Smallpox Vaccine Injury Compensation Program: Administrative Implementation; Interim Final Rule

Federal Register: December 16, 2003
(Volume 68, Number 241)
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUMMARY: The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), authorizes the Secretary of Health and Human Services (the Secretary), to establish the Smallpox Vaccine Injury Compensation Program (``the Program''). This program is designed to provide benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of these injuries.

On August 27, 2003, the Secretary published an interim final rule that set out a Smallpox (Vaccinia) Vaccine Injury Table (``the Table''). The table includes adverse effects (including injuries, disabilities, conditions, and deaths) within specific time periods that shall be presumed to result from the receipt of, or exposure to, the smallpox vaccine. The Secretary will use this table, as well as the procedures set out in this regulation, in deciding whether persons are eligible to receive benefits under the program. In this interim final rule, the Secretary is setting out the administrative policies, procedures, and requirements governing the program, as authorized by the SEPPA. The Secretary is seeking public comment on this interim final rule.

DATES: This regulation is effective on December 16, 2003. Written comments must be submitted on or before February 17, 2004. The Secretary will consider the comments received and will decide whether to amend the current procedures and requirements based on such comments.

ADDRESSES: All written comments concerning this interim final rule should be submitted to the Director, Smallpox Vaccine Injury Compensation Program, Special Programs Bureau, Health Resources and Services Administration, Parklawn Building, Room 16C-17, 5600 Fishers Lane, Rockville, MD 20857. Express and courier mail should be sent to the Director, Smallpox Vaccine Injury Compensation Program, Special Programs Bureau, Health Resources and Services Administration, 4350 East-West Highway, 10th Floor, Bethesda, Maryland 20814. Electronic comments should be sent to smallpox@hrsa.gov. Comments received will be available for public inspection at the Smallpox Vaccine Injury Compensation Program Office, Special Programs Bureau, Health Resources and Services Administration, 4350 East-West Highway, 10th Floor, Bethesda, Maryland 20814, between the hours of 8:30 a.m. and 5 p.m. on Federal government workdays.

FOR FURTHER INFORMATION CONTACT: Paul T. Clark, Director, Smallpox Vaccine Injury Compensation Program, telephone 1-888-496-0338. This is a toll-free number. Electronic inquiries should be sent to smallpox@hrsa.gov. Interested parties may also wish to consult the program's Web site at http://www.hrsa.gov/smallpoxinjury.

SUPPLEMENTARY INFORMATION:
Background
Before it was eradicated, smallpox (variola) was a serious illness that manifested as outbreaks of either variola major with death rates of greater than 20% or variola minor with death rates of almost 1%. The smallpox (vaccinia) vaccine (referred to in this rule as the ``smallpox vaccine'') contains a live vaccinia virus that induces immunity to smallpox infection, but does not lead to variola infection or disease. Vaccinia virus is an orthopox type virus that is different from, but related to, the smallpox virus. The smallpox vaccine was an essential tool for the successful global eradication of the smallpox virus, announced by the World Health Organization in 1980.

Despite such eradication, concern exists that terrorists may have access to the smallpox virus. On December 13, 2002, the President announced a plan to protect the population of the United States against the threat of a possible smallpox attack. This plan was based on heightened concerns, in the wake of the attacks of September and October 2001, that terrorists may have access to the smallpox virus and may attempt to use it against the population of the United States and government facilities abroad. Under this plan, which the Secretary is actively working to implement, State and local governments have formed smallpox emergency response plans to facilitate the provision of critical services to the population of the United States in the event of a smallpox virus attack.

To further the President's plan, the Secretary issued a Declaration Regarding Administration of Smallpox Countermeasures on January 24, 2003 (68 FR 4212). This Declaration was issued pursuant to statutory authority, 42 U.S.C. 233(p)(2)(A), which was enacted by the Homeland Security Act of 2002, Pub. L. 107-296, 116 Stat. 2135. In this Declaration, the Secretary stated that ``a potential bioterrorist incident makes it advisable to administer, on a voluntary basis, covered countermeasures specified * * * for prevention or treatment of smallpox or control or treatment of adverse events related to smallpox vaccination, to [specified] categories of individuals * * *.''

The specific ``covered countermeasures'' described in the Declaration are smallpox vaccines, cidofovir and its derivatives, and Vaccinia Immune Globulin. The categories of persons to whom the Secretary recommended the administration of such covered countermeasures, on a voluntary basis, included certain health care workers, certain public safety personnel, other members of smallpox emergency response plans identified by State or local government entities or the Department of Health and Human Services, and certain personnel associated with specific Federal facilities abroad. The Secretary recommended that such persons receive the smallpox vaccine to ensure the immediate mobilization of smallpox emergency response personnel who would provide critical services to the population of the United States in the event of a smallpox virus attack.

The Secretary's Declaration became effective on January 24, 2003, and will remain effective until January 23, 2004, unless the Secretary extends or shortens that time period by amendment. Under the Smallpox Vaccine Injury Compensation Program authorized by the SEPPA, certain persons may be entitled to benefits (defined as benefits and/or compensation) for covered injuries, described below, suffered as a direct result of the administration of smallpox covered countermeasures (including the smallpox vaccine) or accidental vaccinia inoculation.

Specifically, the SEPPA authorizes the Secretary to make the benefits available to two categories of eligible persons who sustained covered injuries, provided they meet the legal requirements (e.g., filing deadlines). The first category, ``smallpox vaccine recipients,'' includes certain persons who volunteer for, and are selected to be members of, a smallpox emergency response plan, are vaccinated with a smallpox vaccine under such a plan, and sustain covered injuries. The second category, vaccinia contacts, includes certain persons who have covered injuries as the direct result of exposure to vaccinia through contact with certain persons who received the smallpox vaccine or with the contacts of such recipients. In addition, if a person in either category dies, his or her survivors or his or her estate may be eligible for selected benefits under this program in certain circumstances.

The benefits available under the program include compensation for medical care, lost employment income, and survivor death benefits. To be considered for program benefits, requesters (i.e., smallpox vaccine recipients, vaccinia contacts, survivors, or the representatives of the estates of deceased smallpox vaccine recipients or vaccinia contacts), or persons filing on their behalf as their representatives, must file a Request Form and the documentation required under this regulation to show that they are eligible. As mandated under the SEPPA, the Secretary is herein, at 42 CFR part 102, establishing the procedures and requirements governing the program.

At this time, the Secretary is seeking public comments on these procedures and requirements. Summary of the Regulation Summary of Available Benefits and Secondary Nature of Benefits (Sec. 102.2, Sec. 102.84) The benefits available under this program are medical benefits, benefits for lost employment income, and survivor death benefits. As explained in Sec. 102.2(b), the SEPPA establishes that the government is a secondary payor for most benefits available under the program. Thus, benefits paid under this program are generally secondary to any obligation of any third-party payor, described in Sec. 102.3(aa), to pay for or provide such benefits. Requesters generally must provide the names of all other third-party payors that have already provided benefits, that are expected to do so in the future, or that may have a duty to do so. These payers include, but are not limited to: insurance companies, workers' compensation programs, the Federal Employees' Compensation Act (FECA) Program, or the Public Safety Officers' Benefit (PSOB) Program, a program within the United States Department of Justice that provides payments to public safety officers and their survivors, including death payments for officers killed in the line of duty.

If such a third-party payor 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. For example, if a requester were otherwise entitled to $10,000 in medical benefits from this program and the requester's health insurance company (a third-party payor) has paid $5,000 for the covered medical benefits and services, the program would pay the requester $5,000 (the amount the requester is entitled to under this program, reduced by the amount the requester is entitled to from third-party payors). As explained later in the preamble, upon payment of benefits under the Smallpox Vaccine Injury Compensation Program, the Secretary will be subrogated to the rights of the requester and may assert a claim against any third-party payor with a legal or contractual obligation to pay for, or provide, such benefits.

Description of Eligible Requesters (Sec. 102.10(a))
(1) Smallpox vaccine recipients, as defined in Sec. 102.3(y).

A person who has received a smallpox vaccine is only considered a ``smallpox vaccine recipient,'' for purposes of this program, if he or she meets the criteria described in this regulation. Specifically, he or she must have been in a covered occupation (including health care workers, law enforcement officers, public safety personnel, and supporting personnel), received a smallpox vaccine as a participant in an approved smallpox emergency response plan, and sustained a covered injury, described later in this preamble. The exact requirements for smallpox vaccine recipients are set forth in Sec. 102.3(x). For example, this regulation provides that, in order to be eligible, a smallpox vaccine recipient must have received the smallpox vaccine between January 24, 2003, and January 23, 2004, unless the period is extended by the Secretary.

In order to be covered by the program, a smallpox vaccine recipient must also have volunteered for and been selected to be a member of a smallpox emergency response plan before the time that the Secretary publicly announces that an active case of smallpox has been identified anywhere in the world. For this reason, persons who become members of smallpox emergency response plans in order to respond to a case of smallpox that has already occurred will not be considered ``smallpox vaccine recipients.'' Likewise, persons who receive the smallpox vaccine as members of the military or members of the public who receive the smallpox vaccine voluntarily, and not as part of an approved smallpox emergency response plan, are not entitled to benefits under the program.

(2) Vaccinia contact, as defined in Sec. 102.3(bb). The SEPPA imposes specific restrictions as to which persons who have contracted vaccinia from another person may be eligible for benefits under this program. The specific requirements pertaining to vaccinia contacts are set forth in Sec. 102.3(bb). As explained in that section, vaccinia contacts are only eligible for benefits under this program if they can show that they contracted vaccinia as a result of contact with a person who either meets the definition of a smallpox vaccine recipient (except that the vaccine recipient does not need to sustain a covered injury) or who was accidentally inoculated by such a person. For this reason, if the source of a contact's exposure to vaccinia is a person who received a smallpox vaccine other than under an approved smallpox emergency response plan, the contact would not fall within the regulation's definition of a ``vaccinia contact'' and would not be eligible for benefits under the program. For example, the contacts of members of the military and State Department personnel who receive the smallpox vaccine for their employment, but not as part of an approved smallpox emergency response plan, would not be entitled to benefits under this program.

Likewise, the contacts of members of the general public who receive the smallpox vaccine voluntarily, and not as part of an approved smallpox emergency response plan, would not be covered under this program. In addition, vaccinia contacts must have contracted vaccinia during the effective period of the Declaration (between January 24, 2003, and January 23, 2004, unless extended by the Secretary), or within 30 days after the end of such period, and must have sustained a covered injury.

(3) Certain survivors of deceased smallpox vaccine recipients or vaccinia contacts, as defined in Sec. 102.3(z). Categories of eligible survivors and the priority of such survivors to receive benefits from the program are discussed in the section of this preamble concerning death benefits (the only type of benefit survivors are eligible to receive).

(4) Representatives of estates of deceased smallpox vaccine recipients or vaccinia contacts. Representatives of estates of deceased smallpox vaccine recipients or vaccinia contacts may file Request Packages with the program as long as they are seeking benefits on behalf of the deceased person's estate. Benefits Available to Different Categories of Requesters (Sec. 102.30) An eligible requester who is a smallpox vaccine recipient or a vaccinia contact may be entitled to receive either medical benefits or benefits for lost employment income or both as long as they provide the proper documentation. For example, such requesters must submit documentation showing that they have out-of-pocket reasonable and necessary medical expenses as a result of a covered injury or its health complications in order to receive medical benefits, and documentation showing that they lost employment income as a result of a covered injury or its health complications in order to receive benefits for lost employment income. Such documentation requirements are discussed later in this preamble. An eligible requester who is the survivor of a deceased smallpox vaccine recipient or vaccinia contact may be entitled to receive a death benefit. The estate of a deceased smallpox vaccine recipient or vaccinia contact may be eligible to receive medical benefits or benefits for lost employment income or both if such benefits were accrued during the deceased person's lifetime as a direct result of a covered injury or its health complications, but were not paid during the deceased person's lifetime. 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 person might have accrued if he or she had not died.

Covered Injuries (Sec. 102.20--Sec. 102.21)
Covered injuries are defined in Sec. 102.3(g) and set out in subpart C of this rule. Covered injuries are those injuries in smallpox vaccine recipients or vaccinia contacts that the Secretary determines are more likely than not (i.e., by a preponderance of the evidence) the direct result of the administration of a covered countermeasure (including a smallpox vaccine) or of vaccinia acquired through accidental vaccinia inoculation. Because even survivors of, and representatives of estates of, deceased smallpox vaccine recipients and vaccinia contacts must demonstrate that the deceased person sustained a covered injury, a requester will not be deemed eligible for benefits under the program unless the Secretary determines that an eligible smallpox vaccine recipient or vaccinia contact sustained a covered injury. One way that requesters can demonstrate that they sustained a covered injury is by demonstrating that they sustained an injury listed on the Smallpox (Vaccinia) Vaccine Injury Table (the table) within the required time interval, as set out in Sec. 102.21. In accordance with the SEPPA, a smallpox vaccine recipient or vaccinia contact shall be presumed to have sustained a covered injury as the direct result of the administration of, or exposure to, the smallpox vaccine if the requester submits sufficient documentation demonstrating that he or she sustained an injury included on the table, with the onset of the first symptom or manifestation within the time interval specified on the table.

The injury must also meet the table's definitions and requirements, set forth in Sec. 102.21(b). In such circumstances, the Secretary will presume, solely for purposes of the program, that the smallpox vaccine recipient or vaccinia contact's injury was caused by the smallpox vaccine or exposure to vaccinia. Such a requester need not actually demonstrate that the vaccine (or the vaccinia contracted from accidental vaccinia inoculation) caused the underlying injury, only that an injury listed on the table 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 SEPPA to make this presumption absolutely conclusive. For this reason, based on his review of the submitted documentation and other relevant evidence, the Secretary may determine that an injury meeting the table requirements was more likely than not (i.e., by a preponderance of the evidence) caused by other factors and was not caused by the smallpox vaccine or exposure to vaccinia (e.g., if the Secretary determined that the medical records demonstrated that an individual's injury of encephalopathy was caused by a car accident that occurred post-vaccination and not by the smallpox vaccine or exposure to vaccinia). In these circumstances, which we expect to occur rarely, the Secretary could rebut the table presumption and decide that the requester may not be entitled to benefits under the program.

Requesters who believe they sustained an injury included on the table, but did not meet all the table requirements (e.g., the first manifestation of the injury did not become apparent within the required time interval), or requesters who believe they sustained an injury not included on the table, may still be able to demonstrate that the injury is one that is covered under the program. In order to establish a covered injury, such requesters may need to submit sufficient relevant medical documentation (such as isolation of vaccinia from the injured part of the body) or scientific evidence (such as results of studies published in peer-reviewed medical literature). In order to establish a covered injury, the Secretary, upon review of this evidence, must conclude that, more likely than not, the injury was actually caused by the administration of a covered countermeasure or by vaccinia through accidental inoculation during the time periods set forth by law. In other words, in evaluating such claims, the Secretary will employ a preponderance of the evidence standard, taking into consideration all relevant medical and scientific evidence, including all relevant medical records.

As provided under the SEPPA, this determination, as with all other actions by the Secretary under this Act, is not reviewable by any court. Any injury that the Secretary considers minor is not a covered injury. For example, covered injuries do not include expected skin reactions or expected minor scarring at the vaccination or inoculation site. No benefits will be paid for these reactions, as stated in Sec. 102.20(b). Medical Benefits--Summary and Calculation (Sec. 102.31 and Sec. 102.80) Medical benefits that may be available under the program are described in Sec. 102.31. 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 its direct health complications (sequelae).

Past, current, and expected future medical services and items may be included in medical benefits. 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 health care practitioner. In considering benefits for future medical services and items, the Secretary will consider statements by health care practitioners 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. In order for a requester to receive medical benefits for a health complication, the health complication must have resulted from the covered injury and not be more likely due to other factors or conditions. Examples of health complications include complications of a covered injury that occur as part of the natural course of the underlying disease, an adverse reaction to a prescribed medication or diagnostic test used in connection with a covered injury, or a complication of a surgical procedure used to treat the injury.

If a smallpox vaccine recipient or vaccinia contact dies before filing for, or being paid, benefits for the cost of medical services or items accrued during his or her lifetime as a result of a covered injury or its health complications, the deceased person's estate may be paid such medical benefits. Because such payments are for medical expenses accrued as a result of a covered injury while the injured person was alive, the cause of death does not have to be related to the covered injury for these medical benefits to be paid. The calculation of medical benefits is described in Sec. 102.80. There are no caps on medical benefits. However, the Secretary may limit the payment of such benefits to the amounts he considers reasonable for those services and items he 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 payor, 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 payors that may have a statutory or contractual obligation to pay for or provide medical benefits. When the Secretary has determined that the requester is eligible for medical benefits and that all of the documentation is available by which he can compute the amount, he will do the following, consistent with the calculations described in Sec. 102.80:

(1) Determine which medical expenses that have been submitted are reasonable and necessary to diagnose or treat a covered injury or 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 his computation the total amount paid, or payable, by all other third-party payors. This will be the basis for the program's payment. For example: An eligible, injured individual 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 the preamble, the Secretary may make a payment of medical benefits and later pursue such a payment from a third-party payor with an obligation to pay for or provide the medical services or items.

Lost Employment Income--Summary and Calculation (Sec. 102.32 and Sec. 102.81)
Lost employment income benefits that may be available under the program are set out in Sec. 102.32. The program will provide benefits for lost employment income (secondary to other benefits that may be available to the requester) 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). These benefits are a percentage of the employment income lost and are based on the number of eligible work days for which such income was lost. Employment income includes the injured person's gross employment income. The 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 workday 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 will be considered one total day of lost work. As described in Sec. 102.32(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 in which the injured person's employer restores the paid leave taken and puts the requester in the same position as if he or she had not used paid leave on the lost work day (i.e., treats the employee as if he or she did not take paid leave by taking back the payments made when the leave was used and giving back the leave to the employee for future use). Under 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 individual lost employment income for 10 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 of employment income as a result of a covered injury, he or she will not be eligible for any benefits for lost employment income. The calculation of benefits for lost employment income is described in Sec. 102.81. The annual cap on benefits for lost employment income for a requester 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 and benefits, to document his or her employment income. The benefit terminates once the requester reaches the age of 65. Benefits that represent future lost employment income will be adjusted to account for inflation.

It is important to remember that future lost employment income will be calculated based on an individual's 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 this 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 approximately $262,100, but subject to change). 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, a requester deemed to have a permanent and total disability by the Secretary may be eligible to receive up to $50,000 a year until he or she reaches the age of 65.

As with medical benefits, if a smallpox vaccine recipient or vaccinia contact dies before filing for, or being paid, benefits for lost employment income incurred during his or her lifetime as a result of a covered injury or its health complications, the representative 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. Once the Secretary has determined that he has all the information necessary to compute lost employment income, the calculation will be made as follows, as set out in Sec. 102.81:

(1) If the eligible individual lost five days or fewer of employment income, then there will be no benefits for lost employment income.

(2) If the eligible individual lost six to nine days of employment income, then the Secretary will subtract five days from the number of lost work days; if the eligible individual lost 10 or more days of employment income, then every lost work day will be counted.

(3) The Secretary will multiply the injured individual'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.

(4) The Secretary will compute 75% of the lost employment income if the injured individual had one or more dependents (at the time of the covered injury) or 66 2/3% 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.

(5) The amount of payment will be reduced by any benefit that the requester is entitled to receive from a third-party payor (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 payor 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 State if its program determines that such a benefit is due the requester). (6) The payments made will be subject to an annual cap of $50,000. 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. No State law workers' compensation lien may be maintained on any benefit for lost employment income paid under this program. Death Benefits--Summary and Calculation (Sec. 102.11, Sec. 102.33, and Sec. 102.82) Certain survivors of smallpox vaccine recipients or vaccinia contacts 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. 102.11 (eligible survivors and their priority to receive death benefits), Sec. 102.33 (general description of death benefits) and Sec. 102.82 (calculation of death benefits). The SEPPA provides that death benefits under this program may be available under two different calculations. The ``standard calculation'' is a lump-sum payment to eligible survivors and is described in Sec. 102.82(c). 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. 102.82(d). This method is based upon the deceased person's employment income at the time of the covered injury. Eligible Survivors and Priorities for Receiving Death Benefits With limited exceptions, the Smallpox Vaccine Injury Compensation Program 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 to them. The order of priority for survivors to receive death benefits under the program is subject to changes made in the future under 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;

(3) individuals designated by the deceased person as the beneficiaries under the deceased person's most recently executed life insurance policy; and

(4) surviving parents.

Such survivors, as defined under the PSOB Program, are also eligible survivors under this program. 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 is 18 years of age or younger, or between 19 and 23 years of age and a full-time student, or is over 18 years of age and incapable of self- support because of physical or mental disability. 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 (some of whom may also fall within the category of surviving eligible children). As discussed below, special criteria apply to the final category of eligible survivors. Under current practices, in the event that the deceased eligible individual is survived by a spouse and eligible children, the spouse will receive 50% of the death benefit and the children will divide the remaining 50% 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 individual has no surviving spouse or children, the individual designated by the deceased individual as the beneficiary under his or her most recently executed life insurance policy will receive the death benefit. If there is no life insurance policy or no surviving designated beneficiary under such a policy, the parents will divide the death benefit in equal shares. If none of these categories of survivors exists, the legal guardian of a deceased minor (who was a smallpox vaccine recipient or vaccinia contact) with no living parent will receive the death benefit, if applicable.

As explained in Sec. 102.11(b)(5), surviving dependents younger than the age of 18 will have the same priority as surviving eligible children. Only the legal guardians of persons qualifying both as surviving eligible children under the PSOB Program and as dependents younger than the age of 18 can choose between a proportional death benefit under the standard and the alternative methods of payment. 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 calculation. Dependents who are minors and who do not qualify under another category of eligible survivors (for example, eligible surviving children of the deceased) are only covered by the alternative method of payment. Death Benefits Under the Standard Calculation, Described in Sec. 102.82(c) Under the ``standard calculation,'' the amount of the death benefit that can be paid under the program in a particular fiscal year will equal the amount of the death benefit available under the PSOB Program in the same fiscal year (without regard to any reduction in PSOB Program death benefits due to a limitation in appropriations). The amount of the PSOB Program death benefit, which is subject to change, is currently approximately $262,100.

Survivors who already collected, or are eligible to collect, death benefits under the PSOB Program are not eligible to receive Smallpox Vaccine Injury Compensation Program death benefits under the standard calculation. Survivors receiving a death benefit under the standard calculation from this program will receive the difference between any disability benefit paid under the PSOB Program and the death benefit available under the standard calculation if the PSOB Program disability benefit was underpaid due to a limitation in appropriations.

Death benefits under the standard calculation will be reduced by the amount of lost employment income benefits that were paid under this program either to the deceased individual during his or her lifetime, or to his or her estate after death. For example, if a smallpox vaccine recipient received $40,000 from the program during his lifetime in benefits for lost employment income and later died, his survivors would be entitled to receive a total of approximately $222,100 in this fiscal year (the approximate $262,100 death benefit, minus the $40,000 in benefits for lost employment income paid to the injured person during his lifetime).

Death Benefits Under the Alternative Calculation, Described in Sec. 102.82(d)
Payments made under the ``alternative calculation'' of death benefits are based on the deceased person's employment income at the time he or she sustained the covered injury. Under this calculation, 75% of the deceased person's employment income (determined in the same manner as employment income for purposes of lost employment income benefits) at the time he or she sustained the covered injury resulting in death will be paid annually until the youngest of the dependents reaches the age of 18. However, the maximum annual amount that may be paid to dependents (in total) under the alternative calculation is $50,000. No lifetime caps apply to death benefits under this alternative calculation. Death benefits under this alternative calculation are available only to surviving dependents who are younger than the age of 18.

In order for such surviving dependents to receive payments under the alternative calculation as opposed to the standard calculation, the legal guardian of all the dependents younger than the age of 18 must choose to receive a proportionate share of the benefits under this calculation on their behalf, as described in Sec. 102.82(d)(1). In the event that multiple dependents have different legal guardians, each legal guardian is responsible for choosing the calculation of death benefits on behalf of the dependents of whom he or she is the legal guardian. For this reason, the legal guardian of several individuals who qualify both as surviving dependents younger than the age of 18 and as surviving eligible children cannot select a death benefit under the standard calculation for some of those dependents and a death benefit under the alternative calculation for other dependents.

For those survivors who are eligible for a death benefit under both calculations, the particular circumstances (e.g., the age of the survivors, the employment income of the deceased person at the time of the covered injury) will determine which method of calculation will provide the greatest financial benefit. If dependent survivors choose to receive death benefits under the alternative calculation, no death benefits will be paid to those dependents under the standard calculation. However, such payments would not preclude other eligible survivors of equal priority from receiving a proportionate death benefit under the standard calculation. For example, if a deceased smallpox recipient or vaccinia contact is survived by two dependents younger than the age of 18 from a prior marriage and by a spouse who is not the legal guardian of the dependents, the legal guardian of the two dependents could choose to receive a 50% share of the death benefit for the dependent children under the alternative calculation and the surviving spouse would still be able to receive his or her 50% share of the death benefit under the standard calculation. As another example, if a deceased smallpox recipient is survived by two minor, dependent children, one whose living parent is the deceased person's surviving spouse and another whose living parent is the deceased person's former spouse, the surviving spouse could receive a 50% share of the death benefit under the standard calculation and each of the dependent children would be eligible for a proportionate share (25%) of the death benefit available under the standard calculation or the alternative calculation, as determined by the children's respective legal guardians. Although the Program will generally apportion death benefits among multiple eligible survivors, it will not do so on behalf of dependents receiving death benefits under the alternative calculation if the dependents share the same legal guardian (because such payments would be made to the legal guardian on behalf of all of the dependents for whom he or she is the legal guardian).

The legal guardian would be expected to apportion the award appropriately. Death benefits paid to survivors under this alternative calculation are secondary to all payments made, or expected to be made in the future, by any third party payor for: (i) Compensation for the deceased person's loss of employment income on behalf of the dependents receiving death benefits under the alternative calculation, or their legal guardian(s); (ii) disability, retirement, or death benefits in relation to the deceased person on behalf of the dependents receiving death benefits under the alternative calculation, or their legal guardian(s); and (iii) life insurance benefits on behalf of the dependents receiving death benefits under the alternative calculation. Such secondary benefits are described in Sec. 102.83(d)(3)(A). Reductions will not be made if such benefits were paid to other persons (for example, if a retirement benefit was paid to the surviving spouse who is not the dependents' legal guardian, no deduction would be made to the dependents' death benefit to account for the benefit the spouse received). In calculating such reductions, the Secretary will have discretion to apportion over multiple years any lump-sum third-party payments. The Secretary has a right to recover benefits paid under this program from third-party payors that have an obligation to pay for or provide such benefits. As with other determinations made under this regulation, any determination concerning the calculation and payment of death benefits is not subject to any judicial review.

Filing a Request Package (Sec. 102.40-Sec. 102.41)
A Smallpox Vaccine Injury Compensation Request Form (hereinafter ``Request Form'') available from the program and all the eligibility and benefits documentation comprise the Smallpox Vaccine Injury Compensation Request Package (hereinafter ``Request Package''). In order for a requester to have his or her request reviewed by the program, the requester must submit, at a minimum, a completed Request Form 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 Request Packages to the applicable address listed in Sec. 102.41.

Representatives of Requesters (Sec. 102.44)
This program has been designed so that requesters do not need to retain the services of lawyers to pursue benefits under this program. However, as provided in Sec. 102.44, requesters may have a legal or personal representative submit the Request Form and/or Request Package on their behalf. A legally competent requester must certify 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 legally incompetent adults will require the assistance of a representative (who does not need to be a lawyer). Representatives of requesters who are minors or adults determined by a court to be legally incompetent are required to submit specific documentation, in addition to the documentation generally required of requesters, which is described in Sec. 102.63. The representative of a requester is required to submit the documents that would ordinarily be required of 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 the same records on behalf of the requester. The Secretary will direct all correspondence to, and communicate exclusively with, a requester's representative unless the Secretary is advised that the representation has stopped. As explained above, although legal representation is permitted, it is not needed for filing for program benefits. As described in Sec. 102.44(d), the Secretary will not be responsible for the payment of any fees for the services of legal or personal representatives or for any associated costs.

Filing Deadlines (Sec. 102.42)
Smallpox vaccine recipients who have a covered injury have one year from the date of a smallpox vaccination administered during the effective period of the Declaration (between January 24, 2003, and January 23, 2004, unless the Secretary extends the time period) to submit a Request Form. This deadline applies even if the requester's injury was the direct result of a covered countermeasure other than the smallpox vaccine (e.g., cidofovir) that was administered after the vaccine administration. Vaccinia contacts have two years to submit their Request Forms from the date of the onset of the covered injury, as documented in their medical records. Because the SEPPA, in its discussion of filing deadlines, refers to requests based on the administration of the smallpox vaccine and requests based on accidental vaccinia inoculation, the filing deadlines that apply to Request Forms filed by smallpox vaccine recipients or vaccinia contacts are the same filing deadlines that apply to Request Forms filed by the survivors or the representatives of the estates of deceased smallpox vaccine recipients and vaccinia contacts.

However, as explained later in the preamble, if a smallpox vaccine recipient or vaccinia contact filed a timely Request Form and later died, his or her survivors (or the representative of his or her estate) could file an amendment to that Request Package outside of the filing deadline. Because the administration of smallpox covered countermeasures other than the smallpox vaccine (cidofovir and its derivatives or Vaccinia Immune Globulin), in the context of this program, generally relates back to complications arising from the administration of the smallpox vaccine or of accidental vaccinia inoculation, the filing deadlines set forth in Sec. 102.42 extend to the administration of such other covered countermeasures.

In the event that the Secretary amends the Table of Injuries, requesters have an extended filing deadline, based on the effective date of the table amendment, which will be published in the Federal Register. However, the extended filing deadline only applies if the table amendment enables a person who could not establish a table injury before the amendment to establish such an injury. To speed the review of eligibility, requesters should file all documentation required for eligibility determinations by the filing deadline. However, a requester will meet the filing deadline requirement by submitting only the completed and signed Request Form by that deadline, with documentation to follow.

Request Forms not filed within the governing filing deadline will not be processed, and the requester will not be considered for any program benefits.

Amendments to Request Packages (Sec. 102.46)
The filing of amendments to previously filed Request Packages is discussed in Sec. 102.46. As explained in that section, if a smallpox vaccine recipient or vaccinia contact filed a Request Package, but later dies, his or her survivors or the representative of his or her estate may amend the Request Package. However, a requester filing such an amended request will only be entitled to benefits under the program if the original Request Form (filed by the smallpox vaccine recipient, vaccinia contact, or representative) was filed within the applicable 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 or estate representative need not resubmit such documentation.

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 Needed for the Secretary To Determine Eligibility (Sec. 102.50-Sec. 102.54) Requesters or their representatives must submit appropriate documentation to allow the Secretary to determine if the requesters are eligible for program benefits. The documentation required will vary somewhat depending on whether the requester is filing as a smallpox vaccine recipient, vaccinia contact, survivor, or representative of an estate.

Medical Records Required of All Requesters To Establish a Covered Injury (Sec. 102.50)
Because all Request Packages filed with the program, including those filed by survivors or representatives of the estates of deceased persons, must relate back to a smallpox vaccine recipient or vaccinia contact who sustained a covered injury, all requesters must submit medical records sufficient to demonstrate to the Secretary that a covered injury was sustained by a smallpox vaccine recipient or a vaccinia contact. Section 102.50(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 either whether an injury set out in the table and meeting the table's requirements was sustained or whether an injury was sustained as the direct result of receiving a covered countermeasure (including a smallpox vaccine) or of contracting vaccinia through accidental exposure. The program will consider copies of medical records to be the same as the original records.

Although the medical records described in Sec. 102.50(a) are t