Appendix TPrivate/Public Funding Example:
Organ Procurement and Transplantation Network *
History and Responsibilities
The National Organ Transplant Act (NOTA) of 1984 created the Organ Procurement and
Transplantation Network (OPTN). Congress envisioned this to be an equitable national system
that would be operated by the transplant community, including physicians and officials of
transplant facilities as well as other specialists and individuals representing transplant patients,
their families, and the general public.
NOTA gave the Secretary of the Department of Health and Human Services (HHS) oversight of
the OPTN and responsibility for ensuring public benefit. Amendments to the Social Security Act
in 1986 underscored the Secretary’s role. Working in partnership with the transplant community,
the Secretary has final authority over OPTN policies and procedures.
Until the enactment of the Omnibus Budget Reconciliation Act of 1986 (Public Law 99-509),
membership in the OPTN was voluntary. Section 9318 of Public Law 99-509 added a new
section (1138) to the Social Security Act. Section 1138(a)(1)(B) required hospitals that perform
organ transplants to be members of and abide by the rules and requirements of the OPTN as a
condition for participation in the Medicare and Medicaid programs. This requirement places at
risk the transplant hospitals’ participation in these programs, not just payments for
transplantation, and as a practical matter makes the hospitals’ survival dependent on following
such rules and requirements. Section 1138(b)(1)(D) required that to be eligible for
reimbursement of organ procurement costs by Medicare or Medicaid, an Organ Procurement
Organization (OPO) must be a member of and abide by the rules and requirements of the OPTN.
The OPTN has responsibility for developing medical criteria for patient listing, medical urgency
criteria (“status” definitions), organ allocation policies, other policies governing organ
transplantation, and policies for the day-to-day operation of the OPTN. The Secretary has
responsibility for (1) oversight of the OPTN, (2) establishment of performance goals and
indicators to guide the national system for organ distribution, and (3) final approval of those
OPTN policies that are to be enforceable. Both the OPTN and the Secretary have responsibility
for dissemination of information to the public, including patients, physicians, payers, and
researchers.
HHS and OPTN Relationships
The United Network for Organ Sharing, a private corporation, operates the OPTN under contract
with HHS. The contract is subject to the competitive bidding process. Under recent requests for
proposals, there have been no effective competitors to the current contractor.
When the OPTN develops policies, or when complaints are raised concerning OPTN policies,
there are a number of options. The Secretary may approve an OPTN-proposed policy or find that
the complaint has no merit. The Secretary also may take another approach, depending on the
issues presented. For example, the Secretary may: Seek broader public input on the issue;
determine whether violations of OPTN-proposed policies should carry any of a range of
consequences (no consequence, loss of membership in the OPTN, or loss of a hospital’s ability
to participate in Medicare and Medicaid); provide comments for the OPTN’s consideration;
direct the OPTN to adopt a policy; or develop a policy that the OPTN must follow.
Questions also have been raised about the relationship of OPTN policies to other standards and
requirements. A number of Federal statutes, including those relating to Medicare and Medicaid,
civil rights, fraud and abuse, clinical laboratories, organ procurement, control of infectious
disease, and regulation of blood and blood products, have provisions that may affect or be
affected by the policies of the OPTN.
In order to prevent such problems, a system was created in which the OPTN has three options
whenever it identifies a policy that it believes will contribute to high performance. The OPTN
can: (1) Recommend its use by members; (2) request that HHS make it enforceable; or (3)
petition HHS to modify other regulations (such as clinical laboratory or blood regulations) to
adopt that policy. What the OPTN cannot do is unilaterally impose a policy that has the effect of,
or changes the terms of, a national policy already subject to the oversight of a cognizant Federal
agency. The Secretary reviews the OPTN policies that may interact with other statutes or with
rules promulgated through other Federal programs.
The OPTN Board
The 30-member Board of Directors is determined as follows: First, at least eight of the board
members are to be transplant candidates, transplant recipients, organ donors, or family members,
and none of these members or general public members may have an employment or similar
relationship with the OPTN or with the categories of members listed in Section 121.3(a)(1)(I) or
(iii)—OPOs, transplant hospitals, etc. Second, at least six members of the Board of Directors are
to represent the general public; these members must be free of an employment or similar
relationship to the OPTN or to institutions or individuals involved in transplantation. Third, not
more than 50 percent of the board members (and of the Executive Committee) may be transplant
physicians or transplant surgeons. Fourth, at least 25 percent of the board members must be
transplant candidates, transplant recipients, organ donors, or family members of individuals in
any of these categories.
Institute of Medicine Recommendations
In 1999, the Institute of Medicine issued a report, Organ Procurement and Transplantation, with
five general recommendations for the OPTN. These included: Establishing organ allocation areas
for livers; changing the waiting-time requirements for some liver transplantation patients;
implementing Federal (HHS) oversight in the form of greater use of patient-centered, outcomeoriented
performance measures for OPOs, transplant centers, and the OPTN; establishing
independent scientific review; improving the collection of standardized and useful data regarding
the system of organ procurement and transplantation; and making these data widely available to
independent investigators and scientific reviewers in a timely manner.
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