The National Living Donor Assistance Center
By cooperative agreement with HRSA, the University of Michigan and the American Society of Transplant Surgeons (ASTS). The grant has been approved for travel and subsistence expenses for living organ donors. Lost wages have not yet been approved for reimbursement.

The proposed eligibility guidelines were published in the Federal Register in April. These guidelines are posted below for you to review so that you have have the opportunity to provide your input. The deadline for public comment is May 24, 2007.

Federal Register: April 9, 2007 (Volume 72, Number 67)] [Notices] [Page 17564-17566] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap07-91]

DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Request for Public Comment.

SUMMARY: HRSA is soliciting comments on the proposed eligibility criteria for the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donations Program. Eligibility criteria were proposed by the program grantee, the Regents of the University of Michigan, to HRSA. HRSA has determined that the proposed eligibility criteria constitute a proper interpretation of the authorizing statute's requirements, including determinations as to which individuals would otherwise be unable to meet the eligible expenses authorized under this Program. HRSA is soliciting public comment on the criteria outlined in this notice. HRSA will consider the comments in light of the authorizing statute and seek feedback from the Regents of the University of Michigan concerning the comments. HRSA will then approve final criteria. The final program eligibility criteria will be posted on the Reimbursement of Travel and Subsistence Expenses for Living Organ Donation Web site, http://www.livingdonorassistance.org. DATES: Written comments must be submitted to the office in the address section below by mail or e-mail on or before May 24, 2007. ADDRESSES: Please send all written comments to James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Room 12C-06, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443-7577; fax (301) 594-6095; or e-mail: jburdick@hrsa.gov.

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443-7577; fax (301) 594-6095; or e-mail: jburdick@hrsa.gov. SUPPLEMENTARY INFORMATION: Congress has provided specific authority under section 377 of the Public Health Service (PHS) Act, as amended, 42 U.S.C. 274f, for providing reimbursement of travel and subsistence expenses for certain living organ donors, with preference for those for whom paying such expenses would create a financial hardship. On September 25, 2006, HRSA awarded a 4-year, $8,000,000, Cooperative Agreement to the Regents of the University of Michigan to establish this program.

The authorizing statute stipulates that the Secretary, in carrying out this program, shall give preference to those individuals that the Secretary determines are more likely to be otherwise unable to meet such expenses. HRSA asked the grantee to propose eligibility criteria to HRSA to satisfy this requirement.

The two main issues raised in developing the program eligibility criteria are:
(1) Which criteria should be used to identify potential living organ donors who may be unable to pay for travel and subsistence expenses associated with living organ donation? This issue is important because such donors are to receive priority under this program; and (2) Which criteria should be established to assess the potential organ recipient's ability to pay the living donor's travel and subsistence expenses? This determination is significant because the authorizing statute provides that payments are not to be made if a donor's eligible expenses have been, or reasonably can be expected to be, paid by the organ recipient.

This program is intended for individuals with end stage organ failure for whom a transplant from a suitable living donor is a viable therapy. The purpose of this solicitation of comments is to obtain feedback from the public on the proposed eligibility criteria. These comments are important to assure that the needs and concerns of the general public, including its views as to the optimal means of carrying out the program's objectives, are addressed. After considering the comments, HRSA will approve final criteria, which will be posted on the Reimbursement of Travel and Subsistence Expenses for Living Organ Donation Web site, http://www.livingdonorassistance.org.

Proposed Eligibility Guidelines:
The program's authorizing legislation explicitly states that funds ``will not be expended to pay the qualifying expenses of a donating individual to the extent that payment has been made, or can reasonably be expected to be made, with respect to such expenses:

(1) Under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; (2) By an entity that provides healt(3) By the recipient of the organ.''

In implementing this authority, the proposed threshold of income eligibility for the recipient of the organ is 200% of the HHS Poverty Guidelines (described below). At any income above this measure, it can reasonably be expected that the recipient of the organ could pay for the donor's qualifying expenses. However, the transplant social worker or appropriate transplant center personnel involved in the potential transplant recipient's evaluation process can provide a written justification that notwithstanding the potential transplant recipient's income level, significant financial hardship is likely to be encountered by the potential transplant recipient of the organ for the payment of the donor's qualifying expenses in the course of the donation process. This justification will be given consideration by the program's Review Committee.

All live organ donors are eligible for reimbursement of qualifying expenses provided all the criteria for donor reimbursement are fulfilled. However, subject to availability of funds, preference will be given to donors who are more likely to be otherwise unable to meet the qualifying expenses, in the following proposed order of priority:
Preference Category 1: Donor income and recipient anticipated income each is < =200% of the HHS Poverty Guidelines in their respective States of primary residence.
Preference Category 2: Donor income is < =200% of the HHS Poverty Guidelines in the State of primary residence.
Preference Category 3: Recipient anticipated income is < =200% of the HHS Poverty Guidelines in the State of primary residence.
Preference Category 4: Donors who can demonstrate that notwithstanding their income level, significant financial hardship is likely to be encountered for qualifying non-medical expenses in the course of the donation process.
Preference Category 5: Any live organ donor, notwithstanding income level or financial hardship, who meets the criteria for donor reimbursement.

Recipient anticipated income is the total income from all sources that the recipient is expected to receive in the year in which live donor organ transplantation will occur for the patient with previous existing organ failure or the subsequent calendar year after the year of onset of end stage organ failure for a new patient with end stage organ failure. The HHS Poverty Guidelines are updated periodically and the guidelines in effect at the time of application will be applied. As an illustration, the HHS Poverty Guidelines for 2006 (71 Fed. Reg. 3848) are shown in the table below.

2006 HHS Poverty Guidelines

Persons in family ------48 Contiguous States & DC--------------Alaska----------- Hawaii

1--------------------------------------------$9,800----------------------- $12,250--------- $11,270
2--------------------------------------------13,200----------------------- 16,500----------- 15,180
3--------------------------------------------16,600----------------------- 20,750----------- 19,090
4--------------------------------------------20,000----------------------- 25,000----------- 23,000
5--------------------------------------------23,400----------------------- 29,250----------- 26,910
6--------------------------------------------26,800----------------------- 33,500----------- 30,820
7--------------------------------------------30,200----------------------- 37,750----------- 34,730
8--------------------------------------------33,600----------------------- 42,000----------- 38,640
For each additional person, add-----------3,400 ------------------------4,250 -------------3,910
--------------------------------------------------------------------------------------------------------------- Source: 71 FR 3848 (Jan. 24, 2006). [[Page 17566]]

Proposed Criteria for Donor Reimbursement

In addition to the eligibility and priority guidelines discussed above, the following criteria for donor reimbursement are proposed:
1. Any individual who in good faith incurs qualifying expenses toward the intended donation of an organ but with respect to whom, for such reasons as the Secretary determines to be appropriate, no donation of the organ occurs (see special provision). This criteria is specifically discussed in the authorizing statute.
2. Donor and recipient of the organ are either U.S. citizens or lawfully admitted residents of the U.S.
3. Donor and recipient have primary residence in the U.S. or its territories.
4. Travel is originating from the donor's primary residence.
5. Donor meets the criteria for informed consent for the planned procedure according to applicable State and Federal laws.
6. Donor and recipient are not participating in a paired exchange program or a living donor/deceased donor exchange for the particular donation procedure for which reimbursement is being sought unless the legality of such practices is clarified by the Federal Government.
7. Donor and recipient attest to full compliance with section 301 of the National Organ Transplant Act (NOTA), as amended (42 U.S.C. 274e) which stipulates in part that `` * * * [i]t shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.''
8. The transplant center where the donation procedure occurs attests to its status of good standing with the Organ Procurement and Transplantation Network (i.e., it is not a Member Not in Good Standing) and assurance that the program follows best practices for the health and safety of living donors such as the recommendations provided in the Consensus Statement of the Ethics Committee of the Vancouver Forum on living organ donation (Source: Pruett TL, Tibell A, Alabdulkareem A, Bhandari M, Cronin DC, Dew MA, Dib-Kuri A, Gutmann T, Matas A, McMurdo L, Rahmel A, Rizvi SA, Wright L, Delmonico FL. The ethics statement of the Vancouver Forum on the live lung, liver, pancreas, and intestine donor. Transplantation 81(10):1386-1387; (2006).

The public is invited to submit comments on these criteria.

Proposed Qualifying Expenses For the purpose of the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program, qualifying expenses presently include only travel, lodging, and meals and incidental expenses incurred by the donor and/or accompanying person(s) as part of: (1) Donor evaluation clinic visit or hospitalization; (2) Hospitalization for the living donor surgical procedure; and/or (3) Medical or surgical follow-up clinic visit or hospitalization within 90 days after the living donation procedure. The Program will pay for up to five trips per donation or intended donation. Three of these trips may be for the potential living donor and up to two trips may be for any accompanying person(s). The total Federal reimbursement for qualified expenses during the donation process for the donor and accompanying individuals shall not exceed $6,000.

The public is invited to submit comments on these criteria.

Special Provisions

The authorizing statute provides that the Secretary may consider as an eligible donating individual a person who in good faith incurs qualifying expenses toward the intended donation of an organ but with respect to whom, for reasons the Secretary determines to be appropriate, no donation of the organ occurs. Many factors may prevent the intended and willing donor from proceeding with the donation. Such circumstances include present health status of the intended donor or recipient that would prevent the transplant or donation from proceeding, perceived long-term risks to the intended donor, circumstances such as acts of God (e.g., major storms or hurricanes), or other unforeseen events outside of the intended donor's control. In such cases, the intended donor and accompanying persons may receive reimbursement for the qualified expenses incurred. In the case that a potential donor no longer wishes to donate, he or she may receive reimbursement for qualified expenses incurred. However, payments received for expenses that were not incurred by the intended donor and accompanying persons must be refunded. Otherwise, such payment will be treated as income to the intended donor, and in accordance withInternal Revenue Service (IRS) regulations, the Regents of the University of Michigan shall notify the IRS (Form 1099) that a payment has been made to the intended donor in the amount equivalent to the unexpended payment.

Dated: March 30, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-6598 Filed 4-6-07; 8:45 am] BILLING CODE 4165-15-P

________________________________________________________________

STSW RESPONSE TO PROPOSED MEDICARE REGULATIONS REGARDING THE QUALIFICATIONS FOR TRANSPLANT SOCIAL WORKERS

March 14, 2005

The Honorable Mark McClellan, Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-3835-P
P.O. Box 8013
Baltimore, MD 21244-8013

Re: CMS-3835-P, Proposed Rule: Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants

Dear Mr. McClellan:

The Society for Transplant Social Workers was formed over 20 years ago to promote professional excellence and ethical social work practice and to advocate for the psychosocial needs of organ transplant patients and their families. Our members work with solid organ transplant programs in the United States and in other countries. We have an annual conference that provides attendees an opportunity for professional growth, continuing education, communication and mutual support among transplant social workers.

The Society for Transplant Social Workers welcomes the opportunity to offer comments regarding the proposed regulations for the Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants (42 CFR Parts 405, 482, 488) which was published February 4, 2005. Our comments are motivated by the desire to ensure that Medicare beneficiaries and others needing organ transplant, as well as living organ donors, will have their psychosocial needs addressed by transplant centers. Specifically, the Society supports the proposed process requirements that address quality of care for patients. We agree that adequate staffing is critical to transplant program efficiency and the resulting organ and patient outcomes. The Society also approves of the recognition that the well-being of living donors is as important as the well being of the transplant recipients.

The Society also supports the proposed requirement that social services be provided by qualified social workers with Master of Social Work Degrees to all living donors, recipients and their families. The specification that transplant centers provide qualified social workers to evaluate psychosocial needs, participate in care planning, and the identification of community resources for patients and their families is very important. The Society also welcomes this proposal as it recognizes the importance of assisting and supporting all living donors and transplant recipients and their families in maximizing their social functioning and adjustment.

However, there is one element of this proposed requirement that actually lowers the standard for the qualified social worker when compared to the existing definition of the qualified social worker found in current kidney transplant center regulations 405.2171. The current regulations have stated that a qualified social worker is:

“A person who is licensed, if applicable, by the State in which practicing, and:

(1) Has completed a course of study with specialization in clinical practice at, and holds a masters degree from, a graduate school of social work accredited by the Council on Social Work Education; or

(2) Has served for at least two years as a social worker, 1 year of which was in a dialysis unit or transplant program prior to Sept 1, 1976 and has established a consultative relationship with a social worker who qualifies under paragraph (f) (1) of this definition.”

The new proposed rule for the definition of a qualified social worker is:

“An individual who meets licensing requirements in the State which practicing, and

(1)has completed a course of study with specialization in clinical practice, and holds a masters degree from a graduate school of social work accredited by the Council on Social Work Education; or

(2) has served for at lease two years as a social worker, one year of which was in a transplantation program, and has established a consultative relationship with a social worker who has obtained the education described above.”

Please note that (2) above seriously undermines the current standard of requiring qualified social workers with masters’ degrees in transplant programs. A recent study showed that of 312 transplant social workers in 411 transplant programs in 139 transplant centers, 96% had Master of Social Work degrees . With the inclusion of (2) above there is nothing to prevent a reduction over time of this standard to a lower rate of social workers with master’s degrees in transplant programs. This would negatively affect the quality of care provided to transplant patients and living donors.

RECCOMENDATION: The Society for Transplant Social Workers recommends that the Final Rule define the standard for social services and qualified social workers as follows:

Page 6180 (d) Standard Social Services. The transplant center must make available social services, furnished by qualified social workers, to transplant patients, living donors, and their families. A qualified social worker is an individual who meets licensing requirements in the State which practicing, and

(1) has completed a course of study with specialization in clinical practice, and holds a masters degree from a graduate school of social work accredited by the Council on Social Work Education; or

(2) Has served for at least 2 years as a social worker, one year of which was in a transplantation program, and has established a consultative relationship with a social worker who is qualified under 482.94, prior to the effective date of this new Final Rule.

Please let me know if I can provide any additional information to substantiate this recommendation or to assist your agency in implementing it.

Thank you.

Sincerely,

Kay Kendal

Organ Donation Legislation
- On April 5, 2004, President Bush signed H.R. 3926, the Organ Donation & Recovery Improvement Act (Public Law 108-216). This is the first organ donation legislation passed by Congress in the last 10 years, despite several previous attempts to enact a bill.

- The National Kidney Foundation, American Society of Transplantation, American Society of Transplant Surgeons, Association of Organ Procurement Organizations and other transplant organizations worked with key Senators and Representatives on both sides of the political aisle to craft the final bill. The transplant community is very appreciative of the inclusion of our various priorities.

- A key provision of the bill establishes a federal grant program to assist living donors with travel and subsistence expenses and incidental expenses incurred by individuals making living organ donations. Grants could be made to states, transplant centers, organ procurement organizations, and other non-profit entities.

-NKF believes living organ donors should not bear any financial costs associated with donation. Removing financial barriers associated with donation could possibly expand access to transplantation for members of lower socio-economic groups who are often precluded from considering living donation.

- Unlike an earlier Senate version, the final bill does not authorize demonstration projects to examine whether financial incentives would increase non-living donation. However, it requires the Secretary of Health and Human Services to submit a report to Congress that evaluates the ethical implications of proposals to increase non-living donation, which could include financial incentives.

- The legislation provides grants to states for organ donor awareness, public education and outreach activities, and to OPOs and hospitals to establish programs coordinating organ donation activities. The Secretary of HHS is required to establish a public education program to increase awareness about organ donation and the need to provide for an adequate rate of donation and to support the development and dissemination of educational materials to inform health care professionals about organ, tissue, and eye donation issues.

- H.R. 3926 establishes authorization for these programs; actual funding is provided through the annual congressional appropriations process. The bill authorizes programs for fiscal years 2005-2009 (FY 2005 begins October 1, 2004). NKF encourages members of the Society for Transplant Social Workers to contact their congressional delegation after the 109th Congress convenes in January, to urge support for these critical programs for fiscal year 2006. This will be among our priorities for the coming year.