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Public Policy Organizations - Who are they and What do they do?
Department of Health & Human Services (DHHS): "The U.S. government's principle agency in protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves." Composed of 11 agencies (including HRSA) and 16 offices.
**Health Resources and Services Administration (HRSA):An agency within DHHS assigned with the responsibility of improving access to health care services, and oversees organ, bone marrow and blood donation. Parent agency to OPTN.
In the past year, HRSA has taken on a much more active role in re-examining the treatment of living donors. In fact, they are currently not awarding any grants which seek to increase the rate of living organ donation due to the 'risk of imminent harm'. They have also recently told OPTN to develop more stringent policies for living donation.
Organ Procurement Transplantation Network (OPTN): Established by the National Organ Transplant Act (NOTA) in 1984 under HRSA, OPTN is a "private, not-for-profit entity with an expertise in organ procurement and transplantation." OPTN is ''contracted' to an outside agency; in this case, UNOS.
"The primary purposes of the OPTN are to operate and monitor an equitable system for allocating organs donated for transplantation; maintain a waiting list of potential recipients; match potential recipients with organ donors according to established medical criteria for allocation of organs and, to the extent feasible, for listing and de-listing transplant patients; facilitate the efficient, effective placement of organs for transplantation; and increase organ donation."
NOTA did not address living donors or living donation. The law's primary function was to create a national waiting list and develop organ allocation policies to standardize the uneven state laws that had been reducing efficiency and endangering people's lives.
Even more confusing, OPTN is not a federal agency, but a membership organization. It has the power to develop policy (regulatory authority), but adherence to those policies by its members is technically voluntary*. All transplant programs and Organ Procurement Organizations (OPO) must be members of OPTN if they wish to receive Medicare reimbursement, with the implied threat that noncompliance to OPTN policies could lead to Medicare withdrawl. However, since the overwhelming majority of OPTN members are also transplant centers or OPOs, such punishment is rarely, if ever, forthcoming.
Final Rule 2000, aka CFR 42, Part 121 establishes membership criteria for OPTN Board of Directors, which should be composed of:
50% of members should be transplant surgeons or transplant physicians;
at least 25 percent should be transplant candidates, transplant recipients, organ donors and family members. They should have with no ties to OPOs, transplant centers, voluntary health organizations, transplant coordinators, histocompatibility experts, or ther non-physician transplant professionals, but the Board can wave this restriction for up to 50% of these members.
In 2006, the Secretary of Health gave OPTN the authority to develop policy regarding living donation that would have the same weight as other policies developed by the agency. That same year, Walter Graham, the Executive Director of UNOS (see below) and Dr. Frank Delmonico, a transplant surgeon, authored an article about OPTN's direction regarding living organ transplantation and solicitation of organs. It said:
The OPTN/UNOS Board, committees and staff are intensifying efforts to support transplant candidates by increasing the supply of organs for transplantation. The mission of the OPTN is to not only increase that supply but to manage those donated organs equitably and efficiently for all candidates who are waiting, independent of any patient’s resources or ability to solicit for organ donors. (137)
Keep that in mind the next time UNOS or OPTN talks about protecting or respecting living donors. It's not part of their 'mission'.
*The Secretary of Health can 'sign' an OPTN policy into law (statutory authority), but it doesn't happen often. So far, the only mandatory living donor policy is in regards to submitting follow-up data, and many transplant centers are still noncompliant. (See: Living Donor Registry)
United Network for Organ Sharing (UNOS): In the same way Lockheed Martin built rockets for NASA, UNOS is the contractor that manages OPTN. It has held the OPTN contract since 1986; the first and only OPTN contractor.
From OPTN's charter: "The OPTN is a part of the OPTN Contractor’s organization and operations. The OPTN Contractor is United Network for Organ Sharing (UNOS), a Virginia non-stock, not-for-profit corporation which is qualified as a tax-exempt public charity under Section 501(c)(3) of the Internal Revenue Code."
Many think UNOS and OPTN are the same thing - they are not. The confusion arises because the current UNOS Board presently serves also as the OPTN Board of Directors. However, OPTN will exist as an entity of HRSA regardless of who, or which entity, administers the contract.
Scientific Registry of Transplant Recipients (SRTR): Founded in 1987, SRTR is a national database of all transplant statistics. Unlike OPTN, who simply gathers data, SRTR analyzes data from multiple sources and draws conclusions from it. Despite the organization's name, they do handle some data regarding living donors and donation (see May 2008 ACOT meeting notes for such a presentation).
Advisory Committee on Organ Transplantation (ACOT): Established in 2000 under HRSA to advise the Secretary of Health on issues related to transplantation.
The original charter describes the function of ACOT as follows:
The Committee shall advise the Secretary, acting through the Administrator, Health Resources and Services Administration (HRSA), on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines. One of its principal functions shall be to advise the Secretary on ways to maximize Federal efforts to increase living and deceased organ donation nationally.
The Committee shall, at the request of the Secretary, review significant proposed OPTN policies submitted for the Secretary's approval to recommend whether they should be made enforceable. It shall provide expert input to the Secretary on the latest advances in the science of transplantation, the OPTN's system of collecting, disseminating and ensuring the validity, accuracy, timeliness and usefulness of data, and additional medical, public health, ethical, legal, financial coverage, social science, and socioeconomic issues that are relevant to transplantation.
The 25 members of ACOT are chosen by the Secretary of health and "shall be...external to the OPTN governing Board of Directors."
A new version of the ACOT charter was posted on September, 2010 on organdonor.gov. The phrase regarding the increase of living donation was removed, and in the second paragraph, the words 'public safety' were added:
The Committee shall advise the Secretary, acting through the Administrator, Health Resources and Services Administration (HRSA), on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines. One of its principal functions shall be to advise the Secretary on Federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation.
The Committee shall, at the request of the Secretary, review significant proposed OPTN policies submitted for the Secretary’s approval to recommend whether they should be made enforceable. It shall provide expert input to the Secretary on the latest advances in the science of transplantation, the OPTN's system of collecting, disseminating and ensuring the validity, accuracy, timeliness and usefulness of data, and additional medical, public health, patient safety, ethical, legal, financial coverage, social science, and socioeconomic issues that are relevant to transplantation.
Center of Medicare and Medicaid Services (CMS): Department of DHHS that administers Medicare and Medicaid, including conditions and policies that must be followed in order to see Medicare and Medicaid patients and receive reimbursement.
Medicare is a federal program, servicing mostly seniors (and those with end-stage renal disease. See Legal).
Medicaid is a mix of federal and state money, servicing those with lower income, and administered by the state.
Neither Medicare or Medicaid will provide transplant coverage for undocumented immigrants (aka illegal residents). However, legal residents, or green card holders, can obtain a Medicare benefit, provided one has worked in the US for at least 40 quarters and paid FICA taxes (or has a spouse who meets these requirements). One must also have lived in the US for at least five continuous years. If an individual has lived in the US for five years but has not worked for the 40 quarters, one can 'buy in', but that varies from state to state.
The Kaiser Family Foundation is a good resource for information on immigration and health care.
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