Advisory Committee on Organ Transplantation

Advisory Committee on Organ Transplantation (ACOT)

Fall Meeting
November 1, 2005

Convened by Conference Call

Welcoming Remarks

Jim Burdick, M.D., Director, DoT
Dennis Williams, Deputy Administrator, Health Resources and Services Administration (HRSA)

Jim Burdick called the meeting to order at 12:00 noon.

Dr. Burdick introduced Dennis Williams, Deputy Administrator of HRSA, to present introductory remarks on behalf of the Administration.

Mr. Williams welcomed the meeting participants on behalf of Dr. Betty Duke. Mr. Williams noted that the unconventional format of the meeting (by conference call) was implemented due to constraints on the travel budget. The ACOT has the thanks of Dr. Duke and the Secretary of Health and Human Services for each member's work to make our Nation's organ transplantation system a model of effectiveness.

Mr. Williams reported that HRSA's continuing resolution covers operations through November 18. The U.S. House of Representatives and Senate have passed separate versions of the Fiscal Year 2006 appropriations bill, and these are being reconciled in meetings between the two houses. Both versions of the bill have very restricted administrative costs; and cost-saving measures will have to be implemented through the rest of the year. The ACOT meeting of May 2006 is scheduled to be held face-to-face, in the regular manner.

Mr. Williams expressed gratitude for the ACOT members' hard work and thoughtful consideration that have gone into the 42 recommendations the ACOT presented to the Department of Health and Human Services.

Mr. Williams closed his remarks with announcing the appointment of Remy Aronoff as the new Executive Director of ACOT. He will begin this role in January.

OPTN/UNOS Response to Hurricane Disasters

Mary D. Ellison, Ph.D., M.S.H.A., Assistant Executive Director for Federal Affairs, United Network for Organ Sharing

Mary Ellison presented an overview of the response of Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS) to the recent hurricanes, Katrina, Wilma, and Rita. After the first 8 hours of hurricane Katrina, UNOS posted a Web resource table of transplant staff outside the affected area that could provide services to transplant patients. Once the Louisiana Organ Procurement Agency was back online, UNOS provided them a list of affected transplant systems. UNOS' patient services phone line provided coordination for candidates and recipients to receive care wherever they had been displaced. MELD scores were distributed to centers accepting transfers so that no allocation priority would be lost. Health status downgrades for hurricane-affected liver and heart patients were prevented. UNOS has extended organ inquiries and provided weekly reports to HRSA on all efforts. In preparation for hurricanes Wilma and Rita, UNOS sent out pre-storm notices, providing transplant centers information of what UNOS could provide and how to access the resources.

Dr. Hans Sollinger noted that from the stories circulating throughout the country, UNOS responded admirably to the circumstances. He asked if there was anything more the transplant community could do over the next few months.

Dr. Ellison responded that the coverage is good at the moment. Efforts are still ongoing to help patients and programs to relocate to other hospitals. Additionally, HRSA is offering support to locate unaccounted for patients.

Increased Costs of DCD/ECD Organs

Fritz Port, M.D., Scientific Registry of Transplant Recipients Project Director

Fritz Port presented results from a study conducted by the SRTR on the increased costs associated with utilizing Donation after Cardiac Death (DCD) and Extended Criteria Donor (ECD) organs. Unlike the usual brain death donor, DCD organs are procured after a donor is "heart dead," that is, after a traditional declaration of death. ECD organs are procured from donors who are over age 60, or who are age 50-59 and also meet two of the conditions for a high risk donor.

The number of DCD organs utilized has substantially increased from 2000-2004; however, there are 19 organ procurement organizations (OPOs) that have no DCD organ transplants. The national average is 2.19 organs transplanted per DCD donor. DCD organs have a similar distribution by donor age to Standard Criteria Donors (SCD), and DCD/ECD organs have a similar distribution by donor age to ECD organs.

There was a conference held on the utilization of DCD organs this year, and many participants were expecting adverse outcomes from using DCD organs. However, the SRTR's study on kidney transplants from 1993 has shown that the adjusted graft survival for DCD organs is very close to that of SCD organs. The risk of graft failure for ECD organs is 70% greater than for ideal donors (age 10-39 with none of the ECD criteria), and the risk of graft failure for co-DCD/ECD is in line with that of ECD.

The majority of DCD donors do not have co-ECD criteria (10.09% are co-DCD/ECD).

The study showed that there is increased cost to ameliorate Delayed Graft Function (DGF), as substantially more DCD implants than SCD implants have DGF for the same Cold Ischemia Time (CIT). However, the DGF for DCD with a short CIT (<13 hours) is consistent with the DGF percentage of SCD organs with a long CIT (> 24 hours).

A question of whether the study included a breakout for kidneys that were pumped or not pumped was raised.

Dr. Port indicated that pumping is associated with better outcomes; however, the pumping criteria for throwing out a kidney are not standardized. It was noted that the Division of Transplantation has a collaborative project grant that is studying pumping.

The hospital days per patient year, 0-12 months pre- and post-transplant were similar for SCD and DCD organs. ECD organs required significantly more hospitalization in the 12 months post-transplant than SCD or DCD organs. DCD and ECD both had longer initial hospitalization after the transplant.

For liver transplants, the graft failure risk is 85 percent higher for DCD organs as opposed to SCD organs.

For kidney transplants, the increased costs of utilizing DCD organs include more frequent need for dialysis in the first week after transplant and a longer initial hospitalization stay after transplant. The increased cost of utilizing ECD organs includes both of the previous factors as well as more hospitalization time required in the first year post-transplant and the increased risk of graft failure.

Dr. Sollinger noted that there is a difference in dialysis and hospitalization practices depending on geography. The Committee noted a need to study these practices around the country through a focus on the transplant administrator level.

Reimbursement for Increased Costs of DCD/ECD Organs

James Bowman, M.D., Center for Medicare Management, Centers for Medicare and Medicaid Services

James Bowman presented information to the ACOT on the current system and future possibilities regarding reimbursement for DCD/ECD organ transplants. Dr. Bowman noted that Dr. Port's summary of the SRTR study was a good presentation of what's going on in the field of DCD and ECD transplants at this time.

The costs associated with the organ donor are handled with a pass-through cost-payment system. Most of the other costs associated with transplantation have been handled through a prospective payment system, such as the DRG system.

Dr. Bowman stated that there were not many critical issues regarding the procurement of DCD organs under the cost payment system. Payment for DCD kidney procurement is handled in the same way as living donor kidneys.

DCD organs have represented a smaller percentage of other organ transplants, including liver, pancreas, and lungs.

Reimbursement for the cost of procurement for a brain-dead donor is more unclear. There is not a standardized methodology for when and what costs are assumed for organ acquisition as opposed to being part of the patient's burden. CMS would like to look at data from current practices about when consent is obtained, when people go to the operating room (OR), and what differences exist when costs begin and stop being assumed between brain-dead, DCD, or living donors.

Michael Seeley noted that from an OPO's experience, there are more overhead resources used up front in a DCD donor scenario, depending on when cost accruing begins.

Dr. Bowman acknowledged that there is up front and behind the scenes work that needs to be performed before consent. He suggested that a list of procedures approved for repayment or a modification of current costs that are approved could be done. CMS is talking to the OPO community to explore such options.

Susan Gunderson noted that as the science is evolving, many more OPOs are utilizing DCD donors; and the costs are changing depending on practices and scenarios. There are a significant number of cases, for example, where DCD is considered and the medical course does not proceed in a timeframe that allows it. Even though organs are not procured in this scenario, there are still costs for the OPOs. The OPOs would be eager to discuss these issues with CMS.

Dr. Bowman noted that there are occasionally brain-dead donors that do not result in procurement, and these costs also get backed into the overhead of the OPOs. However, he acknowledged that it is more frequent with DCD donors.

Though OPOs are getting better at predicting go/no-go scenarios with DCD donors, as OPOs are more aggressive with procurement, there will be times when organs cannot be procured and costs are absorbed into overhead.

There could be ways to address these issues with electronic billing. For example, the OPO could log preparatory charges to a dummy patient to get a clear accounting on an individual patient/donor to determine what goes into such costs. This approach might be preferable to having a list of approved procedures that would have to be updated to stay current to the science. The OPOs' ability to assess potential donors is progressing faster than CMS updates could occur.

It was stressed that the OPOs do not do diagnostic tests before consent. However, there are preparatory costs incurred. After consent in brain-death cases, many OPOs essentially readmit the patient, and separate out all costs at this point to absolutely avoid charging the family for the costs. However, with DCD donors, some OPOs receive the whole bill and pick out donation-related costs by hand before any charges go to the family.

Mark Horney asked how the OPOs split the cost from point of consent through point that the patient dies—how much of patient room costs, operating room costs, etc.

Mr. Seeley replied that after consent, there are generally clear timelines assisting in separating out the costs. From the time of consent, there are very few costs that are on the donor and the donor's insurance. But the OPO community is very eager to have a conversation of when costs are incurred with CMS. Right now there is an opportunity to better define the middle ground.

ACOT members stressed that no action should be taken to discourage donations in any way, either through putting any burden of cost on the family or appearing that diagnostic testing is occurring before consent. Ms. Gunderson emphasized that it is critical not to frame policy that would go against the stated goal of encouraging more donations. Additionally, the discussion around consent for donation must be separate from the decision about withdrawing support, as this is a true conflict of interest. With DCD donations, this creates a more sensitive dynamic of communication with the family.

Ms. Gunderson made a motion that CMS be asked to continue dialogue begun on this call, and establish formal communication with the OPO community regarding expenses during DCD donation to establish criteria and processes for cost demarcation (burden upon OPO vs. patient and private insurance) and reimbursement. The motion was seconded and carried.

ACOT members discussed current barriers to getting OPOs to utilize DCD organs. There are cultural barriers. Physicians worry that it would impact graft survival. Additionally, transplant surgeons need to have additional training to retrieve organs from DCD donors.

Dr. Bowman noted that CMS has not examined the data for transplant recipients in a way that differentiates between SCD, ECD, or DCD donors. The current payment system is a DRG-based system with designated groups for the type of transplant, with a number of adjustments. At this point, payment is blind to whether the organ came from an SCD, ECD, or DCD donor. There is no marker to identify that it came from non-standard donor. Other centers have published on this with their own data, but CMS does not have designation. The implications of the other studies are that there are increased costs for ECD and DCD organs—the DRG system allows for some extraordinary costs for individual patients, but using an ECD or DCD organ will probably not get another specialty payment type. The DRGs are based on the ICD9. There are procedure codes that identify where the transplant comes from (00.93 is the transplant from cadaver code)—CMS encourages the OPOs to submit a coding proposal if this is the best way to go, and CMS will look at expanding the code in this area.

One possible solution is to establish a billing indicator. However, this would set a new precedent in the way CMS would identify and pay; and there are many other factors, such as CIT that affect probability of cost and success of a transplant. To earmark one type of organ for a unique prospective payment would have to be considered fairly closely.

Perhaps it could be done as a rolling covariance for the donor based on the likelihood of trouble, and then increases when the threshold is breached. There are many covariants including DCD/ECD status that can be included for predictive purposes. It is important to note that these organs are part of a spectrum—they're not inferior. Each DCD (kidney) transplant success removes the patient from long-term dialysis cost.

Dr. Bowman noted that there will be less financial disincentive to using DCD and ECD organs if the outlier threshold has been lowered; the burden of additional costs will be lessened.

ACOT members suggested connecting retrospective studies such as that presented by Dr. Port to CMS for analysis to adjust reimbursement processes.

Public Comment

Paul Scwhab, Executive Director of the Association of Organ Procurement Organizations (AOPO), stated that he is most appreciative of the comments of Dr. Bowman and Mr. Horney. He looks forward to AOPO engaging in dialogue with CMS as a follow-up.

Report on Issues in Developing a Living Donor Registry

Jim Burdick, M.D., Director, Division of Transplantation

Only in recent years has HHS been involved in a major way with living donations. There has been an explosion of opportunities in the area of living donors.

The OPTN is tasked with getting information on every living donor of an organ after 1 and 2 years of donation. HHS has funded a study of young living donors through adulthood. There are NIH studies that are predominantly physiological, hypothesis-driven scientific investigations of living donors. These provide a check and balance of health outcomes and patient safety.

Right now the ACOT is in a position to direct the desired content of the living donor registry. Dr. Burdick asked the members what they would like to see in terms of follow-up efforts with living donors. Should donors be surveyed every year for the rest of their lives, or would that be too cumbersome? After the first two years, should contact be done at 5, 10, and 15 years out? What would be the role and services provided by a hotline for donors? Should subsistence expenses be covered for disadvantaged donors?

One area not well served is the examination of the psychological/mental health impact on living donors.

Dr. Burdick also noted that there is disturbing evidence that some sites may not be applying effective screening of potential donors (e.g., there are instances of kidney donors having renal failure themselves within 5 years of donation). An emphasis on renal failure protection needs to be applied. Dr. Roger Evans noted that there is a need to know if past donors who are on the waiting list themselves were higher risk to begin with, or if there were other factors introduced after donation.

Kathy Turrisi stated that there are more living donors than ever before—this increase could be accounted for partially by decreased selectivity for living donors. There seem anecdotally to be more problems with donors than in the past; diligent follow up to assess what is going on is needed to be transparent as a community.

Rhonda Boone noted that 1- and 2-year follow-up is a good start, but not good enough. More long-term follow-up is needed. Additionally, there are quality of life issues that potential donors need to be informed about.

Dr. Burdick stated that various programs have studied kidney donors 10-15 years after donation; but selection criteria are changing and might change validity of some of these studies. The OPTN is requiring 1- and 2-year reporting covering mortality and other medical data. Compliance with this is not yet complete.

Ms. Boone noted that a tremendous number of liver donors have complications. Additionally, other quality of life issues, including lack of insurance, depression, divorce, and medical complications, need to be considered.

Roger Evans stated that there are other factors aside from donation that affect quality of life, and this needs to be kept in mind.

There is currently wide variation of criteria on who can be a donor. Ms. Turrisi suggested that more diligence is needed to protect donors. Dr. Burdick noted that there are guidelines for acceptance, but there are not mandates. One option is to specifically determine what constitutes due diligence.

Ms. Turrisi suggested collecting data and then subsequently eliminating the disincentive of out-of-pocket expenses of the donor.

Setting up a resource center for donors could be a cost-effective way to reach out to donors who feel isolated from their transplant center.

Transplant Centers Collaborative/OPO Re-Design/Spread Initiative

Dennis Wagner, Social Marketing Leader, DoT, HRSA
Virginia McBride, Public Health Analyst, DoT, HRSA

Jim Burdick, Dennis Wagner, and Virginia McBride presented an overview of the breakthrough collaborative, the OPO redesign initiative, and how these initiatives work together.

Dr. Burdick presented the goal of the Organ Transplantation Breakthrough Collaborative—to save and enhance lives by achieving an average of 3.75 organs transplanted per donor. Dr. Burdick stressed that this represents a small revolution in the field. The specific aims are:

• 4.3 organs transplanted per SCD donor;
• 2.75 organs transplanted per DCD donor;
• 2.5 organs transplanted per ECD donor;
• To achieve at least 10 percent of the donors in each service area being DCD donors.

Currently there is variance in baseline levels in these categories across the Nation, depending on area, type of donor, and type of organ. The goals of the collaborative are attainable because there are different leaders in each of these categories to teach others to improve.

Mr. Wagner described the Collaborative's recent conference in Chicago. Ninety-three teams came together from OPOs and donor programs to 1) commit wholeheartedly to the goal, 2) use the change package, 3) learn and apply the model for improvement, and 4) get energized and leave with robust action steps being tested. The model for improvement is a powerful model for taking small changes and applying them on a large scale. A large part of the conference was dedicated to profiling the change package and testing the actions that come from high donation service areas. Currently the Collaborative is in action period 1, and the progress and results will be shared at the subsequent conferences.

Ms. McBride noted that the achievements of the Breakthrough Collaboratives have forced a rethinking of how systems are run and how goals are set. The Collaboratives cannot be solely relied upon—best practices must be proactively and intentionally spread; and the systems must be changed by the process.

The goals of the OPO Redesign Initiative are to:

• Achieve 75% organ donation rates;
• Achieve 3.75 organs transplanted per donor;
• Spread best practices to the 950 largest hospitals;
• Ensure the success of transplant collaborative;
• Sustain and grow the national community of action.

The initiative is a way to spread and sustain changes. Results are being achieved faster, and ground gained is being maintained more quickly as well.

The redesign initiative has evolved as needs and capacities have changed, from the creation of the Leadership Coordinating Council, to creating national improvement leaders, then designing a knowledge management system, to new efforts to maximize organs from each potential donor.

The upcoming efforts of the initiative will be convening three OPO redesign events and monthly conference calls, integrating Improvement Leaders (point contact individuals for assuring the implementing of best practices), implementing the knowledge management system, and sharing efforts at the 2nd National Learning Congress.

Public Comment

Dolph Chianchiano, the National Kidney Foundation's Senior Vice President for Health Policy and Research, stated that the National Kidney Foundation is interested in establishment of a living donor hotline. The value of the hotline would depend on its usability and how many living donors are aware of it.

Future Meeting Date and Agenda Items

May 4 and 5, 2006, are the proposed dates for the next meeting of the ACOT. Members should indicate to the Division of Transplantation if they can make these dates.

Remy Aronoff, the new Executive Director, will begin working with ACOT in January 2006. He will work with Dr. Sollinger and other ACOT members to establish future agenda and action items for carrying these discussions and this work forward.

Discussion of New OPTN Contract

Jim Burdick, M.D., Director, DoT

The new OPTN and SRTR contracts are in place. The new OPTN contract is 2 base years and 3 one-year options. The point is to achieve the program goals of HHS/HRSA/DoT.

OPTN Strategic Plan for Organ Allocation

Frank Delmonico, M.D., President, United Network for Organ Sharing

Frank Delmonico thanked the ACOT for allowing him to make a presentation. The OPTN is implementing a strategic plan with five essential aspects:

• Increasing number of transplants and reducing wastage;
• The oversight of live organ donation and transplantation;
• The use of net benefit in the allocation of organs;
• Improving the efficiency, effectiveness, and equity of the OPTN's policies and processes.
• The collection of data targeted to the following goals: 1) assessment of performance; 2) development of policy; and 3) distribution of organs. Improving information technology and validating data.

In defining the strategic plan, OPTN called on a wide representation across the transplantation community to bring consensus and endorsement of the issues. As such, the plan is integrated with, and suggests courses of action and partnership opportunities for, other key stakeholders in the transplant community. Ways to assess progress are being developed and implemented, hard goals and targets have been established, collaboration is occurring to get the job done, and improvements and best practices are being identified and spread.

The first area of the strategic plan addresses methods to maximize the transplants performed from viable donor organs (reducing wastage). This includes changing perceptions of the use of DCD and ECD organs—e.g., for kidney transplants, these organs should be analyzed compared to ongoing dialysis rather than compared to ideal candidate organs. Another aspect of this issue is to standardize how a person is characterized as sensitized in tissue typing. Virtual crossmatching could take place, leading to:

• Decreased number of patients needing actual final crossmatch (No regional screen trays);
• Decreased time required for final crossmatching;
• Minimized wasted time crossmatching highly sensitized patients with known incompatibilities;
• Decreased CIT in some regions;
• Accelerated organ placement.

The second part of the strategic plan covers the oversight of live organ donation. The OPTN must have an emphasis on live donor safety. There is much interest in a live donor registry. The national organizations are concerned about the health of the donor. If there's a peri-operative death of donor, it should get reported to the OPTN Membership and Professional Standards Committee as an event. If a live donor is in need of a transplant in the peri-operative period, it should get reported to the OPTN Membership and Professional Standards Committee as an event.

Concern for the protection and well-being of the living donor prompted the transplant community to develop a Consensus Statement on the Live Organ Donor:

• The person who gives consent to be a live organ donor should be competent, willing to donate, free of coercion, medically and psychosocially suitable, fully informed of the risks and benefits as a donor, and fully informed of risks, benefits, and alternative treatment available to recipient.
• The benefits to both donor and recipient must outweigh the risks associated with the donation and transplantation of the living donor organ. Donors should not be called upon to donate in clinically hopeless situations. [JAMA 2000; 284: 2919 — 2926]

Dr. Delmonico took questions:

One ACOT member asked what is being done to look at kidney donors who have themselves ended up on the waiting list?

Dr. Delmonico stated that there have been inquiries as to why this is occurring; the individuals themselves get priority on the waiting list.

Another member asked if there is an attempt to look at risk factors for these cases.

Dr. Delmonico stated that predilection to renal failure in the future should be screened, and that's a part of the inquiries.

Ms. Turrisi expressed concern that there are groups that are taking patients with morbidities.

One ACOT member asked that quarterly report cards be provided on the areas of the OPTN strategic plan.

Dr. Delmonico stated that each of the work groups (each handling a different focus area) will be reporting. There will be a report in March, an assessment of progress with all of these items on the strategic plan.

Dr. Burdick thanked the ACOT members and charged them to maximize their use of time during the May 4-5, 2006, meeting. The meeting was adjourned at 4:00 p.m.

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