§ 274k.
National Program
(a)
Establishment
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall by one or more contracts establish and maintain a C.W. Bill Young Cell Transplantation Program (referred to in this section as the “Program”), successor to the National Bone Marrow Donor Registry, that has the purpose of increasing the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood, and that meets the requirements of this section. The Secretary may award a separate contract to perform each of the major functions of the Program described in paragraphs (1) and (2) of subsection (d) if deemed necessary by the Secretary to operate an effective and efficient system that is in the best interest of patients. The Secretary shall conduct a separate competition for the initial establishment of the cord blood functions of the Program. The
(1)
Each member of the Advisory Council shall serve for a term of 2 years, and each such member may serve as many as 3 consecutive 2-year terms, except that—
(A)
such limitations shall not apply to the Chair of the Advisory Council (or the Chair-elect) or to the member of the Advisory Council who most recently served as the Chair; and
(B)
one additional consecutive 2-year term may be served by any member of the Advisory Council who has no employment, governance, or financial affiliation with any donor center, recruitment organization, transplant center, or cord blood bank.
(2)
A member of the Advisory Council may continue to serve after the expiration of the term of such member until a successor is appointed.
(3)
In order to ensure the continuity of the Advisory Council, the Advisory Council shall be appointed so that each year the terms of approximately one-third of the members of the Advisory Council expire.
(4)
The membership of the Advisory Council—
(A)
shall include as voting members a balanced number of representatives including representatives of marrow donor centers and marrow transplant centers, representatives of cord blood banks and participating birthing hospitals, recipients of a bone marrow transplant, recipients of a cord blood transplant, persons who require such transplants, family members of such a recipient or family members of a patient who has requested the assistance of the Program in searching for an unrelated donor of bone marrow or cord blood, persons with expertise in bone marrow and cord blood transplantation, persons with expertise in typing, matching, and transplant outcome data analysis, persons with expertise in the social sciences, basic scientists with expertise in the biology of adult stem cells, and members of the general public; and
(B)
shall include as nonvoting members representatives from the Department of Defense Marrow Donor Recruitment and Research Program operated by the Department of the Navy, the Division of Transplantation of the Health Resources and Services Administration, the Food and Drug Administration, and the National Institutes of Health.
(5)
Members of the Advisory Council shall be chosen so as to ensure objectivity and balance and reduce the potential for conflicts of interest. The Secretary shall establish bylaws and procedures—
(A)
to prohibit any member of the Advisory Council who has an employment, governance, or financial affiliation with a donor center, recruitment organization, transplant center, or cord blood bank from participating in any decision that materially affects the center, recruitment organization, transplant center, or cord blood bank; and
(B)
to limit the number of members of the Advisory Council with any such affiliation.
(6)
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit to Congress an annual report on the activities carried out under this section.
(7)
The Secretary shall convene the Advisory Council at least two times each calendar year.
(c)
Informed consent
The Secretary shall, through a public process, examine issues of informed consent, including—
(1)
the appropriate timing of such consent; and
(2)
the information provided to the maternal donor regarding all of her medically appropriate cord blood options.
Based on such examination, the Secretary shall require that the standards used by the accreditation entities recognized under subsection (b) ensure that a cord blood unit is acquired with the informed consent of the maternal donor.
(d)
Functions
(1)
Bone marrow functions
With respect to bone marrow, the Program shall—
(A)
operate a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably matched to candidate patients;
(B)
consistent with paragraph (3), permit transplant physicians, other appropriate health care professionals, and patients to search by means of electronic access all available bone marrow donors listed in the Program;
(C)
carry out a program for the recruitment of bone marrow donors in accordance with subsection (e), including with respect to increasing the representation of racial and ethnic minority groups (including persons of mixed ancestry) in the enrollment of the Program;
(D)
maintain and expand medical contingency response capabilities, in coordination with Federal programs, to prepare for and respond effectively to biological, chemical, or radiological attacks, and other public health emergencies that can damage marrow, so that the capability of supporting patients with marrow damage from disease can be used to support casualties with marrow damage;
(E)
carry out informational and educational activities in accordance with subsection (e);
(F)
at least annually update information to account for changes in the status of individuals as potential donors of bone marrow;
(G)
provide for a system of patient advocacy through the office established under subsection (h);
(H)
provide case management services for any potential donor of bone marrow to whom the Program has provided a notice that the potential donor may be suitably matched to a particular patient through the office established under subsection (h);
(I)
with respect to searches for unrelated donors of bone marrow that are conducted through the system under subparagraph (A), collect, analyze, and publish data in a standardized electronic format on the number and percentage of patients at each of the various stages of the search process, including data regarding the furthest stage reached, the number and percentage of patients who are unable to complete the search process, and the reasons underlying such circumstances;
(J)
support studies and demonstration and outreach projects for the purpose of increasing the number of individuals who are willing to be marrow donors to ensure a genetically diverse donor pool; and
(K)
facilitate research with the appropriate Federal agencies to improve the availability, efficiency, safety, and cost of transplants from unrelated donors and the effectiveness of Program operations.
(2)
Cord blood functions
(A)
In general
With respect to cord blood, the Program shall—
(i)
operate a system for identifying, matching, and facilitating the distribution of donated cord blood units that are suitably matched to candidate patients and meet all applicable Federal and State regulations (including informed consent and Food and Drug Administration regulations) from a qualified cord blood bank;
(ii)
consistent with paragraph (3), allow transplant physicians, other appropriate health care professionals, and patients to search by means of electronic access all available cord blood units made available through the Program;
(iii)
allow transplant physicians and other appropriate health care professionals to reserve, as defined by the Secretary, a cord blood unit for transplantation;
(iv)
support and expand new and existing studies and demonstration and outreach projects for the purpose of increasing cord blood unit donation and collection from a genetically diverse population and expanding the number of cord blood unit collection sites partnering with cord blood banks receiving a contract under the National Cord Blood Inventory program under section 2 of the Stem Cell Therapeutic and Research Act of 2005, including such studies and projects that focus on—
(I)
remote collection of cord blood units, consistent with the requirements under the Program and the National Cord Blood Inventory program goal described in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005; and
(II)
exploring novel approaches or incentives to encourage innovative technological advances that could be used to collect cord blood units, consistent with the requirements under the Program and such National Cord Blood Inventory program goal;
(v)
provide for a system of patient advocacy through the office established under subsection (h);
(vi)
coordinate with the qualified cord blood banks to support informational and educational activities in accordance with subsection (g);
(vii)
maintain and expand medical contingency response capabilities, in coordination with Federal programs, to prepare for and respond effectively to biological, chemical, or radiological attacks, and other public health emergencies that can damage marrow, so that the capability of supporting patients with marrow damage from disease can be used to support casualties with marrow damage; and
(viii)
with respect to the system under subparagraph (A), collect, analyze, and publish data in a standardized electronic format, as required by the Secretary, on the number and percentage of patients at each of the various stages of the search process, including data regarding the furthest stage reached, the number and percentage of patients who are unable to complete the search process, and the reasons underlying such circumstances.
(B)
Efforts to increase collection of high quality cord blood units
(3)
Single point of access; standard data
(A)
Single point of access
(4)
Definition
The term “qualified cord blood bank” means a cord blood bank that—
(A)
has obtained all applicable Federal and State licenses, certifications, registrations (including pursuant to the regulations of the Food and Drug Administration), and other authorizations required to operate and maintain a cord blood bank;
(B)
has implemented donor screening, cord blood collection practices, and processing methods intended to protect the health and safety of donors and transplant recipients to improve transplant outcomes, including with respect to the transmission of potentially harmful infections and other diseases;
(C)
is accredited by an accreditation entity recognized by the Secretary under subsection (b);
(D)
has established a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance with existing Federal and State law;
(E)
has established a system for encouraging donation by a genetically diverse group of donors; and
(F)
has established a system to confidentially maintain linkage between a cord blood unit and a maternal donor.
(e)
Bone marrow recruitment; priorities; information and education
(1)
Recruitment; priorities
The Program shall carry out activities for the recruitment of bone marrow donors. Such recruitment program shall identify populations that are underrepresented among potential donors enrolled with the Program. In the case of populations that are identified under the preceding sentence:
(A)
The Program shall give priority to carrying out activities under this part to increase representation for such populations in order to enable a member of such a population, to the extent practicable, to have a probability of finding a suitable unrelated donor that is comparable to the probability that an individual who is not a member of an underrepresented population would have.
(B)
The Program shall consider racial and ethnic minority groups (including persons of mixed ancestry) to be populations that have been identified for purposes of this paragraph, and shall carry out subparagraph (A) with respect to such populations.
(2)
Information and education regarding recruitment; testing and enrollment
(A)
In general
The Program shall carry out informational and educational activities, in coordination with organ donation public awareness campaigns operated through the Department of Health and Human Services, for purposes of recruiting individuals to serve as donors of bone marrow, and shall test and enroll with the Program potential bone marrow donors. Such information and educational activities shall include the following:
(i)
Making information available to the general public, including information describing the needs of patients with respect to donors of bone marrow.
(ii)
Educating and providing information to individuals who are willing to serve as potential bone marrow donors.
(iii)
Training individuals in requesting individuals to serve as potential bone marrow donors.
(3)
Transplantation as treatment option
(4)
Implementation of subsection
(f)
Bone marrow criteria, standards, and procedures
The Secretary shall enforce, for participating entities, including the Program, individual marrow donor centers, marrow donor registries, marrow collection centers, and marrow transplant centers—
(1)
quality standards and standards for tissue typing, obtaining the informed consent of donors, and providing patient advocacy;
(2)
donor selection criteria, based on established medical criteria, to protect both the donor and the recipient and to prevent the transmission of potentially harmful infectious diseases such as the viruses that cause hepatitis and the etiologic agent for Acquired Immune Deficiency Syndrome;
(3)
procedures to ensure the proper collection and transportation of the marrow;
(4)
standards for the system for patient advocacy operated under subsection (h), including standards requiring the provision of appropriate information (at the start of the search process and throughout the process) to patients and their families and physicians;
(5)
standards that—
(A)
require the establishment of a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance with Federal and State law; and
(B)
prescribe the purposes for which the records described in subparagraph (A) may be disclosed, and the circumstances and extent of the disclosure; and
(6)
in the case of a marrow donor center or marrow donor registry participating in the program, procedures to ensure the establishment of a method for integrating donor files, searches, and general procedures of the center or registry with the Program.
(g)
Cord blood recruitment; priorities; information and education
(1)
Recruitment; priorities
(A)
The Program shall give priority to supporting activities under this part to increase representation for such populations in order to enable a member of such a population, to the extent practicable, to have a probability of finding a suitable cord blood unit that is comparable to the probability that an individual who is not a member of an underrepresented population would have.
(B)
The Program shall consider racial and ethnic minority groups (including persons of mixed ancestry) to be populations that have been identified for purposes of this paragraph, and shall support activities under subparagraph (A) with respect to such populations.
(2)
Information and education regarding recruitment; testing and donation
(A)
In general
In carrying out the recruitment program under paragraph (1), the Program shall support informational and educational activities in coordination with qualified cord blood banks and organ donation public awareness campaigns operated through the Department of Health and Human Services, for purposes of recruiting pregnant women to serve as donors of cord blood. Such information and educational activities shall include the following:
(i)
Making information available to the general public, including information describing the needs of patients with respect to cord blood units.
(ii)
Educating and providing information to pregnant women who are willing to donate cord blood units.
(iii)
Training individuals in requesting pregnant women to serve as cord blood donors.
(3)
Transplantation as treatment option
(4)
Implementation of subsection
(h)
Patient advocacy and case management for bone marrow and cord blood
(2)
General functions
The Office shall meet the following requirements:
(A)
The Office shall be headed by a director.
(B)
The Office shall be staffed by individuals with expertise in bone marrow and cord blood therapy covered under the Program.
(C)
The Office shall operate a system for patient advocacy, which shall be separate from mechanisms for donor advocacy, and which shall serve patients for whom the Program is conducting, or has been requested to conduct, a search for a bone marrow donor or cord blood unit.
(D)
In the case of such a patient, the Office shall serve as an advocate for the patient by directly providing to the patient (or family members, physicians, or other individuals acting on behalf of the patient) individualized services with respect to efficiently utilizing the system under paragraphs (1) and (2) of subsection (d) to conduct an ongoing search for a bone marrow donor or cord blood unit and assist with information regarding third party payor matters.
(E)
In carrying out subparagraph (D), the Office shall monitor the system under paragraphs (1) and (2) of subsection (d) to determine whether the search needs of the patient involved are being met, including with respect to the following:
(i)
Periodically providing to the patient (or an individual acting on behalf of the patient) information regarding bone marrow donors or cord blood units that are suitably matched to the patient, and other information regarding the progress being made in the search.
(ii)
Informing the patient (or such other individual) if the search has been interrupted or discontinued.
(iii)
Identifying and resolving problems in the search, to the extent practicable.
(F)
The Office shall ensure that the following data are made available to patients:
(i)
The resources available through the Program.
(ii)
A comparison of transplant centers regarding search and other costs that prior to transplantation are charged to patients by transplant centers.
(iii)
The post-transplant outcomes for individual transplant centers.
(iv)
Information concerning issues that patients may face after a transplant.
(v)
Such other information as the Program determines to be appropriate.
(G)
The Office shall conduct surveys of patients (or family members, physicians, or other individuals acting on behalf of patients) to determine the extent of satisfaction with the system for patient advocacy under this subsection, and to identify ways in which the system can be improved to best meet the needs of patients.
(3)
Case management
(A)
In general
In serving as an advocate for a patient under paragraph (2), the Office shall provide individualized case management services directly to the patient (or family members, physicians, or other individuals acting on behalf of the patient), including—
(i)
individualized case assessment; and
(ii)
the functions described in paragraph (2)(D) (relating to progress in the search process).
(m)
Records
(2)
Examination of records
(n)
Penalties for disclosure
(o)
Periodic review of state of science
(2)
Recommendations
Not later than June 30, 2025, the Secretary shall—
(A)
complete the second review required by paragraph (1); and
(B)
informed by such review, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives recommendations on the appropriateness of the inclusion of new types of therapies in the Program.
([July 1, 1944, ch. 373], title III, § 379, as added [Pub. L. 101–616, title I, § 101(a)(2)], Nov. 16, 1990, [104 Stat. 3279]; amended [Pub. L. 105–196, § 2(a)], (b)(1), (c)–(g), July 16, 1998, [112 Stat. 631–635]; [Pub. L. 109–129, § 3(a)], Dec. 20, 2005, [119 Stat. 2553]; [Pub. L. 111–264, § 2(b)], Oct. 8, 2010, [124 Stat. 2791]; [Pub. L. 114–104, § 2(a)], Dec. 18, 2015, [129 Stat. 2216]; [Pub. L. 117–15, § 2(a)]–(c), May 26, 2021, [135 Stat. 277].)