Medicare Final rule 2007 for transplant centers and Living Donors

Currently, the OPTN Living Donor Committee workgroup has identified living donor safety promotion as a major focus of the OPTN. However, standardized OPTN informed consent language for living donors has yet to be developed. In light of the fact that living donation is becoming more common, there is an increasing need to protect the health and safety of living donors.

March 2007 - Medicare & Medicaid released a "Final Rule" on standards of care and requirements for transplant centers to receive Medicare & Medicaid patients and reimbursement.

Section 482.90 (b)

b) Standard: Living donor selection. The living donor selection criteria must be consistent
with the general principles of medical ethics.

Transplant centers must:
• Ensure that a prospective living donor receives a medical & Psychosocial evaluation
prior to donation.
• Document in the living donor’s medical records the living donor’s suitability for
donation.
• Document that the living donor has given informed consent, as required.

The comments read: No comparable OPTN policy/bylaw.

We expect a transplant center to assess the prospective living donor carefully to ensure, insofar as possible, that donation will not cause long-term harm to the individual’s
health. Furthermore, we expect transplant centers to apply the ethical principle of ‘‘equipoise’’* to assess whether the benefits to both the donor and the recipient outweigh the risks associated with the donation and the transplantation.

We expect transplant centers to conduct psychosocial evaluations of all prospective living donors. An evaluation can assist the prospective living donor in evaluating the pros and
cons of donating and the potential psychological impact of donating and thus aid the individual in making an appropriate donation decision.

We expect that transplant centers will use different informed consent forms for living
donors since the informed consent components are slightly different than for transplant recipients.

Section 482.92(c)

(c) Standard: Living donor transplantation. (No comparable OPTN policy/bylaw)
• If a center performs living donor transplants, the transplanting surgeon and at least one licensed health care professional at the transplant center must verify that the donor’s
blood type and other vital information is compatible with transplantation of the intended
recipient immediately before the removal of the donor organ(s) and, if applicable, prior to
the removal of the recipient’s organ(s).

§ 482.94 Condition of participation: Patient and living donor management.
(No comparable OPTN policy/bylaw.)
• Transplant center must have written patient management policies and patient care planning for the pre-transplant, transplant, and discharge phases of transplantation.
• Center must have written donor management policies for the donor evaluation, donation, and discharge phases of living organ donation if it performs living donor transplants.

We believe that well-written patient and living donor selection criteria can reduce the legal risk for a transplant center, as long as the center adheres to its criteria or documents the reason why it has deviated from its criteria.

We expect transplant centers to coordinate follow-up care for living donors upon discharge as well. Although this final rule does not specifically delineate transplant centers’ responsibilities for living donors’ post-discharge care, we expect a transplant
center to provide care, as needed, if a living donor experiences donation-related
problems or complications post-discharge.

[LD101 note: the ambiguity of this requirement allows transplant centers great latitude in defining 'follow-up care', 'as needed', 'donor-related problems' and 'complications'. In too many cases, transplant centers following the letter and not the spirit of the law]

(a) Standard: Patient and living donor care. (No comparable OPTN policy/bylaw.)
Each transplant patient and/or living donor is under the care of a multidisciplinary patient care team coordinated by a physician throughout transplantation or donation.

(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. Definitions for a qualified social worker included.

[LD101 note: transplant centers differ on their definition of 'make available'. Is a business card stuck in a folder enough, or should transplant centers assign social workers to proactively follow-up with donors?]

Related: 42 CFR Part 121.9(a) Designated Transplant Program Requirements

OPTN Bylaw Appendix B, Attachment I, III.C.15 Transplant Programs: Social Support—
Psychiatric and social support services must be available in transplant programs
approved under 121.9(a)(2).

The OPTN bylaw does not define qualification of a qualified social worker. Qualification is much broader . CMS requirement complements OPTN bylaw.

(e) Standard: Nutritional services. Nutritional assessments and diet counseling services
furnished by a qualified dietitian must be available to all transplant patients and living
donors. Definitions for a qualified dietitian included. (No comparable OPTN policy/bylaw)

§ 482.98 Condition of participation: Human resources.
(d) Standard: Independent living donor advocate or living donor advocate team. The
transplant center that performs living donor transplants must identify either an independent living donor advocate or an independent living donor advocate team to ensure protection of the rights of living donors and prospective living donors.

This final rule provides transplant centers with great flexibility in providing either a living donor advocate or donor advocate team. We do not specify requirements for a donor
advocate’s background, education, or training or the donor advocate team’s composition. Instead, we specify their duties and the skills they must be able to demonstrate, specifically:

(1) Knowledge of living organ donation, transplantation, medical ethics, and
informed consent; and

(2) understanding of the potential impact of family and other external pressures on the prospective living donor’s decision whether to donate and the ability to discuss these issues with the donor.

The independent living donor advocate or living donor advocate team is responsible for:

(1) Representing and advising the donor;

(2) protecting and promoting the interests of the donor; and

(3) respecting the donor’s decision and ensuring that the donor’s decision is informed and free from coercion.

A transplant center must identify either an independent living donor advocate or an independent living donor advocate team to ensure protection of the rights of living donors and prospective living donors. The living donor advocate or living donor advocate team must not be involved in transplantation activities on a routine basis.

[LD101 note: Some transplant centers and their Living Donor Advocate think they are only responsible for the living donor pre-surgically. Some advocates are available to their donors long-term, but some consider their job 'done' once the living donor is discharged from the hospital. Also bear in mind that usually the living donor advocate is employed by the same hospital responsible for the transplant surgery.]

§ 482.102 Condition of participation: Patient and living donor rights. (No comparable OPTN policy/bylaw.)
• In addition to meeting the requirements at § 482.13, the transplant center must protect
and promote each transplant patient’s and living donor’s rights.

(b) Standard: Informed consent for living donors.
• Transplant centers must have written policies for the informed consent process.
• Each living donor will be informed about:

—The fact that communication between the donor & the transplant center will remain
confidential, in accordance with the requirements at 45 CFR parts 160 &
164.
—The evaluation process.
—The surgical procedure, including post-op treatment.
—The availability of alternative treatments for the transplant recipient.
—The potential medical or psychosocial risks to the donor.
—The national & center-specific outcomes for recipients & living donors as data are
available.
—The possibility that future health problems related to the donation may not be
covered by the donor’s insurance, and that the donor’s ability to obtain health,
disability, or life insurance may be affected.
—The donor’s right to opt out of donation at any time during the donation process.
—The fact that if his or her transplant is not provided in a Medicare-approved
transplant center it could affect the transplant recipient’s ability to have his
or her immunosuppressive drugs paid under Medicare Part B.

(No comparable OPTN policy/bylaw. CMS adopts many of the informed consent
elements contained in the Secretary’s Advisory Committee on Transplantation (ACOT)
Recommendations.)

We note that transplant patients and living donors are uniquely vulnerable patients. Prospective transplant recipients desperately need scarce, life-saving organs, and many of
them will die waiting. Prospective living donors are healthy individuals who are contemplating undergoing surgery, at some risk to themselves, to provide a life-saving transplant to another individual. These patients and prospective living donors must absorb a great deal of information in order to provide a truly informed consent.

We have added a requirement under the CoP for Patients’ and Living Donor Rights at
§ 482.102(a)(8) and (b)(9) that a transplant center must inform Medicare beneficiaries who are prospective transplant recipients and their prospective living donors that receiving a transplant that is not provided in a Medicare-approved transplant center
could affect the transplant recipient’s ability to have his or her immunosuppressive drugs paid under Medicare Part B.See further discussion of this requirement in this preamble
under ‘‘Patients and Living Donor Rights’’ and ‘‘Centers With Current Medicare Approval.’

Misc:

Some commenters stated their appreciation that the proposed rule is congruent with OPTN policies and bylaws, because OPTN policies and bylaws were developed through a
consensus process with broad participation by the transplant community. Commenters pointed out that the rule sets consistent and unified standards and provides an established infrastructure for performance monitoring and review of transplant centers.

Response: The OPTN’s primary responsibilities are to ensure the effectiveness, efficiency, and equity of organ allocation; increase the supply of transplantable organs; collect and
disburse data; and designate transplant programs. We are responsible for establishing minimum standards to protect patient health and safety, and for implementing oversight mechanisms to ensure that transplant centers provide quality transplant and living donor care to Medicare beneficiaries through the development of health and safety requirements. In developing this rule, we worked closely with HRSA, which oversees the OPTN and SRTR, to ensure consistency and minimize the burden on transplant centers where possible.

We have made a change to the definition of ‘‘adverse event’’ for clarification purposes. The proposed definition listed two examples of adverse events related to living donors: ‘‘living donor death due to mismanagement of the donor’’ and ‘‘avoidable loss of a healthy living donor.’’ We have replaced these two examples with ‘‘serious medical complications or death caused by living donation’’ to clarify that the death of any living donor or a living donor’s serious medical complications caused by living donation should be investigated as an adverse event.

*Equipose: A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient. An investigator who has a treatment preference or finds out that one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects participating in the trial.

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