it to be considered a serious injury under 
the CICP. Therefore, some injured countermeasure recipients may be able 
to show that they sustained a serious injury which resolved within a 
relatively short time-frame (for example, a person who sustains a 
serious injury as the direct result of a covered countermeasure which 
is successfully treated after two weeks of hospitalization).
    The Secretary will consider the unique circumstances of each injury 
claimed and will make determinations on a case-by-case basis as to 
whether particular injuries can be considered serious injuries.

Injuries Sustained as a Direct Result of a Disease, and Not of a 
Covered Countermeasure

    Section 110.20(e) makes clear that an injury sustained as the 
direct result of a disease (or health condition or threat to health) 
for which the Secretary recommended the administration or use of a 
covered countermeasure in a PREP Act declaration is not a covered 
injury. Thus, if an injury was caused by a disease, and not as a direct 
result of the administration or use of a covered countermeasure, it 
cannot qualify as a covered injury. If a covered countermeasure is 
ineffective in preventing or treating a disease and an individual 
suffers the disease, an injury resulting from the disease would not be 
a covered injury because the injury results from the disease and not 
from the administration or use of the covered countermeasure. Two 
examples may be illustrative. Under the first example, an individual 
receives the 2009 H1N1 vaccine and then goes on to develop 2009 H1N1 
influenza because the person failed to develop an immune response to 
the vaccine. Currently, no vaccine achieves 100% efficacy in 
stimulating a protective immune response in the population. This is 
sometimes referred to as failure of vaccine efficacy. If a vaccine 
recipient suffers a serious complication as the result of contracting 
the circulating 2009 H1N1 virus, and not as the result of the 2009 H1N1 
vaccine or another covered countermeasure, such injury will not qualify 
as a covered injury because it results from the disease itself and 
would have occurred even if the vaccine had not been administered. 
Under a second example, a person suffering from serious complications 
as a result of contracting the 2009 H1N1 virus is put on a ventilator 
that qualifies as a covered countermeasure under a PREP Act 
declaration. The ventilator malfunctions and the individual suffers a 
serious health injury as a result of the ventilator malfunction. Such 
an injury may qualify as a covered injury because it would result from 
the use of a covered countermeasure (a ventilator) and not directly 
from the underlying 2009 H1N1 disease. In considering whether an injury 
results from the administration or use of a covered countermeasure, as 
opposed to the disease itself, the Secretary will evaluate whether the 
injury directly resulted from a component or a function of the covered 
countermeasure (in which case, the injury may qualify as a covered 
injury) as opposed to the disease itself (in which case, the injury 
cannot qualify as a covered injury even if a covered countermeasure was 
administered or used, but was ineffective). Some covered 
countermeasures may contain attenuated live organisms, such as 
intranasal 2009 H1N1 vaccine or smallpox vaccine. Despite attenuation, 
serious infections can rarely be caused by these types of 
countermeasures. A serious injury resulting from this type of infection 
(as a result of vaccination) in an injured countermeasure recipient 
could qualify as a covered injury because it would directly result from 
the administration or use of a covered countermeasure.
    With limited exceptions, the PREP Act provides that the CICP's 
procedures for determining eligibility, whether eligible persons have 
sustained covered injuries, whether compensation may be available, and 
the amount of such compensation shall be the same as those authorized 
by the SEPPA and implemented in the SVICP. One of these exceptions 
pertains to individuals who were eligible to apply under the SVICP as a 
``contact case'' based on accidental vaccinia inoculation. The PREP Act 
makes clear that individuals who contract a disease as a result of 
contact with a person who used or was administered a covered 
countermeasure (or other close contacts) may not pursue claims under 
the CICP for any resulting injuries (sections 319F-4(b)(4), (e)(2), and 
(e)(5) of the PHS Act (42 U.S.C. 247d-6e(b)(4), (e)(2), and (e)(5)). 
Thus, although it is possible that in some circumstances, individuals 
may suffer injuries as a result of diseases contracted after exposure 
to individuals because of their use or administration of covered 
countermeasures (for example, a person who contracts vaccinia after 
close contact with another person who was administered a smallpox 
vaccine that qualifies as a covered countermeasure), such contacts 
cannot pursue benefits under the CICP for such injuries. Contracting a 
disease in such a manner is extremely rare and will generally only be 
possible with vaccines containing live viruses.

How To Establish a Covered Injury (Sec.  110.20)

    Covered injuries are defined in Sec.  110.3(g) and are set out in 
Subpart C of this rule. Covered injuries are defined as serious 
injuries (or deaths) sustained by injured countermeasure recipients 
that the Secretary determines are either: (1) An injury meeting the 
requirements of a Countermeasure Injury Table (Table), discussed below; 
or (2) an injury that is, in fact, the direct result of the 
administration or use of a covered countermeasure. The latter 
requirement includes serious aggravations of pre-existing conditions if 
such aggravations were caused by a covered countermeasure (e.g., a 
seizure disorder that is proven, to the satisfaction of the Secretary, 
to have been made significantly more serious as the direct result of 
the administration or use of the countermeasure). All requesters 
(including survivors and executors or administrators of the estate of a 
deceased countermeasure recipient) must demonstrate that an injured 
countermeasure recipient sustained a covered injury in order to be 
eligible for any benefits under the CICP.
Table Injuries
    Section 110.20(c) discusses Table injuries. As noted above, one way 
that requesters can demonstrate that they sustained a covered injury is 
by demonstrating that they sustained an injury listed on a 
Countermeasure Injury Table (Table) within the time interval set forth 
on the Table, as set out in Subpart K (Sec.  110.100 et seq.) of this 
rule. In accordance with the PREP Act (following the SEPPA), an injured 
countermeasure recipient shall be presumed to have sustained a covered 
injury as the direct result of the administration of a covered 
countermeasure if the requester submits sufficient documentation 
demonstrating that the injured countermeasure recipient sustained an 
injury included on a Table, with the onset of the first sign or symptom 
within the time

[[Page 63663]]

interval specified on the Table. The injury must also meet the Table's 
definitions and requirements, which will be described under Subpart K. 
In such circumstances, the Secretary will presume, solely for purposes 
of the Program, that the injured countermeasure recipient's injury was 
caused by the covered countermeasure (absent another cause, as 
described below). Such a requester need not actually demonstrate that 
the covered countermeasure caused the underlying injury, only that an 
injury listed on the Table (and meeting the Table's definition) was 
sustained and that it first manifested itself within the time interval 
listed.
    In directing the Secretary to establish a Table with such a 
presumption, Congress did not direct the Secretary to make this 
presumption conclusive. In the Secretary's view, it would be 
inconsistent with the purposes of the PREP Act to do so. For this 
reason, based on her review of the submitted documentation and other 
relevant evidence, and consistent with the regulations implementing the 
SVICP, the Secretary may determine that an injury meeting the Table 
requirements was actually caused by other factors and was not caused by 
the covered countermeasure (e.g., if the Secretary determined that the 
medical records demonstrated that an individual's injury of 
encephalopathy, a type of brain injury, was caused by a car accident 
that occurred after a covered countermeasure was used, and neither the 
encephalopathy nor the car accident was caused by the covered 
countermeasure itself). In these circumstances, which we expect to 
occur rarely, the Secretary could rebut a Table presumption of 
causation and decide that the requester not be afforded the presumption 
of a Table injury.
    The Secretary is authorized under the PREP Act to issue Table(s) 
for each covered countermeasure identified in a PREP Act declaration. 
According to the PREP Act, the Secretary may only identify such covered 
injuries, for purposes of inclusion on a Table, in circumstances where 
the Secretary determines, based on ``compelling, reliable, valid, 
medical and scientific evidence that administration or use of the 
covered countermeasure directly caused such covered injury'' (section 
319F-4(b)(5)(A) of the PHS Act (42 U.S.C. 247d-6e(b)(5)(A)). The 
Secretary plans on reviewing the available scientific evidence 
concerning covered countermeasures identified in PREP Act declarations 
and to issue such Tables, when appropriate, through rulemaking. In an 
effort to administratively implement the Program as soon as possible, 
the Secretary is not including such Tables within this rulemaking, but 
should such Tables be issued in the future, she will do so as 
amendments to this rule.
Non-Table Injuries
    Section 110.20(c) discusses non-Table injuries. Certain requesters 
who are unable to demonstrate a Table injury may still be able to show 
that they sustained a covered injury. Such requesters may include those 
who believe that an injury included on a Table was sustained, but who 
did not meet all the Table requirements (e.g., the onset of the injury 
did not occur within the required time interval included on the Table) 
or those whose injuries are not included on a Table. To establish a 
covered injury in such circumstances, the Secretary must determine that 
the injury sustained was the direct result of the administration or use 
of a covered countermeasure. Under the PREP Act, the Secretary may only 
make such determinations based on compelling, reliable, valid, medical 
and scientific evidence (section 319F-4(b)(4) of the PHS Act (42 U.S.C. 
247d-6e(b)(4)). As described in Sec.  110.20(d), requesters with such 
claims may need to submit sufficient relevant medical documentation or 
scientific evidence (such as studies published in peer-reviewed medical 
literature). In evaluating such claims, the Secretary will take into 
consideration relevant medical and scientific evidence, including 
relevant medical records. As provided under the PREP Act, this 
determination is not reviewable by any court (section 319F-4(b)(5)(C) 
of the PHS Act (42 U.S.C. 247d-6e(b)(5)(C)). Temporal association 
between administration or use of the covered countermeasure and onset 
of the injury (i.e., the injury occurs a certain time after the 
administration or use) is not sufficient, by itself, to prove that an 
injury is the direct result of a covered countermeasure.

Benefits Available to Different Categories of Requesters (Sec.  110.30)

    An eligible requester who is an injured countermeasure recipient 
may be eligible to receive medical benefits, benefits for lost 
employment income, or both, as long as he or she provides the 
appropriate documentation. For example, such requesters must submit 
documentation showing that they have incurred unreimbursable, 
reasonable, and necessary medical expenses as a result of a covered 
injury or its health complications to receive medical benefits, and 
documentation showing that they lost employment income as a result of a 
covered injury or its health complications for a specified period in 
order to receive benefits for lost employment income. Such 
documentation requirements are discussed later in this rule.
    An eligible requester who is a survivor of an otherwise eligible 
deceased injured countermeasure recipient can only receive a death 
benefit as a survivor, and no other benefits. Such death benefits are 
only available if the survivors demonstrate to the satisfaction of the 
Secretary that the death was caused by the covered injury or its health 
complications.
    The estate of an otherwise eligible deceased injured countermeasure 
recipient may be eligible to receive medical benefits, benefits for 
lost employment income, or both if such benefits were accrued, but were 
not paid in full, during the deceased person's lifetime. Such benefits 
may be available regardless of the cause of death. However, the estate 
would not be eligible to receive payments for benefits that were not 
accrued during the deceased person's lifetime. For example, the estate 
would not be entitled to benefits for projected lost employment income 
that the injured countermeasure recipient might have earned if he or 
she had not died. In addition, the estate would not be eligible for 
death benefits, as those benefits are only available to survivors.

Medical Benefits--Summary and Calculation (Sec.  110.31 and Sec.  
110.80)

    Medical benefits that may be available under the Program are 
described in Sec.  110.31. Under the PREP Act, the medical benefits 
that shall be provided have the same elements and shall be in the same 
amount as those prescribed by section 264 of the PHS Act (the relevant 
provision of the SEPPA) (42 U.S.C. 239c). They include payment(s) or 
reimbursement for medical services and medical items that the Secretary 
determines are reasonable and necessary for the diagnosis or treatment 
of a covered injury, or for the diagnosis, treatment, or prevention of 
the injury's direct health complications. Past, current, and expected 
future medical services and items may be included in medical benefits. 
The Secretary is authorized to pay for medical services or items in an 
effort to cure, counteract, or minimize the effects of any covered 
injury (or its health complications), or to give relief, reduce the 
degree or the period of disability, or aid in lessening the amount of 
benefits to an injured countermeasure recipient. As an example, the 
CICP may purchase a

[[Page 63664]]

health insurance policy for an injured countermeasure recipient, which 
would have the benefit of providing care to the injured countermeasure 
recipient over the course of years or a lifetime and the attendant 
benefit of being an efficient use of Federally-appropriated funds (as 
compared with direct payments for the services and items covered by the 
purchased health insurance policy).
    In making determinations about which medical services and items 
provided in the past were reasonable and necessary, the Secretary may 
consider whether those medical services and items were prescribed or 
recommended by a healthcare provider. In considering benefits for 
future medical services and items, the Secretary may consider 
statements by healthcare providers with expertise in the medical issues 
involved (for example, a statement by a treating neurologist concerning 
services and items likely to be needed to address neurological issues) 
concerning those services and items that appear likely to be needed in 
the future to diagnose or treat the covered injury or its health 
complications. However, the Secretary is not bound by such statements. 
In addition, the Secretary may consider whether the services and items 
are within the standard of care for the injured countermeasure 
recipient's medical condition.
    As set forth in Sec.  110.31(b), for a requester to receive medical 
benefits for a health complication of a covered injury, the health 
complication must have resulted from the covered injury or its 
treatment and must not be more likely due to other factors or 
conditions. Examples of health complications include ill effects that 
stem from the covered injury, an adverse reaction to a prescribed 
medication or as a result of a diagnostic test used in connection with 
a covered injury, or a complication of a surgical procedure used to 
treat the covered injury.
    As explained in Sec.  110.31(d), if an injured countermeasure 
recipient dies before filing with, or being fully paid by, the Program, 
the deceased person's estate may be eligible for benefits for the cost 
of medical services and/or items accrued during his or her lifetime as 
a result of the covered injury or its health complications provided 
such payments and expenses were not paid in full by a third party 
during the deceased injured countermeasure recipient's lifetime. 
Because such payments are for medical expenses accrued as a result of a 
covered injury while the injured countermeasure recipient was alive, 
the cause of death does not have to be related to the covered injury 
for these medical benefits to be paid to the estate.
    The calculation of medical benefits is described in Sec.  110.80. 
There are no caps on medical benefits. However, the Secretary may limit 
the payment of such benefits to the amounts (costs) she considers 
reasonable for those services and items that she considers reasonable 
and necessary. In addition, payment of medical benefits or 
reimbursement of costs for medical services and items by the Program is 
secondary to the obligations of any third-party payer, such as the 
United States (except for payment of benefits under this Program), 
State or local government entities, private insurance carriers, 
employers, or any other third-party payers that may have an obligation 
to pay for or provide medical benefits. Because the Program is a 
secondary payer, requesters are required to make good faith efforts to 
pursue medical benefits from their primary payers. For example, the 
Program will generally not pay for medical benefits that are paid or 
payable by the injured countermeasure recipient's medical insurance. As 
explained in Sec.  110.31(c), requesters are expected to make good 
faith efforts to pursue medical benefits and services from their 
primary payers. Further, Sec.  110.2(b) explains that the benefits 
available under the CICP usually will only be paid after the requester 
has in good faith attempted to obtain all other available coverage from 
third-party payers with an obligation to pay for or provide such 
benefits. Thus, the Se