This part establishes criteria and procedures for implementation of the Ricky Ray Hemophilia Relief Fund Act of 1998 (the Act). This statute provides for compassionate payments to certain individuals with blood-clotting disorders, such as hemophilia, who contracted human immunodeficiency virus (HIV) due to contaminated antihemophilic factor within a specified time period, as well as to certain persons who contracted HIV from these individuals. In the event the individual eligible for payment is deceased, the Act also provides for payments to certain survivors of this individual.

As used in this part:

(a) Act means the Ricky Ray Hemophilia Relief Fund Act of 1998, 42 U.S.C. 300c-22 note, as amended.

(b) Antihemophilic factor means any blood product (including, but not limited to, fresh frozen plasma, cryoprecipitate, factor VIII concentrate, and factor IX concentrate) used to treat a blood-clotting disorder.

(c) Blood-clotting disorder means a disorder (including, but not limited to, hemophilia and von Willebrand's disease) in which the blood does not clot normally, usually resulting in prolonged bleeding.

(d) Child with HIV means the individual described in § 130.10(c).

(e) Former lawful spouse means a person to whom an individual described in § 130.10(a):

(1) Was married according to the laws of the place where the person resided at any time after the date of the individual's treatment with antihemophilic factor (this date of treatment must have been between July 1, 1982, and December 31, 1987); and

(2) Is no longer married.

(f) Former lawful spouse with HIV means the individual described in § 130.10(b)(2).

(g) Fund means the “Ricky Ray Hemophilia Relief Fund,” which is a Trust Fund established in the Treasury of the United States and administered by the Secretary of the Treasury.

(h) Hemophilia means a bleeding disorder in which a clotting factor (including, but not limited to, factors VIII or IX) is missing or does not function normally.

(i) HIV infection or HIV means any of the following:

(1) For individuals diagnosed with the HIV infection at any age, including infants: the presence of an opportunistic disease characteristic of AIDS, sufficient to satisfy the definition of HIV infection as set forth in Appendix A to this part; or

(2) For individuals diagnosed with the HIV infection at over 15 months of age: the presence of laboratory evidence of HIV based on identification of:

(i) HIV antibodies;

(ii) HIV viral antigens;

(iii) HIV viral cultures; or

(iv) Plasma HIV RNA; or

(3) For infants diagnosed with the HIV infection due to perinatal transmission at or before 15 months of age: identification of the presence of HIV by a positive virologic test (i.e., detection of HIV by culture, HIV antigen, or HIV DNA or RNA polymerase chain reaction [PCR]).

(j) Individual with a blood-clotting disorder and HIV means the individual described in § 130.10(a).

(k) Lawful spouse means a person to whom an individual described in § 130.10(a) is married according to the laws of the place where the person resides on the date the petition is filed. If the laws of the place where the person resides consider an individual who is legally separated or in a common law marriage to be married, then such a person is a lawful spouse.

(l) Lawful spouse with HIV means the individual described in § 130.10(b)(1).

(m) Perinatal transmission means transmission of HIV infection from mother to child that occurs during pregnancy, delivery, or breastfeeding.

(n) Person(s) with HIV means all of the individuals described in § 130.10(a), (b) or (c).

(o) Place means any State of the United States of America, the District of Columbia, and United States territories, commonwealths, and possessions.

(p) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department to whom the authority involved has been delegated.

If there are sufficient amounts in the Fund to make payments, the Secretary will make a single payment of $100,000 to eligible individuals, as defined in accordance with subpart B of this part.

The following individuals are eligible for payment under the Act if they are living at the time that payment is to be made on a petition and have an HIV infection:

(a) An individual who has any form of blood-clotting disorder, such as hemophilia, who was treated with antihemophilic factor at any place defined in § 130.2(o), or at any diplomatic area or military installation of the United States, at any time during the time period from July 1, 1982, to December 31, 1987.

(b) An individual who is:

(1) The lawful spouse of the individual with a blood-clotting disorder and HIV; or

(2) The former lawful spouse of the individual with a blood-clotting disorder and HIV, if the former lawful spouse can assert with reasonable certainty, through medical documentation, transmission of HIV from the individual with a blood-clotting disorder and HIV.

(c) An individual who acquired the HIV infection through perinatal transmission from a parent who is the individual with a blood-clotting disorder and HIV, the lawful spouse with HIV or the former lawful spouse with HIV.

(a) Survivors of persons with HIV, as described in § 130.10, are eligible for payment under the Act if:

(1) The person with HIV dies before filing a petition under the Act. In this case, an eligible survivor may file a petition as a survivor of the person with HIV, as set forth in § 130.22; or

(2) The person with HIV has filed a petition under the Act, but dies before payment is made. In this case, an eligible survivor must file an amendment to the petition in order to retain the assigned order number and to receive payment under the Act, as set forth in § 130.23.

(b) Payments to survivors shall be made in the following order:

(1) If the person with HIV is survived by a spouse who is living at the time of payment, the payment shall be made to the surviving spouse (hereinafter referred to as “the surviving spouse”).

(2) If the person with HIV is not survived by a living spouse, the payment shall be made in equal shares to all children of the individual who are living at the time of payment (hereinafter referred to as “the surviving child/children”).

(3) If the person with HIV is not survived by a spouse or children who are living at the time of payment, the payment shall be made in equal shares to the parents of the individual who are living at the time of payment (hereinafter referred to as “the surviving parent(s))'.

(c) If the person with HIV is not survived at the time payment is to be made by any of the survivors listed in paragraph (b) of this section, no payments will be made for the person with HIV and the payment will revert back to the Fund.

(d) For purposes of this section, the following definitions apply:

(1) The term spouse means a person who was lawfully married to the person with HIV according to the laws of the place where the person resided at the time of death.

(2) The term child includes a recognized natural child, a stepchild who lived with the person with HIV in a regular parent-child relationship, and an adopted child.

(3) The term parent includes fathers and mothers through adoption.

In all instances in which medical documentation is referred to, medical documentation may be submitted in the following forms:

(a) Copies of relevant portions of medical records, records maintained by a physician, nurse, or other licensed health care provider, test results, prescription information, or other documentation deemed credible by the Secretary; or

(b) An affidavit, signed under penalty of perjury, by a physician or nurse practitioner, verifying that the medical criteria necessary for a petitioner to be eligible for payment under the Act are satisfied. Such an affidavit must include the physician or nurse practitioner's State and license number. A sample affidavit is set forth at Appendix B to this part.

The following rules apply to all petitions filed by persons with HIV:

(a) All petitions filed under the Act must include written medical documentation showing the following:

(1) That the individual described in § 130.10(a) has (or had) a blood-clotting disorder, such as hemophilia;

(2) That the individual with a blood-clotting disorder and HIV was treated with antihemophilic factor at any time between July 1, 1982, to December 31, 1987; and

(3) That the individual with a blood-clotting disorder and HIV has (or had) an HIV infection under any of the criteria set out in the definition of HIV infection at § 130.2(i).

(b) The individual. Petitions filed by the individual with a blood-clotting disorder and HIV need only include the documentation described in paragraph (a) of this section.

(c) The lawful spouse. Petitions filed by the lawful spouse with HIV must include the following written documentation:

(1) The documentation described in paragraph (a) of this section;

(2) Medical documentation showing that the lawful spouse with HIV has an HIV infection; and

(3) A marriage certificate or other proof of a lawful marriage, which shows that the lawful spouse with HIV and the individual with a blood-clotting disorder and HIV are married.

(d) The former lawful spouse. Petitions filed by the former lawful spouse with HIV must include the following written documentation:

(1) The documentation described in paragraph (a) of this section;

(2) Medical documentation showing that the former lawful spouse with HIV has an HIV infection;

(3) A marriage certificate or other proof of a lawful marriage, which shows that the former lawful spouse with HIV and the individual with a blood-clotting disorder and HIV were married at any time after the date of the individual's treatment with antihemophilic factor (this date of treatment must have been between July 1, 1982, to December 31, 1987);

(4) A divorce certificate or other proof of termination of the marriage between the former lawful spouse with HIV and the individual with a blood-clotting disorder and HIV; and

(5) Medical documentation which shows with reasonable certainty that the former lawful spouse with HIV contracted HIV from the person with a blood-clotting disorder and HIV.

(e) The child. Petitions filed by the child with HIV must include the following written documentation:

(1) The documentation described in paragraph (a) of this section;

(2) Medical documentation showing that the child with HIV has an HIV infection;

(3) A birth certificate or other proof, which shows that the child with HIV is the child of:

(i) The individual with a blood-clotting disorder and HIV;

(ii) The lawful spouse with HIV; or

(iii) The former lawful spouse with HIV;

(4) A marriage certificate or other proof of a lawful marriage, which shows that the lawful spouse with HIV or the former lawful spouse with HIV and the individual with a blood-clotting disorder and HIV are/were married, except where the individual with a blood-clotting disorder and HIV is the mother of the child with HIV;

(5) Medical documentation showing that the child with HIV acquired an HIV infection through perinatal transmission from a parent who is:

(i) The individual with a blood-clotting disorder and HIV;

(ii) The lawful spouse with HIV; or

(iii) The former lawful spouse with HIV; and

(6) Where the child with HIV acquired an HIV infection through perinatal transmission from the former lawful spouse with HIV, medical documentation which shows with reasonable certainty that the former lawful spouse with HIV contracted HIV from the person with the blood-clotting disorder and HIV.

(a) In those cases in which the person with HIV, as described in § 130.10, dies before filing a petition under the Act, a survivor of that person, as described in § 130.11, may file a petition.

(b) Petitions filed by survivors must include two types of information:

(1) Documentation regarding the person with HIV; and

(2) Documentation regarding the eligibility of the survivor to receive payments as a survivor of the person with HIV.

(c) Petitions filed by survivors must include the following information regarding the person with HIV:

(1) The individual. Petitions filed by a survivor of the individual with a blood-clotting disorder and HIV must include the documentation described in § 130.21(b).

(2) The lawful spouse. Petitions filed by a survivor of the lawful spouse with HIV must include the documentation described in § 130.21(c).

(3) The former lawful spouse. Petitions filed by a survivor of the former lawful spouse with HIV must include the documentation described in § 130.21(d).

(4) The child. Petitions filed by a survivor of the child with HIV must include the documentation described in § 130.21(e).

(d) Petitions filed by survivors must include the following information regarding the relationship between the survivor and the person with HIV:

(1) The surviving spouse. Petitions filed by the surviving spouse must include the following written documentation:

(i) A death certificate for the person with HIV, or other evidence of that individual's death;

(ii) A marriage certificate or other proof of a lawful marriage, which shows that the survivor was the spouse, as defined in § 130.11(d)(1), of the person with HIV; and

(iii) A sworn statement signed by the surviving spouse which states that the surviving spouse and the person with HIV were married at the time of that individual's death.

(2) The surviving child/children. Petitions filed by the surviving child/children must include the following written documentation:

(i) A death certificate for the person with HIV, or other evidence of that individual's death;

(ii) A birth certificate, adoption certificate, documentation that shows that the survivor is the stepchild of the person with HIV (for example, a certificate of marriage between the survivor's parent and the person with HIV), or other documentation which shows that the survivor is the child, as defined in § 130.11(d)(2), of the person with HIV; and

(iii) A sworn statement signed by the surviving child/children which either:

(A) States that, to the best of the petitioner's knowledge, there are no other survivors who are eligible for payment under the Act, as described in § 130.11 (i.e., no eligible surviving spouses or other surviving children); or

(B) Provides information regarding other survivors who are eligible for payment under the Act.

(3) The surviving parent(s). Petitions filed by the surviving parent(s) must include the following written documentation:

(i) A death certificate for the person with HIV, or other evidence of that individual's death;

(ii) A birth certificate, adoption certificate or other documentation which shows that the survivor is the parent, as defined in § 130.11(d)(3), of the person with HIV; and

(iii) A sworn statement signed by the surviving parent(s) which either:

(A) States that, to the best of the petitioner's knowledge, there are no other survivors who are eligible for payment under the Act, as described in § 130.11 (i.e., no eligible surviving spouse, surviving children or other surviving parents); or

(B) Provides information regarding other survivors who are eligible for payment under the Act.

(a) The following survivors must file amendments to petitions in order to retain the assigned order number described in § 130.32 and to receive payment under the Act:

(1) A survivor of the person with HIV, when the person with HIV has filed a petition under the Act, but then died before receiving payment;

(2) The next-ranked survivor eligible to receive payment under the Act, as described in § 130.11(b), when a previously-ranked survivor has filed a petition or an amendment to a petition as a survivor of the person with HIV, but then died before receiving payment; and

(3) In the case of petitions filed by multiple survivors (i.e., multiple surviving children or multiple surviving parents), where one of the survivors dies before receiving payment, the other survivors must file an amendment in order to notify the Secretary that the payment should be made to, and divided among, only the remaining survivors.

(b) Survivors described in paragraph (a) of this section shall amend the original petition by filing the petition form set forth at Appendix C to this part, including the section pertaining to amendments to petitions.

(c) Amendments to petitions filed by survivors must include the following documentation:

(1) Survivors described in paragraph (a)(1) of this section must include the documentation described in § 130.22(d), which shows that the survivor is eligible to file a petition as a survivor of the person with HIV.

(2) Survivors described in paragraph (a)(2) of this section must include:

(i) The documentation described in § 130.22(d), which shows that the survivor is eligible to file a petition as a survivor of the person with HIV; and

(ii) A death certificate for the survivor whose petition is being amended, or other evidence of that survivor's death.

(3) Survivors described in paragraph (a)(3) of this section must include a death certificate for the survivor who has died, or other evidence of that survivor's death.

(d) Amendments to petitions filed by survivors described in paragraph (a) of this section will retain the same order number assigned to the original petition.

(e) In those cases in which the Secretary has reviewed the original petition prior to receiving an amendment to the petition, the Secretary will determine whether to pay the survivors described in paragraph (a) as follows:

(1) If the Secretary has determined that the original petition does not include all of the documentation described in this Subpart C (i.e., it is incomplete), the survivor will be given the opportunity to complete the petition prior to a final determination in accordance with the procedures set forth at § 130.33.

(2) If the Secretary has determined that the original petition does not meet the requirements of the Act, the survivor will be so notified and payment will not be made. The survivor may seek reconsideration under § 130.40.

(3) If the Secretary has determined that the original petition meets the requirements of the Act, and the survivor meets the survivor requirements of the Act, the survivor will receive payment as described in § 130.3.

(f) In those cases in which the Secretary has not yet made the determination whether the original petition meets the requirements of the Act, the Secretary will review the amended petition according to the order number assigned to the original petition, and then determine whether the petition is complete and whether to pay the petition as described in paragraph (e) of this section.

The following individuals may file a petition for payment under the Act:

(a) All eligible individuals, as described in subpart B of this part, including living persons with HIV and survivors of persons with HIV; and

(b) Personal representatives of eligible individuals:

(1) Where the eligible individual does not have the legal capacity to receive payment under the Act, as described in § 130.35(e); or

(2) Where the eligible individual does have the legal capacity to receive payment under the Act and signs the sworn statement included at the end of the petition.

(a) In order to receive payment under the Act, all eligible individuals, as described in subpart B of this part, must file a complete petition with the Secretary. A complete petition is one that contains all of the required documentation described in Subpart C of this part.

(b) A copy of the petition form, which must be filed by all eligible individuals, including individuals with a blood-clotting disorder and HIV, the lawful spouse with HIV, the former lawful spouse with HIV, the child with HIV, and the survivors of persons with HIV, is set forth at Appendix C to this part. Appendix C includes the petition form, the instructions for filing the petition form, and a documentation checklist.

(c) Where there are multiple surviving children or surviving parents, payments on the petition will be made to each survivor separately. The survivors shall:

(1) File one petition form jointly, which will contain the required documentation for all survivors, and which will be signed by at least one survivor; or

(2) File separate petition forms, which together will contain all of the required documentation for all survivors, and which will be signed by each survivor.

(d) Petitions may be obtained from the Ricky Ray Program Office, Bureau of Health Professions, HRSA, Room 8A-54, 5600 Fishers Lane, Rockville, Maryland 20857.

(e) All petitions must be submitted to the Ricky Ray Program Office, Bureau of Health Professions, HRSA, Room 8A-54, 5600 Fishers Lane, Rockville, Maryland 20857.

(f) The date on which the Secretary will begin accepting petitions is July 31, 2000.

(1) In order to be eligible for review, petitions may be postmarked on or after this date. A legibly dated receipt from a commercial carrier or U.S. Postal Service will be accepted in lieu of a postmark. Petitions that are postmarked by a private meter will not be accepted.

(2) Petitions that are postmarked, or accompanied by a receipt from a commercial carrier or U.S. Postal Service, prior to this date will be returned to the petitioner. Petitions that are delivered by hand at any time will be returned to the petitioner.

(g) Deadlines. The deadline for filing a petition is November 13, 2001. To meet this deadline, the petition must be postmarked, or accompanied by a receipt from a commercial carrier or U.S. Postal Service, by such date. Any new petition filed after such date will be returned to the petitioner as ineligible for payment, even if the petitioner filed a timely Notice of Intent as provided in the procedure described in the Federal Register of March 24, 1999 (64 FR 14251).

(1) If a petitioner submits a petition to the Secretary by November 13, 2001, and the Secretary has determined, in accordance with § 130.34, that the petition does not meet the requirements of the Act, the petitioner may submit a new petition for payment, which includes additional documentation that was not included in the original petition. The deadline for filing this new petition is November 13, 2001.

(2) If a petitioner submits a petition to the Secretary by November 13, 2001, and the Secretary has not yet made the determination whether the petition meets the requirements of the Act, the petitioner may supplement the original petition with additional documentation at any time until the date of the Secretary's determination.

(3) If a petitioner files an amendment to a petition, as described in § 130.23, the deadline for filing this amendment is the date of the Secretary's determination of eligibility or the date of payment, whichever is later.

(h) Petitioners who filed claims under the Factor Concentrate Settlement. Petitioners who filed claims under the class settlement in the case of Susan Walker v. Bayer Corporation, et al., 96-C-5024 (N.D. Ill.) (i.e., the Factor Concentrate Settlement) must file a complete petition with the Secretary, together with all required documentation, as described in subpart C of this part.

(1) If the petitioner submitted a claim in the Factor Concentrate Settlement which included all of the documents required to establish eligibility under the Act, he or she may submit original or duplicate copies of those documents to the Secretary.

(2) If the petitioner submitted a claim in the Factor Concentrate Settlement which included some, but not all, of the documents required to establish eligibility under the Act, he or she may submit original or duplicate documents as described in paragraph (h)(1) of this section, together with the additional documents required under the Act.

(3) If the petition is filed by someone other than an individual who filed a claim in the Factor Concentrate Settlement (e.g., survivors of the person with HIV, personal representatives), he or she may submit original or duplicate documents as described in paragraph (h)(1) or (h)(2) of this section in order to satisfy that portion of the petition relating to the person with HIV.

(a) The order that the petition was received by the Secretary will be determined by the postmark date or the date indicated by a commercial carrier or the U.S. Postal Service, in accordance with § 130.31(f).

(b) If the Secretary receives more than one petition which is either postmarked or dated by a commercial carrier or the U.S. Postal Service on the same date, the Department will conduct a random selection of each day's submissions to determine the order within each group of petitions.

(c) A number will be assigned to each petition indicating the order in which it is selected.

(a) If the Secretary determines that a petition does not include all of the documentation described in subpart C of this part (i.e., it is incomplete), the petitioner will be given the opportunity to complete the petition prior to a final determination.

(b) The petitioner will be notified that the Secretary has determined that the petition is incomplete and, for purposes of retaining the assigned order number described in § 130.32, will be given 60 calendar days from the date of the notice to submit the missing information. If the petitioner submits the missing information within 60 calendar days, and the Secretary determines that the petition meets the requirements of the Act, the petitioner will be paid according to the assigned order number.

(c) If the petitioner is unable to complete the petition, the petitioner may submit written documentation to the Secretary, within 60 calendar days, which shows good cause why the required medical or legal documentation is unavailable. If the Secretary determines that the petitioner has provided an adequate showing of good cause and is otherwise eligible for payment under the Act, the petitioner will be paid according to the assigned order number.

(d) The Secretary will process the petition according to § 130.34 if:

(1) The petition does not include the required documentation, as described in subpart C, even after the opportunity is given to complete it;

(2) The 60-day deadline to complete the petition is not met; or

(3) An adequate showing of good cause why the required medical or legal documentation is unavailable is not provided.

(a) Subject to available resources, the Secretary will review each petition filed under the Act and make one of the following determinations:

(1) If the Secretary concludes that the petition does not meet the requirements of the Act, the petitioner will be so notified and payment will not be made. These petitioners may seek reconsideration under § 130.40.

(2) If the Secretary concludes that the petition does meet the requirements of the Act, the petitioner will receive payment as described in § 130.3.

(b) Petitions will be reviewed based upon the assigned number indicating the order of receipt, as described in § 130.32.

(a) To the extent practicable, determinations on complete petitions will be made not later than 120 calendar days after the date that the Secretary determines that the petition is complete.

(b) Payments on petitions will be made as soon as practicable after a determination that a complete petition meets the requirements of the Act.

(c) For each eligible individual, as described in subpart B of this part, the Secretary will make only one payment on a petition.

(d) Where there are multiple surviving children or surviving parents, survivors who have submitted all required documentation and are otherwise eligible for payment under the Act, will be paid their share(s) of the payment, as described in § 130.11(b)(2) and (3). If any surviving children or surviving parents who are otherwise eligible for payment have not submitted the required documentation, their share(s) of the payment will remain in the Fund until such time as they complete their petitions by submitting such documentation. If they have not submitted the required documentation by the time that the Fund terminates, their share(s) will revert back to the Treasury.

(e) Payments on petitions will be made to eligible individuals, as described in subpart B, unless the eligible individual is legally incompetent to receive payment. A personal representative may receive payment for a legally incompetent individual by submitting the following written documentation to the Secretary:

(1) Proof showing that the eligible individual does not have the legal capacity to receive payment under the Act, such as a birth certificate showing that the eligible individual is a minor, or other evidence showing that the eligible individual is legally incompetent; and

(2) Proof showing that the personal representative has the authority to receive payment for the eligible individual, such as proof of legal guardianship.

(a) Right of reconsideration. Every individual who has filed a petition and has been denied payment may seek reconsideration. To seek such reconsideration, the petitioner must put a request for reconsideration in writing and send it to the Deputy Associate Administrator for Health Professions, Health Resources and Services Administration, Room 8A-54, 5600 Fishers Lane, Rockville, Maryland 20857. The request for reconsideration must be received by the Deputy Associate Administrator for Health Professions within 60 calendar days of the date the Department denied the petition for payment.

(b) Request for reconsideration. The request for reconsideration must state the reasons why the petitioner is seeking reconsideration. However, the request for reconsideration may not include any additional documentation that was not included in the completed petition.

(c) Review process. When the Deputy Associate Administrator for Health Professions receives a request for reconsideration, he will convene a panel of three individuals, who are independent of the Ricky Ray Program Office, to review the initial determination and make a recommendation regarding payment. The Deputy Associate Administrator for Health Professions will review the panel's recommendation and then determine whether the petitioner is eligible for payment under the Act. The Deputy Associate Administrator for Health Professions' determination will constitute the Department's final action on the request for reconsideration. If the determination is that the petitioner is eligible for payment, the petitioner will receive payment as described in § 130.3. If the determination is that the petitioner is not eligible for payment, the Deputy Associate Administrator for Health Professions will inform the petitioner in writing of the reasons for this determination.

As provided by section 107 of the Act:

(a) Notwithstanding any contract, the representative of an individual may not receive, for services rendered in connection with the petition of an individual under this Act, more than 5 percent of a payment made under this Act (i.e., $5,000) on the petition.

(b) Any such representative who violates this section is subject to a fine of not more than $50,000.