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Living Donor Legalities

Note: LD101 only addresses laws affecting living donors. Here is a complete timeline of transplant-related milestones and federal laws.

For more on U.S. Public Policy Organizations and how they contribute to the U.S. organ transplant system.

 


 

1968 - Congress passes the Uniform Anatomical Gift Act to replace uneven and sporadic state laws governing tissue and organ donation, and expedite the transporting of deceased donor organs across state laws.

UAGA doesn't directly address living organ donation, but it is the first law regarding deceased organ donation and the basis for all future legislature.

 

2006 - Revised UAGA to recognize the creation of OPTN/UNOS and to create uniformity in state laws. As of this date, it has not been approved by every state. Check the map to for your state's status.

 


 

1972 - Social Security Act, Section 1881 [42 U.S.C. 139 rr] establishes Medicare coverage for patients with ESRD (end stage renal disease) and Living Kidney Donors.

**This benefit is ONLY for KIDNEY donors**

(a) The benefits provided by parts A and B of this title shall include benefits for individuals who have been determined to have end stage renal disease as provided in section 226A, and benefits for kidney donors as provided in subsection (d) of this section.

(d) Notwithstanding any provision to the contrary in section 226 any individual who donates a kidney for transplant surgery shall be entitled to benefits under parts A and B of this title with respect to such donation. Reimbursement for the reasonable expenses incurred by such an individual with respect to a kidney donation shall be made (without regard to the deductible, premium, and coinsurance provisions of this title), in such manner as may be prescribed by the Secretary in regulations, for all reasonable preparatory, operation, and post-operation recovery expenses associated with such donation, including but not limited to the expenses for which payment could be made if he were an eligible individual for purposes of parts A and B of this title without regard to this subsection. Payments for post-operation recovery expenses shall be limited to the actual period of recovery.

 

No, the law has not changed; refer to the 2007 Medicare Benefit Manual, Chapter 11 ESRD, Section 140. In 1974, the director of the Social Security Administration issued an edict that living kidney donors be filed under the recipient's Medicare benefit and not given their own, or billed to the recipient's private insurance -a violation of federal law. No one complained, however, because this move kept Medicare costs down and because private insurance reimburses at a higher rate.

Most living kidney donors aren't aware of this coverage, because they are never told it exists. Considering that private (well, publicly traded), for-profit insurance companies are denying coverage to living kidney donors for having a pre-existing condition, and many more are refusing coverage for long-term follow-up care and/or health-related issues like hypertension that can be tied to the kidney donation, the omission and refusal of this benefit to living kidney donors is reprehensible... Please see our Take Action page for information on how to contact your federal legislators about this issue.

 

Note: Medicare is a federal program, primarily for seniors (and anyone with end-stage renal disease). Medicaid is a mix of federal and state funds to provide health care for low-income individuals, and administered by the state. Consequently, Medicaid coverage policies vary between states.


 

1984 - Congress passes the National Organ Transplant Act (PL 98-507) which prohibits the sale of organs and tissues, and establishes the Organ Procurement Transplantation Network (OPTN) to ensure fair and equitable allocation of deceased donor organs.

The law addresses living organ donors directly once. Regarding Prohibition of Organ Purchases, Section 301(c)(2) states:

The term "valuable consideration" does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.

Click here for a diagram describing the federal department and public policy organization chain of command.

While CMS develops and dictates policy to hospitals and practitioners that take Medicaid/Medicare, not all do, so their regulations only have limited reach.

See Take Action page for more on who to contact to improve policies for living donors, or report a problem.

 


 

2000 - 42 CFR Part 121, establishes the Advisory Committee on Organ Transplantation (ACOT to advise the Secretary of Health on all things related to organ transplantation, and provide informal oversight to OPTN.

Also provides requirements for OPTN's Board of Directors (approximately 50% transplant surgeons and transplant physicians), Executive Committee, other committees, and OPTN membership.

 

[Note: Issued and published in the Federal Register on April 2, 1998. Was amended as a result of the Institute of Medicine's report, Organ Procurement and Transplantation, 1999. Issued and published in the Federal Register on October 20, 1999, and went into effect on March 16, 2000.]

 


 

2004 - Organ Donation Recovery and Improvement Act, aka ODRIA, (P.L. 108-216).

Section 3 amends Section 337 of Public Health Service Act (42 U.S.C. 274f) to permit the reimbursement of appropriate travel and subsistence expenses incurred toward living organ donation with priority given to need.

Section 4 amends Part H of Title III of Public Health Service Act (42 U.S.C. 273 et seq.) to allow the Secretary of Health to make grants or contracts with nonprofit entities to carry out projects or studies to increase organ donation and recovery rates, including living donation.

Section 6 requires the Secretary of Health to report, no later than December 31, 2005 and every two years thereafter on the activities of DHHS regarding the recovery, preservation and transportation of organs. Specifically (42 USC 274f–4. SEC. 377D.), (c)(2):

An evaluation of living donation practices and procedures. Such evaluation shall include an assessment of issues relating to informed consent and the health risks associated with living donation (including possible reduction of long-term effects).

SEC. 7. Part H of title III of the Public Health Service Act (42 U.S.C. 273 et seq.) is amended by inserting after section 371 the following: ‘‘SEC. 371A. NATIONAL LIVING DONOR MECHANISMS.

‘‘The Secretary may establish and maintain mechanisms to evaluate the long-term effects associated with living organ donations by individuals who have served as living donors.’’

 

[Note: the funds for ODRIA have been authorized but not appropriated. In other words, it's a law that cannot be enforced because there has been no money to make it happen, an 'unfunded mandate'. And OPTN and the transplant industry don't care.]

 


 

March 2007 - Medicare & Medicaid released a "Final Rule" on standards of care and requirements for transplant centers to receive Medicare & Medicaid patients and reimbursement.  If you don't want to wade through the entire document (and who could blame you - it's 84 pages long), here are the sections pertaining to living organ donors and how the CMS policies compare to those from OPTN.

42 CFR Parts 405, 482, 488, and 498

 


 

December, 2007 - An amendment to NOTA,  the Charlie W. Norwood Living Organ Donation Act (H.R.710/S.487 ) stipulates "that kidney paired donation does not involve the transfer of a human organ for valuable consideration."

Section 3 also calls for Secretary of DHHS to submit a yearly report "that details the progress made towards understanding the long-term health effects of living organ donation"

 


According to 5 U.S.C. 6327, An employee may use up to 7 days of paid leave each calendar year to serve as a bone marrow donor.  An employee may use up to 30 days of paid leave each calendar year to serve as a living organ donor.

 


Certain states have passed laws allowing state tax deductions and donor leave.

 

 

 

If you have any additions or corrections, please contact info(at)LivingDonor101.com


Last Updated: November 30, 2013