PART 110—COUNTERMEASURES INJURY COMPENSATION PROGRAM Authority: 42 U.S.C. 247d-6e. Source: 75 FR 63675, Oct. 15, 2010, unless otherwise noted. Subpart A—General Provisions § 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. § 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 § 110.31. (2) Lost employment income incurred as a result of a covered injury, as described in § 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 § 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., § 110.3 Definitions. This section defines certain words and phrases found throughout this part. (a) Act PHS Act (b) Alternative calculation (c) Approval (d) Benefits (e)(1) Child (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 (3) Stepchild (f) Covered Countermeasure (1) Administered or used within a State (as defined in § 110.3(bb)), 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 (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 (i) Dependent dependent (j) Disapproval (k) Effective period of the declaration (l) Federal Employees' Compensation Act (FECA) Program et seq. (m) Healthcare provider (n) Injured countermeasure recipient (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 § 110.3(g). (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 (p) Medical records (q) Payer of last resort (r) Program (s) PREP Act Public Readiness and Emergency Preparedness Act, (t) Public Safety Officers' Benefits (PSOB) Program et seq. (u) Representative (v) Requester (w) Request Form or Request for Benefits Form (x) Request Package (y) Secretary (z) Serious injury (aa) Standard calculation (bb) State (cc) Survivor (dd) Table Table of Injuries (ee) Third-party payer [75 FR 63675, Oct. 15, 2010, as amended at 76 FR 62308, Oct. 7, 2011] Subpart B—Persons Eligible To Receive Benefits § 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 § 110.3(n); (2) Survivors, as described in § 110.3(cc) and § 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., (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 § 110.42. Amendments to previously filed Request Packages and the filing deadlines for such amendments are described in § 110.46. (c) The benefits available to different categories of requesters are described in § 110.30. § 110.11 Survivors. (a) Survivors of injured countermeasure recipients who died as the direct result of a covered injury. (b) Survivors who may be eligible to receive benefits and the order of priority for benefits. (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. (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 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 § 110.82(c), and is not eligible to receive death benefits under the standard calculation described in § 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 § 110.20 How to establish a covered injury. (a) General. or (b) Table injuries. i.e., (c) Injuries for which causation must be shown (non-Table injuries). e.g., (d) Injuries resulting from the underlying condition for which the countermeasure was administered or used. e.g., Subpart D—Available Benefits § 110.30 Benefits available to different categories of requesters under this Program. (a) Benefits available to injured countermeasure recipients. (b) Benefits available to survivors. (c) Benefits available to estates of deceased injured countermeasure recipients. § 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., (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 § 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 § 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. § 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 § 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 § 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 § 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 § 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., (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 § 110.82. § 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 § 110.82. As provided in § 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 § 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 § 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 § 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., (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 § 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/. (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. § 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. § 110.42 Deadlines for filing Request Forms. (a) General. (b) Letters of Intent. http://www.hrsa.gov/countermeasurescomp/ (c) Determination of proper filing. e.g., (d) Request Forms not filed within the one-year deadline. (e) Constructive receipt. e.g., i.e., (f) Request Forms (or amendments to Request Forms) based on initial publication of a Table of Injuries or modifications to an existing Table. [75 FR 63675, Oct. 15, 2010, as amended at 76 FR 62309, Oct. 7, 2011] § 110.43 Deadlines for submitting documentation. (a) Documentation for eligibility determinations. (b) Documentation for benefits determinations. i.e., § 110.44 Legal or personal representatives of requesters. (a) Generally. e.g., e.g., (b) Legal or personal representatives of legally competent adults. may (c) Legal or personal representatives of minors and adults who lack legal capacity to receive payment of benefits. must (d) No payment or reimbursement for legal or personal representatives' fees or costs. § 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. § 110.46 Amending a Request Package. (a) Generally. eligibility benefits (b) Requesters who are survivors. (c) Requests in which the benefits are sought for the estate of a deceased injured countermeasure recipient. 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. (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 § 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 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., (e) Although the Secretary prefers to receive medical records directly from healthcare providers, she has the discretion to accept them from the requester. § 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 § 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 § 110.3(g), in accordance with the requirements set forth in § 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., (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. § 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 § 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 § 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 § 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 § 110.11 ( e.g., (5) Verification, on the place provided on the Request Form, either that there are no other eligible survivors ( e.g., (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] § 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 § 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 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., (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 § 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. (2) Documents for medical services or items provided since the onset of the covered injury. e.g., e.g., (3) Documents for medical services and items expected to be provided in the future. e.g., (b) [Reserved] § 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., (2) The injured countermeasure recipient's gross employment income at the time the covered injury was sustained ( e.g., (3) Whether the injured countermeasure recipient had one or more dependents at the time the covered injury was sustained ( e.g., (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] § 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 § 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 § 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., (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 § 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 § 110.82(c), in place of proportional benefits available under the standard calculation as described in § 110.82(b). Written selections are described in § 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., (5) A description of all third-party payers that have paid for, or that may be required to pay for, the benefits described in § 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. § 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, §§ 110.60-110.62: (a) For an eligible requester who is a minor: (1) Documentation showing that the requester is a minor ( e.g., (2) Documentation showing that the representative is the legal guardian of the property or estate of the minor ( e.g., (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 § 110.83(b), the Program reserves the right to waive this requirement for good cause. Subpart H—Secretarial Determinations § 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. § 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. § 110.72 Sufficient documentation for eligibility and benefits determinations. (a) Eligibility determinations. (b) Benefits determinations. e.g., (c) Additional documentation required. § 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 § 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., § 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 § 110.90. (b) The Secretary may disapprove a Request for Benefits even before the requester has submitted all the required documentation ( e.g., (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 § 110.90. Subpart I—Calculation and Payment of Benefits § 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 § 110.31. The Secretary will consider and may rely upon benefits documentation submitted by the requester ( e.g., § 110.81 Calculation of benefits for lost employment income. (a) Primary calculation. (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 (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. (c) Limitations on benefits paid. (1) Number of lost work days. (2) Annual limitation. (3) Lifetime limitation. (4) Termination of payments. (d) Reductions for other coverage. (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 § 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 (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. § 110.82 Calculation of death benefits. (a) General. (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., (b) Standard calculation of death benefits. (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. (1) Selection of benefits under the alternative calculation. (2) Amount of payments. (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. not (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. pro rata § 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 § 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 §§ 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., § 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 § 110.90 Reconsideration of the Secretary's eligibility and benefits determinations. (a) Right of reconsideration. (b) Letters seeking reconsideration. (c) Reconsideration process. (d) Effect of reconsideration on amending a Request Package. § 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. § 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 § 110.100 Injury Tables. (a) Pandemic influenza countermeasures injury table. Covered countermeasures under Secretarial declarations Serious physical injury 1 Time interval I. Pandemic influenza vaccines administered by needle into or through the skin A. Anaphylaxis A. 0-4 hours. II. Pandemic influenza intranasal vaccines A. Anaphylaxis A. 0-4 hours. III. Pandemic influenza 2009 H1N1 vaccine A. Guillain-Barré Syndrome A. 3-42 days (not less than 72 hours and not more than 42 days). IV. Oseltamivir Phosphate (Tamiflu) when administered or used for pandemic influenza A. Anaphylaxis A. 0-4 hours. V. Zanamivir (Relenza) when administered or used for pandemic influenza A. Anaphylaxis A. 0-4 hours. VI. Peramivir when administered or used for 2009 H1N1 influenza A. Anaphylaxis A. 0-4 hours. VII. Pandemic influenza personal respiratory protection devices A. No condition covered 2 A. Not applicable. VIII. Pandemic influenza respiratory support devices A. Postintubation Tracheal Stenosis A. 2-42 days (not less than 48 hours and not more than 42 days) after extubation (removal of a tracheostomy or endotracheal tube). B. Ventilator-Associated Pneumonia and Ventilator-Associated Tracheobronchitis B. More than 48 hours after intubation (placement of an endotracheal or tracheostomy tube) and up to 48 hours after extubation (removal of the tube). C. Ventilator-Induced Lung Injury C. Throughout the time of intubation (breathing through an endotracheal or tracheostomy tube) and up to 48 hours after extubation (removal of the tube). IX. Pandemic influenza respiratory support device: Extra-corporeal membrane oxygenation (ECMO) A. Bleeding Events A. Throughout the time of anticoagulation treatment for ECMO therapy, including the time needed to clear the effect of the anti-coagulant treatment from the body. X. Pandemic influenza diagnostic testing devices A. No condition covered A. Not applicable. 1 2 See (b) Qualifications and aids to interpretation (table definitions and requirements). (1) Anaphylaxis. sequelae. (2) Deltoid bursitis. (3) Vasovagal syncope. sequelae. sequelae (4) Guillain-Barré Syndrome (GBS). (ii) The most common subtype in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP) which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and nerve roots. Another subtype called acute motor axonal neuropathy (AMAN) is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the sensory nerves and roots. AIDP, AMAN, and AMSAN are typically characterized by symmetric motor flaccid weakness, sensory abnormalities, and/or autonomic dysfunction caused by autoimmune damage to peripheral nerves and nerve roots. The diagnosis of AIDP, AMAN, and AMSAN requires bilateral flaccid limb weakness and decreased or absent deep tendon reflexes in weak limbs; a monophasic illness pattern; an interval between onset and nadir of weakness between 12 hours and 28 days; subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse); and, the absence of an identified more likely alternative diagnosis. Death may occur without a clinical plateau. (iii) Fisher syndrome (FS), also known as Miller-Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and AIDP may be seen with limb weakness. The diagnosis of FS requires bilateral ophthalmoparesis; bilateral reduced or absent tendon reflexes; ataxia; the absence of limb weakness (the presence of limb weakness suggests a diagnosis of AIDP); a monophasic illness pattern; an interval between onset and nadir of weakness between 12 hours and 28 days; subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse); no alteration in consciousness; no corticospinal track signs; and, the absence of an identified more likely alternative diagnosis. Death may occur without a clinical plateau. (iv) Evidence that is supportive, but not required, of a diagnosis of all subtypes of GBS includes electrophysiologic findings consistent with GBS or an elevation of cerebral spinal fluid (CSF) protein with a total CSF white blood cell count below 50 cells per microliter. The results of both CSF and electrophysiologic studies are frequently normal in the first week of illness in otherwise typical cases of GBS. (v) For GBS to qualify as a Table injury there must not be a more likely alternative diagnosis for the weakness. Exclusionary criteria for the diagnosis of all subtypes of GBS include the ultimate diagnosis of any of the following conditions: Chronic immune demyelinating polyradiculopathy (“CIDP”), carcinomatous meningitis, brain stem encephalitis (other than Bickerstaff brainstem encephalitis), myelitis, spinal cord infarct, spinal cord compression, anterior horn cell diseases such as polio or West Nile virus infection, subacute inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis, cauda equina compression, metabolic conditions such as hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy (such as vincristine, platinum compounds, or nitrofurantoin), porphyria, critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis, organophosphate poisoning, botulism, critical illness myopathy, polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above list is not exhaustive. (5) Tracheal stenosis. (A) Trauma or necrosis from an endotracheal tube; or (B) Stomal injury from a tracheostomy; or (C) A combination of the two. (ii) Tracheal stenosis or narrowing due to tumors (malignant or benign), infections of the trachea (such as tuberculosis, fungal diseases), radiotherapy, tracheal surgery, trauma, congenital, and inflammatory or autoimmune diseases will not be considered post-intubation tracheal stenosis. Post-intubation tracheal stenosis requires either tracheostomy with placement of a tracheostomy tube or endotracheal intubation. Diagnosis requires symptoms of upper airway obstruction such as stridor (inspiratory wheeze) or exertional dyspnea (increased shortness of breath with exertion), and positive radiologic studies showing abnormal narrowing of the trachea or bronchoscopic evaluation that demonstrates abnormal narrowing. (6) Ventilator-Associated Pneumonia (VAP) and Ventilator-Associated Tracheobronchitis (VAT). (ii) VAT will be considered to be present when the patient demonstrates fever, leukocytosis or leukopenia, purulent tracheal secretions, and a positive tracheal aspirate culture in the absence of a change of antibiotics within the 72 hours prior to culture. Tracheal colonization with microorganisms is common in intubated patients, but in the absence of clinical findings is not a sign of VAT. (7) Ventilator-Induced Lung Injury (VILI). (8) Bleeding events. (c) Smallpox countermeasures injury table. Table 2 to Paragraph ( c Covered countermeasures under declarations Serious physical injury 1 Time interval I. Smallpox Vaccines Replication-Deficient A. Anaphylaxis A. 0-4 hours. II. Smallpox Vaccines Replication-Competent A. Anaphylaxis A. 0-4 hours. C. Significant Local Skin Reaction C. 1-21 days. D. Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis D. 4-28 days. E. Inadvertent Autoinoculation E. 1-21 days. F. Generalized Vaccinia F. 6-9 days. G. Eczema Vaccinatum G. 3-21 days. H. Progressive Vaccinia H. 3-21 days. I. Post- vaccinial I. 5-14 days. J. Vaccinial J. 0-21 days. III. Vaccinia A. Anaphylaxis A. 0-4 hours. C. Acute Renal Failure (ARF) C. 0-10 days. D. Drug-Induced Aseptic Meningitis (DIAM) D. Within 48 hours after the first dose and up to 48 hours after the last dose of VIGIV. E. Hemolysis E. 12 hours to 14 days. IV. Cidofovir A. No Condition Covered 2 A. Not Applicable. V. Tecovirimat A. No Condition Covered 2 A. Not Applicable. VI. Brincidofovir A. No Condition Covered 2 A. Not Applicable. VII. Smallpox Infection Diagnostic Testing Devices A. No Condition Covered 2 A. Not Applicable. 1 2 See (d) Qualifications and aids to interpretation (table definitions and requirements). (1) Anaphylaxis. sequelae. (2) Vasovagal syncope. sequelae. sequelae (3) Significant local skin reaction. (4) Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN). (5) Inadvertent autoinoculation (IA). vaccinia vaccinial (6) Generalized vaccinia (GV). vaccinial vaccinia vaccinial vaccinia (7) Eczema vaccinatum (EV). vaccinia vaccinia (8) Progressive vaccinia (PV). vaccinia, vaccinia (9) Post-vaccinial encephalopathy, encephalitis, and encephalomyelitis (PVEM). vaccinial vaccinia sequelae (10) Vaccinial myocarditis, pericarditis, or myopericarditis (MP). vaccinial Vaccinial Vaccinial Vaccinial e.g., e.g., (11) Transfusion-related acute lung injury (TRALI). (12) Acute renal failure (ARF). (13) Drug-induced aseptic meningitis (DIAM). (ii) A Table 2 injury for DIAM has occurred in a recipient if there is sufficient evidence in the medical record of an occurrence of DIAM within the identified timeframe and the individual received the associated countermeasure (VIGIV). DIAM occurring in the absence of the use of VIGIV, or DIAM occurring with the use of VIGIV outside the established timeframe of onset, which is any time after the first dose and up to 48 hours after the last dose of this medication, is not a Table 2 injury. (14) Hemolysis. [80 FR 47416, Aug. 7, 2015, as amended at 86 FR 45657, Aug. 16, 2021]