Federal Register, Volume 75 Issue 199 (Friday, October 15, 2010)

[Federal Register Volume 75, Number 199 (Friday, October 15, 2010)]
[Rules and Regulations]
[Pages 63655-63688]
From the Federal Register Online via the Government Publishing 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 http://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

[[Page 63657]]

the Department's Web site at http://www.hhs.gov/disasters/discussion/planners/prepact/ and on the Program's Web site at http://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
http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html and http://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 http://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 Secretary has the discretion not to pay medical
benefits if a requester has not made such good faith attempts.
When the Secretary has determined that the requester is eligible
for medical benefits and the documentation needed to compute the amount
is available, she will do the following, consistent with the
calculations described in Sec. 110.80:
(1) Determine which medical expenses that have been submitted are
reasonable and necessary to diagnose or treat a covered injury or to
diagnose, treat, or prevent its health complications.
(2) Compute all those reasonable medical expenses, including
medical services and items provided in the past, and anticipated future
medical expenses.
(3) Deduct from the computation the total amount paid, or payable,
by all other third-party payers.
This will be the basis for the Program's payment. For example: an
eligible injured countermeasure recipient incurred $5,000 in reasonable
and necessary medical expenses. If the individual's insurance company
paid $3,000, and the individual is responsible for the $2,000 balance
(due to deductibles and co-payments), then the Secretary will pay a
medical benefit of $2,000.
As explained elsewhere in this preamble, the Secretary may make a
payment of medical benefits and later pursue such a payment from a
third-party payer with an obligation to pay for or provide the medical
services or items.

Lost Employment Income--Summary and Calculation (Sec. 110.32 and Sec.
110.81)

Lost employment income benefits that may be available under the
Program appear in Sec. 110.32. Under the PREP Act, compensation for
lost employment income under this Program shall have the same elements
and shall be in the same amount as prescribed by section 265 of the PHS
Act (the relevant provision of the SEPPA) (42 U.S.C. 239d). The CICP
will provide benefits for lost employment income (secondary to other
benefits that may be available to the requester), subject to
limitations described in Sec. 110.81(c), based on the number of days
of work that the injured person lost as a result of the covered injury
or its health complications (including diagnosis and treatment), and
supported by the degree of disability or injury, medical and employment
records.
These benefits are a percentage of the employment income lost at
the time of injury, due to the covered injury or its health
complications, and are based on the number of eligible work days for
which such income was lost. Employment income means the injured
person's gross employment income at the time of injury. Lost work days
do not have to be consecutive, and partial days of lost work are
included in the calculation. For example, if an individual's work day
is eight hours and he or she missed four hours a day for doctors'
appointments on two different days, the eight hours of work missed may
be considered one total day of lost wages. As described in Sec.
110.32(c), a day in which an individual used paid leave (e.g., sick
leave or vacation leave) in order to be paid for lost work will not be
considered a day for which employment income was lost and will not be
used in calculating benefits for lost employment income. The only
exception to this rule is in a case where the injured person reimburses
the employer for the wages paid and the employer restores the paid
leave taken so it is available for future use, thus putting the injured
countermeasure recipient back in the same position as if he or she had
not used paid leave on the lost work day. The Secretary has the

[[Page 63665]]

discretion to consider the reasonableness of the number of work days
(or partial work days) lost as a result of a covered injury or its
health complications in this calculation, as well as the severity of
the covered injury as demonstrated by the medical records, and to
consider alternative work schedules in determining the number of work
days lost.
Under the PREP Act, following the SEPPA, the Program cannot pay for
the first five days of lost employment income resulting from a covered
injury or its health complications, unless the injured countermeasure
recipient lost employment income for ten or more work days (in which
case, all of the lost work days will be included in the calculation).
For this reason, if an individual lost a total of four days (or fewer)
of employment income as a result of a covered injury, he or she will
not be eligible for any benefits for lost employment income. An injured
countermeasure recipient will be compensated for ten or more days of
work lost if he or she lost employment income for those days as a
result of the covered injury (or its health complications). If the
number of days of lost employment income due to the covered injury (or
its health complications) is fewer than ten, the Secretary will reduce
the number of lost work days by five days.
The calculation of benefits for lost employment income is described
in Sec. 110.81. The annual cap on benefits for lost employment income
is $50,000. A requester may use documents such as pay slips, earning
and leave statements, and other documents concerning the injured
individual's salary, to document his or her employment income. Pursuant
to the PREP Act (incorporating the SEPPA), the lost employment income
benefit terminates once the injured countermeasure recipient reaches
the age of 65. Benefits that represent future lost employment income
will be adjusted to account for inflation. It is important to note that
future lost employment income will be calculated based on an
individual's gross employment income at the time the covered injury was
sustained (except for the inflation adjustment provided for in this
regulation) and will not be based on an individual's anticipated future
employment income. The lifetime cap for the lost employment income
benefit is equal to the amount of the death benefit available under the
PSOB Program in the same fiscal year in which the lifetime cap is
reached (currently $311,810, but subject to change each fiscal year).
However, this lifetime limitation does not apply if the Secretary
determines that an individual has a covered injury considered to be a
total and permanent disability under section 216(i) of the Social
Security Act. For this reason, an injured countermeasure recipient
determined by the Secretary to have a permanent and total disability
may be eligible to receive up to $50,000 a year until he or she reaches
the age of 65, without regard to the lifetime cap.
As is the case for medical benefits, if an injured countermeasure
recipient dies before filing for, or being fully paid, benefits for
lost employment income incurred during his or her lifetime as a result
of a covered injury or its health complications, the executor or
administrator of that person's estate may file for such benefits on
behalf of the estate. Because this payment is made for loss of
employment income that accrued while the injured person was alive, the
death does not have to be related to the covered injury for these
benefits to be paid. However, no such lost employment income may be
paid after the receipt, by the survivor or survivors of a deceased
injured countermeasure recipient, of death benefits under Sec. 110.82.
Once the Secretary has determined that she has all the information
necessary to compute lost employment income, the calculation will be
made as follows, as set out in Sec. 110.81:
(1) The Secretary will make a calculation concerning the number of
lost work days that are reasonable based on the degree of injury or
disability.
(A) If the injured countermeasure recipient lost five days or fewer
of employment income, then no benefits for lost employment income will
be paid.
(B) If the injured countermeasure recipient lost six to nine days
of employment income, then the Secretary will subtract five days from
the number of lost work days for which lost employment income can be
paid.
(C) If the injured countermeasure recipient lost ten or more days
of employment income, then every lost work day will be counted in
calculating the lost employment income benefit.
(2) The Secretary will multiply the injured countermeasure
recipient's daily gross employment income (including income from self-
employment) at the time of the covered injury by the number of lost
work days (as computed above). This figure will be adjusted to account
for inflation, as appropriate.
(3) The Secretary will compute 75 percent of the lost employment
income if the injured countermeasure recipient had one or more
dependents (at the time of the covered injury) or 66\2/3\ percent of
the lost employment income if there were no dependents (at the time of
the covered injury). This calculation will serve as the basis for the
lost employment income benefit.
(4) The amount of payment will be reduced by any benefit that the
requester is entitled to receive from a third-party payer (e.g., a
workers' compensation program). However, the Secretary may make a
payment of lost employment income and later pursue such a payment from
a third-party payer with an obligation to pay for or provide the
benefit (e.g., the Secretary can pay a benefit for lost employment
income to a requester with a claim pending in a State workers'
compensation program, and then has a right to recover such a payment
from the employee or the State if its program determines that such a
benefit is due the requester).
(5) The payments made will be subject to an annual cap of $50,000.
(6) The benefits paid in lost employment income will be subject to
a lifetime cap, as discussed above, unless the Secretary determines
that a requester has a covered injury considered to be a total and
permanent disability under section 216(i) of the Social Security Act.

Death Benefits--Summary and Calculation (Sec. 110.11, Sec. 110.33,
and Sec. 110.82)

Certain survivors of injured countermeasure recipients who died as
a direct result of a covered injury or its health complications may be
eligible for death benefits, as set out in Sec. 110.11 (eligible
survivors and their priority to receive death benefits), Sec. 110.33
(general description of death benefits) and Sec. 110.82 (calculation
of death benefits).
Under the PREP Act, compensation for death benefits has the same
elements and shall be in the same amount as prescribed by section 266
of the PHS Act (the relevant section of the SEPPA) (42 U.S.C. 239e).
Thus, in accordance with the PREP Act (incorporating SEPPA), death
benefits under the CICP may be available under one of two different
calculations: the ``standard calculation'' or the ``alternative
calculation.'' The ``standard calculation'' is a lump-sum payment to
eligible survivors and is described in Sec. 110.82(b). In general,
this method is based on the death benefit available under the PSOB
Program. The ``alternative calculation'' is only available to surviving
dependents who are younger than the age of 18, as described in Sec.
110.82(c). This method is based upon the deceased person's

[[Page 63666]]

employment income at the time of the covered injury.

Filing a Request Package (Sec. 110.40-Sec. 102.41)

A Countermeasures Injury Compensation Program Request for Benefits
Form (hereinafter ``Request Form'') will be available from the Program.
In order for a requester to have his or her Request for Benefits
reviewed by the Program, the requester must submit, at a minimum, a
completed Request Form (or a Letter of Intent to file a Request Form,
described below) postmarked within the filing deadlines established by
this regulation. If requesters choose to use a commercial carrier such
as Federal Express, United Parcel Service, Emery, etc., or a private
delivery service, in the absence of a postmark, the date that the
Request Form or Request Package is marked as received by the delivery
service will be considered the equivalent of a postmark. Requesters
must send their Request Forms and all supporting documentation (the
Request Package) to the address listed in Sec. 110.41. To avoid any
delays in implementing the Program, the Program will not accept Request
Forms or Request Packages electronically at this time. However, the
Program will publish a notice in the future if electronic filing
becomes available. Once the Program assigns a case number to a
requester, all related correspondence should reference the assigned
case number.

Filing Deadlines (Sec. 110.42)

Under the PREP Act, the filing deadlines that applied under SEPPA
are mandatory with respect to Request Forms filed with this Program.
For that reason, injured countermeasure recipients have one year from
the date of the administration or use of a covered countermeasure to
submit a Request Form (or Letter of Intent to file a Request Form, as
described in Sec. 110.42(b)). For covered countermeasures used or
administered over a period of time (for example, antibiotics taken
daily for seven days), the filing deadline is one year from the latest
administration or use associated with the covered injury. For vaccines
administered in more than one dose on different dates (for example,
2009 H1N1 vaccines given in two doses one month apart), the filing
deadline is one year from the date of the vaccine administration
associated with the injury. Because the PREP Act, incorporating SEPPA,
refers to requests based on the administration or use of the
countermeasure, the filing deadline that applies to Request Forms filed
by injured countermeasure recipients is the same filing deadline that
applies to Request Forms filed by the survivors or the representatives
of the estates of deceased injured countermeasure recipients. This one-
year filing deadline is absolute, regardless of when the first symptoms
of the injury occur or when individuals suspect that the injury may
have been caused by a covered countermeasure. Likewise, the one-year
filing deadline applies to injuries sustained by a child described in
section 110.3(n)(3) (a child under certain circumstances whose covered
injuries were the direct result of a covered countermeasure's
administration to, or use by, the mother of the child when she was
pregnant with that child). The filing deadline for a Request for
Benefits to compensate a child qualifying as an injured countermeasure
recipient under section 110.3(n)(3) is one year from the date of
administration or use of the covered countermeasure during the mother's
pregnancy. Pursuant to statute, the date of the child's birth, the date
the injury is discovered, or the date the injury is diagnosed is not
the basis of determining the filing deadline.
This one-year filing deadline does not apply to amendments to
previously filed Request Forms. As explained later in the discussion of
Sec. 110.46, if an injured countermeasure recipient filed a Request
Form within the filing deadline and later dies, his or her survivor(s)
(or the representative of his or her estate) may later amend the
original Request Package outside of the filing deadline (because the
original Request Form was timely filed).
As described in Sec. 110.42(b), requesters may meet the Program's
filing deadline by filing a Letter of Intent to file a Request Form
within the governing filing deadline. This mechanism is available to
ensure that persons with potential claims will have a means of meeting
the Program's filing deadline even if all of the pertinent documents
(e.g., administrative regulation, Request Forms and Instructions) are
not yet available. The Program previously notified the public of the
ability to file Letters of Intent even before the Program's regulations
are published and the Program's forms and instructions are available.
The Program has made this information available on HRSA's Web site.
Thus, if a requester files a Letter of Intent to file within one year
of administration or use of the covered countermeasure that is thought
to have caused the injury, then the requester has met the filing
deadline. The Program has already received several such letters. All
requesters who file a Letter of Intent should file a Request Form as
soon as possible after the Request Form becomes available.
As set forth in Sec. 110.42(d), Request Forms (or Letters of
Intent) not filed within the governing filing deadline will not be
processed, and the requester will not be eligible for any Program
benefits.
Section 110.42(e) also provides for ``constructive receipt'' of
Request Forms, at the Secretary's discretion. When a requester files a
legal action with the Federal Government (e.g., a claim filed pursuant
to the Federal Tort Claims Act (FTCA) or a petition for compensation
with the VICP) that concerns an alleged injury resulting from the
administration or use of a covered countermeasure, then the Secretary
may consider the filing of such a legal action (whether an
administrative action or a lawsuit) to be ``constructive receipt'' of a
Request Form or Letter of Intent filed under the CICP, for the purposes
of determining the filing date. Given the one-year statute of
limitations for this Program and the fact that not all potentially
eligible persons may be aware of the Program, the Department may offer
such constructive receipt in appropriate circumstances to ensure that
claims or lawsuits filed concerning injuries or deaths allegedly
resulting from CICP covered countermeasures will be considered by the
CICP. Thus, if an individual files a VICP claim concerning an injury
allegedly sustained as the result of a covered countermeasure and such
legal action is filed in the United States Court of Federal Claims
within one year of its administration or use, the Secretary has the
discretion to decide that the claim was ``constructively received'' by
the Government on the date that such action is filed in court. Despite
the Secretary's ability to consider certain submissions as timely
filings for the Program relying on such ``constructive receipt,'' there
is no guarantee that the Secretary will follow this approach in
particular cases, and potential requesters must file Request Forms (or
Letters of Intent) within the appropriate Program filing deadline in
order to be assured of timely filing with the Program.
Section 110.42(f) describes an additional filing deadline available
to certain requesters with respect to injuries added to Covered
Countermeasures Injury Tables. Through this regulation, the Secretary
is reserving Subpart K of this part for Covered Countermeasures Injury
Tables, described above. In order to publish this regulation as soon as
possible, the Secretary will publish such Tables separately. However,
because those Tables will later be included in this

[[Page 63667]]

regulation and this part, any initial publications of such Tables or
subsequent modifications to such Tables will be considered amendments
to this regulation. As described in Sec. 110.42(e), in the event that
the Secretary issues a new Covered Countermeasure Injury Table, or
amends a previously published Table, requesters will have an extended
filing deadline based on the effective date of the Table amendment.
However, this extended filing deadline will only apply to requesters if
the Table amendment enables a person who could not establish a Table
injury before the amendment to establish such an injury. As a
hypothetical example, if the Secretary amends this regulation in the
future by adding a Table for the 2009 H1N1 vaccine and the Secretary
includes an associated injury of anaphylaxis, any person who meets the
Table requirements for an injury of anaphylaxis after receiving the
2009 H1N1 vaccine (i.e., suffered the injury of anaphylaxis according
to any definitions included on the Table, and suffered the onset of the
injury within the time frame listed on the Table after the vaccine
administration) would have one year from the effective date of the
Table change adding the injury of anaphylaxis to file a Request Form.
Such an individual will be afforded this alternative filing deadline
because this Table change would enable this potential requester to
establish a Table injury. For such persons, this alternative filing
deadline applies regardless of whether the requesters previously filed
a Request Form with the Program. The filing deadline provided under
Sec. 110.42(f) is an additional and alternative filing period to the
one afforded to all potential requesters under Sec. 110.42(a).
Therefore, persons who would be eligible to use the filing deadline
described in Sec. 110.42(f) could rely on the deadline provided under
Sec. 110.42(a) or Sec. 110.42(f). Depending on the factual
circumstances, it is possible that one or the other deadline could
provide a potential requester with a longer period in which to file a
Request Form. This additional filing deadline is authorized by the PREP
Act's incorporation of SEPPA's filing deadlines for Table amendments.
We expect that the filing deadline described in Sec. 110.42(f) may
make benefits available to individuals who would otherwise be time-
barred with respect to injuries for which new scientific evidence
becomes available linking a particular covered countermeasure with a
particular injury.
It is important to note that the additional filing deadline
described in Sec. 110.42(f) is only available to persons who are
provided with the presumption of causation of a Table injury by virtue
of changes made to a Table. Persons who sustained other injuries or who
do not meet all of the requirements for such a Table injury (for
example, the definition included on the Table, and the time-frame for
onset included on the Table) will not be afforded an additional one
year filing deadline based on the effective date of the Table change.
Because the Table change would not enable such individuals to establish
a Table injury, they would be subject to the standard filing deadline
described in Sec. 110.42(a).

Deadlines for Submitting Documentation (Sec. 110.43)

As described above, a requester will meet the filing deadline
requirement by submitting a completed and signed Request Form (or
Letter of Intent) within the filing deadline set forth in Sec. 110.42,
with documentation to follow at a later date. Although the Secretary
will accept documentation required to make eligibility determinations
(i.e., documentation described in Sec. 110.50 and Sec. Sec. 110.51,
110.52, and 110.53 depending upon the nature of the Request) at the
time the Request Form is filed, requesters need not submit such
documentation at that time. Submitting eligibility documentation as
soon as possible will enable the Secretary to make a prompt eligibility
determination. The documentation necessary to make benefits
determinations (i.e., documentation described in Sec. Sec. 110.60,
110.61, 110.62, and 110.63, depending on the type of benefits sought)
need not be filed until a requester has been notified by the Secretary
that the requester is eligible for Program benefits. However, the
Secretary will accept such documentation if submitted at an earlier
date.
After filing a Request Form (or Letter of Intent) within the filing
deadline, a requester must update the Request Package to reflect new
information as it becomes available. For example, requesters have an
obligation to arrange with their healthcare providers to submit copies
of medical records as they are generated.

Legal or Personal Representatives of Requesters (Sec. 110.44)

Requesters do not need to retain the services of lawyers to pursue
benefits under this Program. However, as provided in Sec. 110.44(a),
requesters may have a legal or personal representative (e.g., lawyer,
guardian, family member, or friend) submit the Request Form (or Letter
of Intent) and/or Request Package on their behalf. In certain
circumstances, described below, requesters may be required to have a
legal or personal representative file on their behalf. All
representatives filing on behalf of requesters will be bound by the
obligations and documentation requirements that apply to the requester.
For example, if this regulation requires a requester to submit his or
her medical records, the requester's representative would be required
to submit those records on behalf of the requester. If a requester has
a legal or personal representative, the Program will generally direct
all communications to the representative unless the Program is advised
that the representation has stopped. However, as described in Sec.
110.40(a), the Secretary reserves the right to contact the requester
directly if necessary (e.g., in circumstances in which the Secretary is
unable to contact the representative). The Secretary also reserves the
right to contact requesters at a later date to conduct a follow-up
survey to help determine improvements in the ability of the Program to
meet the needs of requesters.
As described in Sec. 110.44(b), a legally competent requester may
use a representative to submit a Request Package on his or her behalf.
In such circumstances, the requester must indicate on the Request Form
that he or she has authorized the representative to submit the Request
Package on his or her behalf.
Requesters who are minors or adults who do not have legal capacity
to receive payments (i.e., adults determined to be legally incompetent
by a court having jurisdiction) are required to have the assistance of
a representative (who does not need to be a lawyer). Representatives of
requesters who are minors (excepting emancipated minors), or adults
determined by a court not to have legal capacity to receive payments,
are required to submit specific documentation, in addition to the
documentation generally required of requesters, which is described in
Sec. 100.63.
As explained above, although legal representation is permitted, it
is not needed for filing for Program benefits. As described in Sec.
110.44(d), the Program will not be responsible for the payment or
reimbursement of any fees for the services of legal or personal
representatives or for any associated costs. The authorizing statute
does not permit the Program to pay any attorney's fees or related
costs.

Multiple Survivors (Sec. 110.45)

If there are multiple survivors, then each survivor may submit
Request

[[Page 63668]]

Forms separately or the group of survivors may submit one Request Form
together. Multiple survivors are not required to file separate
supporting documentation; rather, they may submit one complete set of
supporting documentation on behalf of all survivors.

Amendments to Request Packages (Sec. 110.46)

The filing of amendments to previously filed Request Packages is
discussed in Sec. 110.46. As explained in Sec. 110.46(a), all
requesters may amend their documentation concerning eligibility until
the Secretary makes an eligibility determination. After that time, the
Secretary will not accept additional documentation concerning
eligibility (except amendments filed by survivors or the estates of
deceased countermeasure recipients, discussed below).
After the Secretary makes a benefits determination (e.g.,
determines that no benefits may be awarded because all eligible
benefits have been paid by other third party payers, or determines that
a requester is entitled to benefits and sets the amount of the award),
the determination is final and the Secretary will not accept new
benefits documentation regarding that covered injury (except amendments
filed by survivors or the estates of deceased countermeasure
recipients, discussed below). The Secretary believes that benefits
determinations must have finality. The Secretary will do her best to
assess the appropriate level of benefits based on the information
before her at the time of the benefits determination. In certain
circumstances, such determinations may be based on the Secretary's
assessment of the likely future needs of a requester. For example, a
medical benefits award will be based, in part, on the Secretary's best
judgment as to the anticipated future course of an injured
countermeasure recipient's illness. Because reopening such benefits
decisions would create an unreasonable administrative burden and would
prevent finality, the Secretary will not consider new evidence
concerning the appropriate level or type of benefits after the benefits
determination has been made. If another approach were pursued, the
Secretary could be in the position of revisiting benefits every time a
requester's medical condition or insurance coverage altered, even
slightly. The Program is not in a position to constantly re-evaluate
such determinations.
Although new documentation cannot be submitted after a
determination has been made, applicants have a right to seek
reconsideration of an unfavorable eligibility or benefits decision
(Section 110.90).
Section 110.46(b) addresses amendments filed by requesters who are
survivors. If an injured countermeasure recipient filed a Request
Package, but later dies, his or her survivors may amend the Request
Package by filing a new Request Form. A survivor filing such an amended
request will only be entitled to benefits under the Program if the
original Request Form (filed by or on behalf of the injured
countermeasure recipient, his or her estate, or other survivors) was
filed within the applicable one year filing deadline. If such an
amendment is filed, all of the documentation submitted with the
original Request Package will be considered part of the amended Request
Package and the survivor need not resubmit such documentation. If the
injured countermeasure recipient (or his or her estate) never filed a
Request Package, a Request Form filed by a survivor would be considered
the beginning of a new Request Package and not an amendment to a
previously filed Request Package. As set forth in Sec. 110.46(b),
survivors must file an amendment to a Request Package if there is a
change in the eligible survivors (for example, the spouse of an injured
countermeasure recipient dies).
Section 110.46(c) addresses amendments filed by the executor or
administrator of the estate of a deceased injured countermeasure
recipient. If an injured countermeasure recipient filed a Request
Package, but later dies before all benefits are paid by the Program,
the executor or administrator of his or her estate may amend the
Request Package by filing a new Request Form. The estate will only be
entitled to receive benefits under the Program if the original Request
Form (previously filed by or on behalf of the injured countermeasure
recipient or his or her survivor(s)) was filed within the applicable
one-year filing deadline. If such an amendment is filed, all of the
documentation submitted with the original Request Package will be
considered part of the amended Request Package and the executor or
administrator of the estate need not resubmit such documentation. If
the injured countermeasure recipient (or his or her survivor(s)) never
filed a Request Package, a Request Form filed by the executor or
administrator of his or her estate would be considered the beginning of
a new Request Package and not an amendment to a previously filed
Request Package.
Requesters are responsible for notifying the Program of any changes
in circumstances that may have an impact on the Secretary's eligibility
and benefits determinations.

Documentation Required To Be Deemed Eligible (Sec. 110.50-Sec.
110.54)

Requesters or their representatives must submit appropriate
documentation sufficient to enable the Secretary to determine whether
requesters are eligible for Program benefits. The documentation
required will vary somewhat depending on whether the requester is
filing as an injured countermeasure recipient, survivor, or estate
(through the executor or administrator).

Medical Records Necessary To Determine Whether a Covered Injury Was
Sustained (Sec. 110.50)

The phrase ``medical records'' is defined in Sec. 110.3(p), which
provides that ``medical records'' for purposes of this part means
``documentation associated with primary care, hospital in-patient and
out-patient care, speciality consultations, and diagnostic testing and
results.''
Because all Request Packages filed with the Program, including
those filed by survivors or executors or administrators of the estates
of deceased persons, must relate back to an injured countermeasure
recipient who sustained a covered injury, all requesters must submit
medical records sufficient to demonstrate to the Secretary that a
covered injury was sustained by the injured countermeasure recipient.
Section 110.50(a) describes the medical records that are generally
required in order for a requester to establish that a covered injury
was sustained. The Secretary will use the records submitted, as well as
any other available evidence, to evaluate if an injury appearing in a
Table (and meeting the requirements of a Table) was sustained or if an
injury was otherwise sustained as the direct result of the
administration or use of a covered countermeasure. The Program will
consider copies of medical records to be the same as the original
records. Section 110.50 sets forth all of the medical records necessary
for the Secretary to determine whether a covered injury was sustained.
As a general matter, the Secretary expects to receive medical
records directly from healthcare providers. The Secretary requires that
requesters sign an Authorization for Use or Disclosure of Health
Information Form (Authorization for Health Information Form), available
from the Program, for each applicable healthcare provider authorizing
the release of the requested medical records directly to the Program
and send copies of each of these

[[Page 63669]]

Authorization for Health Information Forms to the Program. Section
110.50(b) explains that requesters may submit any additional medical
documentation that they believe supports their Request Packages. The
Program will not expect such documentation. The medical records
described in Sec. 110.50(a) generally will be sufficient for the
Program to make a covered injury determination. As an example of the
type of documentation described in Sec. 110.50(a), a requester may
submit scientific evidence such as a scientific research article in
order to demonstrate that an injury was directly caused by the
administration or use of a covered countermeasure. In making covered
injury determinations, the Secretary may consider the scientific
evidence available (e.g., published articles concerning a relationship
between the countermeasure and an injury) and consult with qualified
medical experts.
Section 110.50(c) addresses circumstances in which certain medical
records are unavailable to a requester (e.g., a medical office has
closed, records have been destroyed due to a natural disaster, a
requester is unable to afford the costs charged by a provider to copy
and release medical records). In these cases, the requester must
provide a statement describing the reasons for the records'
unavailability and the reasonable efforts the requester has made to
provide them. The Secretary may, at her discretion, accept such a
statement from the requester instead of the required medical records,
if the circumstances so warrant. In addition, the Secretary may, at her
discretion, obtain the records directly from healthcare providers on
the requester's behalf.
As described in Sec. 110.50(d), the Secretary may determine that
particular records described in Sec. 110.50(a) are not necessary for
particular requesters (for example, if certain medical records provide
the same information as other records that are submitted) or that
additional medical records may be required in order to make a covered
injury determination. For example, the Secretary generally requires all
medical records for one year prior to the administration or use of a
covered countermeasure as necessary to indicate the injured
countermeasure recipient's pre-existing medical history. Based on her
review of such documents, however, the Secretary may require additional
information concerning a condition that was pre-existing prior to the
injured countermeasure recipient's administration or use of a covered
countermeasure to determine the most likely cause of the covered
injury. Also, depending on the circumstances of the administration or
use of the covered countermeasure and the specifications of the
relevant PREP Act declaration, the Secretary may need additional
information concerning the circumstances of the administration or use
of the covered countermeasure to determine whether the specifications
of the declaration were satisfied (or that a good faith belief of such
existed). The Secretary will notify requesters in such circumstances.
If an injured countermeasure recipient died, and his or her
survivors seek a death benefit under the Program, the Secretary will
need to review the medical records to determine whether the death was
the direct result of a covered injury. As explained in Sec. 110.52(c),
the medical records reviewed for this purpose may be the same as those
submitted for the covered injury determination.

Documentation an Injured Countermeasure Recipient Must Submit for the
Secretary To Make a Determination of Eligibility for Program Benefits
(Sec. 110.51)

Section 110.51 sets forth all of the documentation an injured
countermeasure recipient must submit in order for an eligibility
determination to be made. First, the requester (or his or her
representative) must submit a Request Form. Second, requesters must
submit records sufficient to demonstrate that the injured
countermeasure recipient was administered or used a covered
countermeasure (e.g., medical records, vaccination records, records
from an employer or public health authority). Third, a requester must
submit the medical records described in Sec. 110.50 sufficient to show
that the injured countermeasure recipient sustained a covered injury.
Fourth, a requester should submit a copy of each signed Authorization
for Health Information Form for each healthcare provider authorizing
providers to release medical records directly to the Program. As
described in Sec. 110.51(b), the Secretary has the discretion to
determine that a requester need not submit a copy of such signed
Authorization for Health Information Form with respect to each
healthcare provider in all circumstances. Finally, as described in
Sec. 110.51(b), a requester may be required to submit additional
documentation as required by the Secretary. For example, as a general
matter, the information provided on the Request Form, together with
other documentation submitted with respect to other requirements, will
be sufficient for the Secretary to make a determination as to whether
the injured countermeasure recipient was administered or used a covered
countermeasure in accordance with all of the terms of a Secretarial
declaration (including administration or use during the effective
period of the declaration) or in a good faith belief that the
administration or use met all of the terms of a declaration. However,
in certain circumstances, the Secretary may require requesters to
submit additional documentation in order to make an eligibility
determination. In appropriate circumstances, the Secretary may
determine that all of the records described in Sec. 110.51 will not be
required for a particular injured countermeasure recipient. In such
circumstances, the Secretary will notify the requester of such.

Documentation a Survivor Must Submit for the Secretary To Make a
Determination of Eligibility for Death Benefits (Sec. 110.52)

Section 110.52 describes the documentation that a survivor must
submit for an eligibility determination to be made with respect to
survivor death benefits. With the exception of a Request Form,
discussed below, there is no need to duplicate documentation already
submitted (by an injured countermeasure recipient during his or her
lifetime, by the executor or administrator of his or her estate after
death, or by another survivor). With respect to all requests for death
benefits (payable only to survivors), at least one survivor must file a
Request Form. This is true even if the injured countermeasure recipient
already submitted a Request Form and the survivor(s) are amending the
previously filed Request Package. Section 110.52 makes clear that all
of the documentation required for injured countermeasure recipients
must be filed for an eligibility determination to be made with respect
to death benefits. Additional documentation is also required (e.g., a
death certificate for the injured countermeasure recipient, medical
records demonstrating that the death was the direct result of a covered
injury, documentation showing that the requester is an eligible
survivor). As provided in Sec. 110.52(a)(2), the Secretary has the
discretion to accept other documentation that the injured
countermeasure recipient is deceased if the death certificate is
unavailable and the Secretary is satisfied with a letter submitted by
the requester concerning the reasons for the unavailability of the
certificate. The Secretary expects that this will be a rare occurrence.
In addition, in the place provided on the

[[Page 63670]]

Request Form, a survivor filing a Request Form must verify that there
are no other eligible survivors or that other eligible survivors exist
(together with information about such survivors). As noted above, Sec.
110.11 describes eligible survivors for purposes of death benefits and
the priorities of survivorship.

Documentation the Executor or Administrator of the Estate of a Deceased
Injured Countermeasure Recipient Must Submit for the Secretary To Make
a Determination of Eligibility for Benefits to the Estate (Sec.
110.53)

The executor or administrator of the estate of a deceased injured
countermeasure recipient, seeking benefits under the Program on behalf
of the estate, must submit a completed and signed Request Form. This is
true even if the injured countermeasure recipient or a survivor already
submitted a Request Form and the executor or administrator of the
estate is amending the previously filed Request Package. In addition, a
death certificate for the injured countermeasure recipient is required.
As provided in Sec. 110.53(b), the Secretary has the discretion to
accept other documentation showing that the injured countermeasure
recipient is deceased if the death certificate is unavailable and the
Secretary is satisfied with a letter submitted by the executor or
administrator concerning the reasons for the unavailability of the
certificate. The Secretary expects that this will be a rare occurrence.
Although the estate may receive benefits regardless of whether or not
the death resulted from a covered injury, the Secretary may require
documentation concerning the death in cases in which eligibility has
not yet been determined. For example, the Secretary may require such
documentation to help determine whether an injury was caused by the
administration or use of a covered countermeasure, as opposed to an
underlying health condition that might be apparent at death. No death
benefits are awarded to the estate. Finally, documentation showing that
the individual is the executor or administrator of the deceased injured
countermeasure recipient's estate (e.g., a court order or letters of
administration) is required.

Documentation Required for the Secretary To Determine Program Benefits
(Sec. 110.60-Sec. 110.63)

In addition to the documentation requesters must submit for the
Secretary to make eligibility determinations (including the
determination that a covered injury was sustained), requesters must
submit documentation to enable the Program to calculate the type and
amount of benefits available. Because the benefits available under the
Program are secondary to benefits received or receivable from third-
party payers, it may be possible that certain requesters who are deemed
eligible will not receive benefits from the Program. Sections 110.60-
110.63 describe the documentation that is required for requesters
seeking particular types of benefits.
Although the Program will accept such documentation at any time
after a Request Form is filed, a requester need not submit any of the
documentation pertaining to benefits until the Secretary has informed
the requester that he or she is eligible under the Program. The
submission of benefits documentation is described in Sec. 110.43(b)
and is designed to ease the documentary burden on requesters who do not
know whether or not they will be deemed eligible.
In order to calculate the amount of each type of benefit available,
the Program requires requesters to provide documentation of every
third-party payer that may have paid for or provided the benefits
requested, or that may have an obligation to do so. The information
required concerning such third-party payers with respect to each type
of benefit available under the Program is described in Sec. Sec.
110.60, 110.61, and 110.62. As set forth in Sec. 110.60(a)(3), a
requester may need to give consent for the Program to communicate
directly with third-party payers.
Requesters seeking medical benefits must also submit documentation
concerning the amount paid or expected to be paid by such third-party
payers for the medical services or items for which payment is being
sought under the Program. Third-party payers of medical benefits
include, but are not limited to, medical insurance, Medicaid, Medicare,
and any other source of medical reimbursement. An example of the
documentation necessary to satisfy this requirement is an Explanation
of Benefits form issued by the injured countermeasure recipient's
health insurance company.
Third-party payers of benefits for lost employment income include,
but are not limited to, the injured countermeasure recipient's
employer, disability insurance, workers' compensation programs, and the
Department of Veterans Affairs. In order to satisfy his or her
obligations under Sec. 110.61, an injured countermeasure recipient may
need to submit documentation including his or her earnings and leave
statements, information concerning the number of hours in the
requester's standard work day, as well as documentation concerning any
programs or payments for lost wages.
Survivors seeking death benefits will have to submit different
documentation concerning third-party payers depending on whether they
are seeking death benefits under the standard calculation described in
Sec. 110.82(b) or are choosing a death benefit under the alternative
calculation described in Sec. 110.82(c). For example, survivors
seeking a death benefit under the standard calculation must submit
documentation concerning PSOB Program death and disability benefits.
The legal guardian of survivors seeking a death benefit under the
alternative calculation must submit documentation concerning existing
or potential third-party payers (described fully in the death benefits
calculation section of this preamble and set forth in Sec.
110.82(d)(3)(A)). Survivors seeking death benefits also must submit
other documentation described in Sec. 110.62.
Before payments will be made, the representatives of requesters who
are minors or adults who lack legal capacity to receive payments must
submit additional documentation described in Sec. 110.63. Because some
of this documentation may be time-consuming to obtain (e.g., obtaining
a court decree establishing a guardianship of the estate for an adult
who lacks legal capacity), the requester may wait until a benefits
calculation has been made, and a written approval has been issued,
before submitting such documentation.

Determinations the Secretary Must Make Before Benefits Can Be Paid
(Sec. 110.70-Sec. 110.74)

When the Secretary receives a completed and signed Request Form or
Request Package postmarked within the filing deadline, she will conduct
two separate reviews, as described in Sec. 110.70. First, she will
determine whether the requester is eligible for Program benefits.
Second, the Secretary will determine the type and amount of any
benefits that may be paid.
If the Request Package does not include sufficient documentation to
determine eligibility, the Secretary will send written notice to the
requester (or his or her representative) identifying the documentation
that is needed, as provided for in Sec. 110.71. The requester will be
given 60 days to submit the required documentation. If, after
reasonable efforts to obtain the documents, the documentation remains
unavailable, the requester must submit a letter explaining the
circumstances to the Secretary. The Secretary also has the

[[Page 63671]]

discretion to accept a letter meeting the requirements set out in Sec.
110.71 as a substitute for the unavailable documentation.
If the Secretary determines that a requester is not eligible for
benefits under the Program, she will inform the requester (or his or
her representative) of the disapproval in writing. As described in
Sec. 110.72(a), the Secretary will provide information as to the
options available to the requester, including the requester's right to
seek reconsideration of the eligibility decision.
If the Secretary determines that a requester meets the eligibility
requirements, she will notify the requester in writing of this
decision, at which point the Secretary will review the Request Package
in order to calculate the type and amount of the benefits. If the
Request Package does not have sufficient documentation for the
Secretary to calculate the amount of the benefits, the Secretary will
notify the requester in writing of the documentation she requires to
complete the calculation. As with the eligibility documentation, the
requester will be given 60 days to submit the required documentation or
provide a letter setting forth the circumstances that make the records
unavailable. Again, the Secretary may accept a letter meeting the
requirements set forth in Sec. 110.71 as a substitute for the
unavailable documentation. Once the Secretary has sufficient
documentation to calculate a requester's benefits, the Secretary will
complete this calculation.
As set out in Sec. 110.73, once the Secretary has calculated the
amount of the benefits and determined that payment is to be made, she
will inform the requester of the approval in writing and then initiate
payment. Under Sec. 110.74, if the Secretary disapproves a Request,
which the Secretary may do at any time, she will so notify the
requester (or his or her representative) in writing and provide
information as to the requester's right to seek reconsideration of the
Secretary's decision.

Payment of All Benefits Under the Program (Sec. 110.83)

The Secretary's options in paying all benefits under the Program
are described in Sec. 110.83. The Secretary makes all payment
decisions, consistent with applicable law, and unilaterally determines
the method of payment. If the Secretary determines that there is a
reasonable likelihood that payments of medical benefits, benefits for
lost employment income, or death benefits paid under the alternative
calculation (described in Sec. 110.82(c)) will be required for a
period in excess of a year from the date the Secretary determines that
the requester is eligible for such benefits, the Secretary may pay such
benefits through a lump-sum payment, a trust such as a U.S. grantor
reversionary trust, annuity or medical insurance policy, or appropriate
structured settlement agreement (or a combination of these methods),
provided they are actuarially determined to have a value equal to the
present value of the projected total amount of such benefits that the
requester is eligible to receive.
As described in Sec. 110.83(a), lump sum payments will generally
be made through electronic funds transfers to requesters' accounts.
Under Sec. 110.83(b), if a requester is a minor, the payment will be
made on the minor's behalf to the account of the minor's legal guardian
(generally, the minor's parent). The legal guardians of minor
requesters under this Program will be required to use the payments for
the benefit of the minor. Such legal guardians are subject to
applicable State law requirements concerning payments made on behalf of
minors (e.g., become the guardian of the minor's estate or establish an
account with State court supervision, if required by State law). Such
legal guardians are also required to provide to the Secretary
documentation of guardianship or conservatorship; however, the
Secretary may waive this requirement for good cause. Section 110.83(b)
describes the requirements pertaining to lump sum payments made on
behalf of adults who lack the legal capacity to receive payments.
As provided in Sec. 110.83(c), the Secretary may choose to make
interim payments of benefits under the Program (in other words, issue a
payment for a certain type or portion of Program benefit prior to
making the final benefits payment) to give certain benefits to a
requester more quickly than would otherwise be possible. For example,
the Secretary may pay medical benefits for past services or items to an
eligible requester whose covered injury has resulted in substantial
medical bills before making the final determination concerning the
payment of future medical benefits. In certain cases, the Secretary may
make an interim payment of benefits even before a final eligibility or
benefits determination is made. The Secretary expects such instances to
be rare, and the requester in such circumstances must agree to repay
the Secretary for any benefits later determined to be unavailable under
the Program.

The Tax Consequences of Receiving Benefits from the Program

The Secretary is asking the Internal Revenue Service (IRS) to
provide prompt guidance on the tax consequences of receiving benefits
under the Program. The Program will share this guidance as soon as it
is received.

The Secretary's Right To Recover Benefits Paid Under this Program From
Third-Party Payers (Sec. 110.84)

As described above, the payment of benefits under this Program is
secondary to benefits available from other third-party payers. The
category of third-party payers that have primary responsibility to pay
for or provide such benefits is different for each type of benefit
available under this Program. Such third-party payers are discussed in
the sections of the preamble concerning the different types of
benefits. As described in Sec. 110.84, after the Secretary pays
benefits under this Program, she will be subrogated to the rights of
the requester, meaning that the Secretary may assert a claim against
any third-party payer with a legal or contractual obligation to pay
for, or provide, such benefits. The Secretary may recover from such a
third-party payer the amount of benefits the third-party payer has (or
had) an obligation to pay for (or provide) or may recover them from the
requester if they were paid to the requester. For example, if the
Secretary pays a requester $10,000 in benefits for lost employment
income under this Program and a State workers' compensation program
later determines that it is obliged to pay the requester $5,000 in
workers' compensation benefits, the Secretary may pursue a claim
against the State for $5,000 (because the Secretary, as the secondary
payer, would only be obligated to pay the requester $5,000 in benefits
for lost employment income). No benefits paid under this Program are
subject to any lien by any third-party payer.

Reconsideration of the Secretary's Eligibility and Benefits
Determinations (Sec. 110.90)

Every individual who has filed a Request Package and has received a
determination by the Secretary either disapproving eligibility for
benefits or denying a category or amount of benefits requested has a
right to seek reconsideration of the Secretary's determination(s).
However, no reconsiderations may be filed concerning the mechanisms of
payment.
Although such initial determinations are characterized as
Secretarial

[[Page 63672]]

determinations, this decision-making authority will be delegated to the
Program. The requester or his or her representative must send a letter
seeking reconsideration to the Associate Administrator, Healthcare
Systems Bureau, Health Resources and Services Administration, at the
address provided in Sec. 110.90(b). The letter must be received by the
Department within 60 calendar days of the date of the Department's
determination letter. The letter should state the reasons why the
determination should be reconsidered. No new documentation may be
included with this letter.
The Associate Administrator, Healthcare Systems Bureau, will
convene a panel to review all cases seeking reconsideration. The panel
will consist of qualified individuals who are independent of the
Program. The panel will review the documentation that was before the
Secretary at the time of the determination (and will not consider any
new documentation submitted by the requester).
After reviewing the record, the panel will make a recommendation to
the Associate Administrator, Healthcare Systems Bureau, who will then
make a final determination as to whether or not the requester is
eligible for benefits or as to the type and/or amount of benefits that
may be paid. The Associate Administrator will inform the requester or
his or her representative in writing of the determination(s) and of the
reasons. This decision will be considered the Secretary's final action
on the issue for which reconsideration was sought. Requesters may not
seek review of such a decision.
If the Associate Administrator's final decision is that a requester
who was determined to be ineligible for benefits is, in fact, eligible,
then the Secretary will make a determination as to the type and amount
of benefits to be paid. The requester then has a right to seek
reconsideration of the Secretary's determination on that issue.

Secretary's Review Authority and No Additional Judicial or
Administrative Review of Determinations Made Under This Regulation
(Sec. 110.91, Sec. 110.92)

In accordance with section 262(f)(1) of the PHS Act (SEPPA) (42
U.S.C. 239a(f)(1)) and as described in Sec. 110.91, the PREP Act
authorizes the Secretary to review at any time, on her own motion or on
application, any determination made concerning eligibility, and the
calculation and amount of benefits under the Program and authorizes the
Secretary to affirm, vacate, or modify such determination in any manner
the Secretary deems appropriate. The decision of whether to engage in
such a review rests within the complete discretion of the Secretary.
However, as explained in Sec. 110.92, once the Secretary has made
a final decision as to eligibility or type or amount of benefits and
the requester has exercised his or her right to reconsideration, the
PREP Act, referencing section 262(f)(2) of the PHS Act (SEPPA) (42
U.S.C. 239a(f)(2)), does not allow any further review of that decision
by any court or administrative body (unless the President specifically
directs further administrative review). Given this broad statutory
prohibition against further review, no determination made under this
part (including, but not limited to, eligibility determinations,
benefits calculations, payment decisions, and reconsideration
decisions) will be subject to any review by Federal or State courts.
Finally, there is also no judicial review of the Secretary's
determinations establishing or amending a Covered Countermeasure Injury
Table.

Justification for Omitting Notice of Proposed Rulemaking and for Waiver
of Delayed Effective Date

Through the enactment of the PREP Act, the Secretary was authorized
to establish and administer the Program. Congress authorized the
Secretary to issue regulations implementing the PREP Act as the
Secretary deems reasonable and necessary. In accordance with that
statutory authority, the Secretary is herein establishing the
procedures and requirements to govern the Program.
In addition, the Secretary has determined, under 5 U.S.C. 553(b),
that it is contrary to the public interest to follow proposed
rulemaking procedures (i.e., issuing a proposed rule, with an
accompanying solicitation of public comments) before issuance of these
regulations, because such a process might delay the continuing
implementation of the President's plan to protect the population of the
United States against public health pandemic, epidemic, or security
threats. The sooner this regulation is in effect, the sooner the
Program can be implemented and potential requesters who may have been
seriously injured by a covered countermeasure will be able to be
considered for medical and lost employment income benefits. Further,
survivors of those who they believe have died as a result of a covered
countermeasure will be able to apply for death benefits. Once this
implementing regulation is in effect, the Secretary expects individuals
who believe that they may be eligible for benefits under the Program
will file requests for such benefits within a short time frame since
Letters of Intent to request benefits have already been filed with the
Program. In addition, publishing this regulation promptly is necessary
to make the remedies afforded by this Program available to potential
requesters as soon as possible given the governing one year filing
deadline. As noted above, the Secretary has made every effort to enable
those who suffer covered injuries as the result of covered
countermeasures to have an opportunity to apply for benefits under this
Program. As described above, to the extent that scientific evidence
linking a covered countermeasure to an injury becomes available and
such injury is added to a Table, potential requesters will be able to
take advantage of an alternative filing deadline, which may increase
the likelihood that their Request Forms will be timely filed. In
addition, the Secretary may rely upon constructive receipt of filing,
as described in Sec. 110.42(e). The Secretary further believes that
her omission of a Notice of Proposed Rulemaking and delay of the
effective date of this regulation is warranted given that most of the
eligibility and benefits criteria under this Program are the same as
those included in the SVICP's administrative implementation
regulations--42 CFR part 102. Public comments with respect to those
regulations were solicited, received, and considered by the Secretary.
For the same reasons, the Secretary has determined that there is good
cause to waive a delay in the rule's effective date. Nonetheless, as
noted above, comments on the procedures and requirements in this
interim final rule will be accepted at the above listed address for a
period of 60 days following the rule's publication in the Federal
Register. Thus, although the rule is effective immediately upon
publication, the Secretary will consider the comments received and,
based on them, may amend the procedures and/or requirements pertaining
to this Program.

Economic and Regulatory Impact

Unfunded Mandates Reform Act of 1995: The Secretary has determined
that this interim final rule will not have effects on State, local, and
tribal governments and on the private sector such as to require
consultation under the Unfunded Mandates Reform Act of 1995.
Federalism Impact Statement: The Secretary has also reviewed this
rule in accordance with Executive Order 13132 regarding federalism, and
has determined that it does not have

[[Page 63673]]

``federalism implications.'' The rule does not ``have substantial
direct effects on the states, or on the relationship between the
national government and the states, or on the distribution of power and
responsibilities among the various levels of government.''
Impact on Family Well-Being: This interim final rule will not
adversely affect the following elements of family well-being: Family
safety, family stability, marital commitment; parental rights in the
education, nurture and supervision of their children; family
functioning, disposable income or poverty; or the behavior and personal
responsibility of youth, as determined under section 654(c) of the
Treasury and General Government Appropriations Act of 1999. In fact,
this interim final rule may have a positive impact on the disposable
income and poverty elements of family well-being to the extent that
families of injured persons (and of other persons deemed eligible to
receive benefits under this part) receive, or are helped by, medical,
lost employment income, and/or death benefits paid under this part
without imposing a corresponding burden on them.
Impact of the New Rule: In this interim final rule, the Secretary
establishes the procedures and requirements applicable to requesters
filing for benefits available under the Program. This interim final
rule is based on the PREP Act. It will have the effect of enabling
certain eligible individuals who sustained covered injuries as the
direct result of receiving a covered countermeasure under the
Secretary's declaration, to receive benefits under the Program. In the
event that an otherwise eligible injured countermeasure recipient has
died, his or her estate and/or survivors may be entitled to certain
benefits. This interim final rule sets out the eligibility requirements
that apply to the Program, how benefits will be calculated, and the
documentation that must be submitted.
Paperwork Reduction Act of 1995:
Collection of Information: The Countermeasures Injury Compensation
Program
Description of Respondents: The respondents will be individuals who
sustain serious injuries as a direct result of the administration or
use of covered countermeasures (i.e., injured countermeasure
recipients) identified by the Secretary in declarations issued under
the PREP Act. In addition, respondents may also be certain survivors of
individuals who died as the direct result of their covered injuries or
their health complications (i.e., eligible survivors of deceased
injured countermeasure recipients) and/or the estates of deceased
injured countermeasure recipients. Examples of currently covered
countermeasures are: the 2009 H1N1 vaccine, the influenza antiviral
drugs Tamiflu[reg] and Relenza[reg] when used for pandemic purposes,
pandemic influenza diagnostics, personal respiratory devices (e.g., N-
95 filtering facepiece respirators to prevent the spread of the 2009
H1N1 virus), and respiratory support devices (e.g., ventilators used
for life support for critically ill patients with respiratory failure
due to infection with 2009 H1N1 virus), the influenza intravenous
antiviral drug peramivir when used to treat infection with 2009 H1N1,
and certain anthrax, smallpox, botulism, and acute radiation syndrome
countermeasures.
Estimated Annual Reporting: The estimated annual reporting for this
data collection is a total of five hours for reviewing and completing
the Countermeasures Injury Compensation Program Request for Benefits
Form (Request Form) and the Countermeasures Injury Compensation Program
Authorization for Use or Disclosure of Health Information Form
(Authorization for Health Information Form) as well as the time to
obtain and provide medical and financial documentation for eligibility
and the computation of benefits. The respondents listed above will
complete the Request Form to inform the CICP of their contact
information (e.g., name, address), and the dates and the circumstances
under which a covered countermeasure was administered or used. After
submitting the Request Form, the eligible respondents listed above will
complete the Authorization for Health Information Form to request that
medical records be sent to the CICP. The wage rate is the October 2009
average hourly earnings from the Bureau of Labor Statistics, U.S.
Department of Labor. The estimated annual response burden is as
follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hourly Total burden Total hour
Form respondents respondent response hours Wage rate cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for Benefits Form and Supporting Documentation.. 2,520 1 5 12,600 $18.72 $235,872
Authorization for Use or Disclosure of Health 2,520 1 1 2,520 18.72 47,174
Information Form.......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

As a result of the 2009 H1N1 influenza outbreak, this is the first
time that covered countermeasures identified in PREP Act declarations
are being distributed, administered, and used in the general population
of the United States. This is also the first time that the strain of
2009 H1N1 virus has circulated in the United States and worldwide, and
the first time that a specific influenza vaccine is available to
prevent its illness. In light of these factors, the incidence of
potential adverse events associated with this vaccine cannot be
predicted. However, as the same technology is utilized in the
production of seasonal influenza vaccine, the rate of vaccine-
associated adverse events is not expected to be any different than for
seasonal influenza vaccine. Since the behavior of the 2009 H1N1 virus
may be unpredictable and the number of people who will get the 2009
H1N1 vaccine is unknown, the CICP estimates of the number of Request
for Benefits Forms that will be filed are predicated on currently
available information. The CICP expects that individuals with severe
injuries are more likely to file requests for benefits since they may
have incurred more unreimbursable medical expenses and have more lost
employment income than individuals alleging less serious injuries (for
whom the benefits available under the CICP may be limited). Therefore,
the estimates of Requests for Benefits assumes that a larger percentage
of the more seriously injured will file for Request Packages.
According to the Centers for Disease Control and Prevention (CDC)
127 million doses of 2009 H1N1 vaccine had been distributed to public
health agencies and healthcare providers in the United States as of May
28, 2010. Currently, it is estimated that approximately 90 million
Americans have been vaccinated, although the precise number is not
known. As of May 29, 2010, the Vaccine Adverse Reporting

[[Page 63674]]

System (VAERS) has received 11,180 reports related to 2009 H1N1
vaccination. The vast majority (92.2%) of adverse events reported to
VAERS after receiving the 2009 H1N1 vaccine have not involved serious
health problems or outcomes (e.g., they encompass events such as
soreness at the vaccine injection site). Of the 11,180 reports, 868
(7.7 percent) were reports that involved what would be considered
serious health events as defined by VAERS. The number of these reports
is similar to those historically seen after distribution of a similar
number of seasonal flu vaccine doses. Among the 11,180 reports of
adverse events, there were 60 reports of deaths. The 60 VAERS reports
that involve deaths are under review by CDC, the Food and Drug
Administration (FDA) and the States in which the reported deaths
occurred. VAERS has received 143 reports of Guillain-Barr[eacute]
Syndrome (GBS), for which follow-up assessments are under way. In the
United States, about 80-160 cases of GBS are expected to occur each
week, regardless of vaccination. VAERS is a national passive reporting
system for vaccine adverse events managed by both CDC and the Food and
Drug Administration (FDA) in which reports are submitted voluntarily by
people who think an adverse event occurred after vaccination. VAERS
accepts reports from all sources. VAERS is useful as a signal detection
system to monitor for potential vaccine safety problems.
As outlined above, VAERS has received 868 serious reports and
10,312 nonserious reports. Very little 2009 H1N1 vaccine is currently
being administered so it can be assumed these numbers may increase
slightly but will not change significantly. The CICP expects 75 percent
(or 651) of these reports to result in Requests for Benefits filed with
the CICP, and about 5 percent (or 516) of the reports of less serious
injuries to result in Requests for Benefits with the CICP, for a total
of 1,167 Requests.
In April 2009 there were an estimated 50 million courses of FDA
approved antiviral drugs in the Strategic National Stockpile (SNS).
Eleven million of these 50 million were distributed to project areas
(i.e., all U.S. States, territories and jurisdictions). An additional
23 million courses of antiviral drugs were purchased by project areas
and held as part of State stockpiles available for distribution to the
local level if needed. Assuming all the antiviral drugs provided by the
SNS (approximately 11 million courses) and the State-purchased
antiviral drugs (approximately 23 million courses) were distributed to
the local level and dispensed, the CICP expects that approximately 672
Request for Benefits Forms will be filed concerning serious injuries
allegedly resulting from covered antivirals. Based on estimates by CICP
staff, the incidence of very serious injuries from antivirals may be 2
in 10 million (10 cases) for anaphylaxis, 1 in 1 million (50 cases) for
Toxic Epidermal Necrolysis/Stevens Johnson Syndrome, and 10 in 1
million (500 cases) for bronchospasms. The incidence of less serious
injuries from antivirals is 1 in 1 million (50 cases) for skin
reactions and 100 in 1 million (5,000 cases) for vomiting. The CICP
estimates that 75 percent of 560 (or 420) of the individuals alleging
serious injuries as a result of antivirals qualifying as covered
countermeasures will file requests for benefits with the CICP. However,
the CICP expects that only 5 percent of 5,050 (or 252) of the
individuals alleging less serious injuries will file Request Packages
with the CICP because the benefits available to them may be limited.
Certain ventilators used for life support of critically ill
patients with 2009 H1N1 infection are covered countermeasures.
Critically ill patients with pneumonia and respiratory failure due to
2009 H1N1 infection require invasive mechanical ventilators to assist
them with breathing. Many critically ill 2009 H1N1 patients in the
intensive care unit require invasive mechanical ventilation for several
weeks. Prolonged ventilator use is associated with serious adverse
events such as Ventilator Associated Pneumonia (VAP), which has a high
mortality rate. The CDC estimates that between 183,000 and 378,000
H1N1-related hospitalizations occurred from April 2009 to January 16,
2010. The mid-level in this range of 2009 H1N1-related hospitalizations
is about 257,000. CDC further estimates the 2009 H1N1-related deaths
which occurred between April 2009 and January 16, 2010 to be between
8,330 and 17,160. The mid-level in this range of 2009 H1N1-related
deaths is about 11,690. (The CICP expects that these individuals were
hospitalized before their deaths). The CICP estimates that 5 percent of
the mid-level (or 12,850) of the individuals hospitalized ended up in
the intensive care unit and 25 percent (or 3,213) of them were placed
on ventilators. About 10 percent of the 3,213 (or 321) got VAP, and the
CICP estimates that 5% (or 16) will file Requests for Benefits. Using
the mid-level range for H1N1-related deaths, the CICP estimates that 25
percent (or 2,922) were placed on ventilators and about 10 percent (or
292) of them got VAP. The CICP estimated that 5 percent (or 15) of the
survivors or the estates of those that have died as a result of the
2009 H1N1 virus may submit Requests for Benefits alleging that a death
was caused by a ventilator. Whether such requests will result in the
receipt of benefits depends on many factors, including whether the
administration or use of such ventilators met the requirements of the
applicable PREP Act declaration (or that a good faith belief of such
existed) and whether it is demonstrated that a covered injury was
sustained.
A total of 85 million N-95 filtering facepiece respirators were
distributed to project areas, with an initial distribution of 25
million occurring in April 2009, and a second distribution of 60
million occurring in October, 2009. However, it is impossible to
estimate how many were actually distributed by individual project
areas.
In 2009, the Department of Defense (DoD) provided smallpox
vaccinations to 176,068 persons which is about four times the number of
civilians (39,566) that received the smallpox vaccine between January
2003 and June 2004 when healthcare and emergency workers were receiving
the vaccine to prepare to respond to emergency situations.
Approximately 65 of the 39,566 civilians filed requests for benefits
with the Smallpox Vaccine Injury Compensation Program (SVICP), which
ended in January 2008, for injuries that they sustained after being
administered the smallpox vaccine. The CICP is using the experience
with the SVICP to derive its estimates of the number of requests for
benefits that may be filed with the CICP for injuries from the smallpox
vaccine. The CICP estimates that since four times as many military
personnel receied this vaccine as civilians, about four times as many
individuals who filed claims with the SVICP will file claims with the
CICP (because military personnel were generally not eligible to receive
benefits under the SVICP, but may be eligible to receive benefits under
the CICP). Therefore, the CICP estimates that about 260 Requests for
Benefits for injuries from the smallpox vaccine will be filed.
In 2009, DoD immunized 224,057 individuals with anthrax
vaccinations. Since the anthrax vaccine is as reactogenetic as the
smallpox vaccine, the SVICP experience is used to derive the estimates
of the number of request for benefits that will be filed with the CICP
for injuries from the anthrax vaccine. About six times the number of
military personnel (224,057) received the anthrax vaccine as healthcare
and emergency workers who received the

[[Page 63675]]

smallpox vaccine per year. Therefore, the CICP estimates that about 6
times as many individuals who filed claims with the SVICP will file
claims relating to the anthrax vaccine with the CICP. The CICP
estimates that about 390 requests for benefits for injuries from the
anthrax vaccine will be filed. It is important to note that these
estimates do not reflect the Secretary's assessment of the actual
number of serious injuries or deaths resulting from the covered
countermeasures described here. VAERS is a passive reporting system and
has inherent limitations. Although it is a useful resource to generate
hypotheses, it cannot be relied on to reach conclusions concerning the
numbers of serious injuries or deaths actually resulting from
particular vaccines. Moreover, even if the injuries are indeed serious
and are determined by the Secretary to have resulted from a covered
countermeasure, requesters with the CICP may still be deemed ineligible
for benefits (for example, the person using a covered countermeasure
may not have satisfied all of the specifications of the pertinent PREP
Act declaration, the Request Form might have been filed outside of the
one-year filing deadline).
Comments on this information collection activity should be sent to
OMB Desk Officer, Office of Management and Budget, Room 10235, New
Executive Office Building, 725 17th Street, NW., Washington, DC 20053;
Fax: (202) 395-3888.

List of Subjects in 42 CFR Part 110

Benefits, Biologics, Compensation, Immunization, Public Health,
Pandemic, Countermeasures, Pandemic Influenza, 2009 H1N1 Vaccine,
Influenza Antivirals, Tamiflu[supreg], Relenza[supreg], Peramivir,
Pandemic Influenza Diagnostics, Personal Respiratory Devices, N-95
Filtering Facepiece Respirators, Respiratory Support Devices,
Ventilators, Anthrax, Smallpox, Botulism, Acute Radiation Syndrome.

Dated: July 2, 2010.
Mary K. Wakefield,
Administrator, Health Resources and Services Administration.

Approved: July 12, 2010.
Kathleen Sebelius,
Secretary.

0
For the reasons stated in the preamble, the Department amends title 42
of the CFR by adding part 110 to read as follows:

PART 110--COUNTERMEASURES INJURY COMPENSATION PROGRAM

Subpart A--General Provisions
Sec.
110.1 Purpose.
110.2 Summary of available benefits.
110.3 Definitions.
Subpart B--Persons Eligible To Receive Benefits
110.10 Eligible requesters.
110.11 Survivors.
Subpart C--Covered Injuries
110.20 How to establish a covered injury.
Subpart D--Available Benefits
110.30 Benefits available to different categories of requesters
under this Program.
110.31 Medical benefits.
110.32 Benefits for lost employment income.
110.33 Death benefits.
Subpart E--Procedures for Filing Request Packages
110.40 How to obtain forms and instructions.
110.41 How to file a Request Package.
110.42 Deadlines for filing Request Forms.
110.43 Deadlines for submitting documentation.
110.44 Legal or personal representatives of requesters.
110.45 Multiple survivors.
110.46 Amending a request package.
Subpart F--Documentation Required for the Secretary To Determine
Eligibility
110.50 Medical records necessary for the Secretary to determine
whether a covered injury was sustained.
110.51 Documentation an injured countermeasure recipient must submit
for the Secretary to make a determination of eligibility for Program
benefits.
110.52 Documentation a survivor must submit for the Secretary to
make a determination of eligibility for death benefits.
110.53 Documentation the executor or administrator of the estate of
a deceased injured countermeasure recipient must submit for the
Secretary to make a determination of eligibility for benefits to the
estate.
Subpart G--Documentation Required for the Secretary To Determine
Program Benefits
110.60 Documentation a requester who is determined to be eligible
must submit for the Secretary to make a determination of medical
benefits.
110.61 Documentation a requester who is determined to be eligible
must submit for the Secretary to make a determination of lost
employment income benefits.
110.62 Documentation a requester who is determined to be an eligible
survivor must submit for the Secretary to make a determination of
death benefits.
110.63 Documentation a legal or personal representative must submit
when filing on behalf of a minor or on behalf of an adult who lacks
legal capacity to receive payment of benefits.
Subpart H--Secretarial Determinations
110.70 Determinations the Secretary must make before benefits can be
paid.
110.71 Insufficient documentation for eligibility and benefits
determinations.
110.72 Sufficient documentation for eligibility and benefits
determinations.
110.73 Approval of benefits.
110.74 Disapproval of benefits.
Subpart I--Calculation and Payment of Benefits
110.80 Calculation of medical benefits.
110.81 Calculation of benefits for lost employment income.
110.82 Calculation of death benefits.
110.83 Payment of all benefits.
110.84 The Secretary's right to recover benefits paid under this
Program from third-party payers.
Subpart J--Reconsideration of the Secretary's Determinations
110.90 Reconsideration of the Secretary's eligibility and benefits
determinations.
110.91 Secretary's review authority.
110.92 No additional judicial or administrative review of
determinations made under this part.
Subpart K--Covered Countermeasures Injury Tables
110.100 [Reserved]

Authority: 42 U.S.C. 247d-6e.

Subpart A--General Provisions

Sec. 110.1 Purpose.

This part implements the Public Readiness and Emergency
Preparedness Act (PREP Act), which amended the Public Health Service
Act (herein after ``PHS Act'' or ``the Act'') by including section
319F-3, and section 319F-4 entitled ``Covered Countermeasure Process.''
Section 319F-4 of the PHS Act directs the Secretary of Health and Human
Services, following issuance of a declaration under section 319F-3(b),
to establish procedures for the Countermeasures Injury Compensation
Program (herein after ``CICP'' or ``the Program'') to provide medical
and lost employment income benefits to certain individuals who
sustained a covered injury as the direct result of the administration
or use of a covered countermeasure consistent with a declaration issued
pursuant to section 319F-3(b), or in the good faith belief that
administration or use of the covered countermeasure was consistent with
a declaration. Also, if the Secretary determines that an individual
died as a direct result of a covered injury, the Act provides for
certain survivors of that individual to receive death benefits.

[[Page 63676]]

Sec. 110.2 Summary of available benefits.

(a) The Act authorizes three forms of benefits to, or on behalf of,
requesters determined to be eligible by the Secretary:
(1) Payment or reimbursement for reasonable and necessary medical
services and items to diagnose or treat a covered injury, or to
diagnose, treat, or prevent its health complications, as described in
Sec. 110.31.
(2) Lost employment income incurred as a result of a covered
injury, as described in Sec. 110.32.
(3) Death benefits to certain 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.
(b) In general, the benefits paid under the Program, are secondary
to any obligation of any third-party payer to provide or pay for such
benefits. The benefits available under the CICP usually will be paid
only 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 (e.g., medical insurance for
medical services or items, workers' compensation program(s) for lost
employment income). However, as provided in Sec. 110.84, the Secretary
has the discretion to pay benefits under this Program before a
potential third-party payer makes a determination on the availability
of similar benefits and has the right to later pursue a claim against
any third-party payer with a legal or contractual obligation to pay
for, or provide, such benefits.

Sec. 110.3 Definitions.

This section defines certain words and phrases found throughout
this part.
(a) Act or PHS Act means the Public Health Service Act, as amended.
(b) Alternative calculation means the calculation used in Sec.
110.82(c) of this part for the death benefit available to dependents
younger than 18 years old at the time of payment.
(c) Approval means a decision by the Secretary or her designee that
the requester is eligible for benefits under the Program.
(d) Benefits means payments and/or compensation for reasonable and
necessary medical expenses or provision of services described in Sec.
110.31, lost employment income described in Sec. 110.32, and/or
payment to certain survivors of death benefits described in Sec.
110.33.
(e)(1) Child means any natural, illegitimate, adopted, posthumous
child, or stepchild of a deceased injured countermeasure recipient who,
at the time of the countermeasure recipient's death is:
(i) 18 years of age or younger; or
(ii) Between 19 and 22 years of age and a full-time student; or
(iii) Incapable of self-support due to a physical or mental
disability.
(2) Posthumous child means a child born after the death of the
parent.
(3) Stepchild means a child of an injured countermeasure
recipient's spouse but who is not the child of the injured
countermeasure recipient. For a stepchild to be eligible for survivor
death benefits under the Program, the stepchild's parent must have been
married to the injured countermeasure recipient at the time of that
injured countermeasure recipient's death, and the stepchild must have
been supported by the injured countermeasure recipient.
(f) Covered Countermeasure means the term that is defined in
section 319F-3(i)(1) of the PHS Act and described in a declaration
issued under section 319F-3(b) of the PHS Act (42 U.S.C. 247d-
6d(i)(I),(b)). To be a covered countermeasure for purposes of this
part, the countermeasure must have been administered or used pursuant
to the terms of a declaration, or in a good faith belief of such; and
(1) Administered or used within a State (as defined in Sec.
110.3(aa)), or otherwise in the territory of the United States; or
(2) Administered to, or used by, otherwise eligible individuals--
(i) At American embassies or military installations abroad (such as
military bases, ships, and camps); or
(ii) At North Atlantic Treaty Organization (NATO) installations
(subject to the NATO Status Agreement) where American servicemen and
servicewomen are stationed.
(g) Covered injury means death, or a serious injury as described in
Sec. 110.20(b), and determined by the Secretary in accordance with
Sec. 110.20 of this part, to be:
(1) An injury meeting the requirements of a Covered Countermeasures
Injury Table, which is presumed to be the direct result of the
administration or use of a covered countermeasure unless the Secretary
determines there is another more likely cause; or
(2) An injury (or its health complications) that is the direct
result of the administration or use of a covered countermeasure. This
includes serious aggravation caused by a covered countermeasure of a
pre-existing condition.
(h) Declaration means a recommendation issued by the Secretary
under section 319F-3(b) of the PHS Act (42 U.S.C. 247d-6d(b)), for the
manufacture, testing, development, distribution, administration, or use
of one or more covered countermeasures, following her determination
that a specific disease, condition, or threat represents a public
health emergency or a credible risk of a future public health
emergency.
(i) Dependent means, for purposes of lost employment income
benefits, a person whom the Internal Revenue Service would consider to
be the injured countermeasure recipient's dependent at the time the
covered injury was sustained. For purposes of survivor death benefits,
dependent means a person whom the Internal Revenue Service would
consider to be the deceased injured countermeasure recipient's
dependent at the time the covered injury was sustained, and who is
younger than the age of 18 at the time of filing the Request Form.
(j) Disapproval means a decision by the Secretary that the
individual requesting benefits is not eligible to receive benefits
under the Program for the specified injury that is the basis of the
Request for Benefits.
(k) Effective period of the declaration means the time span
specified in a declaration, or as amended by the Secretary.
(l) Federal Employees' Compensation Act (FECA) Program means the
workers' compensation benefits program for civilian officers and
employees of the Federal Government established under 5 U.S.C. 8101 et
seq. as amended, and implemented by the United States Department of
Labor in regulations codified at 20 CFR part 10, as amended.
(m) Healthcare provider means an individual licensed, certified, or
registered by an appropriate authority and who is qualified and
authorized to provide health care services, such as diagnosing and
treating physical or mental health conditions, prescribing medications,
and providing primary and/or specialty care.
(n) Injured countermeasure recipient means an individual:
(1) Who, with respect to administration or use of a covered
countermeasure pursuant to a Secretarial declaration:
(i) Meets the specifications of the pertinent declaration; or
(ii) Is administered or uses a covered countermeasure in a good
faith belief that he or she is in a category described by paragraph
(1)(i) of this definition; and
(2) Sustained a covered injury as defined in Sec. 110.3(g).

[[Page 63677]]

(3) If a covered countermeasure is administered to, or used by, a
pregnant woman in accordance with paragraphs (1)(i) or (1)(ii) of this
definition, 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.
(o) Lacks legal capacity means legally incompetent to receive
payment(s) of benefits, as determined under applicable law.
(p) Medical records means documentation associated with primary
care, hospital in-patient and out-patient care, specialty
consultations, and diagnostic testing and results.
(q) Payer of last resort means that the Program pays benefits
secondary to all other public and private third-party payers who have
an obligation to pay for such benefits.
(r) Program means the Countermeasures Injury Compensation Program
(CICP).
(s) PREP Act means the Public Readiness and Emergency Preparedness
Act, codified as sections 319F-3 and 319F-4 of the PHS Act (42 U.S.C.
247d-6d, 42 U.S.C. 247d-6e).
(t) Public Safety Officers' Benefits (PSOB) Program means the
Program established under Subpart 1 of part L of title I of the Omnibus
Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.), as
amended, and implemented by the United States Department of Justice in
regulations codified at 28 CFR part 32, as amended.
(u) Representative (legal or personal) means someone other than the
person for whom Program benefits are sought, and who is authorized to
file the Request Package on the requester's behalf pursuant to Sec.
110.44.
(v) Requester means an injured countermeasure recipient, or
survivor, or the estate of a deceased injured countermeasure recipient
(through the executor or administrator of the estate) who files a
Request Package for Program benefits, or on whose behalf a Request
Package is filed, under this part.
(w) Request Form or Request for Benefits Form means the document
designated by the Secretary for applying for Program benefits under
this part.
(x) Request Package means the Request Form, all documentation
submitted by, or on behalf of, the requester, and all documentation
obtained by the Secretary as authorized by, or on behalf of, the
requester for determinations of Program eligibility and benefits under
this part.
(y) Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority conferred on the Secretary under the
PREP Act has been delegated.
(z) Serious injury means serious physical injury. 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 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 injuries.
(aa) Standard calculation means the calculation used in Sec.
110.82(b) of this part for the death benefit available to all eligible
survivors (other than surviving dependents younger than the age of 18
who do not fit the definition of ``child'' under Sec. 110.3(e)).
(bb) State means any State of the United States of America, the
District of Columbia, United States territories, commonwealths, and
possessions, the Republic of the Marshall Islands, the Republic of
Palau, and the Federated States of Micronesia.
(cc) Survivor means a person meeting the requirements of Sec.
110.11 with respect to a deceased injured countermeasure recipient who
died as a direct result of a covered injury.
(dd) Table or Table of Injuries means a Table of Covered
Countermeasure Injuries to be included under Subpart K of this part,
including the definitions and requirements set out therein.
(ee) Third-party payer means the United States (other than for
payments of benefits under this Program) or any other third party,
including but not limited to, any State or local governmental entity,
private insurance carrier, or employer, any public or private entity
with a legal or contractual obligation to pay for or provide benefits.
The Program is the payer of last resort.

Subpart B--Persons Eligible To Receive Benefits

Sec. 110.10 Eligible requesters.

(a) The following requesters may, as determined by the Secretary,
be eligible to receive benefits from this Program:
(1) Injured countermeasure recipients, as described in Sec.
110.3(n);
(2) Survivors, as described in Sec. 110.3(cc) and Sec. 110.11; or
(3) Estates of deceased injured countermeasure recipients through
individuals authorized to act on behalf of the deceased injured
countermeasure recipient's estate under applicable State law (i.e.,
executors or administrators).
(b) If a countermeasure recipient dies, his or her survivor(s) and/
or the executor or administrator of his or her estate may file a new
Request Package (or Request Package(s)) or amend a previously filed
Request Package. A new Request Package may be filed whether or not a
Request Package was previously submitted by, or on behalf of, the
deceased injured countermeasure recipient, but must be filed within the
filing deadlines described in Sec. 110.42. Amendments to previously
filed Request Packages and the filing deadlines for such amendments are
described in Sec. 110.46.
(c) The benefits available to different categories of requesters
are described in Sec. 110.30.

Sec. 110.11 Survivors.

(a) Survivors of injured countermeasure recipients who died as the
direct result of a covered injury. If the Secretary determines that an
injured countermeasure recipient died as the direct result of a covered
injury (or injuries), his or her survivor(s) may be eligible for death
benefits.
(b) Survivors who may be eligible to receive benefits and the order
of priority for benefits. (1) The Act uses the same categories of
survivors and order of priority for benefits as established and defined
by the PSOB Program, except as provided in paragraphs (b)(3), (4), and
(5) of this section.
(2) The PSOB Program's categories of survivors (known in the PSOB
Program as beneficiaries) and order of priority for receipt of death
benefits are detailed under subpart 1 of part L of title I of the
Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et
seq.), as amended, as implemented in 28 CFR part 32.
(3) In the PSOB Program, the person who is survived must have
satisfied the eligibility requirements for a deceased public safety
officer, whereas the person who is survived under this Program must be
a deceased injured countermeasure recipient who would otherwise have
been eligible under this part.
(4) Unlike the PSOB Program, if there are no survivors eligible to
receive death benefits under the PSOB Program (as set forth in
paragraph (b)(2) of this section), the legal guardian of a deceased
minor who was a countermeasure recipient may be eligible as a survivor
under this Program. Such legal guardianship must

[[Page 63678]]

be determined by a court of competent jurisdiction under applicable
State law.
(5) A surviving dependent younger than the age of 18 whose legal
guardian opts to receive a death benefit under the alternative
calculation on the dependent's behalf will have the same priority as
surviving eligible children under the PSOB Program (consistent with
paragraph (b)(2) of this section) even if the dependent is not the
surviving eligible child of the deceased countermeasure recipient for
purposes of the PSOB Program. However, such a dependent may only be
eligible to receive benefits under the alternative death benefits
calculation, described in Sec. 110.82(c), and is not eligible to
receive death benefits under the standard calculation described in
Sec. 110.82(b). Death benefits paid under the alternative calculation
will be paid to the dependents' legal guardian(s) on behalf of all such
dependents.
(6) Any change in the order of priority of survivors or of the
eligible category of survivors under the PSOB Program shall apply to
requesters seeking death benefits under this Program on the effective
date of the change, even prior to any corresponding amendment to this
part. Such changes will apply to Request Packages pending with the
Program on the effective date of the change, as well as to Requests
filed after that date.

Subpart C--Covered Injuries

Sec. 110.20 How to establish a covered injury.

(a) General. Only serious injuries, as described in Sec. 110.3(z),
or deaths are covered under the Program. In order to be eligible for
benefits under the Program, a requester must submit documentation
showing that a covered injury, as described in Sec. 110.3(g), was
sustained as the direct result of the administration or use of a
covered countermeasure pursuant to the terms of a declaration under
section 319F-3(b) of the PHS Act (including administration or use
during the effective period of the declaration) or as the direct result
of the administration or use of a covered countermeasure in a good
faith belief that it was administered or used pursuant to the terms of
a declaration (including administration or use during the effective
period of the declaration). A requester can establish that a covered
injury was sustained by demonstrating to the Secretary that a Table
injury occurred, as described in paragraph (c) of this section. In the
alternative, a requester can establish that an injury was actually
caused by a covered countermeasure, as described in paragraph (d) of
this section. The Secretary may obtain the opinions of qualified
medical experts in making determinations concerning covered injuries.
(b) Table injuries. A Table lists and explains injuries that, based
on compelling, reliable, valid, medical and scientific evidence, are
presumed to be caused by a covered countermeasure, and the time periods
in which the onset (i.e., first sign or symptom) of these injuries must
occur after administration or use of the covered countermeasures. If an
injury occurred within the listed time periods, and at the level of
severity required, there is a rebuttable presumption that the covered
countermeasure was the cause of the injury. A Table is accompanied by
Qualifications and Aids to Interpretation which provide an explanation
of the injuries listed on a Table. A requester may establish that a
covered injury occurred by demonstrating that the countermeasure
recipient sustained an injury listed on a Table, within the time
interval defined by the Table's Definitions and Requirements. In such
circumstances, the requester need not demonstrate the cause of the
injury because the Secretary will presume, only for purposes of making
determinations under this Subpart, that the injury was the direct
result of the administration or use of a covered countermeasure. Even
if the Table requirements are satisfied, however, an injury will not be
considered a covered injury if the Secretary determines, based on her
review of the evidence, that a source other than the countermeasure
more likely caused the injury. In such circumstances, the Table
presumption of causation will be rebutted.
(c) Injuries for which causation must be shown (non-Table
injuries). If an injury is not included on a Table or if the injury
does not meet the requirements set out for an injury that is listed on
a Table (e.g., the first sign or symptom of the injury did not occur
within the time interval specified on the Table), the requester must
demonstrate that the injury occurred as the direct result of the
administration or use of a covered countermeasure. Such proof must be
based on compelling, reliable, valid, medical and scientific evidence.
Temporal association between receipt of the countermeasure and onset of
the injury is not sufficient by itself to prove that the countermeasure
caused the injury.
(d) Injuries resulting from the underlying condition for which the
countermeasure was administered or used. An injury sustained as the
direct result of the covered condition or disease for which the
countermeasure was administered or used, and not as the direct result
of the administration or use of the covered countermeasure, is not a
covered injury (e.g., if the covered countermeasure is ineffective in
treating or preventing the underlying condition or disease).

Subpart D--Available Benefits

Sec. 110.30 Benefits available to different categories of requesters
under this Program.

(a) Benefits available to injured countermeasure recipients. A
requester who is an injured countermeasure recipient may be eligible to
receive either medical benefits or benefits for lost employment income,
or both.
(b) Benefits available to survivors. A requester who is an eligible
survivor of a deceased injured countermeasure recipient may be eligible
to receive a death benefit if the death was caused by the covered
injury or its health complications.
(c) Benefits available to estates of deceased injured
countermeasure recipients. The estate of an otherwise eligible deceased
injured countermeasure recipient may be eligible to receive medical
benefits or benefits for lost employment income, or both, if such
benefits were accrued during the deceased countermeasure recipient's
lifetime, or at the time of death, as a result of a covered injury or
its health complications, but have not yet been paid in full by the
Program. Such medical benefits and benefits for lost employment income
may be available regardless of the cause of death. The estate of the
deceased injured countermeasure recipient may not receive a death
benefit. Death benefits are only available to certain survivors.

Sec. 110.31 Medical benefits.

(a) Injured countermeasure recipients may receive payments or
reimbursements for medical services and items that the Secretary
determines to be reasonable and necessary to diagnose or treat a
covered injury, or to diagnose, treat, or prevent the health
complications of a covered injury. The Secretary may pay for such
medical services and items in an effort to cure, counteract, or
minimize the effects of any covered injury, or any health complication
of a covered injury, or to give relief, reduce the degree or the period
of disability, or aid in lessening the amount of benefits to a
requester (e.g., a surgical procedure that lessens the amount of time
and expense for the treatment of a covered injury). The

[[Page 63679]]

Secretary may make such payments or reimbursements if reasonable and
necessary medical services and items have already been provided or if
they are likely to be needed in the future. In making determinations
about which medical services and items are reasonable and necessary,
the Secretary may consider whether those medical services and items
were prescribed or recommended by a healthcare provider, and may
consider whether the applicable service or item is within the standard
of care for that condition.
(b) To receive medical benefits for the health complications of a
covered injury, a requester must demonstrate that the complications are
the direct result of the covered injury. Examples of health
complications include, but are not limited to, 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 a
covered injury.
(c) The calculation of medical benefits available under this
Program is described in Sec. 110.80. Although there are no caps on
medical benefits, the Secretary may limit payments to the amounts that
she determines are reasonable for services and items considered
reasonable and necessary. All payment or reimbursement for medical
services and items is secondary to any obligation of any third-party
payer to pay for or provide such services or items to the requester. As
provided in Sec. 110.84, the Secretary retains the right to recover
medical benefits paid by the Program to requesters if third-party
payers are obligated to provide those benefits. Requesters are expected
to make good faith efforts to pursue medical benefits and services from
their primary payers. The Secretary reserves the right to disapprove
medical benefits if the requester fails to do so.
(d) The Secretary may make payments of medical benefits or
reimbursements of medical expenses described in this section to the
estate of a deceased injured countermeasure recipient as long as such
payments or expenses were accrued during the deceased injured
countermeasure recipient's lifetime, or at the time of death, as the
result of the covered injury or its health complications, and were not
paid in full by the Program before the deceased injured countermeasure
recipient died.

Sec. 110.32 Benefits for lost employment income.

(a) Requesters who are determined to be eligible for Program
benefits as injured countermeasure recipients may be able to receive
benefits for loss of employment income incurred as a result of a
covered injury (or its health complications, as described in Sec.
110.31(b)). Compensation for lost wages is paid as a percentage of the
amount of employment income earned at the time of injury and lost as
the result of the covered injury or its health complications. The
period of time requested for lost employment income benefits must be
supported by the severity of the covered injury as demonstrated by the
medical and employment records.
(b) The method and amount of benefits for lost employment income
are described in Sec. 110.81. Benefits for lost employment income will
be adjusted if there are fewer than ten days of lost employment income.
Pursuant to law, and as described in Sec. 110.81, benefits provided
for lost employment income may also be adjusted for annual and lifetime
caps. Payment of benefits for lost employment income is secondary to
any obligation of any third-party payer to pay for lost employment
income or to provide disability or retirement benefits to the
requester. It is the obligation of requesters to follow all specified
procedures to apply for and acquire third-party benefits. The Secretary
has the discretion to disapprove lost employment income benefits if the
requester fails to do so. As provided in Sec. 110.84, the Secretary
reserves the right to recover lost employment income benefits paid by
the Program to requesters if third-party payers are obligated to
provide those benefits.
(c) The Secretary does not require an individual to use paid leave
(e.g., sick leave or vacation leave) for lost work days. However, if an
individual uses paid leave for lost work days, the Secretary will not
consider those days to be days of lost employment income unless the
individual reimburses the employer for the paid leave taken and the
employer restores the leave that was used. This puts the individual
back in the same position as if he or she had not used paid leave for
the lost work days.
(d) The Secretary may pay benefits for lost employment income to
the estate of a deceased injured countermeasure recipient as long as
such benefits were accrued during the deceased injured countermeasure
recipient's lifetime as the result of a covered injury or its health
complications, and were not paid in full by the Program before the
deceased injured countermeasure recipient died. However, no such lost
employment income may be paid after the receipt, by the survivor or
survivors of a deceased injured countermeasure recipient, of death
benefits under Sec. 110.82.

Sec. 110.33 Death benefits.

(a) Eligible survivors may be able to receive a death benefit under
this Program if the Secretary determines that an otherwise eligible
countermeasure recipient sustained a covered injury and died as a
direct result of the injury or its health complications. The method and
amount of death benefits are described in Sec. 110.82. As provided in
Sec. 110.84, the Secretary retains the right to recover death benefits
paid by the Program if third-party payers are obligated to provide
those benefits. There are two different calculations for death
benefits: the standard calculation and the alternative calculation.
(b) The standard calculation, described in Sec. 110.82(b), is
based upon the death benefit available under the PSOB Program and is
available to all eligible survivors with one exception (surviving
dependents younger than the age of 18 who do not fit the definition of
``child'' under Sec. 110.3(e)). In the event that death benefits were
paid under the PSOB Program with respect to the deceased injured
countermeasure recipient, no death benefits may be paid under the
standard calculation. In addition, death benefits under this standard
calculation are secondary to disability benefits under the PSOB
Program. If a disability benefit was paid under the PSOB Program, the
amount of that disability benefit would be deducted from benefits
payable under the standard calculation.
(c) The alternative calculation, described in Sec. 110.82(c), is
based on the injured countermeasure recipient's employment income at
the time of the covered injury. Payment under this calculation is only
available to surviving dependents who are younger than the age of 18 at
the time of payment. The legal guardian(s) of such surviving dependents
must select the death benefit as calculated under this alternative
calculation before it will be paid. Annual and lifetime caps may apply.
The payment of a death benefit as calculated under this alternative
calculation is secondary to other benefits paid or payable with respect
to the deceased injured countermeasure recipient, namely:
(1) Compensation for loss of employment income (except for lost
employment income under this Program);
(2) Death or disability benefits (i.e., payments including, but not
limited to, those under the PSOB Program) on behalf of the dependent(s)
or their legal guardian(s);

[[Page 63680]]

(3) Retirement benefits on behalf of the dependent(s) or their
legal guardians; or
(4) Life insurance benefits on behalf of the dependent(s).

Subpart E--Procedures for Filing Request Packages

Sec. 110.40 How to obtain forms and instructions.

(a) Copies of all necessary forms and instructions will be
available:
(1) By writing to the Countermeasures Injury Compensation Program,
Healthcare Systems Bureau, Health Resources and Services
Administration, Parklawn Building, Room 11C-26, 5600 Fishers Lane,
Rockville, MD 20857.
(2) By calling 1-888-ASK-HRSA. This is a toll-free number.
(3) By downloading them from the Internet at http://www.hrsa.gov/countermeasurescomp/. Click on the link to ``Forms and Instructions.''
(b) Before reviewing a Request for Benefits, the Secretary will
assign a case number to the Request for Benefits and so inform the
requester (or his or her representative) in writing. All correspondence
to the requester (or his or her representative) about a specific
Request for Benefits will be referenced by this case number.

Sec. 110.41 How to file a Request Package.

A Request Package comprises all the forms and documentation that
are submitted to enable the Secretary to determine eligibility and
calculate benefits. Request Packages may be submitted through the U.S.
Postal Service, commercial carrier, or private courier service. The
Countermeasures Injury Compensation Program will not accept Request
Packages that are hand-delivered. Electronic submissions are not
currently accepted, but may be in the future. The Program will publish
a notice if electronic filing becomes available. Requesters (or their
representatives) should send all forms and documentation to the
Countermeasures Injury Compensation Program, Healthcare Systems Bureau,
Health Resources and Services Administration, Parklawn Building, Room
11C-26, 5600 Fishers Lane, Rockville, MD 20857. All documentation to
the Program must include the case number once one has been assigned to
the requester.

Sec. 110.42 Deadlines for filing Request Forms.

(a) General. All Request Forms (or Letters of Intent, described in
paragraph (b) of this section) must be filed within one year of the
date of the administration or use of a covered countermeasure that is
alleged to have caused the injury. If no previous Request Form (or
Letter of Intent) has been filed, this deadline also applies to
survivor(s) of an injured countermeasure recipient who is deceased, and
to the executor or administrator of his or her estate. If a Request
Form (or Letter of Intent) was previously filed, Sec. 110.46 describes
amendments to Request Packages.
(b) Letters of Intent. Until Request Forms and Instructions are
available, requesters must file a Letter of Intent to File, in order to
establish that their Requests for Benefits are timely filed within the
one-year deadline. Directions for submitting a Letter of Intent (to
file) are available on the Program's Web site at http://www.hrsa.gov/countermeasurescomp/ or by calling 1-888-ASK-HRSA. Even once Request
Forms are available, the Secretary has the discretion to accept Letters
of Intent (to file) for purposes of meeting the filing deadline.
However, when Request Forms and Instructions are available, all
requesters who have submitted Letters of Intent must still file Request
Forms as soon as possible.
(c) Determination of proper filing. The filing date is the date the
Request Form (or Letter of Intent) is postmarked. A legibly dated
receipt from a commercial carrier, a private courier service, or the
U.S. Postal Service will be considered equivalent to a postmark. If and
when Request Forms are accepted electronically, the filing date is the
date the Request Form is submitted electronically. A Request Form will
not be considered filed unless it has been completed (to the fullest
extent possible) and signed by the requester or his or her personal or
legal representative. After filing a Request Form within the governing
filing deadline, a requester must update the Request Package to reflect
new information as it becomes available (e.g., copies of medical
records generated after the initial submission of the Request Package).
(d) Request Forms not filed within the one-year deadline. If the
Secretary determines that a Request Form or Letter of Intent was not
filed within the governing filing deadline set out in this section, the
Request Form (or Letter of Intent) will not be processed and the
requester will not be eligible for benefits under this Program.
(e) Constructive receipt. The Secretary reserves the right to
consider a legal claim filed with the Federal Government (e.g., a
Federal Tort Claims Act claim or a petition with the National Vaccine
Injury Compensation Program) concerning an alleged injury resulting
from the administration or use of a covered countermeasure to be a
filing of a Request Form or Letter of Intent for purposes of
determining the filing date under this Program. The date of such
constructive filing will be the official filing date of the action,
i.e., when all applicable requirements for proper filing in that forum
have been met.
(f) Request Forms (or amendments to Request Forms) based on initial
publication of a Table of Injuries or modifications to an existing
Table. The Secretary may publish a new Table (or Tables) by
amendment(s) to subpart K of this part. The effect of such a new Table
or amendment may enable a requester who previously could not establish
a Table injury to do so. In such circumstances, the requester must file
a new Request Form if one was previously submitted and eligibility was
denied or if one was not previously submitted within one year after the
effective date of the establishment of, or amendment to, the Table. If
the Secretary has not made a determination, she will automatically
review any pending Request Forms in light of the new or amended
Table(s).

Sec. 110.43 Deadlines for submitting documentation.

(a) Documentation for eligibility determinations. A requester will
satisfy the filing deadline as long as the signed Request Form is
completed (to the fullest extent possible) and submitted within the
governing filing deadline described in Sec. 110.42. The Secretary
generally will not begin review of a requester's eligibility until all
the documentation necessary to make this determination has been
submitted.
(b) Documentation for benefits determinations. Although the
Secretary will accept documentation required to make benefits
determinations (i.e., calculate benefits available, if any) at the time
the Request Form is filed or any time thereafter, requesters need not
submit such documentation until they have been notified that the
Secretary has determined eligibility. The Secretary will not generally
begin review of the benefits available to a requester until the
documentation necessary to make a benefits determination has been
submitted.

Sec. 110.44 Legal or personal representatives of requesters.

(a) Generally. Persons other than a requester (e.g., a lawyer,
guardian, family member, friend) may file a Request Package on a
requester's behalf as his or her legal or personal representative. A
requester need not use the services of a lawyer to apply for

[[Page 63681]]

benefits under this Program. A legal representative, or a personal
representative (who does not need to be a lawyer) is only required, as
described in this section, for requesters who are minors or adults who
lack legal capacity to receive payment of benefits. In the event that a
legal or personal representative files on behalf of a requester, the
representative will be bound by the obligations and documentation
requirements that apply to the requester (e.g., if a requester is
required to submit employment records, the representative must file the
requester's employment records). The representative must also satisfy
the requirements specific to representatives set out in this part. If a
requester has a representative, the Program will generally direct all
communications to the representative. However, the Secretary reserves
the right of the Program to contact the requester directly if
necessary, and to conduct a follow-up survey to determine the ability
of the Program to meet requesters' needs.
(b) Legal or personal representatives of legally competent adults.
A requester who is a legally competent adult may use a legal or
personal representative to submit a Request Package on his or her
behalf. In such circumstances, the requester must indicate on the
Request Form that he or she is authorizing the representative to seek
benefits under this Program on his or her behalf.
(c) Legal or personal representatives of minors and adults who lack
legal capacity to receive payment of benefits. A requester who is a
minor or an adult who lacks legal capacity to receive payment of
benefits must use a legal or personal representative to apply for
benefits under this Program on his or her behalf. In such
circumstances, the representative must indicate, in the place provided
on the Request Form, that the requester is a minor or an adult who
lacks legal capacity to receive payment of benefits and that the
representative is filing on behalf of the requester. In addition,
before the requester will be paid by the Program, the representative
must submit the documentation described in Sec. 110.63. A minor who is
emancipated, as determined by a court of competent jurisdiction, does
not need a legal or personal representative to file a Request Form or
Request Package on his or her behalf.
(d) No payment or reimbursement for legal or personal
representatives' fees or costs. The Act does not authorize the
Secretary to pay for, or reimburse, any fees or costs associated with
the requester's use of the services of a legal or personal
representative under this Program, including those of an attorney.

Sec. 110.45 Multiple survivors.

Multiple survivors of the same deceased injured countermeasure
recipient may file Request Forms separately or together. Multiple
survivors may also submit one set of any required documentation on
behalf of all of the requesting survivors as long as such documentation
is identical for each survivor.

Sec. 110.46 Amending a Request Package.

(a) Generally. All requesters may amend their documentation
concerning eligibility up to the time the Secretary has made an
eligibility determination. Requesters are expected to submit additional
medical records as they become available. Requesters also may amend
their information or documentation concerning the calculation of
benefits until the Secretary has made a benefits determination. Once an
eligibility determination has been made, the Secretary will not accept
additional documentation concerning eligibility, except as described in
paragraphs (b) and (c) of this section. Once a benefits determination
has been made, the Secretary will not accept additional documentation
regarding the type or amount of benefits for that covered injury,
except as described in paragraphs (b) and (c) of this section.
(b) Requesters who are survivors. If an injured countermeasure
recipient submitted a Request Form within the filing deadline, but
subsequently dies, or the executor or administrator timely filed on
behalf of the estate, the survivor(s) may amend the previously filed
Request Package at any time by filing a new Request Form in order to be
considered for death benefits. Such an amendment can be filed
regardless of whether the Secretary made an eligibility determination
or paid benefits with respect to the deceased injured countermeasure
recipient's Request Package. However, a survivor filing an amendment to
a previously filed Request Package may only be eligible for benefits if
the previously filed Request Package was filed within the governing
filing deadline. All documentation that has already been submitted with
respect to the deceased injured countermeasure recipient will be
considered part of the survivor requester's Request Package, and he or
she is not required to resubmit such documentation. Survivor requesters
must also file an amendment to a Request Package if there is a change
in the order of priority of survivors, as described in Sec. 110.11.
(c) Requests in which the benefits are sought for the estate of a
deceased injured countermeasure recipient. If an injured countermeasure
recipient submitted a Request Form within the filing deadline, but
subsequently dies before all due benefits are paid by the Program, the
executor or administrator of his or her estate may amend his or her
Request Package at any time in order for the estate to be considered
for benefits. This opportunity to amend applies also if the Request
Form was timely filed by a survivor. Such an amendment can be filed
regardless of whether the Secretary made an eligibility determination
or paid benefits with respect to the deceased injured countermeasure
recipient's Request Package. However, the executor or administrator of
the deceased injured countermeasure recipient's estate filing an
amendment to a previously filed Request Package may only be eligible to
receive benefits on behalf of the estate if the previously filed
Request Package was filed within the governing deadline. All
documentation that has already been submitted with respect to the
deceased injured countermeasure recipient will be considered part of
that person's Request Package, and the executor or administrator of the
estate is not required to resubmit such documentation.

Subpart F--Documentation Required for the Secretary To Determine
Eligibility

Sec. 110.50 Medical records necessary for the Secretary to determine
whether a covered injury was sustained.

(a) In order to determine whether an injured countermeasure
recipient sustained a covered injury, a requester must arrange for his
or her medical providers to submit to the Program the following medical
records, as defined in Sec. 110.3(p):
(1) All medical records documenting medical visits, procedures,
consultations, and test results that occurred on or after the date of
administration or use of the covered countermeasure; and
(2) All hospital records, including the admission history and
physical examination, the discharge summary, all physician subspecialty
consultation reports, all physician and nursing progress notes, and all
test results that occurred on or after the date of administration or
use of the covered countermeasure; and
(3) All medical records for one year prior to administration or use
of the covered countermeasure as necessary to

[[Page 63682]]

indicate an injured countermeasure recipient's pre-existing medical
history.
(b) A requester may submit additional medical documentation that he
or she believes will support the Request Package. Although generally
not required if a Table injury was sustained, a requester may introduce
additional medical documentation or scientific evidence in order to
establish that an injury was caused by a covered countermeasure.
Letters from treating physicians may be submitted as additional
evidence, but may not substitute for the medical documentation required
in paragraph (a) of this section.
(c) If certain medical records listed in paragraph (a) of this
section are unavailable to the Program after the requester has made
reasonable efforts to facilitate the records being sent to the Program,
the requester must submit a statement describing the reasons for the
records' unavailability and the efforts he or she has made to arrange
for the health care providers to submit them. The Secretary has the
discretion to accept this statement in place of the unavailable medical
records. In this circumstance, the Secretary may attempt to obtain the
records on the requester's behalf.
(d) In certain circumstances, the Secretary may require additional
records to make a determination that a covered injury was sustained
(e.g., medical records more than one year prior to the date of
administration or use of the covered countermeasure) or may determine
that certain records described in paragraph (a) of this section are not
necessary for an eligibility determination.
(e) Although the Secretary prefers to receive medical records
directly from healthcare providers, she has the discretion to accept
them from the requester.

Sec. 110.51 Documentation an injured countermeasure recipient must
submit for the Secretary to make a determination of eligibility for
Program benefits.

(a) An injured countermeasure recipient (or his or her legal or
personal representative) must submit all of the following documentation
in order for the Secretary to make a determination of eligibility:
(1) A completed and signed Request Form submitted within the filing
deadline described in Sec. 110.42; and
(2) Records sufficient to demonstrate that the injured
countermeasure recipient used or was administered a covered
countermeasure; and
(3) Records sufficient to demonstrate that the injured
countermeasure recipient sustained a covered injury, as defined in
Sec. 110.3(g), in accordance with the requirements set forth in Sec.
110.50; and
(4) A copy of each signed Authorization for Health Information Form
authorizing the release of records to the Program that was sent by the
requester to each healthcare provider instructing that the records be
submitted directly to the Program.
(b) In certain circumstances, some of the above documentation may
not be required, or additional documentation may be required, in which
case the Secretary will so notify the requester. For example, the
Secretary may require records sufficient to demonstrate that the
injured countermeasure recipient was administered or used a covered
countermeasure in accordance with the provisions of a Secretarial
declaration, or in the good faith belief that it was so administered or
used, if she is unable to determine this from the records submitted. In
order to meet the specifications of a declaration, some individuals
will need to show that the activity giving rise to the injury (i.e.,
administration or use of the covered countermeasure) was authorized in
accordance with the public health and medical response of the Authority
Having Jurisdiction, as defined in the pertinent declaration, to
prescribe, administer, deliver, distribute or dispense the covered
countermeasure following a declaration of an emergency, as defined in
the pertinent declaration. For purposes of this part, this requirement
can be satisfied by showing that the covered countermeasure was
administered or used following the declaration of an emergency, as
defined in the pertinent declaration, by an Authority Having
Jurisdiction, as defined in the pertinent declaration either:
(1) Pursuant to a written agreement or other formal arrangement
with an Authority Having Jurisdiction; or
(2) In accordance with the written recommendations of an Authority
Having Jurisdiction.

Sec. 110.52 Documentation a survivor must submit for the Secretary to
make a determination of eligibility for death benefits.

(a) A requester who is a survivor under Sec. 110.11 must submit
the following documentation in order for a determination of eligibility
for a death benefit to be made:
(1) All of the documentation required for individuals in Sec.
110.51. There is no need to duplicate documentation already submitted
to satisfy the requirements of other subparts in this part. For
example, if the deceased injured countermeasure recipient had
previously filed, the documentation submitted does not have to be re-
submitted; and
(2) A death certificate for the deceased countermeasure recipient.
If a death certificate is unavailable, the requester must submit a
letter providing the reasons for its unavailability. The Secretary has
the discretion to accept other documentation as evidence that the
injured countermeasure recipient is deceased; and
(3) Medical records sufficient to establish that the deceased
injured countermeasure recipient died as the result of the covered
injury or its health complications. Such medical records may be the
same as those required under Sec. 110.50. If an autopsy was performed,
the requester must submit a complete copy of the final autopsy report;
and
(4) Documentation showing that the requester is an eligible
survivor, pursuant to Sec. 110.11 (e.g., birth certificate or marriage
certificate); and
(5) Verification, on the place provided on the Request Form, either
that there are no other eligible survivors (e.g., for surviving
eligible children, that there is no surviving spouse, no other
surviving eligible children, and no other surviving dependents younger
than the age of 18 who may be eligible for the death benefit under the
alternative calculation) or that other eligible survivors exist (along
with the information known about such survivors). Section 110.11
describes eligible survivors and the priorities of survivorship; and
(6) Even if a Request Form had previously been filed by the injured
countermeasure recipient, the survivor(s) must submit a new Request
Form.
(b) [Reserved]

Sec. 110.53 Documentation the executor or administrator of the estate
of a deceased injured countermeasure recipient must submit for the
Secretary to make a determination of eligibility for benefits to the
estate.

(a) The executor or administrator of the estate of a deceased
injured countermeasure recipient must submit the following
documentation in order for a determination of eligibility for benefits
to the estate to be made:
(1) All of the documentation required for individuals in Sec.
110.51;
(2) A death certificate for the deceased injured countermeasure
recipient. If a death certificate is unavailable, the executor or
administrator must submit a letter providing the reasons for its

[[Page 63683]]

unavailability. The Secretary has the discretion to accept other
documentation as evidence that the injured countermeasure recipient is
deceased; and
(3) Documentation showing that the individual is the executor or
administrator of the estate of the deceased injured countermeasure
recipient, e.g., Letter of Administration issued by a court of
competent jurisdiction; and
(4) Even if a Request Form had previously been filed by the injured
countermeasure recipient, the executor or administrator of the estate
must submit a new Request Form.
(b) [Reserved]

Subpart G--Documentation Required for the Secretary To Determine
Program Benefits

Sec. 110.60 Documentation a requester who is determined to be
eligible must submit for the Secretary to make a determination of
medical benefits.

(a) A requester determined by the Secretary to be eligible for
Program benefits and who seeks payment or reimbursement for medical
services or items must provide the following, in addition to the
documentation submitted under subpart F of this part:
(1) List of third-party payers. The requester must submit a list of
all third-party payers that may have an obligation to pay for or
provide any medical services or items to the injured countermeasure
recipient for which payment or reimbursement is being sought under this
Program. Such third-party payers may include, but are not limited to,
health maintenance organizations, health insurance companies, workers'
compensation programs, Medicare, Medicaid, Department of Veterans
Affairs, military treatment facilities (MTFs), and any other entities
obligated to provide medical services or items or reimburse individuals
for medical expenses. Such a list must include the injured
countermeasure recipient's account numbers and other applicable
information. If the requester knows of no such third-party payer, he or
she must so certify in writing. If the requester becomes aware that a
third-party payer may have such an obligation, the requester must
inform the Secretary within ten business days of becoming aware of this
information, even after benefits have been paid by the Program.
(2) Documents for medical services or items provided since the
onset of the covered injury. A requester seeking payment or
reimbursement for medical services or items already provided for a
covered injury or its health complications must submit an itemized
statement from each healthcare provider or entity (e.g., clinic,
hospital, doctor, or pharmacy) and third-party payer listing the
services or items provided to diagnose or treat the covered injury or
its health complications and the amounts paid or expected to be paid by
third parties for such services or items (e.g., an Explanation of
Benefits from the individual's health insurance company). If no third-
party payer has an obligation to pay for or provide such services or
items, the requester must so certify in writing and submit an itemized
list of the services or items provided (including the total cost of
such services or items). To assist the Secretary in making a
determination as to whether such services or items were reasonable and
necessary to diagnose or treat a covered injury, or to diagnose, treat,
or prevent its health complications, the requester may submit, in
addition to the required medical records, documentation showing that a
health-care provider prescribed or recommended such services or items.
The medical records must support the requested services and items.
(3) Documents for medical services and items expected to be
provided in the future. A requester seeking payments for medical
services or items resulting from a covered injury or its health
complications expected to be provided in the future must submit a
statement from each healthcare provider (e.g., a treating neurologist
for neurological issues and a treating cardiologist for cardiac issues)
describing those services and items that appear likely to be needed to
diagnose or treat the covered injury, or to diagnose, treat, or prevent
its health complications, in the future. The medical records must
support the requested services and items. A requester must submit
documentation, if available, concerning the likely cost of, and the
amount expected to be covered by third-party payers for, such services
or items. Consent for the Program to communicate directly with the
healthcare providers may also be required.
(b) [Reserved]

Sec. 110.61 Documentation a requester who is determined to be
eligible must submit for the Secretary to make a determination of lost
employment income benefits.

(a) A requester determined by the Secretary to be eligible for
Program benefits and who seeks benefits for lost employment income must
provide, in addition to the documentation submitted under subpart F of
this part, documentation describing:
(1) The number of days (including partial days) of work missed by
the injured countermeasure recipient as a result of the covered injury
or its health complications for which employment income was lost (e.g.,
time sheet from the relevant pay period(s) showing work days missed).
As stated in Sec. 110.32(c), days for which an individual used paid
leave will be considered days of work for which employment income was
received and, therefore, would not qualify for lost employment income
benefits. However, if the injured countermeasure recipient reimburses
the employer for the paid leave taken and the employer restores the
leave that was used, the individual may be eligible for lost employment
income benefits for those days; and
(2) The injured countermeasure recipient's gross employment income
at the time the covered injury was sustained (e.g., the individual's
Federal tax return or pay stub(s) from all employers at the time of the
covered injury); and
(3) Whether the injured countermeasure recipient had one or more
dependents at the time the covered injury was sustained (e.g., the
individual's Federal tax return at the time of the covered injury); and
(4) A list of all third-party payers that have paid, or that may be
obligated to pay, benefits to the injured countermeasure recipient for
loss of employment income or provide disability and/or retirement
benefits for which payment or reimbursement is being sought under this
Program (e.g., State workers' compensation programs, disability
insurance programs, Uniform Services Retirement Board determinations,
Department of Veterans Affairs determinations, etc.). A requester must
submit documentation, if available, concerning the amount of such
payments or benefits paid or payable to, or on behalf of, the injured
countermeasure recipient by third-party payers. If the requester knows
of no such third-party payer, he or she must so certify in writing. If,
at any time, the requester becomes aware that a third-party payer may
have such an obligation, the requester must inform the Secretary within
ten business days of becoming aware of this information, even after
benefits have been paid by the Program.
(b) [Reserved]

[[Page 63684]]

Sec. 110.62 Documentation a requester who is determined to be an
eligible survivor must submit for the Secretary to make a determination
of death benefits.

(a) A requester determined by the Secretary to be an eligible
survivor and who seeks a death benefit under Sec. 110.82(b) (the
standard calculation) must provide, in addition to the documentation
submitted under subpart F of this part, a written certification
informing the Secretary whether a disability or death benefit was paid
or payable under the PSOB Program with respect to the deceased injured
countermeasure recipient. If such benefit was provided, the requester
must submit documentation showing the amount of the benefit paid by the
PSOB Program. If the deceased injured countermeasure recipient was
covered under the PSOB and no such benefit was, or will be provided,
the certification must explain whether any survivors are eligible for a
death benefit under the PSOB Program and, if so, whether a death
benefit may be paid or payable under the PSOB Program.
(b) The legal guardian seeking a death benefit under Sec.
110.82(c) (the alternative calculation) on behalf of a dependent
younger than the age of 18 determined by the Secretary to be an
eligible survivor must provide, in addition to the documentation
submitted under Subpart F of this part, the following:
(1) Documentation showing that the deceased injured countermeasure
recipient is survived by one or more dependents younger than the age of
18. Such documentation must show the date of birth of all such
dependents (e.g., copies of birth certificates);
(2) Documentation showing that the requester is the legal guardian
of all of the dependents described in paragraph (b)(1) of this section,
as required under Sec. 110.63(a). If multiple dependents have
different legal guardians, the legal guardian of each of the dependents
must submit such documentation;
(3) A written selection by each legal guardian, on behalf of all of
the dependents described in paragraph (b)(1) of this section for whom
he or she is the legal guardian, to receive proportional death benefits
under the alternative calculation as described in Sec. 110.82(c), in
place of proportional benefits available under the standard calculation
as described in Sec. 110.82(b). Written selections are described in
Sec. 110.82(c)(1);
(4) Documentation showing the deceased injured countermeasure
recipient's gross employment income at the time the covered injury was
sustained (e.g., the decedent's Federal tax return or pay stub(s) from
all employers at the time of the covered injury); and
(5) A description of all third-party payers that have paid for, or
that may be required to pay for, the benefits described in Sec.
110.82(c)(3)(i). This description must include the amount of such
benefits that have been paid or that may be paid in the future. If the
representative knows of no such third-party payer, he or she must so
certify in writing. If, at any time, the representative becomes aware
that a third-party payer may have such an obligation, he or she must
inform the Secretary within ten business days of becoming aware of this
information, even after benefits have been paid by the Program.

Sec. 110.63 Documentation a legal or personal representative must
submit when filing on behalf of a minor or on behalf of an adult who
lacks legal capacity to receive payment of benefits.

Before benefits will be paid by the Program to an eligible
requester who is a minor or an adult who lacks legal capacity to
receive payment of benefits, his or her legal or personal
representative must submit the following, in addition to the
documentation required under Subpart F of this part and, as applicable,
Sec. Sec. 110.60-110.62:
(a) For an eligible requester who is a minor:
(1) Documentation showing that the requester is a minor (e.g.,
birth certificate); and
(2) Documentation showing that the representative is the legal
guardian of the property or estate of the minor (e.g., appointment of
guardianship by a court of competent jurisdiction). If a minor has more
than one legal guardian, this documentation is required only of one
legal guardian. In the alternative, documentation showing that the
minor is considered emancipated under applicable State law. In
accordance with Sec. 110.83(b), the Program reserves the right to
waive the requirement of documentation of guardianship for good cause.
(b) For an eligible requester who is an adult who lacks legal
capacity to receive payment of benefits:
(1) Documentation showing that the requester is an adult who lacks
this legal capacity (e.g., declaration of legal incapacity issued by a
court of competent jurisdiction, or comparable documentation); and
(2) A decree by a court of competent jurisdiction establishing a
guardianship or conservatorship of the requester's estate under
applicable State law, or durable power of attorney, if applicable. In
accordance with Sec. 110.83(b), the Program reserves the right to
waive this requirement for good cause.

Subpart H--Secretarial Determinations

Sec. 110.70 Determinations the Secretary must make before benefits
can be paid.

Before the Secretary will pay benefits under this Program, she must
determine that:
(a) The requester or his or her representative submitted a
completed and signed Request Form within the governing filing deadline;
and
(b) The requester meets the eligibility requirements set out in
this part (including a determination that a covered injury was
sustained); and
(c) The requester is entitled to receive benefits from the Program.
In making this determination, the Secretary will decide the type(s) and
amounts of benefits that will be paid to the requester.

Sec. 110.71 Insufficient documentation for eligibility and benefits
determinations.

In the event that there is insufficient documentation in the
Request Package for the Secretary to make the applicable determinations
under this part, the Secretary will so notify the requester, or his or
her representative. The requester will be given 60 calendar days from
the date of the Secretary's notification to submit the required
documentation. If the requester is unable to provide the additional
documentation, he or she may provide a written explanation of the
reason(s) that the requested documentation is unavailable and the
efforts the requester has made to obtain the documents. The Secretary
may accept such a statement in place of the required documentation or
disapprove the Request for Benefits due to insufficient documentation.
If insufficient documentation is submitted in response to the
Secretary's letter, the Secretary may disapprove the Request for
Benefits.

Sec. 110.72 Sufficient documentation for eligibility and benefits
determinations.

(a) Eligibility determinations. When the Secretary determines that
there is sufficient documentation in the Request Package to evaluate a
requester's eligibility, she will begin the review to determine whether
the requester is eligible for Program benefits. If the Secretary
determines that the requester is not eligible, the Secretary will
inform the requester (or his or her representative) in writing of the
disapproval, and the right to reconsideration of the determination, as
described in subpart J.

[[Page 63685]]

(b) Benefits determinations. If the Secretary determines that the
requester is eligible for benefits, she will, after receiving adequate
documentation from the requester for a benefits determination, either
calculate the amount and types of benefits, as described in subpart I
of this part, or request additional documentation in order to calculate
the benefits that can be paid (e.g., an Explanation of Benefits from
the requester's health insurance company, if none was submitted). As
provided in subpart J, requesters have the right to reconsideration of
the Secretary's determination of the category and amount of benefits
payable under the Program.
(c) Additional documentation required. At any time after a Request
Form has been filed, the Secretary may ask a requester to supplement or
amend the Request Package by providing additional information or
documentation.

Sec. 110.73 Approval of benefits.

When the Secretary has determined that benefits will be paid to a
requester and has calculated the type and amount of such benefits, she
will so notify the requester (or his or her representative) in writing.
The Secretary will make payments in accordance with Sec. 110.83. Once
all benefits have been paid, the Request Package can no longer be
amended (except for survivor benefits). The payment determination will
constitute final agency action with regard to the particular
countermeasure injury that is the subject of the Request for Benefits
and payment (i.e., the Request for Benefits is closed with regard to
the injury that is the basis of the payment of benefits).

Sec. 110.74 Disapproval of benefits.

(a) If the Secretary determines that a requester is not eligible
for payments under the Program, the Secretary will disapprove the
Request for Benefits and provide the requester, or his or her
representative, with written notice of the basis for the disapproval,
and the right to reconsideration of the determination, as provided in
Sec. 110.90.
(b) The Secretary may disapprove a Request for Benefits even before
the requester has submitted all the required documentation (e.g., the
Secretary may determine that a requester did not meet the filing
deadline, or that a covered countermeasure was not used or
administered).
(c) The Secretary may re-open a disapproved Request for Benefits on
her own accord should medical or scientific evidence later become
available to justify a re-determination of the disapproval of
eligibility or payments. In extraordinary circumstances, to be
determined at the Secretary's discretion, she may re-open a disapproved
Request for Benefits even after the requester has exercised the right
to reconsideration and the disapproval determination has been upheld in
accordance with the procedures set out in Sec. 110.90.

Subpart I--Calculation and Payment of Benefits

Sec. 110.80 Calculation of medical benefits.

In calculating medical benefits, the Secretary will take into
consideration all reasonable costs for reasonable and necessary medical
items and services to diagnose or treat a countermeasure recipient's
covered injury, or to diagnose, treat, or prevent its health
complications, as described in Sec. 110.31. The Secretary will
consider and may rely upon benefits documentation submitted by the
requester (e.g., bills, Explanation of Benefits, and cost-related
documentation to support the expenses relating to the covered injury or
its health complications), as required by Sec. 110.60. The Secretary
will make such payments only to the extent that such costs were not,
and will not be, paid by any third-party payer and only if no third-
party payer had or has an obligation to pay for or provide such
services or items to the requester, except as provided in Sec. Sec.
110.83(c) and 110.84. There are no caps on the benefits for reasonable
and necessary medical expenses that may be provided under the Program.

Sec. 110.81 Calculation of benefits for lost employment income.

(a) Primary calculation. Benefits under this section may be paid
for days of work lost as a result of a covered injury or its health
complications if the injured countermeasure recipient lost employment
income for the lost work days as reasonable based on the degree of
injury or disability. As stated in Sec. 110.32(c), days for which an
individual used paid leave will be considered days of work for which
employment income was received and, therefore, would not qualify for
lost employment income benefits. However, if the injured countermeasure
recipient reimburses the employer for the paid leave taken and the
employer restores the leave that was used, the individual may be
eligible for lost employment income benefits for those days;
(1) The Secretary will calculate the rate of benefits to be paid
for the lost work days based on the injured countermeasure recipient's
gross employment income, which includes income from self-employment, at
the time he or she sustained the covered injury. The Secretary may not,
except with respect to injured individuals who are minors, consider
projected future earnings in this calculation.
(i) For an injured countermeasure recipient with no dependents at
the time the covered injury was sustained, the benefits are 66\2/3\
percent of the individual's gross employment income at the time of
injury.
(ii) For an injured countermeasure recipient with one or more
dependents at the time the covered injury was sustained, the benefits
are 75 percent of the individual's gross employment income at the time
of injury; and
(iii) In the case of an injured countermeasure recipient who is a
minor, the Secretary may consider the provisions of 5 U.S.C. 8113
(authorizing the FECA Program), and any implementing regulations, in
determining the amount of payments under this section and the
circumstances under which such payments are reasonable and necessary.
(b) Adjustment for inflation. Benefits for lost employment income
paid under the Program that represent future lost employment income
will be adjusted annually to account for inflation.
(c) Limitations on benefits paid. The Secretary will reduce the
benefits calculated under paragraphs (a) and (b) of this section
according to the limitations described in this paragraph (c):
(1) Number of lost work days. An injured countermeasure recipient
will be compensated for ten or more days of work lost if he or she lost
employment income for those days as a result of the covered injury (or
its health complications). If the number of days of lost employment
income due to the covered injury (or its health complications) is fewer
than ten, the Secretary will reduce the number of lost work days by
five days. If the injured countermeasure recipient lost employment
income for a period of five days or fewer, no benefits for lost
employment income will be paid. Lost work days do not need to be
consecutive. Partial days of lost employment income may be aggregated
to calculate the total number of lost work days. The Secretary has the
discretion to consider the reasonableness of the number of work days
(or partial work days) lost as a result of a covered injury or its
health complications in this calculation, and to consider alternative
work schedules in determining the number of work days lost.

[[Page 63686]]

(2) Annual limitation. The maximum amount that an injured
countermeasure recipient may receive in any one year in benefits for
lost employment income under this Program is $50,000.
(3) Lifetime limitation. The maximum amount that an injured
countermeasure recipient can receive during his or her lifetime in
benefits for lost employment income under this Program is the amount of
the death benefit calculated under the PSOB Program in the same fiscal
year as the year in which this lifetime cap is reached. This amount is
the maximum death benefit payable to survivors under this Program using
the standard calculation described in Sec. 110.82(b). However, this
lifetime cap does not apply if the Secretary determines that the
countermeasure recipient has a covered injury (or injuries) meeting the
definition of ``disability'' in section 216(i) of the Social Security
Act, 42 U.S.C. 416(i).
(4) Termination of payments. The Secretary will not pay benefits
for lost employment income after the injured countermeasure recipient
reaches the age of 65.
(d) Reductions for other coverage. From the amount of benefits
calculated under paragraphs (a), (b), and (c) of this section, the
Secretary will make reductions:
(1) For all payments made, or expected to be made in the future, to
the injured countermeasure recipient for compensation of lost
employment income or disability or retirement benefits, by any third-
party payer in relation to the covered injury or its health
complications, consistent with Sec. 110.32(b); and
(2) So that the total amount of benefits for lost employment income
paid to an injured countermeasure recipient under this Program,
together with the total amounts paid (or payable) by third-party
payers, as described in paragraph (d)(1) of this section, does not
exceed 66\2/3\ percent (or 75 percent, if the injured countermeasure
recipient had at least one dependent at the time the covered injury was
sustained) of his or her employment income at the time of the covered
injury for the lost work days.
(3) If an injured countermeasure recipient receives a lump-sum
payment from any third-party payer under any obligation described in
paragraph (d)(1) of this section, the Secretary shall consider such a
payment to be received over a period of years, rather than in a single
year. The Secretary has discretion as to how to apportion such payments
over multiple years.

Sec. 110.82 Calculation of death benefits.

(a) General. (1) If the legal guardian(s) of dependents younger
than 18 years of age does not file a written selection to receive death
benefits under the alternative calculation, as described in paragraph
(c)(1) of this section, or if the Secretary does not approve such a
selection, the Secretary will pay proportionate death benefits under
the standard calculation to all of the eligible survivors with priority
to receive death benefits under the standard calculation, as described
in Sec. 110.33(b) and paragraph (b) of this section.
(2) If the Secretary approves a written selection to receive
benefits under the alternative calculation, as described in paragraph
(c)(1) of this section:
(i) If no other eligible survivors are of equal priority to receive
death benefits, the Secretary will pay a death benefit in an amount
calculated under the alternative calculation to the aggregate of the
dependents on whose behalf the election was filed; and
(ii) If other eligible survivors are of equal priority to receive
death benefits as the dependents receiving death benefits under the
alternative calculation, the Secretary will pay the other eligible
survivors a proportionate amount of the death benefit available and
calculated under the standard calculation. In such circumstances, the
Secretary will pay the aggregate of the dependents receiving a death
benefit under the alternative calculation a proportionate share of the
benefits available under that calculation (in place of the
proportionate share of the death benefit that would be available under
the standard calculation). For example, if a deceased countermeasure
recipient is survived by a dependent ten year-old child and a spouse
who is not the child's legal guardian (e.g., the dependent child's
parents were the deceased injured countermeasure recipient and his or
her former spouse), the current surviving spouse would be able to
receive his or her share of the death benefit under the standard
calculation, and the dependent child's legal guardian, on behalf of the
minor, would receive either the child's proportionate share of the
death benefit under the standard calculation or the child's
proportionate share of the death benefit available under the
alternative calculation (if the legal guardian filed a written
selection for such a death benefit and the Secretary approved the
selection).
(b) Standard calculation of death benefits. (1) The maximum death
benefit available under the standard calculation of death benefits
(described in this paragraph) is the amount of the comparable death
benefit calculated under the PSOB Program in the same fiscal year in
which the injured countermeasure recipient died (regardless of whether
the PSOB Program reduces the amount of its death benefits because of a
limit in appropriations).
(2) No death benefit will be paid under the standard calculation if
a death benefit is paid, or if survivors are eligible to receive a
death benefit, under the PSOB Program with respect to the deceased
injured countermeasure recipient.
(3) The death benefit will not be reduced under the standard
calculation if a total and permanent disability benefit has been, or
will be paid under the PSOB Program with respect to the deceased
injured countermeasure recipient. However, the death benefit will be
reduced if a temporary and partial disability benefit has been, or will
be paid under the PSOB Program with respect to that individual. If the
PSOB Program disability benefit paid was reduced because of a
limitation on appropriations, a death benefit will be available under
the standard calculation to the extent necessary to ensure that the
total amount of disability benefits paid under the PSOB Program,
together with the amount of death benefits paid under the standard
calculation, equals the amount of the death benefit described in
paragraph (b)(1) of this section.
(4) Under the standard calculation, death benefits will be paid in
a lump sum.
(c) Alternative calculation of death benefits available to
surviving dependents younger than the age of 18. If a deceased
countermeasure recipient had at least one dependent who is younger than
the age of 18 (and will be younger than the age of 18 at the time of
the payment), the legal guardian(s) of all such dependents may request
benefits under the alternative calculation described in this paragraph.
To receive such a benefit, the legal guardian, on behalf of all such
dependents for whom he or she is the legal guardian, must file a
selection to receive benefits under the alternative calculation, as
described in paragraph (c)(1) of this section, and the Secretary must
approve such selection. If multiple dependents have different legal
guardians, each legal guardian is responsible for requesting benefits
under the standard calculation or for filing a selection for a death
benefit under the alternative calculation. If a single dependent has
more than one legal guardian, one legal guardian may file the
selection. Payments made under

[[Page 63687]]

the alternative calculation will be made to the legal guardian(s) of
all of the dependents on behalf of all of those dependents until they
reach the age of 18.
(1) Selection of benefits under the alternative calculation. Before
a payment of a death benefit will be approved under the alternative
calculation, the legal guardian(s) of the dependents for whom he or she
is the legal guardian must file a written selection, on behalf of all
such dependents, to receive a death benefit under the alternative
calculation. If such a selection is approved by the Secretary, these
dependents will be paid a proportionate share of the death benefit
under the alternative calculation in place of the proportionate share
of benefits that would otherwise be available to them under the
standard calculation.
(2) Amount of payments. The maximum death benefit available under
this paragraph is 75 percent of the deceased injured countermeasure
recipient's income (including income from self-employment) at the time
he or she sustained the covered injury that resulted in death, adjusted
to account for inflation, except as follows:
(i) The maximum payment of death benefits that may be made on
behalf of the aggregate of the dependents in any one year is $50,000;
(ii) All payments made under this paragraph will stop once the
youngest of the dependents reaches the age of 18.
(3) Reductions for other coverage. The total amount of death
benefits provided under the alternative calculation (described in this
paragraph) will be reduced so that the total amount of payments made
(or expected to be made) under obligations described in paragraph
(c)(3)(i) of this section, together with the death benefits paid under
the alternative calculation, is not greater than the amount of payments
described in paragraph (c)(2) of this section. In other words, the
total amount of death benefits paid to dependents under the alternative
calculation may be reduced if third-party payers have paid (or are
expected to pay) for certain benefits so that such dependents will
receive a total sum (combining the death benefit under the alternative
calculation and the actual and expected benefits covered by third-party
payers) that is not greater than the death benefit that would be
available under the alternative calculation if there were no third-
party payer(s) to pay such benefits. The total amount of death benefits
will not be reduced by lost employment income paid by the Program.
(i) The amount of death benefits paid under the alternative
calculation will be reduced for all payments made, or expected to be
made in the future, by any third-party payer for:
(A) Compensation for the deceased countermeasure recipient's loss
of employment income on behalf of the dependents or their legal
guardians(s) (but not any lost employment income benefits paid by the
Program);
(B) Disability, retirement, or death benefits in relation to the
deceased countermeasure recipient (including, but not limited to, death
and disability benefits under the PSOB Program) on behalf of the
dependents or their legal guardian(s); and
(C) Life insurance benefits on behalf of the dependents;
(4) Timing of payments. Payments made under this paragraph will be
made on an annual basis, beginning from the time of the initial
payment, to the legal guardian(s) on behalf of the aggregate of the
dependents receiving the payment. In the year in which the youngest
dependent reaches the age of 18, payments under this section will be
paid on a pro rata basis for the period of time before that dependent
reaches the age of 18. Once a dependent reaches the age of 18, the
payments under this alternative calculation will no longer be made on
his or her behalf. Because payments under the alternative calculation
are to be made on behalf of dependents who are younger than the age of
18, if a dependent meets this requirement at the time of filing of the
Request Form, but reaches the age of 18 (or is older than 18 years of
age) at the time of the initial payment, no payment will be made to the
dependent's legal guardian on his or her behalf under the alternative
calculation.

Sec. 110.83 Payment of all benefits.

(a) The Secretary determines the mechanism of payment of Program
benefits. She may choose to pay any benefits under this Program through
lump-sum payments. If the Secretary determines that there is a
reasonable likelihood that the payments of medical benefits, benefits
for lost employment income, or death benefits paid under the
alternative calculation (described in Sec. 110.82(c)) will be required
for a period in excess of one year from the date the Secretary
determines the requester is eligible for such benefits, payments may be
made through a lump-sum payment, the purchase of an annuity or medical
insurance policy, establishment of a trust (including a U.S. grantor
reversionary trust) or execution of an appropriate structured
settlement agreement, at the Secretary's discretion. Payments,
annuities, policies, or agreements must be actuarially determined to
have a value equal to the present value of the projected total amount
of benefits that the requester is eligible to receive under Sec. Sec.
110.80, 110.81, and 110.82. Lump sum payments will be made through an
electronic funds transfer to an account of the requester.
(b) If the requester is a minor, the payment will be made on the
minor's behalf to the account of the legal guardian of the estate or
property of the minor. In accepting such payments, the legal guardian
of a minor requester is obligated to use the funds for the benefit of
the minor and to take any actions necessary to comply with State law
requirements pertaining to such payments. If the requester is an adult
who lacks the legal capacity to receive payment(s), the legal guardian
must establish a guardianship or conservatorship of the estate account
with court oversight, in accordance with State law, and payment will be
made to that account. Documentation of guardianship (or
conservatorship) is required for requesters who are minors or adults
who lack legal capacity unless the Secretary waives this requirement
for good cause.
(c) The Secretary has the discretion to make interim payments of
benefits under this Program, even before a final determination as to
the type(s) and total amount of benefits that will be paid. Interim
payments will be made only in exceptional cases. The Secretary may, for
example, make an interim payment of medical benefits that have been
calculated before a final determination on benefits for lost employment
income is completed, or of past medical benefits that have been
calculated before a final calculation of future medical benefits is
completed. The Secretary may make an interim payment even before a
final eligibility or benefits determination is made (e.g., if a piece
of documentation has not been obtained because a person with a severe
countermeasure-related injury is hospitalized, but all other
documentation is consistent with the requester meeting the eligibility
requirements). If such a requester's documentation is incomplete, the
requester must submit the required documentation within the time-frame
determined by the Secretary. The requester must agree that he or she
will be obligated to repay the Secretary such benefits in the event
that a Program payment is later determined to be incorrect. Any
payments made on an interim basis will not entitle a requester to seek
reconsideration of the Secretary's decision on these benefits

[[Page 63688]]

until the Secretary makes a final benefits determination.

Sec. 110.84 The Secretary's right to recover benefits paid under
this Program from third-party payers.

Upon payment of benefits under this 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 and may recover from such third-
party payer(s) the amount of benefits paid up to the amount of benefits
the third-party payer has or had an obligation to pay for (or provide).
In other words, the Secretary may pay benefits before the requester
receives a payment from a third-party payer in certain circumstances.
In those circumstances, the Secretary has a right to be reimbursed by
the third-party payer. The circumstances in which the Secretary may
assert this right include those in which the Secretary pays benefits
under this Program to a requester before a final decision is made that
a third-party payer has an obligation to pay such benefits to the
requester. Requesters receiving benefits under this Program (or their
representatives) shall assist the Secretary in recovering such
benefits. In the event that a requester receives a benefit from a
third-party payer after receiving the same type of benefits from the
Secretary under this Program, the Secretary has a right to recover from
the requester the amount of the benefit(s) received. The requester must
notify and reimburse the Program within ten business days of receiving
the third-party payment(s).

Subpart J--Reconsideration of the Secretary's Determinations

Sec. 110.90 Reconsideration of the Secretary's eligibility and
benefits determinations.

(a) Right of reconsideration. A requester has the right to seek
reconsideration of the Secretary's determination that he or she is not
eligible for Program benefits. In addition, a requester who asserts
that the amount of the benefits paid (or the fact that certain benefits
were not paid or payable) is incorrect may also seek reconsideration. A
requester may not seek reconsideration of the Secretary's decision as
to the mechanism of payment. Requests for reconsideration must be in
writing, describe the reason(s) why the decision should be
reconsidered, and be postmarked within 60 calendar days of the date of
the Secretary's decision on the Request for Benefits. Because no new
documentation will be considered in the reconsideration process, the
reconsideration request may not include or refer to any documentation
that was not before the Secretary at the time of her determination.
(b) Letters seeking reconsideration. A requester, or his or her
representative, may send the letter seeking reconsideration through the
U.S. Postal Service, commercial carrier, or a private courier service.
The Secretary will not accept reconsideration requests delivered by
hand. Electronic submissions of letters seeking reconsideration are not
currently accepted, but may be accepted in the future. The Program will
publish a notice if an electronic method becomes available. Letters
sent through the U.S. Postal Service, commercial carrier or private
courier service must be sent to the Associate Administrator, Healthcare
Systems Bureau, Health Resources and Services Administration, 5600
Fishers Lane, Room 12-105, Rockville, Maryland 20857.
(c) Reconsideration process. When the Associate Administrator of
the Healthcare Systems Bureau (the Associate Administrator), receives a
request for reconsideration, a qualified panel, independent of the
Program, will be convened to review the Secretary's determination. The
panel will base its recommendation on the documentation before the
Secretary when the determination was made. The panel will perform its
own review and make its own findings, which will be submitted to the
Associate Administrator. The Associate Administrator will then review
the panel's recommendation(s) and make a final determination, which
will be sent to the requester (or his or her representative). This will
be the Secretary's final action on the request for reconsideration and
will be considered the Secretary's final determination on the request
for Program benefits with regard to the injury that is the subject of
that Request Package. Requesters may not seek review of a decision made
on reconsideration.
(d) Effect of reconsideration on amending a Request Package. As
stated in Sec. 110.46, a Request Package cannot be amended after
exhaustion of the reconsideration process, except for amendments by
survivors seeking death benefits or executors or administrators on
behalf of an estate.

Sec. 110.91 Secretary's review authority.

Under section 319F-4(b)(4) of the Public Health Service Act (42
U.S.C. 247d-6e(b)(4)) (referencing section 262 of the PHS Act (42
U.S.C. 239a)), the Secretary may, at any time, on her own motion or on
application, review any determination made under this part (including,
but not limited to, determinations concerning eligibility, entitlement
to benefits, and the calculation of amount of benefits under the
Program). Upon review, the Secretary may affirm, vacate, or modify the
determination in any manner the Secretary deems appropriate.

Sec. 110.92 No additional judicial or administrative review of
determinations made under this part.

(a) Under section 319F-4(b)(4) of the PHS Act (42 U.S.C. 247d-
6e(b)(4)) (referencing section 262 of the PHS Act (42 U.S.C. 239a)), no
judicial review of the Secretary's actions concerning eligibility and
benefits determinations under this part (including, but not limited to,
determinations concerning eligibility, the type or amount of benefits,
and the method of payment of benefits) is permitted. In addition, no
further administrative review of such actions are permitted unless the
President specifically directs otherwise.
(b) Under section 319F-4(b)(5)(c) of the PHS Act (42 U.S.C. 247d-
6e(b)(5)(c)), no judicial review of the Secretary's actions in
establishing or amending a Table (or Tables) for purposes of this part
(which include, but are not limited to, identifying injuries on a Table
(or choosing not to identify injuries on a Table), establishing time-
frames or definitions for Table injuries, and amending a Table) is
permitted.

Subpart K--Covered Countermeasures Injury Tables

Sec. 110.100 [Reserved]

[FR Doc. 2010-25110 Filed 10-14-10; 8:45 am]
BILLING CODE 4165-15-P