15198 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 405, 482, 488, and 498 

[CMS–3835–F] 

RIN 0938–AH17 

Medicare Program; Hospital 

Conditions of Participation: 

Requirements for Approval and ReApproval of Transplant Centers To 

Perform Organ Transplants 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule establishes, for 

the first time, Medicare conditions of 

participation for heart, heart-lung, 

intestine, kidney, liver, lung, and 

pancreas transplant centers. This rule 

sets forth clear expectations for safe, 

high quality transplant service delivery 

in Medicare-participating facilities. In 

addition, in this rule we respond to 

public comments on the proposed rule. 

EFFECTIVE DATES: These regulations are 

effective on June 28, 2007. 

FOR FURTHER INFORMATION CONTACT: Eva 

Fung, (410) 786–7539. Marcia Newton, 

(410) 786–5265. Diane Corning, (410) 

786–8486. Jeannie Miller, (410) 786– 

3164. Rachael Weinstein, (410) 786– 

6775. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Key Statutory Provisions 

Section 1102 of the Social Security 

Act (the Act) authorizes the Secretary to 

publish rules and regulations 

‘‘necessary for the efficient 

administration of the functions’’ with 

which the Secretary is charged under 

the Act. Section 1871(a) of the Act 

authorizes the Secretary to ‘‘prescribe 

such regulations as may be necessary to 

carry out the administration of the 

insurance programs under this title.’’ 

Section 1864 of the Act authorizes the 

use of State agencies to determine 

providers’ compliance with Medicare 

conditions of participation (CoPs). 

Responsibilities of the States in 

ensuring compliance with the CoPs are 

set forth in regulations at 42 CFR part 

488, Survey, Certification, and 

Enforcement Procedures. Under section 

1865 of the Act and § 488.5 of the 

regulations, hospitals that are accredited 

by the Joint Commission on 

Accreditation of Healthcare 

Organizations (JCAHO) or the American 

Osteopathic Association (AOA) are not 

routinely surveyed by State agency 

surveyors for compliance with the 

conditions, but are deemed to meet most 

of the requirements in the hospital CoPs 

based on their accreditation. JCAHO, 

AOA, and other national accreditation 

programs with deeming authority under 

§ 488.6 of the regulations must meet 

requirements that are at least as 

stringent as the Medicare CoPs. (See 

Part 488, Survey and Certification 

Procedures.) An accreditation 

organization must apply for and receive 

approval of deeming authority from 

CMS. 

Section 1865(b)(1) of the Act states 

that providers of certain services listed 

in section 1881(b) of the Act cannot be 

deemed by a national accreditation body 

to meet the Medicare conditions of 

participation. Kidney transplant centers 

are entities listed in 1881(b); thus, they 

cannot be deemed to be accredited. 

Section 1881(b)(1) of the Act contains 

specific authority for prescribing the 

health and safety requirements for 

facilities, including renal transplant 

centers, that furnish end stage renal 

disease (ESRD) care to beneficiaries. 

B. Past Medicare Policy Regarding 

Transplantation 

Until now, kidney transplant centers 

have participated in Medicare by 

meeting requirements set forth at 42 

CFR Part 405, subpart U, ‘‘Conditions 

for Coverage of Suppliers of End Stage 

Renal Disease (ESRD) Services.’’ These 

requirements address issues such as 

compliance with applicable Federal, 

State, and local laws and regulations; 

governing body; patient care plans; 

patients’ rights; medical records; and 

the physical environment. In addition, 

the ESRD conditions for coverage (CfCs) 

delineate minimum utilization rates, 

requirements for the director of 

transplantation, and minimum service 

requirements. (See 405.2170 and 

405.2171.) Likewise, we have regulated 

extra-renal transplant centers under 

various national coverage decisions 

(NCDs) published beginning in 1987. 

The NCDs have been based on the 

‘‘reasonable and necessary’’ provision of 

the Medicare statute (section 

1862(a)(1)(A) of the Act). Generally, 

under section 1862(a)(1)(A), Medicare 

does not pay for any item or service 

unless it is medically reasonable and 

necessary. The NCDs provide that 

transplantation of extra-renal organs 

will be considered reasonable and 

necessary if performed in a center that 

meets the criteria specified in the 

applicable NCD. 

C. Our Efforts To Improve Oversight of 

Transplant Centers 

In the preamble of the proposed 

transplant center rule published 

February 4, 2005 (70 FR 6140), we 

discussed our efforts that are underway 

to improve organ donation and 

transplantation services, including the 

Secretary’s Gift of Life Initiative. 

Publication of the proposed rule for new 

CoPs for transplant centers was the first 

step in moving toward a stronger 

oversight process. In February 2004, the 

Office of the Inspector General (OIG) 

published a report titled ‘‘Medicareapproved Heart Transplant Centers’’ 

(OEI–01–02–00520), and outlined three 

recommendations for CMS oversight of 

heart transplant centers: (1) CMS should 

expedite the development of continuing 

criteria for volume and survival rate 

performance and for periodic recertification; (2) CMS should develop 

guidelines and procedures for taking 

actions against centers that do not meet 

Medicare criteria for volume and 

survival rate; and (3) CMS should take 

immediate steps to improve its ability to 

maintain accurate and timely data on 

center performance. All of the OIG’s 

recommendations were incorporated 

into the rule. 

Through this final rule, we are 

codifying requirements for approval and 

re-approval of transplant centers as 

CoPs and placing Medicare-approved 

transplant centers under the survey and 

certification enforcement process used 

for all other providers and suppliers of 

Medicare services. 

Since publication of the proposed 

rule, we have identified quality and 

service issues that some transplant 

centers are experiencing. For example, 

in 2005, we investigated and cited a 

hospital whose liver transplant center 

was accused of turning down a large 

number of organs offered for the 

patients on its waiting list. As a result, 

the hospital closed its liver transplant 

center. In addition, the Government 

Accountability Office (GAO) is currently 

reviewing the Department’s oversight of 

the transplantation system in the United 

States. 

Our current oversight of transplant 

centers relies on self-reporting of 

significant changes within a transplant 

center, as well as beneficiary complaints 

that may lead to a review or survey of 

a transplant center. The transplant 

center NCDs do not delineate explicit 

criteria for de-certifying of organ 

transplant programs. In this final rule, 

we are responding to public comments 

on the proposed rule and 

recommendations for improvement to 

this system by setting forth explicit 


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expectations for outcomes, and high 

quality transplantation services. 

We are codifying the requirements for 

the approval and re-approval of 

transplant centers as an option under 

part 482, subpart E, for hospitals that 

choose to perform transplants. This final 

rule applies to hospitals with heart, 

heart-lung, intestine, kidney, liver, lung, 

and pancreas transplant centers. For 

purposes of this final rule, heart-lung 

transplant centers are those centers that 

are located in a hospital with an existing 

Medicare-approved heart transplant 

center and an existing Medicareapproved lung center that performs 

combined heart-lung transplants. 

Intestine centers are those Medicareapproved liver transplant centers that 

perform intestine transplants, combined 

liver-intestine transplants, and 

multivisceral transplants. Pancreas 

centers are those Medicare-approved 

kidney transplant centers that perform 

pancreas transplants, alone or 

subsequent to a kidney transplant, and 

that also perform kidney-pancreas 

transplants. 

II. Provisions of the Proposed Rule and 

Response to Comments on the February 

4, 2005 Proposed Rule 

In the February 4, 2005 Federal 

Register (70 FR 6140), we published the 

proposed rule entitled, ‘‘Hospital 

Conditions of Participation: 

Requirements for Approval and Reapproval of Transplant Centers to 

Perform Organ Transplants’’ and 

provided for a 60-day comment period. 

On March 25, 2005, we published a 

notice in the Federal Register (70 FR 

15264) extending the comment period 

for an additional 60 days, until June 6, 

2005, to allow sufficient time for the 

public to provide comments on the large 

number of proposed new requirements. 

The proposed rule set forth new 

hospital CoPs for the approval and reapproval of transplant centers at 42 CFR 

part 482, subpart E. Additionally, 

following publication of the proposed 

rule, we conducted an external, 

independent peer review of several of 

the technical aspects associated with the 

proposed outcome measures and 

options. We contacted five scientists, of 

which three sent us detailed comments 

to address the technical questions that 

we raised. One scientist declined to 

provide detailed comments but said his 

views were reflected by the comments 

provided by the American Society of 

Transplant Surgeons/American 

Transplantation Society (ASTS/ATS). 

Comments provided by the ASTS/ATS 

partially addressed these technical 

issues, as well as more general issues of 

concern to the society. These peer 

reviews were received during the public 

comment period. Below we respond to 

the comments of the peer reviewers, in 

addition to the public comments 

received during the comment period. 

We received a total of 91 comments: 

48 from individual transplant centers; 

10 from professional associations 

representing those who work in the field 

of transplantation (including 

physicians, surgeons, dietitians, nurses, 

social workers, transplant coordinators, 

hospitals), 2 from organizations that 

support transplantation, (that is, the 

National Kidney Foundation and 

National Liver Foundation); 9 from 

individual social workers; 6 from 

individual transplant coordinators; 5 

from individual organ procurement 

organizations; and 11 from various 

sources (including the Scientific 

Registry of Transplant Recipients, 

United Network for Organ Sharing, the 

Secretary’s Advisory Committee on 

Organ Transplantation, the New York 

State Department of Health, the Joint 

Commission on Accreditation of 

Healthcare Organizations, individual 

physicians, a histocompatability 

laboratory, a living donor, and a dialysis 

facility). The comments ranged from 

general support or opposition to the 

proposed conditions of participation to 

very specific questions or comments 

regarding the proposed criteria. Note 

that comments made by peer reviewers 

are identified specifically as peer review 

comments. All other comments were 

made by the public. 

Brief summaries of each proposed 

provision, a summary of the public 

comments we received (with the 

exception of specific comments on the 

paperwork burden or the economic 

impact analysis), and our responses to 

the comments are set forth below. 

Comments related to the paperwork 

burden and the impact analysis are 

addressed in the Collection of 

Information and Impact Analysis 

Sections in this preamble. 

General Comments 

Comment: Many commenters 

supported and commended our efforts 

to update Medicare approval and reapproval requirements for transplant 

centers. Some commenters indicated 

they were impressed by our recognition 

of the highly complex issues faced by 

transplant recipients and living donors. 

Other commenters stated that the 

rationales provided in the February 4, 

2005 proposed rule were based on 

sound medical and transplant practices. 

Some commenters stated that this rule 

may help to decrease organ wastage and 

graft failure, which would reduce the 

need for kidney dialysis services and retransplantation of failed organs. 

Some of the professional associations 

and three peer reviewers supported our 

efforts to update transplantation 

standards for Medicare-approved 

centers, codify standards for extra-renal 

organ transplants, and improve care for 

Medicare beneficiaries and living 

donors. One peer reviewer was pleased 

with the comprehensiveness of the 

proposed rule, which the peer reviewer 

said builds upon the work of the Organ 

Procurement and Transplantation 

Network (OPTN), the Scientific Registry 

of Transplant Recipients (SRTR), and 

the Health Resources and Services 

Administration (HRSA). Another peer 

reviewer supported the re-approval 

process and stated that a mechanism to 

re-approve transplant centers is 

essential. 

Response: We thank the commenters 

and peer reviewers for their assistance 

in developing this final rule. We are 

committed to ensuring that Medicareapproved transplant centers consistently 

maintain the expertise and resources 

necessary to provide high quality 

transplantation services to patients. 

Comment: A few commenters stated 

that the proposed rule was too 

prescriptive and expressed concerns 

that implementation of the rule would 

bring extra burden to transplant centers, 

especially kidney transplant centers, in 

terms of cost and nursing hours. One 

commenter suggested a more general 

approach as opposed to using 

prescriptive language. One commenter 

inquired about the source of funding for 

the extra expenses generated by this 

rule. 

Response: One of our goals in 

publishing new CoPs for transplant 

centers is to provide flexibility for 

transplant centers within the framework 

of our regulatory authority. As stated in 

the proposed rule, we have set forth 

requirements that we believe are 

absolutely necessary to ensure quality 

care and protect the health and safety of 

patients. All of the CoPs are specifically 

transplant-oriented, and we believe that 

nearly all requirements in this final rule 

clarify or strengthen normal business 

practices for most transplant centers. 

Centers that have not incorporated the 

requirements in this final rule into their 

normal business practices will need to 

assess their transplantation practices 

and improve their performance. We 

believe this rule will strengthen 

accountability of transplant centers, and 

we expect centers to maintain 

compliance with the requirements in 

this final rule and continuously strive to 

improve quality of care and patient and 


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living donor safety in their pursuit of 

optimal outcomes. 

We believe this rule will neither 

increase nursing workloads nor create 

significant burdens for centers, 

including kidney centers. We estimate 

that on average, the cost for each 

currently-approved Medicare transplant 

center to comply will be less than 

$56,000 in the first full year following 

the effective date of the final rule and 

less than $21,000 in subsequent years. 

Comment: A peer reviewer expressed 

concern that the level of detail in the 

proposed rule may hamper the Agency’s 

ability to make needed modifications in 

the future. 

Response: We have included only 

those requirements that we believe are 

absolutely essential for ensuring quality 

care and protecting the health and safety 

of Medicare beneficiaries and living 

donors. From an oversight perspective, 

we must be specific in our expectations 

so that providers clearly understand the 

requirements for Medicare participation. 

We will continue to stay abreast of the 

latest advances in transplantation. If 

hospitals significantly change how they 

provide transplant patient care or the 

SRTR changes its outcome measure 

methodology, we will review and revise 

the final rule as necessary. 

Comment: One commenter stated that 

the OPTN oversight process and the 

CoPs would create inconsistent parallels 

for review of transplant center 

performance. Another commenter was 

concerned that the OPTN and the 

proposed CMS review processes were 

duplicative or inconsistent in some 

areas. The commenter believed that the 

OPTN oversight and compliance with 

the Medicare CoPs should be consistent 

and work in tandem. 

Response: Our intent is that OPTN 

policies and the requirements in this 

final rule will complement but not 

duplicate each other. Nevertheless, in 

some instances, we have incorporated 

OPTN policies into our requirements so 

that they are enforceable under 

Medicare. Below is a crosswalk chart 

that shows overlap and differences 

between OPTN policies and CMS 

regulations: 

CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

Main focuses of CMS requirements. 

• Regulatory oversight of transplant centers. 

• Patient care & transplant services furnished 

to beneficiaries. 

• Relationship with transplant centers based 

on Provider Agreement & Medicare reimbursement. 

• Medicare approval & re-approval based on 

compliance with Conditions of participation 

(CoPs). 

• Provider responsibilities. 

Part 121 sets forth the governing structure of 

the OPTN and sets standards for availability 

of organ transplantation data. Part 121 lays 

out requirements for transplant program in 

hospitals at §§ 121.9 and 121.11(b)(1)(C) 

(defined as OMB-approved OPTN forms).

Main focuses of Part 121. 

• Govern the operation of the OPTN which is 

under contract with HRSA.

• Require OPTN to develop policies for its 

members. However, as of today, with the 

exception of ‘‘data submission requirements’’, none of the OPTN polices have 

been enforceable because they have not 

been approved and published by the Secretary.

Main focuses of OPTN policies/Bylaws. 

• Organ allocation. 

• Credential of transplant surgeons/physicians. 

• Relationship with transplant hospital members is collegial with the goal to help them 

to improve performance. 

• OPTN Membership application reviewed by 

peer reviewers. 

• Member obligations. 

*Additional requirements for non-Medicare approved transplant programs. 

§ 482.68 Special Requirements for transplant 

centers.

In order to be granted approval from CMS to 

provide transplant services, a transplant center must: 

• Be located within a hospital that has a 

Medicare provider agreement. 

• Meet the CoPs of this final rule. 

• Meet all hospital CoPs. 

Compliance with Part 121 ................................

OPTN membership requirements. 

• This rule now makes the data submission 

requirements of OPTN a Condition of Participation. 

• Transplant centers must comply with CoPs 

to be reimbursed. 

§ 482.70 Definitions. 

CMS has specific definitions for certain types 

of centers.

Generic definitions in part 121 ......................... No comparable OPTN definitions. 

§ 482.72 Condition of participation: OPTN 

membership.

§ 121.9 Designated transplant program requirements.

A transplant center must be located in a transplant hospital that is a member of and 

abides by the approved rules and requirements of the OPTN established and operated in accordance with § 372 of the Public 

Health Service (PHS) Act (42 U.S.C. section 

274).

• (a) To receive organs for transplantation, a 

transplant program must be in a hospital 

that is a member of the OPTN.

§ 482.74 Condition of participation: Notification to CMS.OPTN Bylaw Appendix B–3 ............................. CMS adopts the OPTN bylaw and adds more 

requirements. 

A transplant center must notify CMS immediately of any significant changes related to 

the center’s transplant program or changes 

that would alter elements in the approval/reapproval application: 

OPTN member programs must notify OPTN 

immediately when a key person plans to 

leave.

• A change in key staff members of the transplant team. 

• A decrease in the center’s volume or survival 

rates. 


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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued 

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

• Termination of an agreement between the 

hospital in which the transplant center is located and an OPO for the recovery and receipt of organs. 

• Inactivation of the transplant center. 

§ 482.76 Condition of participation: Pediatric 

Hospitals.

........................................................................... No specific OPTN policy/bylaw for pediatric 

transplant programs. 

• With the exceptions of heart centers, pediatric centers that wish to provide transplantation services to both adult and pediatric 

transplants must meet all requirements (except for clinical experience) in this rule and 

request separate Medical approval. 

• A center that mostly performs adult transplants cannot be approved to perform pediatric transplants if they lose their approval to 

perform adult transplants. 

• A center that mostly performs pediatric transplants cannot be approved to perform adult 

transplants if they lose their approval to perform pediatric transplants. 

• Heart centers that want to obtain Medicare 

approval for pediatric transplants have the 

option to be approved under the criteria listed under OBRA 1987. 

§ 482.80 Condition of participation: Data submission, clinical experience, and outcome requirements for INITIAL APPROVAL of transplant centers.

(a) Standard: Data submission. No later than 

90 days after the due date established by 

the OPTN, a transplant center must submit 

to the OPTN at least 95 percent of required 

data on all transplants (deceased and living 

donor) it has performed. 

§ 121.11(b)(2) Reporting requirements. Member transplant hospitals must submit to the 

Secretary information as the Secretary prescribes (OPTN forms).

§ 121.11(b)(1)(C) 

• The OPTN & the SRTR shall provide to the 

Secretary any data that the Secretary requests.

• Make available to the public timely & accurate program-specific information on the 

performance of transplant programs.

OPTN Policy 7.8 Data Submission Requirements.

• Each transplant center must collect & submit 95% of expected forms complete within 

3 months of the due date and 100% of expected forms complete within 6 months of 

the due date.

By using the publicly available SRTR data for 

outcome measures, CMS’s outcome complements Part 121. 

CMS adopts the OPTN policy for the most 

part. 

(b) Standard: Clinical experience. We require 

an annual volume for the following types of 

transplant centers: 

• Heart, intestine, liver & lung transplant 

centers—10 transplants. 

• Kidney transplant centers—at least 3 

transplants. 

• No annual volume requirement for heartlung, and pancreas centers, and centers 

that primarily perform pediatric transplants. 

No annual volume required by the OPTN. 

However, it has definitions for ‘‘functionally 

inactive’’ centers: 

• No transplants performed in 3 months 

in the case of kidney, liver, & heart 

transplant programs.

• No transplants performed in 6 months 

in the case of pancreas & lung programs.

CMS requirements are straighter than OPTN 

policy for the purpose of monitoring inactivity of centers. 


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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued 

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

(c) Standard: Outcome measures .....................

• We will review outcomes for all transplants 

performed at a center, including outcomes 

for living donor transplants, if applicable. Except for lung transplants, CMS will review 

adult and pediatric outcomes separately 

when a center requests Medicare approval 

to perform pediatric transplants.

• A center’s (risk-adjusted) expected 1-year 

patient survival and 1-year graft survival will 

be compared to its observed 1-year patient 

survival and 1-year graft survival, based on 

the following non-compliance thresholds:.

• O ¥ E >3. 

• O/E >1.5. 

• 1-sided p <0.05. 

OPTN Bylaw Appendix B Attachment Survival 

Rates.

• While the precise numerical criteria may be 

selected by the Membership & Professional 

service Committee, the initial criteria employed to identify programs with low patient/ 

graft survival rates will include the following 

findings: 

• O ¥ E >3. 

• O/E >1.5. 

• 1-sided p <0.05. 

CMS adopts the OPTN bylaws to the extent 

that the outcome measure standards and 

the OPTN policies for survival rate criteria & 

outcome methodology are essentially the 

same in the assessment of a center’s outcomes. However, OPTN uses the survival 

outcomes as flags for further investigation 

while CMS uses them as criteria to make 

approval & re-approval determinations. 

Compliance with the OPTN’s survival rate criteria is not required for initial approval of a 

new transplant program as an OPTN member. The OPTN grants conditional approval 

to new transplant programs, which gives the 

new transplant program 3 years to comply 

with the OPTN requirements. 

(d) Exceptions. No outcome requirements for: 

• Heart-lung transplant centers. 

• Intestinal transplant centers. 

• Pancreas transplant centers. 

§ 482.82 Condition of participation: Data submission, clinical experience, and outcome requirements for RE-APPROVAL of transplant 

centers.

(a) Standard: Data submission. No later than 

90 days after the due date established by 

the OPTN, a transplant center must submit 

to the OPTN 95 percent of the required data 

submissions on all transplants (deceased 

and living donor) it has performed over the 

3-year approval period.

See Initial Approval .......................................... See Initial Approval. 

(b) Standard: Clinical experience. We require 

an annual volume for the following types of 

transplant centers: 

See Initial Approval .......................................... See Initial Approval. 

• Heart, intestine, kidney, liver & lung 

transplant centers—10 transplants.

• No annual volume requirement for heartlung, and pancreas centers, and centers 

that primarily perform pediatric transplants.

(c) Standard: Outcome measures ..................... See Initial Approval .......................................... See Initial Approval. 

• We will review outcomes for all transplants 

performed at a center, including outcomes 

for living donor transplants, if applicable. Except for lung transplants, CMS will review 

adult and pediatric outcomes separately 

when a center requests Medicare approval 

to perform pediatric transplants. 

• A center’s (risk-adjusted) expected 1-year 

patient survival and 1-year graft survival will 

be compared to its observed 1-year patient 

survival and 1-year graft survival, based on 

the following non-compliance thresholds: 

• O ¥ E >3. 

• O/E >1.5. 

• 1-sided p <0.05. 

(d) Exceptions. No outcome requirements for: 

• Heart-lung transplant centers. 

• Intestinal transplant centers. 

• Pancreas transplant centers. 

§ 482.90 Condition of participation: Patient 

and living donor selection.

§ 121.8 Allocation of Organs .......................... CMS requirements complement OPTN policies. 

(a) Standard: Patient selection. Patient selection criteria must: The OPTN has wait list policies for the purpose of organ allocation.

• Assure fair and non-discriminatory distribution of organs. 

• Include a psychosocial evaluation. 


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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued 

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

• Include documentation in the patient’s 

medical record that the candidate’s 

blood type has been determined on at 

least two separate occasions. 

• Include documentation in the patient’s 

medical record of the patient selection 

criteria used. 

(b) Standard: Living donor selection. The living 

donor selection criteria must be consistent 

with the general principles of medical ethics. 

No comparable OPTN policy/bylaw. 

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. 

§ 482.92 Condition of participation: Organ recovery and receipt.

• Written protocols for—deceased organ recovery, organ receipt, and living donor transplantation to validate donor-recipient matching of blood types and other vital information. 

• The transplanting surgeon at the transplant 

center responsible for ensuring medical suitability of donor organs for transplantation 

into the intended recipient. 

(a) Standard: Organ recovery. 

When an intended transplant recipient is 

known, the transplant center’s organ recovery team must review and compare donordata with the recipient blood type and other 

vital information before organ recovery takes 

place.

Policy 3.1 Organ Distribution: Definitions. 

3.1.2 Transplant Center—The transplanting 

surgeon is responsible for ensuring medical 

suitability of donor organ for transplantation 

into the potential recipient, including compatibility of donor and candidate by ABO 

blood type.

CMS requirements complement OPTN policies. 

(b) Standard: Organ receipt. Policy 3.1 Organ Distribution: Definitions. CMS requirements complement OPTN policies. 

• When an organ arrives at the center, the 

transplanting surgeon and at least one licensed health care professional must verify 

that the donor’s blood type and other vital information is compatible with transplantation 

of the intended recipient prior to transplantation.

3.1.2 Transplant Center—Upon receipt of an 

organ, prior to implantation, the transplant 

center is responsible for verifying the recorded donor ABO with the recorded ABO 

of the intended recipient.

(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. 

(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. 


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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued 

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

(b) Standard: Waitlist management. Transplant 

centers must keep their waitlists up to date, 

including: 

• Updating waitlist patients’ clinical information on an ongoing basis. 

• Removing patients from the center’s 

waitlist if a patient receives a transplant 

or dies, or if there is any other reason 

why the patient should no longer be on 

a center’s waitlist. 

• Notifying the OPTN no later than 24 

hours after a patient’s removal from the 

center’s waitlist. 

OPTN Policies 3.2.3.1, 3.6.6 ............................

• Require transplant centers to immediately 

remove transplant candidates that have received a transplant from a deceased donor, 

or have died while awaiting a transplant, 

from the center’s waitlist and from the 

UNOS Patient Waiting List and to notify 

UNOS within 24 hours of such removal.

CMS Requirements complement OPTN policies. 

(c) Standard: Patient records. Transplant centers must maintain up-to-date and accurate 

patient management records for each patient 

who receives an evaluation for placement on 

a center’s waitlist and who is admitted for 

organ transplantation. This includes notification to patient (and patient’s usual dialysis 

facility if patient is a kidney patient) of: 

• Patient’s placement on the center’s 

waitlist; the center’s decision not to 

place the patient on its waitlist; or the 

center’s inability to make a determination regarding the patient’s placement 

on its waitlist because further clinical 

testing or documentation is needed. 

• Removal from waitlist for reasons other 

than transplantation or death within 10 

days. 

• Patient records must contain documentation of: 

• Multidisciplinary patient care planning 

during the pre-transplant period. 

• Multidisciplinary discharge planning for 

post-transplant care. 

OPTN Bylaw Appendix B .................................

II.C.10 Transplant Programs: Patient Notification 

Transplant programs must notify patients in 

writing: 

(i) within ten business days (a) of the patient’s being placed on the UNOS Patient Waiting List including the date the 

patient was listed, or (b) of completion 

of the patient’s evaluation as a candidate for transplantation, that the evaluation has been completed and that the 

patient will not be placed on the UNOS 

Patient Waiting List at this time, whichever is applicable; and 

(ii) within ten business days of removal 

from the UNOS Patient Waiting List as 

a transplant candidate for reasons 

other than transplantation or death that 

the patient has been removed from the 

Waiting List. The transplant program 

must maintain. 

CMS adopts OPTN bylaw for the most part. 

(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. 

§ 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. CMS requirement complement 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. 

§ 482.96 Condition of participation: Quality 

assessment and performance improvement 

(QAPI).

...................................................................... No comparable OPTN policy/bylaw. 

A transplant center must have a data-driven 

QAPI programs to monitor & evaluate performance of all transplantation services. 

§ 482.98 Condition of participation: Human resources. 

(a) Standard: Director of a transplant center. 

Transplant center must be under the general 

supervision of a qualified transplant surgeon 

or a qualified physician-director. 


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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued 

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

(b) Standard: Transplant surgeon and physician.

• Transplant center must identify to the OPTN 

a primary transplant surgeon and a transplant physician with the appropriate training 

and experience to provide transplantation 

services, who are immediately available to 

provide transplantation services when an 

organ is offered for transplantation. 

OPTN Bylaw Appendix B defines the credential of a qualified transplant surgeon and 

physician in 15 pages.

Each transplant center designated under 42 

CFR 121.9(a)(2) must have on-site a qualified transplant surgeon.

The OPTN bylaw for credentials is too detailed for adoption in regulation. 

CMS requirement for ‘‘immediate availability of 

the primary transplant surgeon & physician’’

complement OPTN’s ‘‘on-site’’ bylaw. 

• Transplant surgeon is responsible for providing surgical services related to transplantation. 

• Transplant physician is responsible for providing and coordinating transplantation care. 

(c) Standard: Clinical transplant coordinator. 

The transplant center must have a qualified 

clinical transplant coordinator to ensure the 

continuity of care of patients and living donors throughout transplantation and donation.

OPTN Bylaw Appendix B: Requirement for a 

Clinical Transplant Coordinator with defined 

responsibilities.

CMS requirement complement the OPTN 

bylaw. 

(d) Standard: Independent living donor advocate of 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. 

(e) Standard: Transplant team. The transplant 

center must identify a multidisciplinary transplant team (composed of individuals from 

medicine, nursing, nutrition, social services, 

transplant coordination, and pharmacology) 

and describe the responsibilities of each 

member of the team.

§ 121.9(a) Designated Transplant Program 

Requirements.

OPTN Bylaw Appendix B Attachment I. 

Collaborative Support—Transplant programs 

approved under 121.9(a)(2) must show evidence of collaborative involvement with experts in the field of hepatology, radiology, 

pediatrics, infectious disease, nephrology 

with dialysis capability, pulmonary medicine 

with respiratory therapy support, pathology, 

immunology, anesthesiology, physical therapy and rehabilitation medicine.

CMS requirements complement Part 121 requirements and OPTN bylaw. 

(f) Standard: Resource commitment. The transplant center must demonstrate availability of 

expertise in internal medicine, surgery, anesthesiology, immunology, infectious disease 

control, pathology, radiology, and blood 

banking as related to the provision of transplantation services.

§ 121.9(a) Designated Transplant Program 

Requirements.

Bylaws Appendix B Attachment I. 

Transplant Programs—Ancillary services—

Transplant programs approved under 

121.9(a)(2) must have immediate access to 

sophisticated microbiology, clinical chemistry, tissue typing, bloodbank support, radiology services, as well as the facilities required for monitoring immunosuppressive 

drugs.

CMS adopts the Part 121 requirements and 

OPTN bylaw. 

§ 482.100 Condition of participation: Organ 

procurement.

• Transplant center must ensure that transplant hospital has written agreement (with 

delineated responsibilities for both parties) 

with an OPO designated by the Secretary.

§ 121.9(a) Designated Transplant Program 

Requirements.

Bylaws Appendix B Attachment I A transplant 

program approved under 121.9(a)(2) must 

have letters of agreement or contracts with 

an OPO.

CMS requirement complement the OPTN 

bylaw because the OPTN bylaw does not 

require transplant centers to notify the 

OPTN or CMS when an agreement with an 

OPO is terminated. 

§ 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. 

(a) Standard: Informed consent for transplant 

patients.

........................................................................... No comparable OPTN policy/bylaw. 

• Transplant centers must have written policies 

for the informed consent process. 

• Each patient will be informed about: 

—The evaluation process; 

—The surgical procedure; 

—Alternative treatments; 


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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued 

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

—Potential medical or psychosocial risks; 

—National & center-specific outcomes 

from the most recent SRTR center-specific report, including (but not limited to) 

the transplant center’s observed and expected 1-year patient and graft survival, 

national 1-year patient and graft survival, and notification about all Medicare 

outcome requirements not being met by 

the transplant center; 

—Organ donor risk factors that could affect the success of the graft or health of 

the patient; 

—His or her right to refuse transplantation; 

—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. 

(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: 

........................................................................... No comparable OPTN policy/bylaw. 

CMS adopts many of the informed consent 

elements contained in the Secretary’s Advisory Committee on Transplantation (ACOT) 

Recommendations. 

—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 postop 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. 


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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued 

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

(c) Standard: Notification to patients .................

Transplant centers must notify patients placed 

on the center’s waiting list of information 

about the center that could impact the patient’s ability to receive a transplant should 

an organ become available, and what procedures are in place to ensure the availability 

of a transplant team: 

—The fact the center is served by a single 

transplant surgeon or physician, the potential unavailability of the transplant 

surgeon or physician, and whether or 

not the center has a mechanism to provide an alternative transplant surgeon or 

transplant physician that meets the hospital’s credentialing policies. 

• At least 30 days before a center’s Medicare 

approval is terminated, whether voluntarily or 

involuntarily, the center must inform: 

—Patients on the waiting list & provide assistance to waiting list patients who 

choose to transfer to the waiting list of 

another Medicare-approved center without loss of time accrued on the waiting 

list; and 

§ 121.9 Designated Transplant Program Requirements.

(a) To receive organs for transplantation, a 

transplant program approved under 

121.9(a)(2) agrees to promptly notify OPTN 

& patients awaiting transplantation if it becomes inactive.

OPTN Bylaws Appendix B Attachment I—Criteria for Institutional Membership.

III.C Transplant programs—A transplant program served by a single surgeon or physician shall inform patients of this fact and 

potential unavailability of 1 or both of these 

individuals during the year.

OPTN Bylaws, Appendix B. 

VI. Change in Program Status. 

When a transplant program is voluntarily or involuntarily inactivated, waitlist patients may 

retain existing waiting time and continue to 

accrue waiting time. Accrued waiting time 

may be transferred to the patient’s credit 

when s(he) is listed with a new program.

CMS adopts Part 121 and OPTN bylaws. 

—Medicare beneficiaries on the center’s 

waiting list that Medicare will no longer 

pay for transplants performed at the 

center after the effective date of the 

center’s termination of approval. 

• As soon as possible prior to a transplant 

center’s inactivation, the center must inform 

patients on the center’s waiting list and, as 

directed by the Secretary, provide assistance 

to waiting list patients who choose to transfer 

to the waiting list of another Medicare-approved transplant center without loss of time 

accrued on the waiting list. 

§ 482.104 Condition of participation: Additional requirements for kidney transplant centers............................................................................ No comparable Part 121 requirements or 

OPTN policy/bylaw for kidney transplant 

centers. 

(a) Standard: End stage renal disease (ESRD). 

• Kidney transplant centers must furnish directly transplantation & other medical & surgical specialty services required for the care 

of ESRD patients. 

(b) Standard: Dialysis services. 

• Kidney transplant centers must furnish inpatient dialysis services directly or under arrangement. 

(c) Standard: Participation in network activities. 

• Kidney transplant centers must cooperate 

with the ESRD Network designated for its 

geographical area, in fulfilling the terms of 

the Network’s current statement of work. 

No comparable CMS requirements ................... Bylaws Appendix B—Criteria for Institutional 

Membership.

Relocation and transfer of established programs is not addressed in CMS requirements. 

III.E Relocation and Transfer of Established 

Programs.

No comparable CMS requirements ................... Part 121.8 Allocation requirements of Organs.

OPTN Policy 3.0 Organ Distribution. 

The OPTN policies are all organ allocation/acceptance policies. 

3.3 Acceptance Criteria.

3.4 Organ Procurement, distribution, and alternative systems for organ distribution or 

allocation.

3.9 Allocation System for Organs Not Specifically Addressed.


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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued 

CMS requirements 42 CFR Part 121, OPTN policies, and bylaws 

for transplant centers Comments 

3.10 Back-up for Inactive Transplant Programs.

3.11 Intestinal Organ Allocation.

Appendix to Policy 3.0.

A. HLA Antigen Values and Split Equivalences.

C. Resolving Discrepant Donor and Recipient 

HLA Typing Results in the OPTN Database.

Policy 4.0 Acquired Immune Deficiency Syndrome (AIDS) and Human Pituitary Deceived Growth Hormone (HPDGH) and 

Human T-Lymphotropic Virus Type I 

(HTLV–I).

Policy 6.0 Transplantation of Non-Resident 

Aliens.

§ 488.61 Special procedures for approval and 

re-approval of organ transplant centers.

• Survey, certification, and enforcement procedures at 42 CFR part 488, subpart A, including the periodic review of compliance and 

approval contained in § 488.20. 

• Transplant centers that meet all data submission, clinical experience, outcome, and 

process requirements will be approved for 3 

years. 

• Current Medicare-approved centers will continue to be Medicare approved after submitting applications and awaiting CMS’s decision for approval. 

• At the end of 3-year approval period, CMS 

will review transplant center’s data to determine compliance with data submission, clinical experience and outcome requirements at 

§ 482.82. 

• If a center is in compliance with § 482.82, 

CMS may choose to review its compliance 

with the rest of the CoPs. 

• A transplant center may remain inactive and 

retain its Medicare approval for a period not 

to exceed 12 months during the 3-year approval cycle. 

• Centers that have lost their Medicare approval may seek re-entry into the Medicare 

program at any time, and the center must: 

§ 121.10(c)(1)(2) Enforcement of OPTN 

rules. 

Sanctions for violations of non-mandatory policies or mandatory policies (w/o approval 

from the Secretary of DHHS) include: 

• Warning, letter of admonition, or letter of 

reprimand.

• Probation. 

• Member Not in Good Standing. 

Additional Sanctions (only for violation of mandatory policies): 

• Suspension of member privileges. 

• Termination of OPTN membership. 

• Termination of Status as Designated Transplant Program, Termination of Participation 

in Medicare/Medicaid, Termination of Reimbursement under Medicare/Medicaid.

The 3 additional sanctions can only be imposed by the Secretary.

§ 121.10(c) Sanctions can also be imposed for 

violations of Part 121, including its data 

submission requirements, and when the 

Secretary determines that the public health 

or patient safety is at risk.

OPTN policies and bylaws are voluntary, until 

approved (i.e., codified) by the Secretary. At 

this time, the Secretary has not approved or 

published any OPTN policies and bylaws, 

except for data submission requirements. 

For the first time, transplant centers have the 

same appeal rights as other Medicare providers. 

(1) Request initial approval; 

(2) Comply with the initial approval requirements; and 

(3) Submit a report to CMS documenting 

any changes or corrective actions taken 

by the center as a result of the loss of 

its Medicare approval status. 

Part 498 Appeals procedures for determinations that affect participation in the 

Medicare program and for determinations that affect the participation of ICFs/ 

MR and certain NFs in the Medicaid 

program. 

• The definition of ‘‘provider’’ is amended 

by adding ‘‘transplant center’’ after 

‘‘hospital’’ the first time it appears. 

CMS Oversight and OPTN Policies 

Some commenters voiced their 

opinions about our oversight of 

transplant centers in comparison to 

OPTN oversight of its transplant 

hospital members. 

Comment: 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 


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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. 

Comment: A commenter requested 

that we limit our role to reimbursement 

of clinical services. 

Response: As a health care regulatory 

agency and a prudent health care 

purchaser, our responsibility cannot be 

limited to reimbursement. The Secretary 

has the statutory authority and 

responsibility to protect patient health 

and safety and to ensure that high 

quality care is provided to patients. 

Comment: Many commenters stated 

that the OPTN oversight process and our 

approval and re-approval process would 

create an inconsistent and duplicative 

mechanism in the oversight of 

transplant centers. The commenters 

stated that we should collaborate with 

the OPTN to streamline the two 

processes into one unified consistent 

process, but with more reliance on 

OPTN oversight. One public commenter 

stated that CMS should consider 

termination of a center only if the OPTN 

Board reports to the Secretary that it has 

made a final decision to take adverse 

action against the center. A peer 

reviewer was concerned that the 

collegial relationship between OPTN 

and the transplant centers might be 

jeopardized by codification of some of 

the OPTN requirements. 

Response: We understand the 

commenters’ concerns. However, for the 

most part, we and the OPTN have 

different roles vis-a ́-vis transplant 

centers. For example, when surveying 

transplant centers for compliance with 

the CoPs in this final rule, we will focus 

on protections for patient health and 

safety. When the OPTN surveys (or 

performs desk audits of) transplant 

centers, it focuses on compliance with 

candidate listing and delisting, data 

submission, and its patient notification 

policies and verifies that the designated 

physician and surgeon are the same 

individuals approved by the OPTN. The 

degree of authority to act in the event 

of non-compliance also differs. The 

OPTN generally takes a collegial 

approach and assists centers in 

improving their performance, while we 

generally take a regulatory approach 

which sometimes may lead to 

termination of the Medicare agreement 

with providers. However, compliance 

with the OPTN’s policies will facilitate 

transplant centers’ compliance with the 

requirements in this final rule. 

Therefore, the OPTN will continue to 

play a consultative role with transplant 

centers to assist them in complying with 

Medicare requirements. We believe the 

collegial relationship between the OPTN 

and the transplant centers may be 

enhanced and strengthened rather than 

compromised. 

Comment: Many commenters stated 

that the OPTN oversight process is 

vigorous and effective and that the 

OPTN should have full oversight of 

transplant centers to avoid duplicative 

efforts. The commenters cited 42 CFR 

part 121 as the regulation governing the 

operation of the OPTN and stated that 

the OPTN has legally binding rules 

enforceable on transplant centers. 

Other commenters noted that the 

OPTN already surveys heart and liver 

programs once every 3 years. The 

commenters recommended that the 

OPTN be recognized as the accrediting 

body to audit and survey centers 

periodically based on its expertise in 

dealing with the complexity of 

transplantation. A commenter 

recommended that we review a center 

for potential termination from the 

Medicare program only if the Secretary 

has been notified of a final decision of 

the OPTN Board to take an adverse 

action against the center. The 

commenters stated that reviews or 

surveys conducted by an inexperienced 

CMS designee would burden centers 

and lead to misinterpretation of OPTN 

policies and CMS regulations, which 

could cause confusion and loss of 

Medicare approval. 

Response: The commenters are correct 

that 42 CFR part 121 governs the 

operation of the OPTN, which 

establishes policies for transplant 

hospital members. OPTN policies are 

enforceable only when they have been 

incorporated into regulations by the 

Department. However, with the 

exception of the OPTN data submission 

requirements, OPTN policies have not 

been incorporated by the Department. 

Therefore, if the OPTN determines that 

removal of a member’s designation as a 

transplant hospital is warranted for 

reasons of non-compliance with other 

OPTN policies, with the final rule 

governing the operation of the OPTN (42 

CFR part 121), or because of a threat to 

public health and safety, the OPTN will 

recommend to the Secretary that the 

member’s designation be revoked. The 

OPTN has made this recommendation 

on only two occasions. 

We have an obligation to oversee 

transplant centers serving Medicare 

beneficiaries, and we do not have the 

statutory authority to delegate oversight 

responsibilities to the OPTN. In our 

view, the OPTN oversight approach is a 

complement to the Medicare regulatory 

authority. Once the final rule becomes 

effective, and before conducting 

surveys, our surveyors will be trained in 

applicable OPTN policies for transplant 

centers. 

Comment: A commenter 

recommended that the Secretary take 

action to expand the role of the OPTN 

relative to oversight of living donors. 

Response: The commenter’s 

recommendation falls outside the scope 

of this final rule. We will forward this 

recommendation to the Secretary for 

consideration. 

Comment: A commenter stated that 

despite the fact that the OPTN requires 

transplant programs to abide by OPTN 

policies and bylaws, we should not 

codify the OPTN policies and bylaws as 

regulatory language. One commenter 

stated that the relatively fluid OPTN 

policies and bylaws would allow the 

incorporation of future changes in 

transplant practice more quickly. 

Response: The requirements in this 

final rule are intended to be broadly 

applicable to transplant centers over a 

long period of time. OPTN policies or 

elements of OPTN policies that we have 

included in this final rule conform to 

this intent. We understand that many 

OPTN policies, particularly organ 

allocation, transplant surgeon and 

transplant physician credentials, and 

criteria for listing and de-listing 

transplant candidates are subject to 

rapid changes as transplant medicine 

advances. Therefore, we did not include 

such policies in this final rule. 

Comment: Some commenters raised 

confidentiality concerns regarding the 

sharing of data between the OPTN and 

CMS under applicable laws and 

regulations protecting the peer review 

process. One commenter suggested 

adding language to state that the 

regulation is not intended to affect the 

confidentiality of the process in any 

manner. 

Response: We understand the 

commenters’ concerns about the 

confidentiality of data shared between 

the OPTN and CMS. However, under 

reporting requirements set forth in 42 

CFR 121.11(b)(1)(iii), the OPTN and the 

SRTR are required to provide to CMS 

any data that we request, as appropriate. 

Nonetheless, it is not our intention to 

disrupt the OPTN confidential peer 

review process. We will obtain only the 


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OPTN data that is necessary for our 

oversight of transplant centers. 

Comment: One commenter suggested 

that section 1865 of the Act and 

regulations at 42 CFR part 488 mean 

that only CMS’s designated national 

accrediting organizations are eligible for 

deeming authority for transplant 

centers. The commenter further stated 

that organizations that accredit both 

hospitals and transplant centers are in 

the best position to ensure consistent 

quality oversight and avoid fragmented 

survey arrangements. 

Response: We will consider 

applications from any national 

accrediting organization for deeming 

authority for initial approval and reapproval for any of the extra-renal 

transplant centers. We believe that we 

have the statutory authority to permit 

national accrediting organizations to 

accredit most transplant centers as 

‘‘facilities,’’ pursuant to paragraph 

1865(b)(4) of the Act, with the exception 

of kidney transplant centers. As 

discussed previously, section 1864 of 

the Act authorizes the use of State 

agencies to determine providers’

compliance with the CoPs. A national 

accreditation program may apply for 

deeming authority for the providers that 

are specifically listed in § 488.6. Since 

‘‘transplant centers’’ are not specifically 

identified in § 488.6, this final rule 

inserts the language ‘‘transplant centers, 

except for kidney transplant centers’’ in 

§ 488.6(a) with the list of providers 

eligible for deeming authority. Kidney 

transplant centers are specifically 

excluded because they are not eligible 

for deeming authority by statute. (See 

sections 1864 and 1865(b)(4) of the Act.) 

Special Requirements for Transplant 

Centers (Proposed § 482.68) 

We proposed that a transplant center 

located within a hospital that has a 

Medicare provider agreement must meet 

the CoPs specified in § 482.72 through 

§ 482.104 in order to be granted our 

approval to provide transplant services. 

We proposed that the CoPs specified 

in § 482.72 through § 482.104 would 

apply to all heart, heart-lung, intestine, 

kidney, liver, lung, and pancreas 

transplant centers, unless specified 

otherwise. 

We also proposed that transplant 

centers seeking Medicare approval must 

meet the hospital CoPs specified in 

§ 482.1 through § 482.57. 

We received no comments on this 

section of the proposed regulation and 

are finalizing it as proposed. 

Definitions (Proposed § 482.70) 

We proposed definitions for 

‘‘transplant hospital,’’ ‘‘transplant 

program,’’ and ‘‘transplant center’’ to 

clarify the usage of these terms 

throughout the regulation. 

We proposed deleting the definitions 

for ‘‘histocompatibility testing,’’ ‘‘ESRD 

Network,’’ ‘‘network organization,’’

‘‘organ procurement,’’ ‘‘renal 

transplantation center,’’

‘‘transplantation service,’’ and 

‘‘transplantation surgeon’’ contained in 

§ 405.2102, as these terms are no longer 

used in the section. 

We proposed including the 

definitions for ‘‘ESRD,’’ ‘‘ESRD 

network,’’ and ‘‘network organization’’

from § 405.2102 in this final rule to 

emphasize the distinct statutory 

authority and requirements that kidney 

transplant centers have to meet and to 

clarify the use of the terms in the 

proposed CoPs for transplant centers. 

We proposed adding definitions for 

‘‘adverse event,’’ ‘‘heart-lung transplant 

center,’’ ‘‘pancreas transplant center,’’

and ‘‘intestinal transplant center.’’

This final rule includes all definitions 

related to ESRD Network programs from 

42 CFR part 405, subpart U, § 405.2102, 

as well as §§ 405.2110 through 2114. We 

note that in the proposed rule we 

incorrectly stated that our proposed 

definition for ‘‘adverse event’’ was 

derived from the JCAHO’s definition of 

‘‘adverse event.’’ In fact, JCAHO has a 

definition for ‘‘sentinel event’’ but not 

‘‘adverse event.’’ Additionally, 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. 

Following are summaries of the 

comments we received and our 

responses. 

Comment: One commenter applauded 

our efforts to standardize definitions for 

transplant hospitals for the purpose of 

improving communication. The 

commenter noted that JCAHO 

developed a Patient Safety Event 

Taxonomy in response to the lack of 

agreement on definitions regarding 

medical errors. The commenter 

suggested that the adoption of the 

Patient Safety Event Taxonomy 

developed by the JCAHO in the quality 

assessment and performance 

improvement (QAPI) CoP would 

decrease confusion, improve patient 

safety, and promote quality. 

Response: A Patient Safety Event 

Taxonomy is a system of classifying 

adverse events at hospitals or other 

providers of health care. Thus, the 

Taxonomy is a ‘‘language’’ in which 

providers can report adverse events. 

One of the JCAHO’s current initiatives 

is to ‘‘promote using health information 

technology to improve patient safety 

reporting, data analysis and learning 

from errors, and to promote a national 

reporting system for adverse events 

through the use of standardized patient 

safety taxonomy and ontology.’’

Although the final rule provides a 

general definition for an ‘‘adverse 

event’’ in transplantation, it does not 

attempt to classify all possible adverse 

events in health care or transplantation. 

The Patient Safety Event Taxonomy 

classifies all health care events, not just 

those related to transplantation. 

Incorporation of the Taxonomy into the 

QAPI CoP would be inappropriate 

because it falls outside the scope of this 

rule. Therefore, we have not adopted the 

commenter’s suggestion. 

Comment: One commenter noted that 

the term ‘‘transplant center’’ is 

commonly used interchangeably with 

the term ‘‘transplant hospital.’’ For this 

reason, the commenter stated that our 

proposal to use the term ‘‘transplant 

center’’ interchangeably with 

‘‘transplant program’’ is confusing and 

the commenter suggested the removal of 

the term ‘‘transplant center’’ in the final 

rule. 

Response: Although we agree that 

these terms often are used 

interchangeably, we believe the 

transplant community understands our 

use of the term ‘‘transplant center’’ in 

this final rule. We do not believe it is 

necessary to make a change based on 

this comment. 

Proposed General Requirements for 

Transplant Centers 

Condition of Participation: OPTN 

Membership (Proposed § 482.72) 

We proposed that a transplant center 

must be located in a transplant hospital 

that is a member of, and abides by the 

rules and requirements of, the OPTN, as 

set forth at § 482.45(b)(1), and that are 

enforceable under 42 CFR 121.10. 

We proposed that no transplant 

hospital would be considered to be out 

of compliance with section 1138(a)(1)(B) 

of the Act (which requires participation 

in the OPTN) unless the Secretary gave 

the OPTN formal notice that he or she 

approved the decision to exclude the 

transplant hospital from the OPTN and 

notified the center in writing. 


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We received no comments on this 

section of the proposed rule. Therefore, 

we are finalizing it as proposed. 

Condition of Participation: Notification 

to CMS (Proposed § 482.74) 

We proposed requiring each 

transplant center to notify us 

immediately of any significant changes 

related to the center’s transplant 

program or any change that would 

otherwise alter specific elements in its 

application for approval or re-approval. 

We proposed that instances in which 

we should be notified would include, 

but not be limited to, changes in key 

staff members of the transplant team 

(such as the individual who has been 

designated to the OPTN as the center’s 

primary transplant surgeon or 

physician) or a decrease in the center’s 

volume or survival rate that could result 

in the center being out of compliance 

with § 482.82. 

Note that in this final rule, we have 

added to this section two specific 

instances that must be reported to us 

immediately. First, a transplant center 

must notify us if the hospital in which 

it is located terminates its agreement 

with an OPO for recovery and receipt of 

organs. Further information about this 

requirement can be found in this 

preamble in our discussion of the CoP 

for organ procurement. Second, a 

transplant center must notify us if it 

becomes inactive. Further information 

about our requirements in regard to 

transplant center inactivity can be found 

in this preamble in our discussion of 

clinical experience requirements and 

special procedures for approval and reapproval of organ transplant centers. 

For clarity, we have replaced the 

language stating that a transplant center 

must notify us of any change that would 

otherwise alter specific elements in its 

application for approval. Section 

482.100 of this final rule states that, ‘‘a 

transplant center must notify CMS 

immediately of any significant changes 

related to the center’s transplant 

program or changes that could affect its 

compliance with the conditions of 

participation.’’

Following are summaries of the 

comments we received and our 

responses. 

Comment: A number of commenters 

supported the requirement for 

transplant centers to notify us of 

significant changes that may affect their 

approved status. However, some 

commenters stated that the requirement 

would be redundant and burdensome 

because the OPTN already requires such 

notification. 

Response: The OPTN bylaws require 

transplant hospital members to notify 

the OPTN immediately if the hospital 

learns that its primary surgeon or 

primary physician plans to leave. The 

transplant hospital is required to submit 

to the OPTN the name of the 

replacement surgeon or physician, 

curriculum vitae, and documentation of 

credentials and qualification at least 30 

days (if possible) prior to the departure 

of the individual being replaced. 

Although we have avoided 

duplicating OPTN policies in this final 

rule (unless we have done so 

deliberately so that we can enforce a 

requirement), in this instance, we 

believe a transplant center should 

inform us in addition to the OPTN so 

that we can actively monitor the 

situation to confirm that the departing 

surgeon or physician is replaced. We 

note that the current NCDs require 

Medicare-approved heart, liver, and 

lung centers to report such information 

to us. 

Comment: One commenter suggested 

that transplant centers should not be 

required to notify us of a significant 

decrease in volume or survival rates. 

The commenter stated that an unusually 

large number of early deaths may not 

significantly affect 1-year outcomes if 

the transplant center subsequently has 

increased volume with successful 

results. Furthermore, these outcomes 

will be reflected in the subsequent 

SRTR 1-year survival reports. 

Response: As one component of the 

active monitoring and oversight of 

transplant centers, we need to be made 

aware of any significant changes at 

transplant centers. However, the 

outcome requirements in this final rule 

are based on 1-year patient and graft 

survival as calculated and reported by 

the SRTR, meaning that there may be a 

considerable lapse of time before we 

have access to data from the SRTR 

indicating that a transplant center’s 

outcomes have dropped significantly. 

Although we understand that a decrease 

in clinical experience (that is, volume) 

and survival rates within a short period 

of time does not necessarily signify a 

problem, we need to be aware of these 

changes so that we can determine 

whether they are meaningful, for 

example, whether a decrease in the 

number of transplants signals ongoing 

inactivity and whether a decrease in 

outcomes signals a significant problem. 

When notified by a transplant center 

of a significant change, we will assess 

the information to determine how to 

proceed. We may note the information 

(such as a change in staff) and take no 

further action, contact the center for 

more information, analyze the 

information in conjunction with HRSA 

and the OPTN, and/or conduct an onsite review of the center. 

We recognize that it may be 

challenging for centers to determine 

whether decreases in the volume and 

unadjusted survival rates would be 

significant enough to warrant reporting 

to CMS. Centers will not be required to 

independently decide what constitutes a 

significant change. Centers will receive 

guidance from CMS through interpretive 

guidelines and provider notifications as 

to what constitutes a significant enough 

decrease in clinical experience or 

survival rates to necessitate reporting. 

This guidance is under development. 

Interpretive guidelines provide 

guidance to Medicare surveyors and 

clarify the intent of regulations. Each 

provider type is surveyed in accordance 

with the appropriate protocols based on 

the substantive requirements in the 

statute and regulations to determine 

whether a citation of non-compliance is 

appropriate. A center will be deemed 

deficient if it fails to meet the 

requirements of the statute or 

regulations, which, in turn, are based on 

the surveyor’s observations of the 

providers’ performance or practices. 

The specific process that surveyors 

use for each type of provider or supplier 

is outlined in the CMS State Operations 

Manual. The State Operations Manual is 

publicly available under the ‘‘Manuals’’

section of the CMS Web site. Included 

in the appendices of the State 

Operations Manual are the Interpretive 

Guidelines (also known as ‘‘Guidance to 

Surveyors’’) for each type of provider or 

supplier. The Interpretive Guidelines 

interpret and clarify the Conditions and 

Standards that are outlined in statute 

and regulations. The Interpretive 

Guidelines merely define or explain the 

relevant statute and regulations and 

describe the specific elements that a 

surveyor will be reviewing and/or 

observing. The Interpretive guidelines 

do not impose any requirements that are 

not otherwise sets forth in statute or 

regulation. 

Implementation of the survey and 

certification process for transplant 

programs will follow this same process. 

CMS is developing revisions to the State 

Operations Manual and a separate 

appendix that will include the 

Interpretive Guidelines that will be used 

for surveyors of organ transplant 

programs. CMS will also be posting 

informational material on its Web site 

for providers that would like to request 

approval for their transplant program. 

We made no changes based on this 

comment. 

Comment: One commenter noted that 

there was no definition provided for the 

term ‘‘immediately’’ for purposes of 


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describing the time frame within which 

a transplant center must notify us of 

changes. Other commenters questioned 

the term ‘‘significant changes’’ and 

recommended that the definition should 

be limited to staff changes and adverse 

events. 

Response: We disagree that the scope 

of significant changes should be limited 

to staff changes and adverse events. As 

we said in our previous response, 

decreases in the number of transplants 

performed and in the number of positive 

outcomes are also significant changes. 

We will address the time frame within 

which a transplant center must notify us 

of any significant changes and the 

meaning of ‘‘significant changes’’ in our 

interpretive guidelines for Medicare 

surveyors, as that medium permits a 

more thorough explanation of our 

expectations. Interpretive guidelines 

provide guidance to surveyors and serve 

to clarify and explain the intent of 

regulations. No changes were made 

based on this comment. 

Comment: One commenter inquired 

about the consequence of failure to 

comply with this requirement. The 

commenter stated that a good faith 

failure to comply should not constitute 

grounds for termination. 

Response: Notification to us is one of 

the conditions of participation required 

for Medicare-approved transplant 

centers. A center that fails to notify us 

of any significant changes as delineated 

in § 482.74 would be considered noncompliant with the transplant 

conditions of participation and 42 CFR 

part 488, may be subject to 

investigation, and could ultimately have 

its transplant center approval revoked. 

Comment: One commenter asked for a 

CMS contact for notification of changes. 

A commenter suggested linking 

transplant centers’ notification of 

changes to the appropriate accrediting 

organization so that further assessment 

of the situation can be conducted 

promptly. 

Response: At this time, we do not 

know whether we or a designee will 

survey transplant centers. Therefore, 

under this final rule, a transplant center 

must report a significant change to us. 

(See § 482.74.) 

Comment: A commenter asked how 

we will communicate the changes in 

primary surgeons and physicians to the 

OPTN, once notified by transplant 

centers of the change. 

Response: The OPTN policies that 

transplant centers must meet as OPTN 

members already require transplant 

centers to inform the OPTN of changes 

in primary surgeons and physicians 

immediately; therefore, there is no need 

for us to communicate such changes to 

the OPTN. 

Condition of Participation: Pediatric 

Transplants (Proposed § 482.76) 

Children are eligible for Medicare on 

the basis of ESRD as follows: under 

section 226A of the Act, an insured 

worker’s dependent child (as defined in 

regulations) who is medically 

determined to have ESRD is eligible for 

Medicare Part A and Part B. According 

to 42 CFR 408.13, a child is considered 

‘‘dependent’’ if he or she is unmarried 

and is under the age of 22 or is between 

ages 22 and 26 and has been receiving 

at least one half of his or her support 

from the insured worker continuously 

since before attainment of age 22. 

Children are eligible for Medicare on 

the basis of disability as follows: (1) 

Under section 223(b) of the Act, 

individuals who have been entitled to 

Childhood Disability Benefits (CDB) 

under section 202(d) of the Act by 

reason of a disability (as defined in 

section 223(d) of the Act) for 24 months 

are entitled to Medicare Part A and Part 

B the 25th month of disability benefit 

entitlement. Section 202(d) restricts the 

first month of CDB entitlement to the 

month the child attains age 18. 

Therefore, the earliest month a CDB 

beneficiary can qualify for Medicare is 

the month he or she attains age 20; or 

(2) section 223 of the Act provides that 

any individual who is under age 65 and 

has the necessary Social Security work 

credits, as defined in section 223(c) of 

the Act, and is under a disability as 

defined in section 223(d) of the Act, is 

entitled to Medicare Parts A and B on 

the 25th month of disability benefit 

entitlement. 

In 2005, Medicare paid for 404 

pediatric transplants of different organ 

types. 

We proposed that in order to be 

reimbursed for transplants performed on 

pediatric Medicare beneficiaries, a 

hospital that furnishes transplantation 

services to both adult and pediatric 

patients must seek separate Medicare 

approval to provide pediatric 

transplantation services. 

We also proposed retaining the 

statutory criteria found at section 

4009(b) of the Omnibus Budget 

Reconciliation Act (OBRA) 1987 (Pub. 

L. 100–203) as an extra option for heart 

transplant centers that wish to become 

Medicare-approved to perform pediatric 

heart transplants. We did not reference 

this citation in the proposed rule as an 

oversight. We proposed that a center 

that wishes to become Medicareapproved to perform pediatric heart 

transplants may also be approved by 

meeting data submission, outcome, and 

process requirements in the final rule. 

We proposed that a center that 

performs 50 percent or more of its 

transplants on adult patients must be 

approved to perform adult transplants 

in order to be approved to perform 

pediatric transplants. For these centers, 

we proposed that a loss of Medicare 

approval to perform adult transplants, 

whether voluntary or involuntary, 

would result in a loss of the center’s 

approval to perform pediatric 

transplants. We also proposed that a 

loss of Medicare approval to perform 

pediatric transplants, whether voluntary 

or involuntary, would not impact the 

center’s Medicare approval to perform 

adult transplants. 

We proposed that a center that 

performs 50 percent or more of its 

transplants on pediatric patients must 

be approved to perform pediatric 

transplants in order to be approved to 

perform adult transplants. For these 

centers, we proposed that loss of 

Medicare approval to perform pediatric 

transplants, whether voluntary or 

involuntary, would result in a loss of 

the center’s approval to perform adult 

transplants. We proposed that loss of 

Medicare approval to perform adult 

transplants would not impact the 

center’s Medicare approval to perform 

pediatric transplants. 

For a center that performs 50 percent 

or more of its transplants on pediatric 

patients, we proposed that there would 

be no minimum number of adult or 

pediatric transplants required prior to 

its request for Medicare approval. 

Following are summaries of the 

comments we received and our 

responses. 

Comment: A commenter noted that it 

is important for pediatric transplant 

centers to continue to transplant 

adolescent and young adults beyond the 

pediatric age range (18–25) to maintain 

continuity of care of established 

patients. 

Response: We agree. In some 

situations, a young adult for whom an 

organ becomes available has received 

treatment for end stage organ failure 

from the same pediatric transplant 

surgeon and pediatric transplant 

physician for many years and 

understandably wishes to have the 

transplant performed at the pediatric 

center where these physicians practice. 

Under the proposed rule and this final 

rule, which require separate Medicare 

approvals for performing adult and 

pediatric transplants, a transplant center 

performing predominately pediatric 

transplants will be able to transplant 

adolescents and young adults age 18 

and older. We recognize that pediatric 


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programs may need to continue 

transplanting young adults beyond the 

pediatric age range in order to maintain 

continuity of care for established 

patients. The health care needs of these 

patients are best addressed in a 

pediatric setting until appropriate 

transition to adult care can occur. 

Pediatric centers are required to become 

certified as both a pediatric and adult 

transplant center if they intend to 

provide transplantation services to both 

populations. 

Comment: A few commenters agreed 

that pediatric centers should meet the 

transplant center conditions of 

participation, but they did not agree that 

adult and pediatric centers should be 

approved separately. The commenters 

noted that the low volume of adult 

transplants performed at pediatric 

centers does not justify the cost and 

labor for the centers to seek separate 

approval to perform adult transplants. 

Likewise commenters said it would be 

burdensome to require an adult center 

to seek separate Medicare approval just 

to perform a few pediatric transplants. 

Response: We understand the 

commenters’ concerns. In our view, a 

center that performs 50 percent or more 

of its transplants on adult patients in a 

12-month period is considered to be an 

adult transplant center whereas a center 

that performs 50 percent or more of its 

transplants on pediatric patients in a 12- 

month period is considered to be a 

pediatric transplant center. There are 

distinct differences between adult 

centers performing occasional pediatric 

transplant and pediatric centers 

performing occasional adult transplants 

in terms of patient selection criteria, 

patient management, and the number of 

transplants performed. Because of these 

differences, we believe that approving 

adult and pediatric centers as one 

unified program is problematic. For 

example, it would be difficult, if not 

impossible, for pediatric centers to meet 

clinical experience requirements that 

are appropriate for adult transplant 

centers, which could impair access to 

pediatric transplants. 

However, we will permit a transplant 

center to submit its request for approval 

as a pediatric transplant center and its 

request for approval as an adult 

transplant center using the same 

application, which should minimize the 

paperwork burden. We made no 

changes based on this comment. 

Comment: Some commenters stated 

that in most pediatric centers, the core 

transplant team performs both adult and 

pediatric transplants. The commenters 

said that to be consistent with OPTN 

requirements for pediatric centers, we 

should allow the sharing of personnel in 

transplant hospitals that have both adult 

and pediatric transplant programs. 

Some commenters recommended 

treating adult and pediatric transplant 

centers as one unified program or 

adopting the statutorily-based approval 

criteria as used in pediatric heart 

transplant centers. 

Response: We recognize that many 

centers that perform pediatric 

transplants are operated by, or affiliated 

with, a Medicare-approved adult 

transplant center. In some transplant 

centers, the core transplant team 

performs both adult and pediatric 

transplants. We have no objection to 

such arrangements, provided that a 

transplant center has committed 

sufficient resources to both its pediatric 

and its adult transplant programs. There 

is nothing in the final rule that 

precludes a pediatric center and an 

adult center from operating as one 

unified program. Nevertheless, we 

would emphasize that an adult 

transplant center may not attempt to 

meet the clinical experience 

requirement by combining the number 

of adult transplants it has performed 

with pediatric transplants that were 

performed at its pediatric center. The 

outcomes of pediatric and adult 

transplant centers are reviewed 

separately. 

Comment: A commenter 

recommended adopting the OPTN 

pediatric transplant standards. 

Response: OPTN pediatric transplant 

policies relate primarily to pediatric 

organ allocation, and transplant surgeon 

and physician training and experience, 

and they differ significantly from our 

proposed CoPs for pediatric centers. We 

did not make any changes based on the 

comment. 

We received no comments on our 

proposal to allow a heart transplant 

center to provide transplantation 

services to pediatric heart patients to be 

approved to perform pediatric heart 

transplants by meeting the OBRA 1987 

criteria in section 4009(b) (Pub. L. 100–

203). Therefore, the proposal was 

finalized without change except for the 

addition of the OBRA 1987 citation. 

Condition of Participation: Data 

Submission, Clinical Experience, and 

Outcome Requirements for Initial 

Approval of Transplant Centers 

(Proposed § 482.80) 

We proposed that transplant centers 

must meet all of the data submission 

and outcome requirements in order to 

be granted our initial approval. If a 

center failed to meet any of the 

requirements, no waiver would be 

granted. However, we did propose 

certain exceptions, which are discussed 

below. 

Proposed Data Submission 

Requirements 

We proposed at § 482.80(a) that no 

later than 90 days after the due date 

established by the OPTN, a transplant 

center must submit to the OPTN at least 

95 percent of required data submissions 

on all transplants (deceased and living 

donor) that the center has performed at 

the center. 

We proposed that required data 

submissions would include, but not be 

limited to, the submission of the 

appropriate organ-specific OPTN forms 

for transplant candidate registration, 

transplant recipient registration, and 

transplant recipient follow up. 

We proposed using the same data 

submission requirements for both initial 

approval and re-approval. 

Proposed Outcome Requirements 

We proposed using the same outcome 

requirements for both initial approval 

and re-approval. 

We proposed using the SRTR’s centerspecific reports as the foundation of our 

outcome evaluation system. We 

proposed reviewing outcomes for all 

transplants performed at a center, 

including outcomes for living donor 

transplants, if applicable. With the 

exception of lung transplants, we will 

review adult and pediatric outcomes 

separately when a center requests 

Medicare approval to perform both 

adult and pediatric transplants. The 

OPTN policies for the cutoff for 

pediatric lung allocation and outcome 

assessment is under 12 years old, and 

the number of pediatric (under 12 years 

old) lung transplants is very small. 

Therefore, the outcomes of pediatric 

lung transplants and adult lung 

transplants are reviewed together. We 

proposed that we would compare each 

transplant center’s observed number of 

patient deaths and graft failures 1-year 

post-transplant to the center’s expected 

number of patient deaths and graft 

failures 1-year post-transplant (or under 

certain circumstances, 1-month posttransplant patient and graft survival in 

lieu of 1-year post-transplant patient 

and graft survival.) 

We proposed that under most 

circumstances, an adult transplant 

center requesting Medicare approval 

would need to have 1-year patient and 

1-year graft survival follow-up data on 

at least 9 transplants of the appropriate 

organ type during the 2.5 year period 

reported in the most recent SRTR 

center-specific report. 

We proposed that we would compare 

each transplant center’s observed 


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number of patient deaths and graft 

failures 1-year post-transplant to the 

center’s expected number of patient 

deaths and graft failures 1-year posttransplant using the data contained in 

the most recent SRTR center-specific 

report, as long as the center had 1-year 

post-transplant follow up on at least 9 

transplants of the appropriate organ 

type. We also proposed that if a center’s 

observed patient survival or graft 

survival rate was lower than the 

expected patient or graft survival rate 

and the center crossed over all 3 of the 

non-compliance thresholds for all 3 

tests (p-value less than 0.05, observed—

expected greater than 3, and observed/ 

expected greater than 1.5) for either graft 

or patient survival, we would not 

consider the center to be in compliance 

with the outcome requirements. 

We proposed that a heart-lung 

transplant center, an intestine transplant 

center, and a pancreas transplant center, 

as defined in the final rule, would not 

be required to comply with the outcome 

requirements for re-approval. 

We proposed that a center requesting 

Medicare re-approval to perform 

pediatric transplants would not be 

required to perform a minimum number 

of pediatric transplants prior to its 

request for Medicare re-approval. 

Comment: Some commenters 

supported the proposed data submission 

requirements. The commenters were 

pleased that the provisions would not 

require additional data beyond the 

OPTN requirements. The commenters 

asked us to emphasize that follow-up 

data are essential for evaluating and 

reporting of outcomes and the 

refinement of organ allocation policies. 

Response: We appreciate the 

commenters’ understanding of the 

importance of data submission in the 

accurate assessment of transplant center 

performance. We did not propose and 

are not requiring under this final rule 

that transplant centers report additional 

data beyond what they already report to 

the OPTN. The OPTN’s comprehensive 

data reporting policies provide 

sufficient data for us to determine 

whether transplant centers meet the 

outcome measures in this final rule. 

Comment: A commenter stated that 

we should coordinate our data 

submission requirements with the 

OPTN’s, so that centers do not have to 

submit data both to us and to the OPTN. 

Response: Under this final rule, we 

require transplant centers to continue to 

submit the required data to the OPTN 

UNetSM system (or any successor system 

under the OPTN Contract) in 

accordance with the specified time 

frame. UNetSM is a secure system for 

transplant hospitals to communicate 

transplant information and data to 

UNOS. We are not requiring transplant 

centers to submit data to us separately 

on a routine basis. 

Comment: A commenter stated that 

compliance with the data submission 

requirements should not be used as the 

basis for denial of Medicare approval 

and re-approval. The commenter said 

that there is no evidence linking failure 

to submit OPTN-required data with poor 

outcomes. 

Response: Given that the national and 

center-specific outcome measures 

calculated by the OPTN are based 

largely on data submitted by the 

transplant centers, it is imperative for 

centers to report data to the OPTN 

completely, accurately, and in a timely 

manner. We cannot provide meaningful 

oversight of center activities without 

complete and timely data submission. 

To ensure that the data used by the 

SRTR for analysis and compilation of 

the national and center-specific reports 

are comprehensive and accurate, we 

must have data submission 

requirements. We made no changes 

based on this comment. 

Comment: Some commenters 

expressed concern that the expanding 

scope and complexity of OPTN data 

submission have significant personnel 

and financial implications for transplant 

centers. The commenters urged us to 

confer with the OPTN to limit the 

Federal data submission requirements to 

data needed only to calculate 1-year 

post-transplant outcomes. 

Response: We understand the 

administrative workload required to 

achieve compliance with OPTN data 

submission policies. In 2006, the OPTN 

engaged in an extensive effort to review 

all data elements currently submitted by 

transplant centers to determine whether 

the number of elements could be 

reduced to lessen the burden on centers. 

Based on collaboration with the 

American Society of Transplant 

Surgeons and the American Society of 

Transplantation and input from the 

public, the OPTN succeeded in reducing 

the data entry burden on its transplant 

hospital members. For example, 268 

data fields will no longer be required for 

validation of UNetSM forms, such as the 

transplant candidate registration form 

and the transplant recipient registration 

and follow up forms. Additionally, the 

requirement to follow transplant 

recipients for 2 years after graft failure 

has been eliminated. With significant 

reduction in data submission elements 

such as these, the OPTN anticipates that 

data quality will improve significantly. 

We continue to support the OPTN’s 

commitment to review its data 

collection process annually for 

opportunities to reduce burden. 

However, we believe that the data 

submitted by transplant centers cannot 

be limited only to those data needed to 

calculate 1-year post-transplant 

outcomes. The more extensive data 

submitted by transplant centers form the 

backbone for the research and analyses 

produced by the SRTR, and the data are 

necessary for the OPTN, CMS, and 

transplant centers to develop sound 

policies. No changes were made based 

on this comment. 

Comment: Some commenters 

requested that we quantify whether ‘‘95 

percent compliance’’ means 95 percent 

of forms, patients, or data fields. A 

commenter suggested a data compliance 

threshold of less than 95 percent. 

Response: By 95 percent compliance, 

we mean that 95 percent of the OPTNrequired forms on all transplants 

(deceased and living donors) must be 

completed and submitted within 90 

days following the OPTN-required time 

frame. This requirement provides 

transplant centers with an additional 90 

days beyond the OPTN due date to 

comply. In our view, lowering the 

threshold to less than 95 percent is 

unacceptable and inconsistent with 

OPTN requirements. Therefore, we did 

not make any changes based on this 

comment. 

Comment: A commenter 

recommended that if a center produces 

independent evidence that it has 

submitted the required data timely or if 

a center’s failure to produce the 

required data is attributable to unique 

circumstances that are unlikely to recur, 

we should consider the center to be 

compliant with data submission 

requirements. One commenter stated 

that the imposition of the ‘‘no later than 

90 days after the OPTN due date’’

deadline is unnecessarily harsh and 

recommended that, as long as a 

transplant center submits 95 percent of 

the required 1-year data in time to be 

included in the SRTR report, we should 

consider the transplant center to be 

compliant. Another commenter 

expressed concern that tying Medicare 

approval to compliance with the 95 

percent data submission requirement 

would result in centers submitting poor 

quality data. The commenter suggested 

that in an effort to comply, centers may 

resort to marking data elements as 

‘‘unknown’’ or ‘‘lost to follow up’’ more 

often than is currently done. 

Response: Data submission policies 

that differ from those of the OPTN are 

likely to confuse transplant centers and 

result in decreased compliance with 

OPTN policies. When reviewing a 

center’s compliance with the data 


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submission requirements, we will take 

into consideration whether 

circumstances beyond the control of the 

center prevented it from fully 

complying with the data submission 

policies. Nevertheless, any willful 

falsification of data by a transplant 

center will be considered a violation of 

the data submission requirements in 

this final rule, as well as that of 42 CFR 

121.11(b)(2). 

Comment: Some commenters asked 

that we exempt kidney transplant 

centers from data submission and 

outcome requirements because kidney 

transplants are covered under the Act. 

Response: The Act provides the 

authority for Medicare to pay for kidney 

transplantation. However, it does not 

preclude us from establishing 

requirements that kidney transplant 

centers must meet to participate in the 

Medicare program. In fact, the statute 

specifies that payment will be made for 

kidney transplantation to providers of 

services that ‘‘meet such requirements 

as the Secretary shall by regulation 

prescribe * * *’’ (See section 

1881(b)(1)(A) of the Act.) 

Further, as noted in the preamble to 

the proposed rule, we are committed to 

bringing both the kidney and extra-renal 

transplant requirements up to date. For 

consistency across all types of 

transplant centers, we are requiring 

Medicare-approved transplant centers, 

including kidney transplant centers, to 

submit transplant data per OPTN data 

submission requirements. No changes 

were made based on this comment. 

Comment: Another commenter 

recommended that we amend the 

regulation text to require the submission 

of 95 percent of a program’s data within 

3 months of the due date and 100 

percent of the program’s data within 6 

months of the due date. 

Response: We expect transplant 

centers to comply with the OPTN policy 

to submit 100 percent of the required 

data within 6 months of the due date. 

However, we are not including the 

requirement in this final rule because a 

requirement for 100 percent compliance 

would be problematic within our 

framework for Medicare oversight and 

enforcement. For example, if the OPTN 

notified us that a transplant center had 

submitted only 99.9 percent of its data 

within the required time frame, under 

such a requirement we would consider 

the transplant center to be out of 

compliance, which could subject the 

transplant center to review and adverse 

action. 

Clinical Experience 

We requested comments on: (1) 

Whether requiring a minimum number 

of 9 transplants during a 2.5 year period 

would be acceptable for the application 

of the SRTR methodology; and (2) 

whether our proposal to focus more 

heavily on a center’s outcomes by 

eliminating volume as a separate 

standard and integrating volume into 

our outcome measures would provide 

us with the necessary data. In addition, 

three peer reviewers provided 

comments on the following specific 

issues related to volume: (1) Other 

alternative minimum volume criteria 

that would ensure that the 3 test criteria 

can be applied properly; and (2) 

appropriateness of volume standards for 

pediatric transplants. 

Comment: Only one commenter said 

that eliminating volume as a separate 

standard would be a positive change. 

Overall, commenters said that the 

proposed methodology-based volume of 

9 transplants in a 2.5 year cohort would 

be unacceptable as a basis for approval 

or re-approval of transplant centers. 

Commenters noted that a threshold of 9 

transplants in 2.5 years would be much 

lower than the current Medicare annual 

thresholds (10 for lungs and intestines, 

12 for hearts and livers, and 15 for 

kidneys). One commenter said that the 

proposed volume should not be used to 

assess a center’s performance because it 

neither serves the best interests of 

patients nor supports our stated goal to 

raise transplant standards. Another 

commenter said that no center 

performing only 9 transplants in 2.5 

years can be considered a legitimate 

transplant program. Still another 

commenter said that the proposed 

volume is so low that it essentially 

would eliminate a requirement for 

volume. One commenter suggested that 

with the exception of isolated 

geographic locations, we should require 

15 transplants as the absolute minimum 

annual volume, with a higher annual 

requirement for kidney and liver 

transplants, such as 30 transplants of 

each organ per year. 

Two peer reviewers voiced concern 

that the methodology-based volume 

requirement we proposed may allow 

Medicare-approved centers to become 

inactive but retain their Medicare 

approval. 

Response: We proposed requiring 

only 9 transplants in the 2.5 year cohort 

used for SRTR center-specific reports 

because 9 transplants is the minimum 

number necessary for the SRTR-based 

methodology to flag a poorly-performing 

center. In the preamble to the proposed 

rule, we acknowledged the possibility 

that a center could perform 9 

transplants in a short period of time and 

remain inactive for a much longer 

period, while still retaining its Medicare 

approval. Nevertheless, we posited that 

the OPTN’s oversight of transplant 

center ‘‘functional inactivity’’ would 

guard against this circumstance. 

Additionally, in our move toward an 

outcome-focused system that reflects the 

clinical experience, resources, and 

commitment of a transplant program, 

we have revised the preamble and the 

regulations text by removing references 

to ‘‘volume requirements’’ and instead 

refer to ‘‘clinical experience 

requirements.’’ We believe this change 

reflects our intent to approve transplant 

centers using an outcome-based 

methodology under which the number 

of transplants performed is one of 

several factors we consider. 

However, the comments we received 

from the public and from peer 

reviewers, as well as recent findings of 

prolonged inactivity or sub-optimal 

clinical experience at some transplant 

centers, have caused us to re-evaluate 

our position. In analyzing this issue, we 

considered several factors, including the 

possible impact of clinical experience 

on quality of outcomes and the ability 

of a patient on a transplant center’s 

waiting list to obtain a transplant. 

Few research studies have been 

conducted on the link between volume 

and quality of outcomes in 

transplantation. A 1994 study found a 

significantly higher 1-year posttransplant mortality rate among patients 

transplanted at centers that performed 

fewer than 9 heart transplants per year 

when compared to patients transplanted 

at centers that performed 9 or more 

heart transplants per year. (Hosenpud 

JD, Breen TJ, et al. The effect of 

transplant center volume on cardiac 

transplant outcomes: a report of the 

United Network for Organ Sharing 

Registry. Journal of the American 

Medical Association, 1994; 271: 1844–

1849.) 

A 1999 study using 1994 through 

1997 data showed a similar correlation 

between liver transplant volumes and 

outcomes. Specifically, patients 

transplanted at liver centers that 

performed 20 or fewer transplants per 

year had significantly higher 1-year 

post-transplant mortality than patients 

transplanted at liver centers that 

performed more than 20 transplants per 

year. (Edwards, EB, Roberts JP, et al. 

The effect of the volume of procedures 

at transplantation centers on mortality 

after liver transplantation. New England 

Journal of Medicine, 1999; 341: 2049–

2053.) 

However, we believe it would be 

problematic to base clinical experience 

requirements on research conducted on 

transplants performed when survival 

rates, particularly liver transplant 


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survival rates, were significantly lower 

than they are today. That is, 1-year riskadjusted survival after heart 

transplantation was 83.4 percent in 

1994 but had increased to 87.96 percent 

during the most recent SRTR cohort for 

which data are available, July 1, 2002 

through December 31, 2004. Further, 1- 

year risk-adjusted survival after liver 

transplantation was 76.3 percent in 

1994 but had increased to 86.59 percent 

during the most recent time period for 

which data are available, January 1, 

2003 through June 30, 2005. In contrast, 

1-year survival from 1994 through 1997 

at the high-volume liver centers in the 

1999 study was only 80 percent. 

A study published in 2004 looked at 

data for adult patients who received 

kidney or liver transplants between 

January 1, 1996 and December 31, 2000. 

(Axelrod DA, Guidinger MK, et al. 

Association of center volume with 

outcome after liver and kidney 

transplantation. American Journal of 

Transplantation, 2004; 4: 920–927.) The 

study found a significantly lower rate of 

1-year post-transplant kidney graft 

failure at high volume centers when 

compared to medium, low, or very low 

volume centers. The study also found a 

significantly different rate of 1-year 

post-transplant patient mortality at high, 

medium, and low volume liver centers; 

low volume centers were associated 

with a significantly higher risk of death. 

Despite these findings, the study’s 

authors concluded that there is no clear 

minimal threshold volume. 

Additionally, the study’s authors 

identified several potential implications 

from the results of the study, noting that 

efforts are underway in other (nontransplant) surgical fields to concentrate 

procedures at high volume centers when 

there is a relationship between volumes 

and outcomes. The study suggested that 

even with a clear association between 

volume and outcomes in 

transplantation, ‘‘The adoption of such 

a policy for liver and kidney 

transplantation would not be 

straightforward even if it were desirable, 

particularly in the case of deceased 

donor transplantation [because] the 

benefit of high-volume center 

performance must be carefully weighed 

against the increased risk of graft loss 

associated with the increased cold 

ischemia time [that] would likely 

accompany increased regionalization of 

transplant services.’’ The authors also 

pointed out that ‘‘the frequent follow-up 

visits necessary after transplantation 

might prove to be an added hardship if 

patients were forced to travel great 

distances. Because patients may be more 

compliant with follow-up visits if 

appointments are convenient, 

compliance may also be an important 

determinant of outcome.’’

Because research on the effect of 

volume on outcomes in transplantation 

provides little guidance in establishing 

the appropriate amount of clinical 

experience for Medicare approval, we 

looked at the waiting lists at heart, liver, 

and kidney centers that have volumes 

below current Medicare requirements, 

(12 transplants per year for heart centers 

and liver centers and 15 transplants per 

year for kidney centers), and compared 

them to the waiting lists at higher 

volume heart, liver, and kidney centers. 

We found indications that there may be 

a link between clinical experience and 

how well patients fare while they are 

still on the waiting list. 

For example, in 2005, there were 

approximately 117 adult heart 

transplant centers in the United States. 

According to the SRTR, 69 centers 

performed 12 or more transplants, and 

48 performed fewer than 12 transplants. 

Out of the 69 centers that performed 12 

or more transplants, 1 had a higher than 

expected mortality on the waiting list. 

Of the 48 centers that performed fewer 

than 12 transplants, 5 had higher than 

expected mortality on the waiting list. 

Nationwide in 2005, there were 

approximately 106 adult liver transplant 

centers in the United States. There were 

6,122 patients on the liver transplant 

waiting list. Slightly more than 28 

percent (1,745) of these patients died 

without receiving a transplant. Of the 96 

adult liver transplant centers that 

performed 12 or more transplants in 

2005, only one center had more deaths 

on the waiting list than the number of 

transplants it performed. However, 

among the 10 liver centers that 

performed fewer than 12 transplants in 

2005, 5 centers had more deaths on the 

waiting list than the number of 

transplants it performed. Of those 5 

centers, 2 centers had approximately 3 

times the number of deaths on the 

waiting list as the number of transplants 

they performed. For example, one liver 

center performed 7 transplants in 2005 

and had 20 waiting list deaths during 

the same time period. 

We also considered whether center 

clinical experience affects the ability of 

waiting list patients to obtain a 

transplant by reviewing transplant rates 

for kidney centers in 2004/2005. The 

SRTR calculates whether a center’s 

transplant rate for deceased donor 

transplants is statistically higher, 

statistically lower, or not significantly 

different from other transplant centers. 

Although we found no definitive link 

between a kidney center’s clinical 

experience and the transplant rate 

calculated by the SRTR, we note that the 

transplant rate of a small center 

generally would not be considered 

statistically lower than expected even if 

the center performed no transplants 

during a given year due to the small 

number of patients on its waiting list. 

However, in reviewing the data, we 

found that 7 out of the approximately 

231 adult kidney transplant centers in 

the United States in 2004 and 2005 

performed no transplants at all during 

those 2 years. The number of patients on 

the waiting lists of the 7 centers 

numbered between 9 and 47. Although 

the number of patients affected was 

small, we are concerned that patients 

continued to be listed on the waiting 

lists of centers that performed no 

transplants in 2 years. We note that, at 

present, all 7 centers are listed as 

inactive on the SRTR’s Web site. 

In summary, public commenters and 

some peer reviewers recommended a 

volume standard higher than the 

proposed 9 transplants in 2.5 years. 

None of the peer reviewers 

recommended a specific volume. 

Studies of the effect of volume on 

outcomes in transplantation suggest that 

higher volume centers have better 

outcomes, although there is no evidence 

that indicates what the minimum 

threshold should be. Also, our review of 

waiting list data raises the concern that 

waiting list patients at small centers 

may not fare as well as waiting list 

patients at larger centers, both in terms 

of waiting list mortality and the ability 

to obtain a transplant. 

Further, as discussed earlier in this 

preamble, in the fall of 2005, we found 

that some centers, although not 

considered ‘‘functionally inactive’’ by 

the OPTN, performed few transplants 

and refused a high percentage of organs 

that were offered to them for 

transplantation into their waiting list 

patients, leading to longer than average 

waiting times and, possibly, an 

increased number of deaths among their 

waiting list patients. These factors must 

be weighed against the necessity to 

maintain Medicare beneficiaries’ access 

to transplantation. Also, we must keep 

in mind the concerns raised by the 2004 

study of volume and outcomes in 

kidney and liver transplantation that 

centralizing transplants in too few 

centers could be detrimental to 

transplant outcomes. 

Based on these considerations, we 

believe transplant centers should be 

required to perform more than 9 

transplants in 2.5 years to become 

Medicare approved and, once approved, 

retain their Medicare approval. Without 

strong statistical evidence supporting a 

particular threshold for any of the organ 

types, we believe the most appropriate 


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1Although nearly half of all transplant centers in 

the United States are kidney transplant centers, 

there are barriers to access to kidney transplantation 

services in some areas of the country where there 

are large dialysis populations but few kidney 

transplant centers, and in some largely rural States 

that have no in-State kidney transplant centers and 

few centers in neighboring States. 

solution is to establish a clinical 

experience requirement that is close to 

the current volume requirements in our 

NCDs for heart, intestine, liver, and lung 

transplant centers and in our CfCs for 

kidney transplant centers. We believe 

establishing a clinical experience 

requirement of 10 transplants per year 

for all organ types for both approval and 

re-approval of transplant centers is both 

sensible and the least disruptive for 

transplant centers that have current 

Medicare approval and for the 

beneficiaries on the waiting lists of 

these centers. 

We are revising § 482.80(b) to state 

that to be Medicare approved under this 

final rule, adult transplant centers (with 

the exception of heart-lung centers, 

kidney transplant centers, and pancreas 

centers) generally must perform 10 

transplants over a 12 month period. We 

are revising § 482.82(b) to state that to 

be re-approved under this final rule, a 

transplant center must perform an 

average of 10 transplants per year 

during the re-approval period. There are 

no minimum clinical experience 

requirements for initial approval or reapproval for heart-lung, pancreas, or 

pediatric centers. (Kidney transplant 

centers generally must perform 3 

transplants over a 12-month period for 

initial approval and 10 transplants 

annually for re-approval.) (See 

§§ 482.80(d)(4) and 482.82(d)(4).) Note 

that an adult transplant center may not 

attempt to meet the clinical experience 

requirement by combining adult 

transplants with pediatric transplants 

performed at an affiliated pediatric 

center. 

As stated previously, the main intent 

of the clinical experience requirement 

for re-approval is to ensure that 

Medicare-approved centers stay active. 

We recognize that a center’s transplant 

numbers may fluctuate at times. 

Nonetheless, we believe that a 

transplant center must perform an 

average of 10 or more transplants per 

year to demonstrate commitment to its 

transplant program and gain adequate 

clinical experience. 

To determine a center’s compliance 

with the clinical experience 

requirement, we will review the data 

contained in the most recent OPTN Data 

Report and SRTR center-specific 

reports. (See § 488.61(a)(2) and 

§ 488.61(c)(1)(ii).) 

Comment: Some commenters said that 

all kidney transplant centers should be 

exempt from initial approval 

requirements (such as the requirement 

to perform 9 transplants) because a 

lengthy initial approval process would 

delay access to the new kidney center’s 

transplantation services for Medicare 

beneficiaries. That is, until a new 

kidney transplant center receives 

Medicare approval, Medicare will not 

pay for beneficiaries to receive 

transplants at the facility. 

Response: We share the commenters’

concern that a lengthy approval process 

for kidney centers, particularly a 

requirement to perform 10 transplants 

prior to approval, may prevent kidney 

transplant centers from opening in areas 

of the country where access to kidney 

transplant services is already limited.1

Meeting a clinical experience 

requirement of 10 transplants would be 

particularly difficult for new kidney 

transplant centers, because Medicare is 

either primary payer or secondary payer 

for 69 percent of kidney transplants 

performed in the United States, while 

the other 31 percent of kidney 

transplants are paid for by private 

insurance, Medicaid, and the 

Department of Veterans Affairs (unlike 

extra-renal transplants for which 

Medicare pays between approximately 

20 percent and 40 percent, depending 

upon organ type). Thus, a new kidney 

transplant center would have 

considerable difficulty finding 10 nonMedicare patients to transplant. 

Under the current ESRD CfCs for 

kidney transplant centers, a new center 

may be approved without performing 

any transplants if it has a written plan 

detailing how it will achieve 

conditional status (7–14 transplants) 

within 2 years and unconditional status 

(15 or more transplants) within 4 years. 

Currently, there are no outcome 

requirements for kidney transplant 

centers. However, this final rule 

contains outcome requirements for 

initial approval of kidney transplant 

centers, and in order for us to assess a 

new kidney transplant center’s 

performance, the center must perform 

some transplants. Taking this 

information into consideration, we have 

determined that requiring new kidney 

transplant programs to complete 10 

transplants before applying for approval 

could prevent new centers from entering 

the Medicare program. 

We believe that completing 3 

consecutive, successful transplants, as 

determined by 1-year post-transplant 

graft and patient survival outcomes, is 

necessary for a new kidney center to 

demonstrate sufficient experience in 

transplantation and enhances the new 

transplant center’s ability to recruit 

transplant candidates from the limited 

pool of the non Medicare-eligible 

kidney transplant candidate population. 

We are sensitive to the difficulty a 

new kidney transplant center will have 

in finding non-Medicare patients to 

transplant. We are committed to 

maintaining and improving access to 

kidney transplantation services for 

Medicare beneficiaries, but we also 

believe it is essential to assess a kidney 

transplant center’s performance prior to 

approving it for the Medicare program. 

Therefore, this final rule establishes a 

clinical experience requirement of 3 

transplants for initial Medicare approval 

for kidney transplant centers that had 

not been approved by Medicare under 

§ 405.2122 as of this rule’s effective date 

at § 482.80(d)(5). We believe this 

requirement will allow new kidney 

transplant centers to obtain Medicare 

approval expeditiously, while ensuring 

that some data are available to 

demonstrate whether the center’s 

outcomes are acceptable. 

Like extra-renal transplant centers, 

kidney transplant centers will be 

approved for 3 years and will be 

required to perform an average of 10 

transplants per year for re-approval. 

However, because a kidney center will 

be required to perform only 3 

transplants before obtaining initial 

approval, we will scrutinize the center’s 

clinical experiences and outcomes 

closely, particularly in the year 

following its initial approval. CMS will 

monitor the clinical experience and 

outcomes statistics of the center in the 

year following its initial approval. We 

are requesting center-specific data 

already collected through the OPTN, 

and expect to review the data at least 

quarterly. If the center’s clinical 

experience and outcomes highlight a 

need for additional investigation, CMS 

will follow up through its survey and 

certification process. 

We note that in the past, new 

transplant centers interested in applying 

for Medicare approval have offered to 

perform transplants for Medicare 

beneficiaries free of charge so that the 

center could meet the clinical 

experience requirement for initial 

Medicare approval quickly. This 

practice has serious implications for a 

Medicare beneficiary who accepts a 

transplant center’s offer of a free 

transplant. Medicare pays for 

prescription drugs used in 

immunosuppressive therapy under 

Medicare Part B only if the transplant 

was performed in a Medicare approved 

facility. Although an individual may be 

eligible for payment for his or her 

immunosuppressive drugs under 


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Medicare Part D, the beneficiary may 

pay several thousand dollars more out 

of pocket every year. 

Therefore, 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.’’

Comment: A commenter stated that 

OPTN policies do not specify that 

transplant centers must perform a 

minimum number of transplants per 

year and said that our requirements and 

those of the OPTN should be consistent. 

A commenter also asked us to clarify in 

more detail what the OPTN means when 

it terms a transplant center 

‘‘functionally inactive,’’ as well as how 

this status may impact a center’s 

eligibility to receive organs. 

Response: As discussed in the 

proposed rule, although the OPTN does 

not require a transplant center to 

perform a minimum number of 

transplants, programs (centers) are 

reviewed and may be classified as 

‘‘functionally inactive’’ if they have not 

performed a single transplant within a 

specified period of time. The specific 

time frame that the OPTN Membership 

and Professional Standards Committee 

(MPSC) uses to determine ‘‘functional 

inactivity’’ is 3 months for kidney, liver, 

and heart programs, 6 months for 

pancreas and lung programs, and 1 year 

for stand-alone pediatric programs. 

Under OPTN Bylaws, Appendix B(II), 

an OPTN member transplant hospital 

that fails to remain functionally active 

with respect to any designated 

transplant program may be encouraged 

to voluntarily deactivate its transplant 

program until such time as the 

circumstances affecting the status of the 

program have been resolved (up to 12 

months) or relinquish designated 

transplant status for the program. If the 

member fails to take either action 

voluntarily, the MPSC may recommend 

that the Board of Directors notify the 

Secretary of this inactivity (if the 

transplant program is Medicare 

approved or located within a Federal 

hospital) and take appropriate action in 

accordance with the OPTN bylaws. 

The OPTN’s determination that a 

transplant program is ‘‘functionally 

inactive’’ does not, by itself, prohibit a 

center from receiving organs. However, 

hospitals with transplant centers 

usually follow the recommendation of 

the MPSC by voluntarily inactivating 

the transplant center in question. 

Although we want to ensure that 

transplant centers remain active, we do 

not want a transplant center that is 

experiencing problems to continue to 

perform transplants just to avoid losing 

its Medicare approval. Therefore, we 

have added a provision to this final rule 

that a transplant center may inactivate 

its program for a period not to exceed 

12 months during the 3-year approval 

cycle without losing its Medicare 

approval (see § 488.61(e)), but the center 

must notify us immediately of 

significant changes in the number of 

transplants performed, as required at 

§ 482.74(a)(4). The transplant center also 

must notify the patients on its waiting 

list and, as requested by the Secretary, 

assist patients in transferring to the 

waiting list at another transplant center, 

without loss of time accrued on the 

waiting list. (See § 482.102(c)(3).) We 

will confer with HRSA and the OPTN 

on a case-by-case basis to determine 

whether to instruct an inactive center to 

notify its waiting list patients and assist 

them in transferring to another 

transplant center’s waiting list. 

We proposed that a center that was 

requesting initial Medicare approval to 

perform pediatric transplants would not 

be required to perform a minimum 

number of pediatric transplants prior to 

its request for Medicare approval. 

Comment: Most commenters agreed 

that volume requirements are not 

relevant for pediatric centers and they 

strongly supported having no volume 

requirements for centers performing 

pediatric transplants. Two peer 

reviewers said that a volume 

requirement would be inappropriate for 

pediatric centers. One peer reviewer 

agreed that volume standards are not 

appropriate for pediatric transplant 

programs, but also expressed concerns 

about the ability of pediatric centers to 

maintain their expertise because many 

centers perform so few pediatric 

transplants. Another peer reviewer 

stated that since setting a volume 

requirement for small pediatric centers 

is challenging, Medicare approval for 

pediatric centers that are affiliated with 

Medicare-approved adult transplant 

programs is recommended. Like the 

other peer reviewer, this peer reviewer 

also had concerns about small, standalone pediatric transplant programs’

ability to maintain resources and 

expertise in transplantation. 

However, two commenters stated that 

a minimum volume requirement is 

necessary to ascertain the commitment 

and investment a hospital has made in 

its pediatric transplant center. One 

commenter recommended ten pediatric 

transplants a year for liver and kidney 

programs and a lower volume for heart 

programs. The commenter suggested 

counting open and closed congenital 

heart surgeries toward the volume 

requirement for pediatric heart 

transplants. One commenter expressed a 

strong belief that having no volume 

requirement for pediatric transplant 

centers would allow small programs 

with limited resources to perform 

transplants, with potential poor 

outcomes. 

Response: Given the nature of the 

pediatric transplants performed and the 

low numbers of pediatric transplants in 

general, it would be impossible for most 

pediatric transplant centers to obtain 

Medicare approval if we required them 

to meet clinical experience 

requirements, limiting access for 

pediatric Medicare beneficiaries who 

need transplants. As stated earlier, we 

will monitor pediatric centers’ outcomes 

to ensure they provide high quality 

transplantation services to Medicare 

pediatric patients. We made no changes 

based on this comment. 

Comment: Some commenters stated 

that in most pediatric centers, the core 

transplant team performs both adult and 

pediatric transplants. The commenters 

said that to be consistent with OPTN 

requirements for pediatric centers, we 

should allow the sharing of personnel in 

transplant hospitals that have both adult 

and pediatric transplant programs. 

Some commenters recommended 

treating adult and pediatric transplant 

centers as one unified program or 

adopting the pediatric heart transplant 

center statutory approval criteria. 

Response: We recognize that many 

centers that perform pediatric 

transplants are operated by or affiliated 

with a Medicare-approved adult 

transplant center. In some transplant 

centers, the core transplant team 

performs both adult and pediatric 

transplants. We have no objection to 

such arrangements, provided that a 

transplant center has committed 

sufficient resources to both its pediatric 

and its adult transplant programs. There 

is nothing in the final rule that 

precludes a pediatric center and an 

adult center from operating as one 

unified program. Nonetheless, approval 

of the pediatric center is not automatic. 

The pediatric center and adult center 

must apply for separate approval. 

We invited comments from the public 

on the proposed outcome requirements. 


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In addition, we conducted independent 

peer reviews of the following specific 

issues related to the outcome 

requirements: 

(1) Appropriateness and usefulness of 

using 1-year post-transplant graft and 

patient survival rates to assess 

transplant center performance; 

(2) Alternative outcome measures; 

(3) Appropriateness of using 1-month 

post-transplant data for initial approval 

of new centers; 

(4) Outcome measures for heart-lung, 

intestine and pancreas transplant 

centers; 

(5) Use of the Cox model to explain 

the risk-adjusted expected 1-year posttransplant graft and patient survival 

rates; 

(6) Appropriateness of using the 3 

proposed thresholds to determine center 

performance; and 

(7) Use of the proposed p-value to 

assess centers with ≥ 9 transplants 

during a 2.5-year period. None of the 

peer reviewers suggested alternative 

outcome measures. All reviewers agreed 

that the Cox model is the most widely 

used, flexible, and reliable tool to 

measure transplant outcomes because it 

allows adjustments, additions, or 

deletions of co-variables to reflect 

clinical changes in transplantation over 

time. 

Following are summaries of the 

comments we received and our 

responses. 

Use of 1-Year Post-Transplant Graft and 

Patient Survival Rates as Outcome 

Measure Standards 

In our discussion of outcome 

measures in the preamble to the 

proposed rule, we said that we would 

compare each transplant center’s 

observed number of patient deaths and 

graft failures 1-year post-transplant to 

the center’s expected number of patient 

deaths and graft failures 1-year posttransplant, using the most recent SRTR 

center-specific reports. We also stated 

that we would not consider a center’s 

patient and graft survival rates to be 

acceptable if a center’s observed patient 

survival rate and observed graft survival 

rate is lower than its expected patient 

survival rate or expected graft survival 

rate. 

Comment: Many commenters agreed 

that risk-adjusted graft and patient 

survival rates are appropriate measures 

of transplant center performance. Some 

commenters stated that the proposed 

comparison of 1-year observed graft/ 

patient survival rates with 1-year 

expected graft/patient survival rates is 

reasonable and achievable. The 

commenters noted that the proposed 

risk-adjusted survival data with a 1-year 

follow-up period has more statistical 

validity than the evaluation of a survival 

curve at a particular time point, such as 

when the Kaplan Meier model is used. 

The commenters appreciated our effort 

to strive for consistency with OPTN 

standards and in establishing 

meaningful outcome standards. One 

commenter believed that outcome 

measure reviews should be based on 

trends and not just on one single 

snapshot in the SRTR reports. 

All three peer reviewers agreed with 

the public commenters that it is 

appropriate to use 1-year graft and 

patient survival rates to assess 

transplant center performance. Three 

peer reviewers added that a survival 

time frame longer than 1 year, such as 

3 years or 5 years, may provide a more 

accurate assessment of center 

performance and minimize statistical 

deviations for small centers. However, 

they pointed out that the drawback of a 

longer time frame is that more patients 

would be lost to follow up, and a longer 

time frame may not be applicable to 

smaller programs. 

Response: Although we agree that a 

time frame for the outcome measures 

longer than 1-year post-transplant 

would provide some additional 

information, the drawbacks include 

increased mortality from patients’ comorbidities and more patients lost to 

follow up. We believe that utilizing 1- 

year survival data for approvals and reapprovals is sufficient. We have made 

no changes based on these comments. 

Alternatives to the OPTN Outcome 

Thresholds 

We solicited comments on different 

options to apply the SRTR methodology. 

Following are summaries of the 

comments we received and our 

responses. 

Comment: A commenter stated that 

graft and patient survival rates alone do 

not give a complete picture of transplant 

center performance. The commenter 

encouraged us to continue to identify or 

develop measures to capture the full 

scope of a transplant center’s 

performance. 

Response: We agree with the 

commenter that graft and patient 

survival rates alone do not provide a 

complete picture of transplant center 

performance. To provide a broader 

view, we will assess each center’s 

compliance with the other CoPs, which 

focus on other measures of quality, such 

as direct patient care. If the OPTN and 

SRTR develop additional measures, we 

will consider whether those measures 

should be incorporated into our CoPs 

through the rulemaking process. We 

made no changes based on this 

comment. 

Comment: A commenter suggested 

including waiting list mortality, the 

number of organ donors, and the size of 

the waiting list in the outcome measure 

analysis. 

Response: We considered using 

waiting list mortality as one of the 

outcome measures, but after careful 

deliberation, we determined that using 

this criterion would be problematic 

because transplant centers do not 

provide direct patient care for all of the 

patients on their waiting lists. Some 

waiting list patients routinely receive 

their primary care from other providers, 

particularly patients awaiting kidney 

transplants who are likely to receive 

their care through a dialysis facility. In 

addition, some waiting list patients are 

listed at more than one center. We 

would have considerable difficulty 

determining which transplant center 

should be accountable for the death of 

a patient listed on more than one 

waiting list. Finally, waiting list patients 

may die for reasons unrelated to their 

end-stage organ failure. We believe it 

would be unfair to hold a transplant 

center responsible for the death of a 

waiting list patient if the cause of death 

were unrelated to the patient’s 

transplant. 

Although the commenter suggests 

using the number of organ donors as one 

of the outcome measures in the final 

rule, we would point out that 

cooperating with organ procurement 

organizations (OPOs) in the organ 

donation process would be a function of 

the hospital in which a transplant center 

is located, not of the transplant center 

itself. Furthermore, the hospital CoP at 

§ 482.45 ‘‘Organ, tissue, and eye 

procurement’’ lists specific 

requirements all hospitals must meet 

related to their performance as donor 

hospitals. We made no changes based 

on this comment 

Comment: A commenter also 

suggested using the size of a transplant 

center’s waiting list as an outcome 

measure. 

Response: We disagree. There are 

many different variables affecting the 

size of a transplant center’s waiting list, 

such as geographic location, patient 

selection criteria, cultural factors, and 

transplant resources, among others. 

Thus, we do not believe the size of a 

transplant center’s waiting list is an 

appropriate outcome measure. We did 

not make any changes based on these 

comments. 


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The 3 Thresholds (p < 0.05, Observed—

Expected > 3, and Observed/Expected 

> 1.5) 

We requested comments on the three 

proposed non-compliance thresholds for 

the outcome measures and solicited data 

and evidence that would support 

alternative thresholds, especially 

thresholds specific to a particular organ 

type. 

We proposed that a transplant center’s 

performance would not be acceptable if 

its observed patient survival rate and 

observed graft survival rate were lower 

than its expected patient survival rate 

and expected graft survival rate and if 

all three of the following thresholds 

were crossed over: 

(1) One-sided p-value is less than 

0.05; 

(2) Number of observed events 

(patient deaths or graft failures) minus 

the number of expected events is greater 

than 3; and 

(3) Number of observed events 

divided by the number of expected 

events is greater than 1.5. 

Comment: Although some 

commenters expressed support for the 

three proposed thresholds, a few 

commenters stated that these thresholds 

would be too lenient. Other commenters 

suggested making the thresholds more 

rigorous but only if the outcome 

measures were used solely as a trigger 

for further investigation. Three peer 

reviewers supported using all 3 

proposed non-compliance thresholds (p 

< 0.05, O—E > 3, and O/E > 1.5) to 

determine transplant center 

performance. However, one peer 

reviewer recommended changing the 

threshold for O/E > 1.5 to O/E > 1.3 in 

order to narrow the variations among 

centers. One commenter stated that the 

three thresholds for outcome measures 

are arbitrary since the outcome measure 

methodology may change in the future. 

Response: We disagree that the 

proposed thresholds are too lenient. The 

OPTN uses the same thresholds 

currently to flag centers for further 

review, and the SRTR uses the 

thresholds to report observed and 

expected patient and graft survival. 

Changing the threshold of O/E > 1.5 

to O/E > 1.3, as one peer reviewer 

suggested, would be inconsistent with 

the OPTN O/E threshold for flagging 

centers for further review. If the OPTN 

changes the criteria to narrow the 

variation in the future or we determine 

that the threshold is insufficiently 

rigorous for our purposes, we will reassess it. 

We will not use these thresholds 

simply to flag centers for further review 

as suggested by some of the 

commenters. Although failure to meet 

the outcome requirements does not 

mean that a transplant center will be 

denied Medicare approval automatically 

or lose Medicare approval 

automatically, a transplant center’s 

performance on the outcome 

requirements is the single most 

important factor we will consider in 

making these determinations because 

these measures are designed to reflect 

the importance of the need for a 

transplant center to have sufficient 

expertise in all phases of 

transplantation, such as conducting pretransplant evaluations, performing the 

surgical procedure, and regulating posttransplant immunosuppression and 

other medications to prevent graft 

failure. Since we will be using outcomes 

data, along with other data and 

information on transplant center 

performance, to make decisions on 

initial approvals and re-approvals of 

transplant centers, we believe the 

thresholds are sufficiently rigorous to 

ensure we can identify transplant 

centers whose performance is 

unacceptable. 

We do not agree that simply because 

we or the OPTN may change the 

proposed outcome requirements in the 

future, they are definitionally arbitrary. 

We are establishing thresholds at a level 

that is optimal to identify transplant 

centers whose performance is not 

adequate for delivery of transplantation 

services to Medicare beneficiaries. If we 

determine in the future that any of the 

three thresholds is too low or too high, 

we will propose changes in the 

threshold through the rulemaking 

process. We made no changes based on 

these comments. 

Comment: A few commenters 

suggested that we should establish the 

criteria for unacceptable performance at 

crossing over 2 out of the 3 (instead of 

all 3) non-compliance thresholds. 

Response: Throughout the final rule, 

we have been careful to conform our 

requirements to OPTN policies in 

almost all cases, so that our 

requirements for and our oversight of 

transplant centers does not conflict with 

the OPTN’s. Currently, the OPTN 

requires that a transplant center has 

crossed over all three thresholds to be 

flagged for further review. We do not 

believe it would make sense to adopt 

the SRTR methodology and most of the 

OPTN’s outcome measures policies in 

this final rule but establish a different 

criterion for the thresholds. In addition, 

we are mindful that the existing OPTN 

thresholds were established with the 

support of the transplant community. If 

the OPTN changes its thresholds in the 

future, we will determine at that time 

whether we should change the 

thresholds in our regulations. We made 

no changes based on this comment. 

Comment: A commenter pointed out 

that the OPTN uses a 2-year cohort, but 

we proposed using a 2.5-year cohort. 

Commenters said that use of different 

cohort lengths would lead to different 

results when centers are reviewed. 

Response: As of 2005, the SRTR 

changed the OPTN cohort from 2 years 

to 2.5 years to be consistent with the 

public SRTR center-specific reports. 

Appropriateness of Using the Proposed 

Outcome Requirements, the 3 

Thresholds, and the SRTR Methodology 

as the Basis To Approve and ReApprove Transplant Centers 

Comment: A few commenters 

supported the basis for the outcome 

measure methodology designed by the 

SRTR and tested within the transplant 

community. Commenters said they 

believed that the proposal meets the 

principles of equity and fairness, and 

the outcome measures can be applied 

equitably to all types of transplant 

centers, both large and small. However, 

one commenter stated that the OPTN 

outcome data were never designed as a 

test for Medicare approval and reapproval. The commenter recommended 

that we defer any approval or reapproval decisions regarding data 

submission or outcome requirements to 

the OPTN Board, which makes the final 

decision about transplant center 

performance. 

Response: We have been using patient 

survival outcome measures as approval 

criteria for transplant centers since 

Medicare began paying for heart 

transplants in 1987. Over the years, we 

have established outcome requirements 

for approval of liver, lung, and intestine 

transplant centers, as well. The 

sophisticated SRTR methodology 

described in this final rule allows us to 

improve upon the current outcome 

requirements by incorporating risk 

adjustment and ensuring statistical 

validity. Clearly, the outcome 

requirements that we are establishing in 

this final rule also can be utilized as 

indicators for potential problems, which 

is how we will use them in the approval 

and re-approval processes. Noncompliance with data submission, 

clinical experience, or outcome measure 

requirements may trigger a review for 

compliance with the CoPs, similar to the 

OPTN process, which also uses 

transplant outcomes data to flag centers 

for further review and investigation. 

However, as stated previously, the 

OPTN does not have the oversight 

authority to approve or re-approve 

transplant centers for Medicare. We 


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must conduct the review and 

investigation of a transplant center that 

does not meet the outcome measures. 

We have made no changes in this final 

rule based on this comment. 

Comment: A few commenters stated 

that the SRTR center-specific report that 

we cited for review and approval/reapproval of transplant centers is 1 to 3 

yrs behind current data and does not 

reflect a transplant center’s current 

outcomes. Therefore, centers that have 

improved recently may be sanctioned 

unnecessarily. The commenters 

recommended that we review more 

recent data or data in at least two 

previous SRTR reports to evaluate a 

transplant center’s outcome trends. 

A peer reviewer stated that the 

outcome measure review should be 

based on outcome trends over a longer 

period of time and not on a single 

snapshot in the SRTR report. Another 

reviewer recommended a review of graft 

and patient survival rates in two 

consecutive SRTR reports. 

Response: We agree that some 

transplant centers’ outcome trends may 

be best understood by reviewing two 

SRTR reports. However, since our 

approach to approving centers is multidimensional (data, clinical experience, 

outcomes, and process), and the OPTN 

review of transplant centers is ongoing, 

we believe that review of one SRTR 

report is sufficient to assess a transplant 

center’s performance. If we consistently 

use the SRTR center-specific reports for 

outcome review, the trend of a center’s 

performance or a clinically significant 

pattern should be reasonably apparent 

over an extended period of time. The 

SRTR updates its center-specific reports 

every 6 months. However, since the 

outcome requirements in this rule 

include 1-year post-transplant data, the 

delay in compiling and reporting the 

data by the SRTR is unavoidable. Thus, 

the age of the data that we review will 

vary from 1.5 to 3 years old. 

Nevertheless, the SRTR reports 

provide the most cost-effective, 

transparent, and objective measures 

currently available. Since we will use 

the SRTR center-specific reports 

consistently to review outcomes, the 

trend of a center’s performance or a 

clinically significant pattern should be 

reasonably apparent over an extended 

period of time. An on-site survey will 

counterbalance the outcomes data if the 

outcome trend is negative but is not 

reflective of the center’s performance. 

On the other hand, the reporting of 

significant (negative) changes and 

inactivity to CMS will counterbalance 

the outcomes data if the center’s 

performance trend appears to be 

positive but is, in fact, not reflective of 

the center’s performance. 

Comment: Some commenters were 

concerned that the proposed outcomes 

requirement may not be able to 

accommodate future changes in the 

OPTN’s policies for application of the 

SRTR methodology or the methodology 

itself. A commenter suggested that we 

should include provisions to assure 

automatic adoption of future changes in 

the OPTN/SRTR data submission and 

outcome measure policies through 

issuance of Program Notices. 

Response: The SRTR refines their 

methodology on an ongoing basis. For 

example, the SRTR reassesses the 

methodology’s risk adjustment factors 

periodically and makes changes based 

on research and changes in the field of 

transplantation. The SRTR also adds or 

changes data sources, as appropriate. 

Periodically, the OPTN asks the SRTR to 

look into statistical techniques to 

improve data analysis. Such changes 

will not require us to engage in 

rulemaking. If the OPTN makes a 

substantive change to its policies 

regarding the methodology or chooses a 

different methodology for calculation of 

outcomes, we will assess the change to 

determine whether we should adopt it. 

For example, if the OPTN were to 

change the threshold for the p-value, 

and we determined that the change to 

the threshold would be appropriate for 

our outcome requirements, we likely 

would be required to engage in 

rulemaking so that the public would 

have the opportunity to comment. Based 

on our knowledge of the OPTN’s past 

practices, we do not expect substantive 

changes to occur frequently. In fact, 

since the OPTN published the first 

annual report containing transplant 

center-specific outcomes data and 

transplant survival rates in 1992, there 

has been only one major change in the 

methodology used to measure 

outcomes—the change from the OPTN 

methodology to the SRTR methodology, 

which took place in 2002. We have 

made no changes based on these 

comments. 

Risk-Adjustment Factors 

Comment: Many commenters 

expressed concern that the SRTR model 

does not include all the risk-adjustment 

factors impacting outcomes, for 

example, new immunosuppression 

protocols, organs from extended criteria 

donors (ECDs) and donors after cardiac 

death (DCDs), steatosis, and centers’

participation in research. The 

commenters were concerned that: (1) 

Transplant centers may be penalized for 

using organs from ECDs and DCDs if 

using such organs leads to poorer 

outcomes; (2) centers may refuse to use 

such organs because they fear their 

outcomes will be affected; (3) centers 

may be penalized for participating in 

research studies that yield negative 

outcomes; and (4) some centers may 

deny access to high-risk patients in 

order to meet the outcome measures. 

One peer reviewer also expressed 

concern that the SRTR model does not 

risk adjust for organs from DCD or ECD 

donors, which the reviewer said may 

need to be incorporated into the model 

to meet the needs of an increasingly 

aging recipient population. 

Response: We understand the 

commenters’ and the peer reviewers’

concerns. However, the SRTR 

methodology is not simply a list of 

covariates or values for parameter 

estimates. The SRTR revises riskadjustment factors periodically in 

response to trends in organ donation 

and transplantation. For example, it has 

already included ECD organs as one of 

the risk-adjustment factors in its 

outcome methodology model so that 

centers using ECD organs frequently are 

not disadvantaged. We are confident 

that the OPTN/SRTR will be able to 

develop appropriate risk-adjusted 

outcome measures for DCD donor 

organs in the future. We made no 

changes based on these comments. 

Appropriateness of Allowing a New 

Center to Use 1-Month Post-Transplant 

Data and Frequency of Subsequent 

Review of the Center’s Post-Transplant 

Data 

We proposed that if a new transplant 

center hired an experienced team from 

another transplant center, we would 

permit the new center to request that we 

review its 1-month post-transplant 

patient and graft survival for all 

transplants performed in the previous 1- 

year period, if the following conditions 

were met: (1) The key members of the 

center’s transplant team performed 

transplants at a Medicare-approved 

transplant center for a minimum of 1 

year prior to the opening of the new 

center; (2) the transplant team met the 

human resources requirement at 

§ 482.98; and (3) the most recent SRTR 

report on the center did not contain 1- 

year post-transplant follow-up data on 

at least 9 transplants of the appropriate 

organ type for the reported time frame. 

We proposed that if we approved a 

transplant center based on 1-month post 

transplant outcomes data, we would reevaluate the center when 1-year posttransplant data became available. 

We asked for comments on our 

proposal, as well as comments regarding 

the frequency with which we should reVerDate Aug<31>2005 19:11 Mar 29, 2007 Jkt 211001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 E:\FR\FM\30MRR2.SGM 30MRR2

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assess these new centers after they 

receive initial Medicare approval. 

Comment: Some commenters 

supported the idea of approving new 

centers based on 1-month posttransplant data. The three peer 

reviewers did not object to the proposal 

to review a new center’s 1-month posttransplant graft and patient survival 

outcome; however, they believed that 

reviewing a new center’s 3-month or 6- 

month post-transplant data would 

provide more relevant information. One 

peer reviewer recommended an interim 

approval of new centers based on a 1- 

month post-transplant data review, 

pending a subsequent review of 3- 

month post-transplant data. Another 

peer reviewer recommended the 

comparison of projected 1-year posttransplant graft and patient survival 

rates with the expected 1-year posttransplant graft and patient survival 

rates, in addition to review of 1-month 

post-transplant data. 

Some commenters stated that 1-month 

post-transplant data may be more 

reflective of the transplant team’s 

surgical outcomes than the quality of 

the transplant center. One peer reviewer 

suggested that 1-month post-transplant 

data is too close to the date of the 

transplant and, thus, patient outcomes 

may not truly reflect the impact of the 

transplantation itself. The peer reviewer 

recommended that a 3-month posttransplant data review, in conjunction 

with three consecutive annual reviews, 

is a better marker for new center 

approval. 

Another peer reviewer stated that 

approval of new centers based on 

review of 1-month post-transplant data 

for approval of new centers would be 

ill-advised. The peer reviewer said that 

1-month post transplant data likely 

reflect primarily surgical expertise and 

the quality and the thoroughness of pretransplant evaluation, rather than the 

skill of the multi-disciplinary transplant 

team. The peer reviewer stated that the 

use of 1-month post-transplant data for 

approval of new centers should be 

allowed only when the new center has 

demonstrated acceptable 1-year posttransplant graft and patient survival 

rates in other established organ 

transplant programs. The peer reviewer 

said that having acceptable 1-year posttransplant graft and patient survival 

rates for a minimum of 9 transplants 

should be mandatory for a new center 

that has no other organ transplant 

experience. Some commenters stated 

that simply having an experienced 

surgeon or transplant team should not 

be sufficient to qualify a new center. 

One commenter said that there are other 

factors besides surgical or 

transplantation experience that we 

should use to assess a new transplant 

center’s performance. Another 

commenter expressed concern that 

Medicare approval of new centers based 

on review of 1-month post-transplant 

data would: 

(1) Create an incentive for transplant 

teams to move from center to center, 

thus causing disruption to transplant 

patient services, negatively impacting 

patient follow up, significantly 

undermining the financial and human 

resource investment of transplant 

centers, and increasing costs to the 

health care system; and 

(2) Raise patient safety issues, because 

experience indicates that it takes more 

than a year for a transplant center to 

develop and maintain a comprehensive 

transplant program. 

Response: The comments from peer 

reviewers and the public, as well as the 

recent, abrupt closure of a new kidney 

transplant center following an 

investigation by the California 

Department of Managed Health Care, 

have led us to the conclusion that 

approving new transplant centers based 

on a review of 1-month post-transplant 

outcomes data and the experience of the 

transplant surgeon and transplant 

physician would not serve the best 

interests of Medicare beneficiaries who 

need transplants. 

We share the commenter’s concern 

that approving transplant centers based 

on 1-month post-transplant data has the 

potential to harm patient care. Most 

important, we have been unable to 

identify a need for centers to be 

approved quickly using abbreviated 

data. 

Establishing a new transplant center 

is not an easy task. Clearly, a transplant 

center must provide non-surgical 

support services for transplant patients 

and perform many functions in addition 

to the transplant surgery itself, 

including, but not limited to, nursing, 

nutrition counseling, social services, 

pharmacology, immunology, pathology, 

and radiology. In fact, the president of 

the managed care organization that 

recently shut down its new kidney 

center was quoted as saying that 

establishing a transplant program was 

much more difficult than anticipated 

and that the organization was naı ̈ve to 

think the program could be established 

quickly. 

Furthermore, we believe it would be 

inadvisable to approve a new center 

based on the fact that the hospital in 

which the center is located has a 

successful center that transplants 

another type of organ, as one commenter 

recommended (unless there is a direct 

relationship between organ types, such 

as a kidney center that seeks approval 

as a pancreas center). The SRTR centerspecific reports indicate that the 

performance of organ transplant centers 

is not always consistent within a multicenter transplant hospital. Within the 

same transplant hospital, some centers 

may have outstanding outcomes while 

some centers may have marginal or suboptimal outcomes. 

Taking these factors into 

consideration, we believe it would be 

inappropriate for us to use the expertise 

of the key members of a transplant 

center’s team as a proxy for the quality 

of a transplant center’s overall 

operations. 

Consequently, we have eliminated 

proposed § 482.80(b)(4) through (6). 

Under this final rule, we will use 1-year 

post-transplant patient and graft 

survival data to assess the performance 

of all transplant centers seeking initial 

Medicare approval. 

Outcome Requirements for Heart-Lung, 

Intestine, and Pancreas Centers 

We requested comments on the 

appropriateness of having no outcome 

requirements for heart-lung, intestine, 

and pancreas centers. We also asked for 

recommendations for alternative 

methods to evaluate centers that 

transplant these types of organs. 

We proposed defining a heart-lung 

transplant center as a center that is 

located in a hospital with an existing 

Medicare-approved heart transplant 

center and an existing Medicareapproved lung transplant center that 

performs combined heart-lung 

transplants. We proposed defining an 

intestine transplant center as a 

Medicare-approved liver transplant 

center that performs intestine 

transplants, combined liver-intestine 

transplants, or multivisceral transplants. 

We proposed defining a pancreas 

transplant center as a Medicareapproved kidney transplant center that 

performs pancreas transplants alone or 

subsequent to a kidney transplant, as 

well as kidney-pancreas transplants. 

That is, we proposed that a Medicareapproved kidney transplant center 

would be permitted to perform all types 

of pancreas transplants. 

Comment: Some public commenters 

supported having no outcome measure 

requirements for heart-lung, intestine, 

and pancreas transplant centers since 

there are no risk-adjusted outcome 

measure models for these types of 

transplants. Three peer reviewers agreed 

with our proposal for heart-lung, 

intestine, and pancreas centers but 

added that once a risk-adjusted outcome 

measure model becomes available in the 


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future, it should be applied to these 

centers. 

Response: Once the SRTR has 

developed risk-adjusted models for 

heart-lung transplants, intestine 

transplants, and pancreas transplants, 

we will consider establishing outcome 

measure criteria for the approval and reapproval of centers that perform these 

transplants. 

In the absence of risk-adjusted 

outcome measure models for these types 

of organ transplants, we believe the 

approach we proposed and have made 

final in this rule without change is most 

appropriate at this time. 

Outcome Measures for Pediatric 

Transplants 

We requested comments on our 

proposed approach to evaluating 

pediatric transplant centers’ outcomes 

and approving centers performing 

pediatric transplants. 

Comment: Some peer reviewers were 

concerned about pediatric centers’

ability to maintain resources due to 

infrequent transplantation activities. A 

reviewer stated that the OPTN routinely 

peer reviews pediatric program case 

logs, and the peer reviewer 

recommended that the OPTN notify us 

about under-performing programs using 

pre-established thresholds. 

One commenter agreed with our 

proposal to apply outcome requirements 

for adult centers to centers performing 

pediatric transplants. However, one 

commenter voiced concern that the 

inability of pediatric centers to perform 

9 transplants in a 2.5-year period (as 

required for the SRTR methodology to 

be valid) may prevent them from 

participating in Medicare. Nonetheless, 

the commenter urged the SRTR to 

continue analyzing pediatric 1-year 

post-transplant outcomes. The 

commenter encouraged the SRTR to 

develop evidence-based outcome 

guidelines by analyzing center-specific 

1-year outcomes of pediatric patients 

transplanted over a 2.5-year period. 

Response: We intend to confer with 

the OPTN, as appropriate, about both 

pediatric and adult centers to ensure 

that we can effectively monitor the 

quality of transplant programs. 

Proposed Process Requirements for 

Transplant Centers 

Condition of Participation: Patient and 

Living Donor Selection (Proposed 

§ 482.90) 

We proposed requiring centers to use 

written patient selection criteria in 

determining a patient’s suitability for 

placement on the waiting list for 

transplantation. We proposed that 

patient selection criteria must ensure 

fair and non-discriminatory distribution 

of organs. 

We proposed that before a patient is 

selected for a non-renal transplant, the 

transplant center must consider or 

employ all other appropriate medical 

and surgical therapies that might be 

expected to yield both short and longterm survival comparable to 

transplantation. 

We proposed that before a center 

places a patient on its waiting list, the 

center must ensure that the prospective 

transplant candidate receives a 

psychosocial evaluation and that the 

potential transplant candidate’s medical 

record contains documentation of the 

candidate’s blood type. (A psychosocial 

evaluation conducted by transplant 

centers of potential transplant recipients 

screens for issues that could affect the 

patient’s compliance with the posttransplant treatment that is necessary to 

maximize the chances of a successful 

transplant, such as substance abuse or 

behavioral or psychiatric issues.) We 

also proposed that when a patient is 

placed on a center’s waiting list, the 

center must document in the patient’s 

medical record the patient selection 

criteria used. 

We proposed that if a center performs 

living donor transplants, the center 

must use written donor selection criteria 

in determining the suitability of living 

donors for donation. We proposed that 

the living donor selection criteria must 

be consistent with the general principles 

of medical ethics. We proposed that the 

transplant center must: (1) Ensure that 

a prospective living donor receives a 

medical and psychosocial evaluation 

prior to donation; (2) document in the 

transplant candidate’s and living 

donor’s medical records the living 

donor’s suitability for donation; and (3) 

document that the living donor has 

given informed consent, as required 

under § 482.102. The psychosocial 

evaluation conducted by a transplant 

center of a potential living donor 

assesses the donor’s motivation and his 

or her understanding of the donation 

process and post-donation treatment. A 

center assesses whether the potential 

living donor has any behavioral or 

psychiatric issues that could influence 

the decision to donate and whether he 

or she is being pressured to donate. 

Following are summaries of the 

comments we received and our 

responses. 

Comment: Many commenters 

supported the proposed written patient 

and living donor selection requirements. 

Commenters stated that the 

requirements are reasonable and that 

many centers already have these 

selection criteria in place. One 

commenter applauded us for giving 

transplant centers the flexibility to 

develop their own criteria. The 

commenter commended us for 

refraining from defining patient 

selection criteria. However, some 

commenters opposed the requirement 

for transplant centers to have written 

patient and living donor selection 

criteria. Commenters stated that the 

requirements are too prescriptive and 

would be burdensome. 

Response: We disagree that these 

requirements are too prescriptive. In 

fact, current Medicare requirements for 

heart, liver, and lung transplant centers 

have specific patient selection criteria 

guidelines for centers to use to select 

patients for transplantation. Conversely, 

this final rule permits transplant centers 

to develop the criteria that best fit the 

needs of their patients and gives centers 

the flexibility to change their criteria as 

transplant medicine changes over time. 

We will no longer require transplant 

centers to use the existing patient 

selection criteria. As long as their 

patient selection criteria are fair and 

non-discriminatory, transplant centers 

are free to develop their criteria based 

on the medical judgment of their 

transplant physicians and surgeons. 

Comment: Some commenters said 

they believe that written patient 

selection criteria may pose undue risk to 

centers when the criteria used to select 

a transplant patient deviate from the 

transplant center’s written criteria. 

Another commenter stated that the 

disclosure of deviations from patient 

selection criteria will pose legal risks for 

transplant centers. 

Response: We disagree with the 

commenters that written patient and 

living donor selection criteria will pose 

undue legal risk to centers. Instead, 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. Given 

the scarcity of organs, we believe 

established written patient selection 

criteria, at a minimum, will ensure 

equity and consistency when transplant 

risk-benefit decisions are made. No 

change was made based on these 

comments. 

Comment: Some commenters stated 

that patient selection is a medical 

judgment and that there are gray areas, 

subtleties, and subjectivities involved in 

selecting patients for transplants. 

Response: We acknowledge that 

selecting patients for transplantation is 

the responsibility of the transplant 

surgeon and that transplant surgeons 


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must exercise their medical judgment 

when weighing the risks and benefits of 

transplantation. This final rule does not 

dictate how transplant candidates 

should be selected for placement on the 

waiting list and transplantation. 

Although we require transplant centers 

to have written patient selection criteria, 

transplant centers are free to include a 

process for justifying exceptions to the 

selection criteria. 

Comment: A few commenters stated 

that the proposed requirement for 

written patient criteria is duplicative of 

the OPTN patient listing policies. The 

commenters said that a center’s 

adherence to the OPTN policies should 

satisfy our patient selection criteria. 

Response: The OPTN policies for 

patient placement on the waiting list 

focus mainly on the criteria for organ 

allocation and not on the criteria for 

placement on or exclusion from a 

center’s waiting list. We believe that if 

transplant centers adhere to OPTN 

policies and comply with the patient 

selection criteria requirement in this 

final rule, they will place patients on 

their waiting lists appropriately. 

Therefore, we have finalized the patient 

selection criteria requirement as 

proposed. 

Comment: A commenter stated that 

patient selection for transplants is 

usually a medical judgment based on 

guidelines developed by professionals. 

Guidelines change from time to time. A 

commenter recommended the Patient 

Care and Education Guidelines 

developed by the American Society of 

Transplantation as a helpful resource for 

transplant decisions. 

Response: We support the concept of 

incorporating professional guidelines 

into a transplant center’s transplant 

candidate selection policies, as the 

center deems appropriate. We expect 

that transplant centers will revise their 

policies periodically as needed. We 

have made no changes based on this 

comment. 

Comment: A commenter stated that 

we should encourage patients to take 

some responsibility for their own care. 

The commenter suggested that in the 

transplant candidate evaluation process 

provision, we should include some 

patient self-management provisions. 

Response: We agree with the 

commenter that transplant candidates 

should share responsibility for their 

own care. Transplant centers are free to 

incorporate this concept in their patient 

evaluation policies. However, including 

such a requirement in regulations would 

be unnecessarily prescriptive. 

Comment: Some commenters opposed 

the requirement that a transplant center 

must employ or consider all other 

appropriate medical and surgical 

therapies that might be expected to 

yield both short and long-term survival 

comparable to transplantation before a 

patient is selected for placement on the 

waiting list. The commenters said this 

practice interferes with medical 

judgment and may place transplant 

centers at legal risk. A few commenters 

requested an exemption for kidney, 

heart, and pancreas transplant centers 

from this requirement because 

transplant decisions for these organ 

types are sometimes based on quality of 

life considerations, rather than survival 

alone. Commenters pointed out that 

medical and surgical therapy changes 

constantly, and it is difficult for 

transplant centers to set the upper and 

lower parameters in exhausting all 

available therapies before placing 

patients on the waiting list. Some 

commenters asked us to define ‘‘all 

other appropriate medical and surgical 

therapies’’ and questioned how 

compliance with this requirement 

would be determined. 

Response: We understand the 

commenters’ concerns that some 

transplant risk-benefit decisions are not 

based on survival alone and that it may 

be difficult for transplant centers to 

establish parameters for alternative 

medical and surgical therapies. 

Therefore, we are not finalizing our 

proposed requirement at § 482.90(a)(1). 

Comment: Some commenters 

supported our proposal to require a 

psychosocial evaluation for prospective 

transplant candidates and suggested that 

a transplant center should designate 

qualified staff to perform the evaluation. 

One commenter suggested that 

prospective transplant candidates who 

have a history of psychiatric illness and 

substance abuse should be further 

evaluated by a psychologist or 

psychiatrist. 

Response: We agree that a 

psychosocial evaluation should be 

performed by qualified staff. For good 

patient care, we expect that the 

individual who performs a psychosocial 

evaluation of a transplant candidate or 

prospective living donor will make a 

referral for further evaluation if a patient 

shows symptoms of, or has a history of, 

psychiatric illness or substance abuse. 

However, we have made no changes 

based on this comment. 

Comment: Many commenters 

recommended changing our proposed 

language to state that a prospective 

transplant candidate or prospective 

living donor must receive a ‘‘qualified 

social worker evaluation’’ because the 

proposed language ‘‘psychosocial 

evaluation’’ is too ambiguous and does 

not indicate who conducts the 

evaluation. Other commenters 

recommended that a qualified social 

worker should be designated to perform 

the evaluation using the Standards for 

Social Work Services in ESRD Facilities 

developed by the ESRD Network of 

Texas, Inc. as the standardized 

assessment tool. 

Response: We appreciate the 

commenters’ recommendations. 

However, since there is more than one 

category of qualified professional who 

can conduct a psychosocial evaluation 

of a prospective transplant candidate, 

we have chosen to give transplant 

centers the flexibility to designate the 

type of qualified individual who will 

conduct the psychosocial evaluation. 

This individual may be a qualified 

social worker or another qualified 

individual. 

In our view, there is no standardized 

psychosocial evaluation tool that would 

be applicable to all prospective organ 

transplant candidates. Therefore, this 

final rule, as proposed, provides a 

transplant center with the flexibility to 

select a standardized psychosocial 

evaluation tool or to devise its own 

psychosocial evaluation tool. We have 

made no changes based on this 

comment. 

Comment: One commenter stated that 

it is impractical and inappropriate to 

require transplant centers to conduct a 

psychosocial evaluation of some 

prospective transplant candidates, such 

as infants and very small children, as 

well as patients who are acutely ill with 

fulminate hepatic failure or acute 

cardiomyopathy. 

Response: In nearly all cases, a 

transplant center should ensure that 

patients receive a psychosocial 

evaluation prior to placement on the 

center’s waiting list. However, we agree 

with the commenters that conducting a 

psychosocial evaluation is not always 

possible, for example, in emergency 

situations or when the patient is very 

young. Therefore, we have revised the 

regulation text at § 482.90(a)(1) to state 

that ‘‘prior to placement on the center’s 

waiting list, a prospective transplant 

candidate must receive a psychosocial 

evaluation, if possible.’’ We expect 

transplant centers to perform 

psychosocial evaluations in every 

situation in which it is possible to do so. 

Comment: A few commenters 

supported the requirement for 

determining and documenting a 

transplant candidate’s blood type in 

medical records prior to being placed on 

the waiting list. However, one 

commenter suggested that we should 

refer to the UNetSM system to determine 

a candidate’s ABO blood type, instead 


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of establishing a new blood type 

documentation requirement. 

Response: We are not establishing a 

new blood type documentation 

requirement. We require only that 

before a transplant center places a 

transplant candidate on its waiting list, 

the candidate’s medical record must 

contain documentation of the 

candidate’s blood type. Similarly, OPTN 

policies require a transplant program to 

be responsible for ensuring the accuracy 

of candidate ABO data on the waiting 

list. OPTN policies also include on-line 

verification of a candidate’s ABO data 

against the source document by an 

individual other than the person 

initially entering the candidate’s ABO 

data in UNetSM. The OPTN expects a 

transplant program to maintain records 

documenting that such separate 

verification of the source document 

against the entered ABO has taken place 

and make such documentation available 

for audit. Our requirements complement 

these OPTN policies. The individual 

who verifies the source document 

(which could be the determination of 

blood type in the candidate’s medical 

record against the UNetSM) may simply 

annotate the verification in the medical 

record. 

Comment: A commenter questioned 

the rationale for requiring 

documentation of the patient selection 

criteria used. One commenter stated that 

documenting patient selection criteria 

would be time-consuming and a 

departure from current practice. 

Another commenter suggested that 

adherence to some written basic patient 

selection criteria or cross-referencing 

the patient selection criteria should be 

adequate evidence of compliance. A few 

commenters stated that the 

documentation of patient selection 

criteria, including the evaluation 

process and analysis of extensive 

medical work-up, would add 

administrative burden to transplant 

centers and increase Medicare expenses. 

Response: The rationale for requiring 

documentation of the patient selection 

criteria used is to ensure that the 

transplant center’s written patient 

selection policies and procedures are 

consistently implemented and that this 

is reflected in medical records. We agree 

that repeating a written narrative of all 

previous pre-transplant evaluation 

processes and medical work-ups would 

be burdensome. However, in 

documenting the patient selection 

criteria used, a transplant center may 

choose to use electronic formats, forms, 

or checklists to indicate the applicable 

criteria, as set forth in the center’s own 

policies and procedures manual. We 

believe that any administrative burden 

associated with the patient selection 

criteria documents will be minimal and 

will not raise Medicare expenses 

appreciably. 

Comment: A few commenters 

supported the requirement that living 

donor selection criteria must be 

consistent with general medical ethics. 

Commenters stated that selection 

criteria are important in bringing some 

standardization to the living donor 

evaluation and selection processes. A 

commenter recommended giving 

flexibility to transplant centers to 

evaluate medical ethics issues on a caseby-case basis. However, one commenter 

stated that there is no consensus on 

what constitutes medical ethics. 

Another commenter requested more 

explicit clarification of the meaning of 

general medical ethics. 

Response: 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 believe the 

provisions set forth in this final rule 

provide flexibility for transplant centers 

to evaluate every prospective living 

donor individually, using the same 

medical ethics they would use in 

providing health care to any patient. No 

changes were made based on these 

comments. 

Comment: A commenter questioned if 

Internet donor matching is ethical. 

Response: The commenter is correct 

that the transplant community has not 

reached consensus on the ethics of 

certain donation practices, such as 

Internet donor matching. However, such 

issues are beyond the scope of this final 

rule. 

Comment: Some commenters 

suggested adopting the OPTN Ad Hoc 

Living Donor Committee Living Liver 

and Kidney Donor Evaluation 

Guidelines or the Living Donor 

Evaluation Criteria developed by the 

American Society of Transplantation. 

Response: We support the concept of 

incorporating professional guidelines 

into a transplant center’s living donor 

selection policies. However, we believe 

incorporating the suggested guidelines 

or evaluation criteria into this final rule 

would be too prescriptive and would 

not provide centers with sufficient 

flexibility. We made no changes based 

on this comment. 

Comment: Although some 

commenters supported medical and 

psychosocial evaluation of living 

donors, one commenter did not support 

the requirement for a living donor to 

receive a psychosocial evaluation, as it 

might delay transplantation and would 

add to the cost of the transplantation. 

The commenter noted that, in the case 

of parent to child donation, the 

psychosocial evaluation would not be 

warranted. 

Response: Transplant centers are free 

to include a process in their policies 

and procedures to respond to emergency 

situations when it may not be possible 

to conduct a psychosocial evaluation 

prior to donation. However, in the 

absence of such a situation, 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. Even a 

parent donating to a child may feel 

conflicted; for example, a parent may 

worry about the possible impact of the 

parent’s donation on other children in 

the family. 

Comment: One commenter supported 

the documentation of living donor 

suitability in medical records. However, 

some commenters had concerns that 

such documentation in the transplant 

candidate’s medical records would 

compromise the privacy of the donor’s 

individually identifiable health 

information and violate the HIPAA 

regulations, putting transplant centers at 

legal risk. Another commenter stated 

that this requirement deprives the 

potential living donor of an exit out of 

the donation process if the individual is 

reluctant to donate but prefers the 

transplant candidate to think he or she 

cannot donate for medical reasons. 

Response: We believe the commenters 

have valid concerns, and we agree that 

documentation of a living donor’s 

suitability for donation in the transplant 

recipient’s medical records would be 

inappropriate. Therefore, we have 

eliminated the proposed requirement at 

§ 482.90(b)(2) to document the 

transplant recipient’s medical record 

with the living donor’s suitability for 

donation. However, we have finalized 

our proposal to require documentation 

of the living donor’s suitability for 

donation in the living donor’s medical 

record. (See § 482.90(b)(2).) 

Availability of Patient Selection Criteria 

In the proposed rule, we requested 

comments on whether transplant 

centers should be required to make the 


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patient selection criteria available to 

patients routinely or upon request. 

Comment: One commenter stated that 

providing transplant patients with 

patient selection criteria would restore 

public trust in the transplant system and 

ensure fairness in organ allocation. 

However, another commenter stated that 

providing candidates with patient 

selection criteria may set unrealistic 

expectations in the complex organ 

allocation and transplantation process. 

A few commenters recommended that a 

copy of the patient selection criteria 

should be given to patients only if 

requested. 

Response: We agree that the 

knowledge of a transplant center’s 

patient selection criteria would help a 

patient to better understand his or her 

treatment options. However, given that 

transplantation is not a straightforward 

decision, we agree with the commenter 

who expressed concern that providing 

the patient selection criteria to patients 

may lead to misunderstanding or give 

some patients unrealistic expectations 

of their likelihood of receiving a 

transplant. Some patients may want to 

rely on their surgeons and physicians to 

give them advice and recommendations 

about transplantation. Therefore, this 

final rule requires a transplant center to 

provide a copy of its patient selection 

criteria to a patient only upon the 

patient’s request. 

We are sympathetic to the view of the 

commenter who said that providing 

copies of patient selection criteria to 

patients would ensure fairness in organ 

allocation. We believe that additional 

transparency in the selection process 

can further the goal of equity in 

transplantation and give dialysis 

facilities a tool to ensure that referral of 

dialysis patients to kidney transplant 

centers for evaluation is fair and nondiscriminatory. That is, once a dialysis 

facility knows the specific patient 

selection criteria used by each kidney 

transplant center in its vicinity, it can 

better ensure that it refers all patients 

who may be eligible for transplantation. 

Therefore, we have added a requirement 

to this final rule specifying that a kidney 

transplant center must provide a copy of 

its transplant patient selection criteria to 

a transplant candidate or a dialysis 

facility, at the request of the patient or 

the facility. (See § 482.90(a)(4).) 

We note that a patient who believes 

that a transplant center’s patient 

selection criteria are unfair or 

discriminatory or that a transplant 

center has not followed its patient 

selection criteria may find a remedy in 

the grievance process of the hospital in 

which the transplant center is located. 

Section 482.13, Patient Rights, requires 

hospitals to protect and promote each 

patient’s rights. Section 482.13(a)(2) 

further requires that hospitals establish 

a grievance process for the prompt 

resolution of patient grievances and that 

the hospital’s grievance procedures are 

clearly explained to the patient. 

Condition of Participation: Organ 

Recovery and Receipt (Proposed 

§ 482.92) 

We proposed that transplant centers 

must have written protocols to validate 

donor-recipient matches and other vital 

data for deceased organ recovery, organ 

receipt, and living donor 

transplantation. We proposed assigning 

responsibility to the transplanting 

surgeon for ensuring the medical 

suitability of donor organs for 

transplantation into the intended 

recipient. 

We proposed that a transplant center’s 

organ recovery team would have to 

review and compare the recipient and 

donor data with the recipient blood type 

and other vital data before recovery took 

place. We also proposed requiring that, 

when an organ arrives at a transplant 

center, the transplanting surgeon and at 

least one other individual at the 

transplant center must verify prior to 

transplantation that the donor’s blood 

type and other vital data indicate that 

the donor’s organ is compatible with 

transplantation of the intended 

recipient. 

We proposed that if a center 

performed living donor transplants, the 

transplanting surgeon and at least one 

other individual at the transplant center 

would be required to verify that the 

living donor’s blood type and other vital 

data indicated that the donor’s organ is 

compatible for transplantation of the 

intended recipient, immediately before 

the removal of the living donor organ(s) 

and, if applicable, prior to the removal 

of the recipient’s organ(s). 

Following are summaries of the 

comments we received and our 

responses. 

Comment: Some commenters 

supported the proposed requirement for 

transplant centers to have written 

protocols to validate donor-recipient 

compatibility in organ recovery, receipt, 

and transplantation to prevent 

unintended transplantation of organs 

mismatched by blood type. However, a 

commenter stated that protocols for 

validation of data may pose a legal risk 

for transplant centers. 

Response: A crosscheck verification of 

the donor’s blood type with the blood 

type of the intended recipient is a 

critical step in organ allocation and 

transplantation. Therefore, in this final 

rule, as we proposed, we require 

transplant centers to have written 

protocols to ensure that this essential 

process takes place. We believe that 

consistent application of such sound 

protocols ultimately will reduce legal 

risks for transplant centers. 

Comment: A commenter stated that it 

is impossible to be inclusive of all 

possible scenarios encountered in organ 

recovery; therefore, the use of a written 

protocol for organ recovery would be 

limited. 

Response: We recognize that the 

unexpected may happen during organ 

recovery. However, a well-written organ 

recovery protocol should anticipate as 

many of these scenarios as possible. 

Comment: Some commenters 

disagreed that the transplant surgeon 

should be fully responsible for 

suitability of donor organs during organ 

recovery because: 

(1) Information provided by an OPO 

may not be accurate; 

(2) At the time of organ recovery, the 

identity of the intended recipient may 

not be known; and 

(3) At the time of organ recovery, 

information about the organ donor may 

not be complete. 

Response: The requirement does not 

mean that the transplant surgeon is 

responsible for the suitability of donor 

organs prior to or during recovery. The 

transplant surgeon is responsible for 

ensuring the medical suitability of a 

donor organ for transplantation into the 

intended recipient only after the organ 

has arrived at the transplant center. If 

the transplant surgeon makes the 

determination of medical suitability 

based on inaccurate information 

provided by the OPO about the donor 

organ (for example, the paperwork that 

accompanies the organ to the transplant 

center is marked with the wrong blood 

type), the transplant surgeon will not be 

held responsible for his or her 

determination of medical suitability. 

Comment: A commenter suggested 

that the transplant coordinator should 

be responsible for blood type 

verification. 

Response: Transplant centers may 

delegate this responsibility to transplant 

staff or the transplant coordinator. No 

change was made based on this 

comment. 

Comment: Some commenters stated 

that the proposed blood type validation 

is duplicative of OPTN policies; 

therefore, additional requirements 

would not be necessary. Some 

commenters suggested that the OPTN 

policies and Medicare requirements 

should be consistent. 

Response: The commenters are correct 

that our requirement is similar to the 

OPTN policy, which requires a 


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transplant center, upon receipt of an 

organ and prior to transplantation, to 

perform and document crosscheck 

verification of the donor’s blood type 

with the blood type of the intended 

recipient. As we have stated previously 

in this preamble, with the exception of 

OPTN data submission requirements, 

OPTN policies are not enforceable 

unless they are approved by the 

Secretary under 42 CFR 121.4. 

Comment: Some commenters 

suggested that our proposals for organ 

recovery were unnecessary. For 

example, a commenter stated that organ 

procurement procedures start before the 

recipient is identified or the transplant 

center is notified. Another commenter 

stated that many large OPOs already 

have developed protocols for organ 

recovery teams that recover organs for 

the OPO or for transplant centers, which 

means that transplant centers would 

have minimal involvement in the organ 

recovery process. However, another 

commenter agreed with our proposal 

and said that a transplant center’s 

recovery team should validate donor 

and recipient blood type and other vital 

data before organ recovery takes place. 

Response: We recognize that in many 

cases, transplant centers may have little 

involvement in the process of organ 

recovery. Therefore, we have revised the 

regulation text at § 482.92(a) to reflect 

that when the intended recipient is 

known, and the transplant center sends 

a team to recover organ(s), the 

transplant center’s recovery team must 

review and compare the donor data with 

the recipient blood type and other vital 

data before organ recovery takes place. 

Comment: A commenter suggested 

that instead of requiring at least one 

other individual to verify donorrecipient blood type and vital 

information, we should specify that the 

individual must be a licensed health 

care professional. 

Response: We agree with the 

commenter. We have changed the 

regulatory text at § 482.92(b) to require 

that after an organ arrives at a transplant 

center, prior to transplantation, the 

transplanting surgeon and another 

licensed health care professional must 

verify that the donor’s blood type and 

other vital data are compatible with 

transplantation of the intended 

recipient. In addition, we have changed 

the regulatory text at § 482.92(c) to say 

that if a center performs living donor 

transplants, the transplanting surgeon 

and another licensed health care 

professional at the center must verify 

that the living donor’s blood type and 

other vital data are 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). Since cross checking donor 

and recipient information generally is 

performed in the operating room just 

prior to transplantation, nurses and 

other licensed health care professionals 

should be readily available. 

Condition of Participation: Patient and 

Living Donor Management (Proposed 

§ 482.94) 

We proposed that transplant centers 

must have written patient management 

policies for the pre-transplant, 

transplant, and discharge phases of 

transplantation. We proposed that if a 

center performs living donor 

transplants, it must have written donor 

management policies for the donor 

evaluation, donation, and discharge 

phases of the living organ donation. We 

proposed that a transplant center must 

ensure that each transplant patient and 

living donor is under the care of a 

multidisciplinary patient care team 

coordinated by a physician throughout 

all phases of the transplantation or 

living donation. 

We proposed that transplant centers 

must keep their waiting lists current, 

including updating waiting list patients’

clinical information on an ongoing 

basis. We also proposed that a 

transplant center must remove a patient 

from its waiting list if the patient 

receives a transplant, if the patient dies, 

or if there is any other reason that the 

patient should no longer be on a center’s 

waiting list. 

We proposed requiring transplant 

centers to notify the OPTN of a patient’s 

removal from the center’s waiting list no 

later than 24 hours after the removal. 

We proposed that transplant centers 

must maintain up-to-date and accurate 

patient management records for each 

patient who receives an evaluation for 

placement on a center’s waiting list and 

who is admitted for organ 

transplantation. For each patient who 

receives an evaluation for placement on 

a center’s waiting list, we proposed that 

the center must document in the 

patient’s record that the patient is 

informed of his or her transplant status, 

including notification of: (1) The 

patient’s placement on the center’s 

waiting list; (2) the center’s decision not 

to place the patient on its waiting list; 

or (3) the center’s inability to make a 

determination regarding the patient’s 

placement on its waiting list because 

further clinical testing or documentation 

is needed. 

We proposed that once a patient is 

placed on a center’s waiting list, the 

center must document in the patient’s 

record that the patient has been notified 

of: (1) His or her placement status (at 

least once a year, even if there was no 

change in the patient’s placement 

status); and (2) his or her removal from 

the waiting list for reasons other than 

transplantation or death no later than 10 

days after removal. 

We proposed that kidney transplant 

centers must document in the patient’s 

record that both the patient and the 

patient’s usual dialysis facility have 

been notified of the patient’s transplant 

status and of any changes in the 

patient’s transplant status. 

We proposed that when a patient is 

admitted for transplantation, the 

patient’s record must contain written 

documentation of multidisciplinary 

patient care planning during the pretransplant period and multidisciplinary 

discharge planning for the patient’s 

post-transplant care. 

We proposed that transplant centers 

must make social services, furnished by 

qualified social workers available to 

transplant patients, living donors, and 

their families. We proposed that a 

qualified social worker is an individual 

who meets licensing requirements in the 

State in which he or she is practicing 

and: (1) Has completed a course of study 

with specialization in clinical practice 

and holds a master’s 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, 1 year 

of which was in a transplantation 

program, and has established a 

consultative relationship with a social 

worker. 

We proposed that transplant centers 

must make nutritional assessment and 

diet counseling services furnished by a 

qualified dietitian available to all 

transplant patients and living donors. 

We proposed that a qualified dietitian 

is an individual who: (1) Is eligible for 

registration by the American Dietetic 

Association under its requirements in 

effect on June 3, 1976 and has at least 

1 year of experience in clinical 

nutrition; or (2) has a baccalaureate or 

advanced degree with major studies in 

food and nutrition or dietetics and has 

at least 1 year of experience in clinical 

nutrition. 

We also are responding to comments 

we received on the ESRD proposed rule 

from dialysis facilities relating to 

transplant referral tracking of dialysis 

patients and the grandfather 

requirement for social workers. 

Although these comments were 

submitted along with comments on the 

ESRD proposed rule (February 4, 2005, 

70 FR 6184), we are responding to them 

in the preamble to this final rule 

because they are relevant to our 


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proposed requirements for notification 

of waiting list patients and our proposed 

requirements for social workers. 

Following are summaries of the 

comments we received and our 

responses to the comments. 

Comment: Commenters agreed that 

transplant centers should play an active 

role in the care and management of 

transplant patients. Some commenters 

suggested that transplant centers should 

be required to provide pre-transplant 

and post-transplant care to transplant 

recipients in conjunction with the 

recipient’s local provider team. 

However, many commenters stated that 

transplant centers should not be held 

accountable for transplant patients’ preand post-transplant care because many 

waiting list patients do not live near the 

transplant center and are cared for by 

their local providers, particularly in the 

case of dialysis patients. Kidney 

transplant patients usually receive their 

pre- and post-transplant care from their 

local nephrologists and dialysis 

facilities. Commenters stated that pretransplant care planning for kidney 

patients is the responsibility of the 

dialysis facilities where the patients 

receive care. 

Response: As stated previously, we 

agree with the commenters that the care 

of transplant patients is best 

coordinated by local health care 

providers and transplant centers. 

Transplant patients require clinical 

evaluation before being placed on the 

waiting list, clinical care while they are 

on the waiting list, and follow-up 

monitoring after transplantation. In 

most cases, while transplant candidates 

are waiting for suitable organs, they 

continue to receive non-transplantrelated routine medical care from their 

local health care providers and (for 

kidney patients) dialysis facilities, 

rather than from the transplant center 

where they are listed. Therefore, based 

on public comments, we have not 

finalized our proposed requirement at 

§ 482.94 that transplant centers must 

have written patient management 

policies for the pre-transplant phase of 

transplantation or our proposed 

requirement that they must provide pretransplant care to transplant patients. 

We agree with the commenters that 

transplant patient management is better 

coordinated with the transplant 

patient’s local providers, and we expect 

that for the most part, this is already a 

standard practice. However, we see no 

reason to prescribe explicitly how 

transplant centers should work with 

other providers, with the exception of 

dialysis facilities. 

The relationship between dialysis 

facilities and kidney transplant centers 

is unique because dialysis facilities treat 

and monitor their patients more 

frequently than other health care 

providers. Any changes in a dialysis 

patient’s’ clinical status may affect his 

or her transplant suitability. Thus, it is 

important for kidney transplant centers 

to have open and frequent 

communication with dialysis facilities 

to ensure that all transplant-related 

issues are communicated clearly to the 

patient and to the patient’s provider(s) 

of care. Based on these comments, we 

have added a requirement at 

§ 482.104(a) that a kidney transplant 

center must have written policies and 

procedures for ongoing communication 

with dialysis patients’ local dialysis 

facilities. 

Coordination also ensures that the 

transplant center has the information 

about the patient’s status that it needs 

to keep its waiting list and the OPTN’s 

waiting list current. For example, a 

patient may have to be removed from 

the waiting list because he or she has 

become too ill to receive a transplant. 

Therefore, we are finalizing the 

proposed requirement at § 482.94(c) as 

follows. Section 482.94(c)(1) specifies 

that for each patient who receives an 

evaluation for placement on a center’s 

waiting list, the center must document 

in the patient’s record that the patient 

(and in the case of a kidney patient, the 

patient’s usual dialysis facility) has been 

informed of his or her transplant status, 

including notification of: (i) The 

patient’s placement on the center’s 

waiting list; (ii) The center’s decision 

not to place the patient on its waiting 

list; or (iii) The center’s inability to 

make a determination regarding the 

patient’s placement on its waiting list 

because further clinical testing or 

documentation is needed. Section 

482.94(c)(2) requires that if a patient on 

the waiting list is removed from the 

waiting list for any reason other than 

death or transplantation, the transplant 

center must document in the patient’s 

record that the patient (and in the case 

of a kidney patient, the patient’s usual 

dialysis facility) was notified no later 

than 10 days after the date the patient 

was removed from the waiting list 

For post-transplant care, we expect a 

transplant center to use the discharge 

planning process to coordinate 

transplant-related follow-up care. (See 

§ 482.94(c)(3)(ii).) As a general rule, 

patients receive several months of posttransplant care from the transplant 

center that performed the transplant, 

even if they do not live near the 

transplant center. After that, patients 

often continue to receive care from the 

transplant center for an extended period 

of time in conjunction with their local 

physician or dialysis center. 

Coordination of care ensures that the 

transplant center will have access to the 

patient follow-up data it needs to abide 

by the OPTN data collection and 

submission policies. 

Comment: One commenter stated that 

the provision for multidisciplinary 

patient care planning is overly detailed 

and would place a burden on centers. 

Response: We disagree with the 

commenters. We believe the 

multidisciplinary patient care planning 

provision proposed at § 482.94(c)(4) is 

flexible and general in nature. We 

believe the requirements will allow a 

transplant center to assemble a 

multidisciplinary patient care team 

using in-house hospital staff, which 

should create little or no extra burden. 

Therefore, we are finalizing this 

requirement as proposed. 

Comment: One commenter stated that 

the proposed patient care requirements 

are duplicative of the JCAHO survey 

standards for inpatient care planning 

and discharge planning. Another 

commenter noted that the OPTN 

policies already address transplant care 

and patient management guidelines. 

Response: We agree that there are 

similarities between the JCAHO survey 

standards for inpatient care planning 

and discharge planning and our 

requirements for patient care in this 

final rule. However, some requirements 

in this final rule (such as living donor 

care, management of the waiting list, 

and patient records) are absent from 

JCAHO’s survey standards for acute care 

hospitals. Furthermore, even if 

Medicare requirements were identical to 

JCAHO standards and OPTN policies, 

this fact would not eliminate the need 

to incorporate the requirements into our 

regulations because JCAHO standards 

and the OPTN’s policies are not legally 

enforceable by CMS. 

Comment: Many commenters stated 

that kidney transplant centers should be 

exempt from the requirement for a 

written long-term care plan because 

kidney transplant candidates are usually 

cared for by their referring physicians, 

nephrologists, social workers, dietitians, 

and dialysis facilities while awaiting 

transplants. Some commenters 

suggested that instead of developing a 

care plan, kidney transplant centers 

should be required only to obtain a copy 

of the patient’s long-term care plan from 

the dialysis facility and keep it with the 

transplant candidate’s medical records. 

Response: The commenters may have 

misunderstood the proposed patient 

management requirement. We are not 

requiring transplant centers to develop 

long-term care plans for transplant 

patients. We agree that this is the 


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responsibility of each patient’s local 

health care providers and dialysis 

facility, as appropriate. As stated earlier, 

we strongly encourage transplant 

centers to collaborate with local 

providers and dialysis facilities to tailor 

patient management policies to their 

patients’ needs. Given that it is a 

standard practice for health care 

providers to request medical records 

from other providers who are actively 

treating their patients, we do not believe 

we need to require a transplant center 

to obtain a copy of the patient’s longterm care plan from the dialysis facility, 

nor do we need to exempt kidney 

transplant centers from these 

requirements. No changes have been 

made to this final rule based on these 

comments. 

Comment: One commenter supported 

the proposal that living donors should 

be under the care of a multidisciplinary 

team to safeguard their interests and 

well-being. The commenter suggested 

that we should require centers to be 

responsible for living donors’ postdischarge issues or complications and 

provide specialists to follow living 

donors. 

Response: Since some living donors 

may receive immediate post-donation 

care in hospital units outside the 

transplant center, we want to ensure 

that living donor care is well 

coordinated. 

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’ postdischarge care, we expect a transplant 

center to provide care, as needed, if a 

living donor experiences donationrelated problems or complications postdischarge. 

Comment: Many commenters 

commended us for our clarity in 

describing the waiting list management 

requirements that would positively 

impact the organ allocation system. The 

commenters stated that it is important 

for transplant centers to update the 

status of waiting list patients 

continuously to increase the efficiency 

of organ allocation and ultimately 

reduce organ wastage and organ discard 

rates. However, a few commenters 

stated that the waiting list management 

requirements are overly detailed and 

may put centers at legal risk. 

Response: We disagree that the 

waiting list management standard is 

overly detailed. The waiting list 

management requirements in this final 

rule are steps transplant centers must 

take to help the OPTN keep the waiting 

list current, so that: (1) Organ allocation 

is prioritized based on medical urgency 

and other relevant factors; (2) OPOs do 

not waste valuable time contacting 

centers about patients who should no 

longer be on the waiting list; and (3) 

organ wastage is minimized. 

We have no evidence that keeping its 

waiting list current will create a legal 

risk for a transplant center. 

Comment: One commenter suggested 

that we should specify how frequently 

transplant centers must update their 

waiting lists (that is, daily, weekly, or 

monthly). 

Response: We are not imposing an 

arbitrary timeframe for transplant 

centers to keep their waiting lists up to 

date. The availability of waiting list 

patients’ clinical information varies 

from patient to patient, and clinical 

information may change frequently or 

infrequently. We expect transplant 

centers to update their waiting lists, 

including updates of clinical 

information and removal of patients 

from waiting lists an ongoing basis as 

the information becomes available. For 

clarity we have added ‘‘on an ongoing 

basis’’ at § 482.94(b) to emphasize that 

transplant centers must keep their 

waiting lists up to date. 

Comment: Some commenters 

expressed appreciation that we did not 

propose to mandate an annual 

evaluation of all patients on the waiting 

list. One commenter suggested that 

waiting list management should be 

clinically driven. That is, we should 

require centers to identify ‘‘high risk’’

transplant candidates and evaluate them 

annually. A commenter suggested 

requiring centers to conduct periodic 

clinical re-evaluations of transplant 

candidates to enhance updating of 

clinical information in those patients’

medical records and their information 

on the waiting list. 

Response: We developed the 

requirement for transplant centers to 

update clinical information for their 

waiting list patients on an ongoing basis 

based on the assumption that updating 

of patients’ clinical information is 

clinically driven. We understand that 

some patients are in critical condition, 

requiring more intense evaluation and 

monitoring, and other patients remain 

stable for longer periods of time. We 

expect transplant centers to keep their 

waiting lists updated accordingly. We 

expect that transplant centers will 

determine how often waiting list 

patients should be evaluated, based on 

the acuity of the individual patient. No 

changes were made in this final rule 

based on these comments. 

Comment: A commenter stated that it 

is unreasonable to expect large centers 

with long waiting lists to update all 

patients’ clinical information on an 

ongoing basis because the requirement 

would be too burdensome. 

Response: We believe it is essential 

for a transplant center to stay abreast of 

its waiting list patients’ clinical status 

and keep its waiting list updated on an 

ongoing basis so that when an organ 

offer is made, the transplant center 

knows the clinical status of the potential 

recipient. If a long waiting list is the 

reason for a center’s failure to update 

waiting list patients’ clinical status, the 

transplant center may need to reevaluate its policies to determine if the 

number of patients on its waiting list is 

beyond its capacity to manage. 

Comment: Some commenters stated 

that managing a transplant center’s 

waiting list is a very complex task and 

is already subject to OPTN oversight. 

Some commenters suggested that the 

OPTN should be the entity to set 

guidelines for waiting list management, 

and one commenter recommended that 

we should ask the OPTN to develop 

guidelines for transplant centers. 

Another commenter suggested that the 

OPTN should incorporate and publish 

the transplant waiting list management 

guidelines developed by the American 

Society of Transplant Surgeons (ASTS). 

Commenters said that our regulations 

should require only that transplant 

centers comply with OPTN waiting list 

policies. 

Response: As appropriate, we have 

included OPTN patient waiting list 

policies in this final rule for oversight 

and enforcement purposes. The OPTN 

has waiting list management policies 

that go beyond our requirements, 

including patient screening and listing 

criteria, waiting time modifications, 

multiple listings, and removal of 

transplant candidates from waiting lists. 

As we proposed at § 482.94(c), we have 

included some OPTN patient waiting 

list policies in this final rule for 

oversight and enforcement purposes. 

Suggestions regarding the OPTN’s 

incorporation of specific guidelines, 

such as those developed by ASTS, fall 

outside the purview of this final rule 

and should be addressed to the OPTN. 

Comment: Some commenters stated 

that dialysis facilities do not always 

inform kidney transplant centers about 

changes in the clinical status of their 

dialysis patients. The commenters 

suggested that transplant centers, 

referring nephrologists, and dialysis 

facilities all should be held accountable 

for collaboration and communication 

regarding the clinical and listing status 

of patients on the waiting list. The 

commenter said that the collaboration 

process would help the transplant 


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center to keep patients’ clinical 

information current. 

Response: We agree. Based on public 

comments, we have added a 

requirement for kidney transplant 

centers to have written policies and 

procedures for ongoing communication 

with dialysis patients’ local dialysis 

facilities. (See § 482.104(a).) We believe 

this requirement will resolve the 

commenters’ concern about insufficient 

communication or lack of 

communication between transplant 

centers and dialysis facilities. 

Comment: A commenter stated that 

the requirement to notify the United 

Network of Organ Sharing (UNOS) (i.e., 

the OPTN Contractor) within 24 hours 

after a patient’s removal from the 

center’s waiting list does not take into 

consideration the inaccessibility of the 

UNetSM over the weekend for on-call 

staff. 

Response: UNetSM is available 24 

hours a day, 7 days a week to the 

transplant community. Transplant 

centers need to provide access for oncall or weekend staff so that they can 

notify the OPTN timely outside of 

normal business hours. 

Comment: A commenter stated that 

timely notification to the OPTN about 

patients’ removal from the waiting list is 

affected by data provided by dialysis 

facilities and local clinicians. One 

commenter suggested that we purchase 

software to help centers interface with 

dialysis facilities timely. 

Response: As we developed the 

proposed ESRD rule, we recognized the 

need for dialysis facilities to inform 

transplant centers about changes in the 

status of kidney transplant candidates. 

Although currently there is no 

software available to provide an 

interface between transplant centers and 

dialysis facilities, we do not expect 

transplant centers to have difficulty 

communicating with dialysis facilities. 

Comment: Some commenters 

supported the requirement for centers to 

notify each patient who is evaluated for 

transplant of his or her transplant status. 

However, some commenters stated that 

our patient notification requirements 

would be duplicative of OPTN policies. 

Response: Current OPTN bylaws for 

transplant hospitals include notification 

of patients in writing within 10 business 

days of: (1) A patient’s placement on the 

waiting list, including the date the 

patient was listed; (2) completion of a 

patient’s evaluation as a candidate for 

transplantation, if the evaluation has 

been completed and the patient will not 

be placed on the waiting list; or (3) 

removal from the waiting list as a 

transplant candidate for reasons other 

than transplantation or death. Further, 

transplant hospitals are expected to 

maintain documentation of these 

notifications and make the 

documentation available to the OPTN. 

As we proposed at § 482.94(c)(2), we 

have incorporated similar notification 

policies into this final rule for purposes 

of oversight and enforcement. In 

addition, as proposed at § 482.94(c)(3), 

this final rule requires a transplant 

center to document that it has notified 

the patient and dialysis facility, if 

applicable, if the transplant center is 

unable to make a decision whether to 

place the patient on the waiting list 

because further clinical testing or 

documentation is needed, as required by 

§ 482.94(c)(1)(iii). 

Comment: A commenter stated that 

communicating waiting list status to 

patients via mail is too labor-intensive. 

A few commenters stated that our 

impact analysis in the proposed rule 

underestimated the cost of notifying 

patients and dialysis facilities. One 

commenter stated that the cost quoted to 

notify patients and dialysis facilities 

does not include management oversight 

time and expenses. Another commenter 

suggested that centers should use a 

letter to notify patients whether they 

will be placed on the waiting list and 

use phone calls for other types of 

communication. 

Response: As we proposed, the 

patient notification requirements in this 

final rule do not mandate how 

transplant centers will notify patients 

and dialysis facilities about patients’

waiting list status. Transplant centers 

have the flexibility to determine how 

they will communicate such 

information to patients and dialysis 

facilities. Further discussion of the 

paperwork and the economic impact of 

these requirements are found in the 

Collection of Information and Impact 

Analysis sections of this preamble. 

Comment: Some commenters stated 

that the yearly requirement to notify 

transplant patients goes beyond the 

OPTN requirement and is unreasonable, 

costly, prescriptive, burdensome, and 

impractical. 

Response: We have carefully 

evaluated all the public comments we 

received on this issue and concluded 

that annual notification to patients 

would be unduly burdensome for 

transplant centers and is not necessary, 

as long as transplant centers can 

document that they notified transplant 

candidates, as appropriate, about the 

transplant candidate’s placement status 

in accordance with § 482.94(c) in this 

final rule. Therefore, we are not 

adopting the yearly notification 

requirement we proposed at 

§ 482.94(c)(2)(i). 

However, as we proposed at 

§ 482.94(c), we are requiring that if a 

transplant center evaluates a patient for 

placement on the waiting list, the center 

must document in the patient’s record 

that the patient is informed of his or her 

transplant status, including notification 

of: (1) The patient’s placement on the 

center’s waiting list; or (2) the center’s 

decision not to place the patient on its 

waiting list. Furthermore, as we 

proposed, once a patient is placed on a 

center’s waiting list, the center must 

document in the patient’s record that 

the patient is notified of his or her 

removal from the waiting list for reasons 

other than transplantation or death no 

later than 10 days after the patient’s 

removal from the center’s waiting list. 

To clarify that the requirement for 

notifying patients of their status after 

they have been evaluated for 

transplantation is the same for all 

patients but that a kidney patient’s 

usual dialysis facility also must be 

notified, we have removed proposed 

section 482.94(c)(3) and added language 

to sections 482.94(c)(1) and (2). Section 

482.94(c)(1) now reads in part, ‘‘For 

each patient who receives an evaluation 

for placement on a center’s waiting list, 

the center must document in the 

patient’s record that the patient (and in 

the case of a kidney patient, the 

patient’s usual dialysis facility) has been 

informed of his or her transplant status, 

including notification of * * *.’’

Section 482.94(c)(2) now reads in part, 

‘‘ If a patient on the waiting list is 

removed from the waiting list for any 

reason other than death or 

transplantation, the transplant center 

must document in the patient’s record 

that the patient (and in the case of a 

kidney patient, the patient’s usual 

dialysis facility) was notified * * *.’’

Comment: A commenter stated that 

patients should take some responsibility 

for waiting list accuracy. Another 

commenter suggested that transplant 

patients should be given the ‘‘Patient 

Bill of Rights and Responsibilities’’

package in which the patient 

acknowledges in writing that he or she 

has the responsibility to keep the 

transplant center informed of his/her 

whereabouts. 

Response: We agree that waiting list 

patients should keep the center or 

centers where they are listed informed 

of their whereabouts and informed of 

any other relevant information. We 

encourage transplant centers to educate 

potential transplant candidates about 

their responsibilities. However, we have 

made no changes based on this 

comment. 

Comment: A commenter suggested 

that a center should be found in 


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compliance if it documents that it made 

a reasonable attempt to notify a patient 

without actually succeeding. 

Response: When notification of a 

waiting list patient or a prospective 

waiting list patient is required under 

this final rule, we expect the transplant 

center to make a concerted effort to 

locate and notify the patient. 

Nevertheless, we understand there may 

be circumstances in which the patient 

cannot be found. At a minimum, a 

transplant center should maintain 

documentation in the medical record 

that it made several attempts to contact 

the patient. 

Comment: Some individuals who 

commented on the ESRD proposed rule 

stated that dialysis facilities should 

relinquish transplantation referral 

tracking responsibility once the referral 

has been made. Commenters expressed 

concerns that some transplant centers 

do not communicate with dialysis 

facilities regularly. One commenter 

stated that transplant centers should 

provide dialysis facilities with the 

information they need to monitor 

transplantation status. 

Response: As we proposed, and as 

adopted in this final rule, a kidney 

transplant center bears considerable 

responsibility for patient tracking once 

a dialysis facility has referred a patient 

for evaluation. Section 482.94(c)(1) 

requires documentation of notification 

of the patient of his or her placement on 

the center’s waiting list, the center’s 

decision not to place the patient on its 

waiting list, or the center’s inability to 

make a determination regarding the 

patient’s placement on its waiting list 

because further clinical testing or 

documentation is needed. Under 

§ 482.94(c)(3), transplant centers must 

document in the patient’s medical 

record that both the patient and the 

patient’s local dialysis facility have been 

notified of the patient’s transplant status 

and of any changes in the patient’s 

transplant status (in accordance with 

§ 482.94(c)(1)). 

Comment: Many commenters 

supported the requirement that 

transplant centers must make social 

services furnished by qualified social 

workers available to transplant patients, 

living donors, and their families. Some 

commenters recommended that 

transplant centers should be required to 

provide transplant patients and living 

donors with ongoing access to qualified 

transplant social workers for continuity 

of care after discharge. One commenter 

inquired about the time frame for posttransplant social services provided by 

transplant centers and the potential for 

Medicare reimbursement for the 

services. 

Response: Under the final rule and as 

we proposed, transplant centers are 

responsible for making social services 

furnished by a qualified social worker 

available to all transplant patients, 

living donors, and their families while 

a transplant patient or living donor is 

hospitalized. For Medicare beneficiaries 

(and their living donors), the services 

are often reimbursed. We did not 

propose requiring, nor does this final 

rule require, transplant centers to 

provide post-discharge social services to 

all transplant recipients or living 

donors. Nonetheless, we expect any 

social services needed post-discharge 

would be arranged through the 

discharge planning process. Some 

centers may choose to continue to 

provide such services to patients and 

living donors even though they may not 

be Medicare reimbursable. Medicare 

reimbursement for post-transplant social 

services outside the hospital setting falls 

outside the purview of this rule. 

Comment: Many commenters 

supported the proposed definition of a 

qualified social worker as an individual 

with a master’s degree in social work 

(MSW). Commenters noted that the 

MSW degree requires an additional 900 

hours of specialized training beyond a 

baccalaureate degree in social work, 

which prepares the individual with an 

MSW to work independently in the 

transplant setting where supervision 

and peer support is not always readily 

available. 

Many commenters recommended that 

we not allow social work experience to 

substitute for an MSW, as we proposed. 

We proposed permitting social workers 

to qualify if they served for at least 2 

years as a social worker, 1 year of which 

was in a transplantation program, and 

had established a consultative 

relationship with a social worker who 

qualified under our requirements for 

social workers with a master’s degree. 

(See proposed § 482.94(d)(2).) 

Conversely, in the ESRD proposed rule 

(70 FR 6184), we proposed eliminating 

a provision found in the current ESRD 

regulations at § 405.2102 (which applies 

both to dialysis facilities and to kidney 

transplant centers), which defines a 

social worker, in part, as an individual 

who, ‘‘* * * Has served for at least 2 

years as a social worker, 1 year of which 

was in a dialysis unit or transplantation 

program prior to September 1, 1976 

***’’

Many who commented on the ESRD 

proposed rule said that we should retain 

this ‘‘grandfather clause’’ for non-MSWs 

so that currently employed non-MSWs 

working as social workers do not lose 

their jobs. Some commenters said that 

experienced non-MSW social workers 

are competent and have a lot to offer, 

and they recommended that we 

continue the grandfather clause. 

Response: In general, we agree with 

commenters who stated that a social 

worker with an MSW degree is the best 

qualified individual to evaluate and 

assess transplant candidates, recipients, 

families, and living donors who are 

facing multiple psychosocial stressors. 

However, we also agree with 

commenters who said that non-MSW 

social workers who were employed as 

such prior to September 1, 1976 have 

much to offer patients and families. We 

also believe that there should be one 

standard for all transplant centers. 

To reconcile the conflicting 

viewpoints of commenters opposed to 

non-MSW social workers providing 

social services in transplant centers and 

commenters who urged us to retain the 

grandfather clause in the ESRD final 

rule, we have finalized the requirements 

for an individual to be a qualified social 

worker in any transplant center (not just 

a kidney transplant center) as follows. 

This final rule states that a qualified 

social worker is an individual who 

meets licensing requirements in the 

State in which he or she practices 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) is working as a 

social worker in a transplant center as 

of the effective date of this final rule and 

has served for at least 2 years as a social 

worker, 1 year of which was in a 

transplantation program, and has 

established a consultative relationship 

with a social worker who is qualified 

under § 482.94(d)(1). 

This grandfather clause applies only 

to individuals who are currently 

employed as social workers in a 

transplant center as of the effective date 

of this final rule. Although we believe 

the number of these individuals to be 

small, we do not intend that these 

employees should lose their jobs 

because of the deletion of the 

‘‘grandfather clause.’’

Comment: A commenter suggested 

that we adopt the OPTN policies for the 

psychosocial services that transplant 

centers should offer without defining 

the required qualifications for a social 

worker. 

Response: We do not agree that 

adopting OPTN policies without 

establishing requirements for social 

worker qualifications would serve the 

best interests of patients and living 

donors. As commenters overwhelmingly 

agreed, master’s degree-prepared social 

workers are best qualified to provide 


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social services to transplant candidates 

and recipients, as well as living donors. 

Social workers often perform 

psychosocial evaluations of prospective 

transplant candidates and prospective 

living donors, and social workers 

provide critical services to transplant 

recipients and living donors during the 

inpatient and discharge phases of 

donation and transplantation. For 

example, prior to discharge, social 

workers provide counseling services to 

transplant recipients to assist them in 

maintaining the resolve they need to 

remain compliant with their 

immunosuppressive and other 

medications, which are necessary to 

prevent graft failure. We made no 

changes based on this comment. 

Comment: A commenter 

recommended that a qualified social 

worker should have training in, and 

knowledge of, pediatric transplant 

issues. 

Response: We agree that qualified 

social workers should have transplant 

training and knowledge of pediatric 

transplant issues, which can be 

achieved through on-the-job training or 

continuing education, if they are 

providing services in a pediatric center. 

We expect transplant centers to ensure 

that qualified social workers working in 

pediatric transplant programs receive 

ongoing staff development training to 

better handle issues that are unique to 

pediatric transplantation. We made no 

changes based on this comment. 

Comment: Some commenters 

supported the requirement for 

transplant centers to have nutritional 

assessments and diet counseling 

services furnished by a qualified 

dietitian available to all transplant 

patients and living donors. One 

commenter stated that medical nutrition 

therapy is important for patients and 

living donors. However, some 

commenters stated that transplant 

centers should not be responsible for 

transplant candidates’ pre-transplant 

nutritional care or care during the 

evaluation phase for transplant, which 

is usually provided by candidates’ local 

providers. A few commenters stated that 

transplant centers should not be 

required to provide ongoing posttransplant nutritional services to 

patients and living donors. The 

commenters requested clarification of 

the time frame for nutritional services 

provided to post-transplant patients, 

and stated that Medicare should 

reimburse for such services. 

Response: We agree that pre- and 

post-transplant nutritional care is 

usually provided by transplant patients’

and living donors’ local health care 

providers. This final rule requires 

transplant centers to provide nutrition 

services to transplant recipients and 

living donors only during their inpatient 

stay. For example, a transplant recipient 

may need to be counseled on the 

modification of his or her dietary 

regimen after organ transplant or a 

living donor may need to be counseled 

for his or her temporary adjustment in 

nutritional intake after living organ 

donation. These services are part of the 

hospital inpatient services reimbursed 

by Medicare for beneficiaries and often 

for their living donors. 

Comment: Some commenters 

suggested that living donors, 

particularly living kidney donors, 

should be exempt from nutritional 

services since they are healthy 

individuals. 

Response: Although living donors are 

usually healthy individuals, we believe 

they should receive the same care 

provided to transplant recipients. Under 

the final rule and as proposed, 

transplant centers are responsible for 

making nutritional assessment and 

dietary counseling services furnished by 

a qualified dietitian available to all 

living donors while they are 

hospitalized for organ donation. 

Comment: A commenter suggested 

that we should adopt the OPTN policy 

for nutritional services without defining 

the qualifications for a qualified 

dietitian. 

Response: Currently, the OPTN does 

not have a policy for nutritional services 

furnished by transplant centers. 

Comment: One commenter suggested 

adopting the Medical Nutrition Therapy 

(MNT) regulation definition of 

‘‘qualified dietitian.’’ A few commenters 

suggested that the definition of a 

qualified dietitian in the transplant 

center rule and the ESRD rule should be 

consistent. 

Response: We have not used the MNT 

definition for registered dietitian in this 

final rule because it includes both 

registered dietitians and other 

nutritional professionals, and we 

believe this may cause confusion. 

However, we have revised the proposed 

requirements at § 482.94(e). 

In this final rule, we require that a 

qualified dietitian must be a registered 

dietitian with the Commission on 

Dietetic Registration (CDR), who meets 

the practice requirements in the State in 

which he or she is employed. (See 

§ 482.94(e).) For the most part, these 

requirements are similar to those 

included in the proposed rule for new 

conditions for coverage for ESRD 

facilities published February 4, 2005 (70 

FR 6184). To date, the ESRD facility 

final rule has not yet been published. 

Condition of Participation: Quality 

Assessment and Performance 

Improvement (QAPI) (Proposed 

§ 482.96) 

We proposed that every transplant 

center must develop, implement, and 

maintain a written, comprehensive, 

data-driven QAPI program designed to 

monitor and evaluate the performance 

of all transplantation services, including 

services provided under contract or 

arrangement. 

We proposed requiring a transplant 

center’s QAPI program to use objective 

measures to evaluate the center’s 

performance with regard to transplant 

activities and outcomes. We proposed 

that these activities and outcomes may 

include, but would not be limited to, 

patient and donor selection criteria, 

accuracy of the waiting list in 

accordance with the OPTN waiting list, 

accuracy of donor-recipient matching, 

patient and donor management, 

techniques for organ recovery, consent 

practices, patient satisfaction, and 

patient rights. We proposed that the 

transplant center must take actions that 

result in performance improvements 

and track performance to ensure that 

improvements are sustained. 

We proposed that transplant centers 

must establish and implement written 

policies to address and document any 

adverse events that occur during any 

phase of an organ transplantation case. 

We proposed that a transplant center 

must have policies to address, at a 

minimum, the process for identification, 

reporting, analysis, and prevention of 

adverse events. We also proposed that a 

transplant center must conduct a 

thorough analysis of, and document, 

any adverse event and must utilize the 

analysis to effect changes in the 

transplant center’s policies and 

practices to prevent repeat incidents. 

Following are summaries of the 

comments we received and our 

responses. 

Comment: Some commenters 

supported the proposed requirement for 

a transplant center to have a defined 

QAPI process. Commenters said the 

proposed objective measures and 

adverse events standards were 

reasonable and would provide impetus 

for transplant centers to scrutinize and 

improve performance. A commenter 

stated that QAPI programs should be 

quality-driven and not complaintdriven. 

Response: We appreciate the 

commenters’ support of the proposed 

QAPI requirements. We anticipate that 

transplant centers will take advantage of 

their own transplant data as well as the 

wealth of transplant data available 


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through the OPTN and the SRTR and 

utilize them effectively to evaluate their 

own performance and effect positive 

changes. 

Comment: Some commenters stated 

that the proposed requirement for a 

transplant center to develop, 

implement, and maintain a QAPI 

program would not contribute to 

improving patient outcomes. 

Response: We disagree with the 

commenters. The effectiveness of QAPI 

programs in improving the delivery of 

health care is widely accepted 

throughout the health care community. 

An effective QAPI program uses 

objective data to study and make 

improvements to all patient care 

processes on a continuing basis. We 

expect transplant centers to focus on 

areas of sub-optimal performance and 

prioritize outcome measures for 

improvement. Using this approach, a 

transplant center can: (1) Identify areas 

where outcomes indicate a need for 

improvement; (2) define systematic 

changes needed to improve outcomes; 

(3) review implementation of 

improvement actions; and (4) determine 

the success of the actions to improve 

performance. 

Comment: Some commenters stated 

that the QAPI program of a JCAHO 

accredited hospital and the OPTN 

oversight of transplant centers should 

eliminate the need for a separate 

transplant center-based QAPI program. 

Some commenters were concerned 

about the extra resources needed for a 

transplant center to have a separate 

QAPI program. Commenters suggested 

using the OPTN and SRTR as surrogates 

for transplant centers’ QAPI programs. 

Some commenters recommended that 

transplant centers should be given the 

choice of using the hospital QAPI 

program or establishing a transplantcenter-based QAPI program. A few 

commenters suggested using a formal 

QAPI program as part of a remediation 

process for centers that failed to comply 

with outcome measures. 

Response: It is a common practice to 

use QAPI programs to improve the 

delivery of health care to patients. The 

intent of the QAPI requirement in this 

final rule is to develop a structured 

process for transplant centers to analyze 

and evaluate transplant patient 

outcomes data and transplant center 

processes continuously and effect 

changes accordingly. Hospitals have the 

flexibility to incorporate a transplant 

center’s QAPI program into the hospital 

QAPI process. However, given the 

complexity and the uniqueness of some 

transplant issues, we disagree that a 

general hospital QAPI program or OPTN 

oversight alone could adequately 

substitute for a transplant center-based 

QAPI program. Further, we disagree that 

the OPTN and the SRTR should serve as 

surrogates for transplant centers’ QAPI 

programs. Every transplant center 

should tailor its QAPI program to meet 

its needs and its patient population to 

better serve the best interests of its 

patients. 

Comment: A commenter 

recommended expanding the 

components of the QAPI program to 

include adverse events, electronic 

prescribing, clinical decision support, 

bar coding, and provider and patient 

education. 

Response: We thank the commenter 

for the suggestions. We agree that it is 

appropriate to include patient education 

as part of the QAPI components, and we 

have included this requirement in the 

regulation text at § 482.96(a) in this final 

rule. 

As we proposed, this final rule 

includes a separate QAPI standard at 

§ 486.92(b) that requires transplant 

centers to establish and implement 

written policies to address and 

document adverse events. Therefore, we 

do not believe it is necessary to list 

adverse events as one of the specific 

components of a QAPI program at 

§ 482.96(a). 

We believe the other components 

suggested by the commenter belong in 

the hospital’s overall QAPI program 

because they affect patient care and 

other functions throughout the 

organization. Therefore, no other 

changes have been made based on this 

comment. 

Comment: A few commenters 

supported the proposed standard for 

transplant centers to address transplantrelated adverse events. A commenter 

noted that we should specify the 

frequency of internal and external 

audits of the adverse events reporting 

and analysis. 

Response: We expect transplant 

centers to analyze adverse events as 

they occur and to make systemic and 

other changes promptly, as necessary, 

based on their analysis. However, this 

final rule does not specify the frequency 

of internal audits or external audits of 

adverse events. The frequency of 

adverse events reporting and analysis 

should be contained in a transplant 

center’s QAPI adverse events policies. 

Comment: Some commenters stated 

that JCAHO survey standards require 

hospitals to have QAPI policies and 

sentinel events reporting and 

investigation. The commenters were 

concerned that the proposed adverse 

event standard is redundant and 

resource-intensive. 

Response: As stated earlier, to reduce 

redundancy, a transplant-oriented QAPI 

program can be integrated into a 

hospital’s QAPI program for 

accreditation purposes. Therefore, we 

do not believe the adverse events 

requirement, which is one of the QAPI 

standards in this final rule, will be 

excessively resource-intensive. 

Comment: A few commenters 

requested the exclusion of nontransplantation-related end-stage organ 

disease in the adverse events definition. 

Response: We did not propose 

including non-transplantation-related 

end-stage organ disease in the definition 

of ‘‘adverse events.’’ The examples of 

adverse events provided in the 

definition of adverse events in both the 

proposed rule and this final rule relate 

only to donation by living donors and 

to transplantation. 

Condition of Participation: Human 

Resources (Proposed § 482.98) 

We proposed that transplant centers 

must ensure that all individuals who 

provide services and/or supervise 

services at the center, including 

individuals furnishing services under 

contract or arrangement, are qualified to 

provide or supervise such services. 

We proposed that each transplant 

center must be under the general 

supervision of a qualified transplant 

surgeon or a qualified physiciandirector with designated 

responsibilities. We proposed that the 

director of a transplant center need not 

serve full-time and may also serve as a 

center’s primary transplant surgeon or 

transplant physician in accordance with 

§ 482.98(b). 

We proposed that the director would 

be responsible for planning, organizing, 

conducting and directing the transplant 

center and must devote sufficient time 

to carrying out these responsibilities, 

which include, but are not limited to, 

ensuring: 

(1) Adequate training of nursing staff 

in the care of transplant patients; 

(2) That tissue typing and organ 

procurement services are available; 

(3) That transplantation surgery is 

performed under the direct supervision 

of a qualified transplant surgeon in 

accordance with § 482.98(b). 

We proposed that transplant centers 

must identify to the OPTN both a 

primary transplant surgeon and a 

primary transplant physician with the 

appropriate training and experience to 

provide transplantation services. We 

proposed that the transplant surgeon is 

responsible for providing surgical 

services related to transplantation, and 

the transplant physician is responsible 


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for providing and coordinating 

transplantation care. 

We proposed that transplant centers 

must have a qualified clinical transplant 

coordinator to ensure the continuity of 

care of patients and living donors 

during the pre-transplant, transplant, 

and discharge phases of transplantation 

and the donor evaluation, donation, and 

discharge phases of donation. We 

proposed requiring that a qualified 

clinical transplant coordinator must be 

certified by the American Board of 

Transplant Coordinators (ABTC). 

We proposed that a transplant center 

must identify a multidisciplinary 

transplant team and describe the 

responsibilities of each member of the 

team. We also proposed that the team 

must be composed of individuals with 

the appropriate qualifications, training, 

and experience in the relevant areas of 

medicine, nursing, nutrition, social 

services, transplant coordination, and 

pharmacology. 

We proposed that a transplant center 

must demonstrate the availability of 

expertise in internal medicine, surgery, 

anesthesiology, immunology, infectious 

disease control, pathology, radiology, 

and blood banking as related to the 

provision of transplantation services. 

Following are summaries of the 

comments we received and our 

responses. 

Comment: Although some 

commenters supported the proposal that 

transplant centers must ensure that all 

individuals providing transplant 

services are qualified, one commenter 

stated that transplant centers should 

have the flexibility to determine their 

own personnel needs. The commenter 

voiced concern that the cost of meeting 

the proposed staffing requirements 

would increase costs to such an extent 

that facilities would no longer be able to 

contract with managed care companies 

because managed care reimbursement 

would be insufficient to cover costs. 

Response: We believe the staffing 

requirements in this final rule are 

critical for the protection of the health 

and safety of living donors and 

transplant recipients. Based on public 

comments, we have eliminated our 

proposed requirement for ABTC 

certification for clinical transplant 

coordinators, and we have added a 

requirement in this final rule for a living 

donor advocate or advocate team, which 

may increase overhead costs for some 

transplant centers. However, as we 

discuss in more detail in the Impact 

Analysis Section of this preamble, we 

do not expect the donor advocate or 

donor advocate team requirement in this 

final rule to increase costs substantially. 

In fact, we expect an average increase of 

less than $18,500 per transplant center 

annually. 

Comment: Some commenters stated 

that the OPTN policies for transplant 

personnel are industry gold standards 

and that they should be adopted by us 

and monitored by the OPTN. One 

commenter stated that the OPTN and 

CMS human resources requirements 

should be consistent. 

Response: We believe our 

requirements are consistent with OPTN 

policies and bylaws. Section 482.72 of 

this final rule requires transplant 

centers to be OPTN members. While the 

final rule governing the operation of the 

OPTN does not require transplant 

programs within OPTN member 

hospitals that receive their designation 

by virtue of their Medicare approval to 

meet the OPTN’s on-site primary 

transplant surgeon and transplant 

physician requirements, such programs 

are reviewed by the OPTN, on a 

voluntary basis, for compliance with 

such requirements. We expect that 

transplant centers, as members of the 

OPTN, will have no difficulty meeting 

these regulatory requirements, as the 

OPTN requirements are more extensive 

than our requirements. 

Comment: One commenter suggested 

that we should add a ‘‘grandfather 

clause’’ for transplant staff to § 482.98, 

Human resources, as a transition to the 

new human resources requirements. 

That is, transplant centers should be 

permitted to continue to employ their 

current staff, even if some staff do not 

meet specific education, training, or 

licensure requirements in the final rule. 

Response: As we stated in our 

previous response, we expect that 

transplant centers who are OPTN 

members will have no difficulty meeting 

our requirements. Our requirements for 

transplant surgeons and physicians are 

congruent with OPTN requirements. 

Furthermore, we have eliminated the 

proposed requirement for ABTC 

certification for transplant coordinators 

based on public comments, and we 

replaced it with a requirement for a 

clinical transplant coordinator to be an 

RN or clinician licensed in the State in 

which the coordinator practices and to 

have specific job-related skills. We 

expect that all or nearly all currentlyemployed clinical transplant 

coordinators already have these 

qualifications. We are requiring a donor 

advocate or donor advocate team to 

have certain knowledge and abilities but 

not specialized education or training. 

Comment: A commenter 

recommended that we require 

transplant centers to have a transplant 

pharmacist on the transplant team. 

Response: Section 482.98(e) of this 

final rule states that the 

multidisciplinary transplant team must 

be composed of individuals with the 

appropriate qualifications, training, and 

experience in the relevant areas of 

medicine, nursing, nutrition, social 

services, transplant coordination, and 

pharmacology. Therefore, we expect 

that the team will include an individual 

with expertise in transplant 

pharmacotherapy. We have not made 

any changes in this final rule based on 

this comment. 

Director of a Transplant Center 

Comment: Some commenters 

supported the proposal that a transplant 

center be under the general supervision 

of a qualified transplant surgeon or a 

qualified transplant physician director. 

However, one commenter suggested that 

we clarify the requirements for a 

qualified director of a transplant center. 

The commenter suggested that we 

permit a surgeon or a physician who 

meets the OPTN requirements for a 

designated surgeon or physician to be a 

transplant center director. Other 

commenters suggested that we crossreference the OPTN definition for 

transplant surgeon or transplant 

physician qualification in the final rule. 

Some commenters recommended that 

we require the qualified transplant 

center director to be a certified surgeon 

or physician who has completed an 

approved American Society of 

Transplant Surgeons (ASTS) training/ 

fellowship and who has been certified 

for all transplant programs. 

Response: We did not define the 

qualifications for a transplant center 

director, so that transplant centers will 

have the flexibility to recruit an OPTNqualified transplant surgeon or 

physician for the position. The ASTS 

training/fellowship is one of the options 

for transplant surgeons to meet the 

OPTN training program requirement. 

However, there are other options 

surgeons can choose to meet the OPTN 

training requirement. We do not believe 

it is necessary to require transplant 

surgeons to participate in a specific 

organization’s training program to be 

qualified to provide transplantation 

services in a Medicare-approved 

transplant center. 

As we have stated in some of our 

previous responses, we are not 

incorporating OPTN policies and 

bylaws into regulations by cross 

reference because we would be required 

to go through notice and comment 

rulemaking every time the policies and 

bylaws changed. OPTN policies for 

transplant surgeons and physicians are 

very detailed and subject to frequent 


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changes. We believe that such changes 

will occur too often for us to incorporate 

them expeditiously into our regulations. 

We will provide guidance regarding the 

definitions of qualified transplant center 

directors, surgeons, and transplant 

physicians in the Interpretive 

Guidelines. However, we can assure 

transplant centers that transplant 

surgeons and physicians who meet 

current OPTN requirements will meet 

the requirements in this final rule. 

Comment: One commenter pointed 

out that nurses do not routinely report 

to physicians in hospital settings. The 

commenter suggested that instead of 

holding the director of a transplant 

center responsible for ensuring adequate 

training of nursing staff in the care of 

transplant patients, we should require 

the hospital in which the transplant 

center is located to be responsible for 

the training of nursing staff. 

Response: The commenter was correct 

in stating that nursing staff do not 

usually report to physicians in a 

hospital setting. Therefore, we have 

modified our proposed language at 

§ 482.98(a)(1) in this final rule, to state 

that the director of a transplant center 

must collaborate with the transplant 

hospital in which the transplant center 

is located to ensure adequate training of 

nursing staff and clinical transplant 

coordinators in the care of transplant 

patients and living donors. 

Transplant Surgeon and Physician 

Comment: Some commenters 

recommended grandfathering all 

currently active transplant surgeons 

who have not completed an ASTS 

fellowship. They also recommended 

that we require an ASTS fellowship for 

all new transplant surgeons. 

Response: Given that the OPTN gives 

transplant surgeons different options 

toward meeting the OPTN qualification 

requirements, we do not believe a 

grandfather clause is advisable. As 

stated previously, the ASTS training/ 

fellowship is just one of the options for 

transplant surgeons to fulfill the OPTN 

training program requirements. 

Requiring all new transplant surgeons to 

complete an ASTS fellowship would be 

far too prescriptive and would be 

inconsistent with the OPTN bylaws. 

Availability of Primary Transplant 

Surgeon and Physician 

We received many comments urging 

us to conform our requirements to the 

OPTN policies and bylaws for 

transplant surgeons and physicians, and 

we believe that we should be consistent 

with the OPTN rules in this regard. 

Under OPTN bylaws, a transplant center 

designated under 42 CFR 121.9(a)(2) 

must have a primary transplant surgeon 

and a primary transplant physician 

onsite at all times. The immediate 

availability of a transplant surgeon is 

imperative to minimize time on the 

waiting list and mortality of transplant 

candidates. Recently, our surveyors 

discovered that the inability of a liver 

transplant center in California to retain 

a full-time transplant surgeon was a 

contributing factor to the center’s high 

organ refusal rate, low numbers of 

transplants, and prolonged waiting time 

for transplant candidates. 

Therefore, under the final rule, we 

require not only that a transplant center 

must identify to the OPTN a primary 

transplant surgeon and a transplant 

physician with the appropriate training 

and experience to provide 

transplantation services as proposed at 

§ 482.98(b), but also that these 

individuals are immediately available to 

provide transplantation services when 

an organ is offered for transplantation. 

By ‘‘immediately available,’’ we mean 

that the transplant surgeon and 

transplant physician must be available 

to provide transplantation services 

within a time frame that ensures there 

is no compromise to the viability of the 

organ or the health of the organ 

transplant recipient. 

Clinical Transplant Coordinator 

Comment: Most commenters 

supported the proposed requirement for 

a transplant center to have a clinical 

transplant coordinator. 

Response: Clinical transplant 

coordinators are important links for 

transplant patients and living donors to 

transplant centers and dialysis facilities. 

We believe that clinical transplant 

coordinators are essential in 

coordinating the continuity of care of 

patients and living donors. They 

provide guidance to transplant 

recipients during the pre-transplant, 

transplant, and post-transplant phases 

and to living donors during the predonation, donation and post-donation 

phases. 

Comment: Many commenters 

supported the proposed requirement for 

American Board of Transplant 

Coordinators (ABTC) certification for a 

qualified clinical transplant coordinator 

and stated that the ABTC certification 

would minimize medical errors 

associated with donation and 

transplantation. A commenter stated 

that the ABTC certification is the ‘‘gold 

standard’’. 

However, many commenters strongly 

objected to our proposed requirement 

for ABTC certification. The commenters 

said that a requirement for ABTC 

certification would be arbitrary, given 

that there are other agencies that certify 

coordinators. Many transplant center 

commenters attested that their clinical 

transplant coordinators are Advance 

Practice Nurses, have received in-house 

training, have received continuing 

education training, or are ABTCqualified but not ABTC certified, yet 

they perform their responsibilities well 

and provide excellent patient care. The 

commenters suggested accepting subspecialty certifications, such as critical 

care or case management, to qualify 

clinical transplant coordinators. 

Some commenters stated that the 

ABTC requirement would create 

recruitment hardship, especially for 

pediatric centers, and eventually raise 

overhead expenses for transplant 

centers. A few commenters requested an 

extension for pediatric centers to meet 

the ABTC requirement. The commenters 

noted that pediatric transplant programs 

usually hire Pediatric Advanced 

Practice Nurses who then acquire 

pediatric transplant experience through 

on-the-job training. Some commenters 

estimated that it takes about 18 months 

for a clinical transplant coordinator to 

become ABTC certified. To ease the 

difficulty of recruiting ABTC certified 

transplant coordinators, especially 

pediatric clinical transplant 

coordinators, some commenters 

suggested that we should allow 2 years 

for a newly-hired transplant coordinator 

to obtain ABTC certification while he or 

she continues to work under the 

supervision of an ABTC-certified 

coordinator. One commenter suggested 

requiring ABTC certification for non-RN 

clinical transplant coordinators while 

allowing RNs to be certified by 

credentialing bodies other than the 

ABTC. Some commenters recommended 

grandfathering all clinical transplant 

coordinators with at least 5 years of 

work experience. 

Some commenters did not believe that 

ABTC certification would improve the 

care of transplant patients. Other 

commenters suggested requiring the 

transplant director to be responsible for 

ensuring that clinical transplant 

coordinators receive adequate education 

and training. Several commenters 

recommended eliminating the ABTC 

certification requirement in the final 

rule. 

Response: Since the publication of the 

proposed rule, we have further 

examined the education, training, and 

experience of individuals who serve as 

clinical transplant coordinators. 

Although the ABTC certification 

examination is a valuable avenue to 

demonstrate transplant knowledge and 

skill, we found that many clinical 

transplant coordinators are RNs, clinical 


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nurse specialists, and nurse 

practitioners who have acquired 

transplant knowledge and practice 

experience in a variety of roles and 

settings. In recent decades, alternative 

health care practice models have 

provided the opportunity for nurses and 

clinicians to take on an expanded role 

in transplantation. Therefore, we have 

concluded that commenters were 

correct that there is more than one way 

to acquire the necessary knowledge and 

skill to be a clinical transplant 

coordinator. Furthermore, we agree with 

the commenters that limiting 

certification to a single organization is 

not appropriate. Therefore, we have not 

included a requirement for ABTC 

certification for transplant coordinators, 

as we proposed at § 482.98(c). 

However, we believe that clinical 

transplant coordinators should be 

registered nurses or have clinical 

experience, and we note that OPTN 

policies require the clinical transplant 

coordinator to be either a registered 

nurse or other licensed clinician. 

Therefore, in this final rule, we have 

added a requirement that the clinical 

transplant coordinator must be either a 

registered nurse or a clinician licensed 

by the State in which the clinical 

transplant coordinator practices, who 

has experience in and knowledge of, 

transplantation and living donation 

issues. (See § 482.98(c).) In addition, 

this final rule requires that the director 

of the transplant center must ensure that 

clinical transplant coordinators have 

adequate training in the care of 

transplant patients and living donors. 

(See § 482.98(a)(1).) Also, we have 

added language that describes the 

responsibilities of the clinical transplant 

coordinator, which include, but are not 

limited to: (1) Ensuring the coordination 

of the clinical aspects of transplant 

patient and living donor care; and (2) 

acting as a liaison between a kidney 

transplant center and dialysis facilities, 

where applicable. (See § 482.98(c).) 

Comment: Some commenters asked 

how many ABTC-certified coordinators 

are required, that is, whether one 

coordinator per transplant hospital or 

organ-specific transplant center is 

sufficient or whether all coordinators 

would need to be ABTC certified. A 

commenter suggested requiring only one 

ABTC-certified coordinator on site to 

provide overall supervision to other 

non-ABTC certified coordinators. A 

commenter recommended requiring a 

transplant center to have either an 

ABTC-certified clinical transplant 

coordinator or a State-licensed nurse 

with proficiency in complex 

professional and administrative 

transplant skills. 

Response: Although this final rule 

does not require ABTC certification, 

each organ-specific transplant center 

must have at least one clinical 

transplant coordinator who meets the 

requirements at § 482.98(c) of this final 

rule. Small transplant centers may share 

one clinical transplant coordinator. 

Donor Advocate or Donor Advocate 

Team 

Comment: The majority of 

commenters supported our proposed 

requirement for an independent living 

donor advocate or a multidisciplinary 

advocate team. The commenters stated 

that a living donor advocate or 

multidisciplinary advocate team can 

ensure continuity of care of living 

donors during the pre-donation, 

donation and post-donation phases. 

Only one commenter said that the 

services of a donor advocate or donor 

advocate team would not add value to 

the process of living donation. A few 

commenters stated that the requirement 

for a living donor advocacy team would 

cause hardship for small transplant 

programs. 

Response: We agree with the 

commenters who said that this 

requirement will serve the best interests 

of living donors. We expect that donor 

advocates and donor advocate teams 

will educate potential living donors 

about living donation, ensure that living 

donors have comprehensive medical 

and psychosocial evaluations, and make 

recommendations to the transplant team 

regarding prospective donors’ suitability 

for donation. The presence of either a 

living donor advocate or an advocate 

team will encourage accountability for 

the protection of living donors’ health 

and safety and ensure that principles of 

medical ethics and informed consent 

standards are applied to the practice of 

living donation. 

Under this final rule at § 482.98, we 

state that a transplant center may choose 

to have either a living donor advocate or 

a donor advocate team. These 

individuals may be in-house hospital 

staff members who perform other duties 

in addition to their living donor 

advocate responsibilities. We believe 

this flexible approach will minimize the 

burden of providing donor advocacy 

services. 

Comment: Some commenters stated 

that transplant centers should be given 

the flexibility to define their own 

policies for a living donor advocate 

program. A few commenters stated that 

it is unnecessary to require a transplant 

center to designate a living donor 

advocate or an advocate team as long as 

there is an independent process to 

assess a living donor’s risks and the 

benefits of donation. One commenter 

suggested that transplant centers should 

be required only to offer the consulting 

services of an in-house transplanteducated health care worker not directly 

involved in transplant procedures. 

Response: 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. 

Comment: Many commenters 

suggested that the donor advocate team 

should include a qualified social worker 

as described in the proposed rule or a 

medical social worker (a social worker 

working in a medical setting). One 

commenter suggested that a 

multidisciplinary advocate team should 

include an internal medicine physician, 

a transplant coordinator/nurse clinician, 

a licensed social worker with a master’s 

degree, a psychiatrist, and an ethicist. 

Some commenters suggested that either 

the living donor advocate or advocate 

team members should be educated in 

organ transplants. 

Response: We appreciate the 

commenters’ suggestions for the 

composition of the multidisciplinary 

donor advocate team, and we agree that 

all the named professionals would be an 

asset to a donor advocate team. 

Transplant centers that choose to have 

a multidisciplinary donor advocate team 

may want to consider these suggestions 

in selecting appropriate team members 

to meet their needs. However, we 

believe it would be unnecessarily 


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prescriptive to require that donor 

advocate teams be composed of 

individuals from specific professions. 

Comment: Many commenters stated 

that the living donor advocate or the 

advocate team should be independent 

from the transplant team. That is, 

transplant centers should use different 

physicians and social workers to work 

with transplant patients and living 

donors. A commenter stated that it is 

difficult for a hospital-employed living 

donor advocate to stay independent. 

Response: We agree that the living 

donor advocate or donor advocate team 

should function independently from the 

transplant team to avoid conflicts of 

interest. Therefore, as stated earlier, this 

final rule at § 482.98 (d)(1) requires that 

the living donor advocate or living 

donor advocate team not be involved 

routinely in transplantation. 

Comment: A commenter suggested 

that we designate the United Network 

for Organ Sharing (UNOS) as the 

gatekeeper for living donor rights and 

establish an Ombudsman as a resource 

for all donors nationwide. 

Response: UNOS functions as a 

contractor for the OPTN to collect and 

track all transplant data, including 

living donor transplants. CMS does not 

have the authority to designate UNOS as 

the gatekeeper for living donor rights. 

Such suggestions should be referred to 

UNOS and HRSA. The suggestion that 

we establish an Ombudsman as a 

resource for all donors nationwide falls 

outside the purview of this regulation. 

Therefore, no changes have been made 

based on this comment. 

Multidisciplinary Transplant Team and 

Resource Commitment 

Comment: A few commenters stated 

that the OPTN policies already stipulate 

personnel requirements for transplant 

centers and that our proposed 

requirements either duplicated or were 

inconsistent with OPTN policies. 

Response: We proposed that a 

transplant center must identify a 

multidisciplinary transplant team and 

describe the responsibilities of each 

member of the team. The team must be 

composed of individuals with the 

appropriate qualifications, training, and 

experience in the relevant areas of 

medicine, nursing, nutrition, social 

services, transplant coordination, and 

pharmacology. The OPTN has personnel 

requirements for certain personnel, such 

as a clinical transplant coordinator, 

transplant pharmacist, and financial 

coordinator. However, the OPTN does 

not have the transplant team 

requirements that we proposed and that 

we have finalized in this rule. 

Comment: Many commenters 

suggested changing the term ‘‘social 

services’’ to ‘‘social work’’ (because 

there is ambiguity about who provides 

such services), and the term 

‘‘pharmacology’’ to ‘‘pharmacist’’

because not all centers have 

pharmacologists but all centers have 

pharmacists. 

Response: This final rule requires 

transplant centers to employ individuals 

with expertise in different relevant 

areas. We do not believe the terms 

‘‘social services’’ or ‘‘pharmacology’’

need to be changed or clarified because 

this standard addresses the expertise of 

the individual transplant team 

members, and not the profession of 

these individuals. We made no changes 

based on this comment. 

Comment: A commenter 

recommended changing ‘‘immunology’’

to ‘‘immunology and 

immunosuppression management’’. 

Response: One facet of immunology 

as a science is the study of organ 

transplantation and 

immunosuppression. We expect that to 

comply with the requirement in this 

final rule to demonstrate resource 

commitment in immunology, a 

transplant center will demonstrate 

resource commitment and availability of 

expertise in both immunology and 

immunosuppression. We have made no 

changes based on this comment. 

Comment: A commenter requested 

that we require pediatric transplant 

centers to demonstrate availability of 

expertise in ‘‘pediatric medicine, 

pediatric surgery, pediatric urology, 

pediatric nursing, pediatric dialysis and 

pediatric intensive care.’’

Response: To be in compliance with 

the requirements in this final rule, a 

transplant center must provide services 

appropriate to its patient population. 

For example, § 482.98(e) requires a 

transplant center to identify a 

multidisciplinary transplant team 

composed of individuals with the 

appropriate qualifications, training, and 

experience in the relevant areas of 

medicine, nursing, nutrition, social 

services, transplant coordination, and 

pharmacology. This means that the 

individuals who are part of a transplant 

team at a pediatric transplant center 

must have the qualifications, training, 

and experience to provide 

transplantation services to pediatric 

patients. Section 482.98(f) requires a 

transplant center to demonstrate 

availability of expertise in internal 

medicine, surgery, anesthesiology, 

immunology, infectious disease control, 

pathology, radiology, blood banking, 

and patient education as related to the 

provision of transplantation services. To 

meet this requirement, a pediatric 

transplant center must ensure that the 

expertise is commensurate with the 

needs of pediatric patients. 

Furthermore, the Department’s OPTN 

regulations at 42 CFR 121.9 require 

transplant programs in OPTN member 

hospitals designated under OPTN 

criteria in § 121.9(a)(2)(v) to show 

evidence of collaborative involvement 

with experts in the fields of, among 

other disciplines, pediatrics as 

appropriate. 

Comment: One commenter 

anticipated the rule will increase 

demand for nursing staff and suggested 

that we should recognize that Advanced 

Practice Registered Nurses (APRN) can 

play a role in transplant patient care. 

Response: We agree with the 

commenter that APRNs play an 

important role in health care. 

Transplant centers certainly have the 

discretion to recruit APRNs for their 

transplant teams as they believe 

necessary. 

Comment: One commenter said that 

the proposed resource commitment 

requirements would enhance patient’s 

self-care management and positive 

patient outcomes. The commenter 

suggested that we add patient 

education. 

Response: We agree that patient 

education enhances patient’s self-care 

management and positive patient 

outcomes. In fact, most transplant 

centers provide ongoing patient 

education, which is provided by the 

transplant center staff, including 

transplant surgeons, physicians, nurses, 

transplant coordinators, dietitians, 

pharmacists, and social workers. We 

have adopted the comment to include 

patient education in this final rule as a 

required resource commitment for 

transplant centers at § 482.98(f). 

Condition of Participation: Organ 

Procurement (Proposed § 482.100) 

We proposed requiring transplant 

centers to ensure that the hospital in 

which the center operates has a written 

agreement for the receipt of organs with 

an OPO designated by the Secretary. 

We proposed that the transplant 

center would be required to ensure that 

the transplant hospital’s agreement with 

the OPO identifies specific 

responsibilities for the hospital and for 

the OPO with respect to organ recovery 

and organ allocation. 

We proposed that the transplant 

center must notify us in writing no later 

than 30 days after the termination of any 

agreement between the hospital and the 

OPO. Following is a summary of the 

comments we received on our proposed 


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provisions and our responses to the 

comments. 

Comment: A commenter stated that 

the proposed organ procurement 

provision is duplicative of 42 CFR 

121.9(a)(2)(i). 

Response: The commenter was correct 

in identifying similarities between this 

provision and the designated transplant 

program requirements in the 

Department’s regulations for the OPTN 

at 42 CFR 121.9(a)(2)(i). Including the 

organ procurement requirements in this 

final rule provides us with oversight 

and enforcement authority and imposes 

the requirements on transplant 

programs that received their designation 

by virtue of their approval for 

reimbursement for Medicare. 

Comment: A few commenters 

suggested requiring a center to notify 

the OPTN if its hospital’s agreement 

with an OPO has been terminated. 

Response: We do not believe 

terminating an agreement with an OPO 

is a step a hospital would take without 

the knowledge of the OPTN. Thus, we 

do not believe it is necessary for us to 

require a transplant center to notify the 

OPTN if the hospital in which it is 

located terminates its agreement with an 

OPO. We have made no change in this 

final rule based on this comment. 

Note that for the sake of consistency 

and to facilitate transplant centers’ use 

of the regulations, we have moved the 

requirement to notify us if the hospital 

in which a transplant center is located 

terminates its agreement with an OPO 

for organ recovery and receipt from 

§ 482.100 to § 482.74(a)(3), Notification 

to CMS. This change locates all events 

that must be reported to us within the 

same condition of participation and 

results in consistent time frames for 

notification. The requirement for 

notifying us if the hospital in which a 

transplant center is located terminates 

its agreement with an OPO for organ 

recovery and receipt is changed from 30 

days to ‘‘immediately,’’ to facilitate 

monitoring of waiting list patients’

access to organs. 

Condition of Participation: Patient and 

Living Donor Rights (Proposed 

§ 482.102) 

In our discussion of patient rights in 

the preamble to the proposed rule, we 

said that we believed a living donor 

advocate or advocate team would ensure 

that the informed consent standards 

meet ethical principles as applied to the 

practice of living donor organ 

transplantation. Thus, we requested 

comments on whether we should 

include a requirement in the final rule 

for transplant centers performing living 

donor transplants to provide the 

services of an independent living donor 

advocate or advocate team, as well as 

recommendations for individual or team 

credentials. Based on public comments, 

we have added a requirement in this 

final rule, at § 482.98(d) CoP: Human 

resources, for an independent living 

donor advocate or living donor advocate 

team. The preamble discussion of an 

independent living donor advocate or 

living donor advocate team is located 

under the Human resources section of 

this final rule. 

We proposed that in addition to 

meeting the general hospital 

requirements for patients’ rights in the 

hospital CoPs at § 482.13, a transplant 

center must protect and promote each 

transplant patient’s and living donor’s 

rights. 

We proposed that the transplant 

center must have a written informed 

transplant patient consent process that 

informs each patient of: (1) The 

evaluation process; (2) the surgical 

procedure; (3) alternative treatments; (4) 

potential medical and psychosocial 

risks; (5) national and transplant centerspecific outcomes; (6) the fact that 

future health problems related to the 

transplantation may not be covered by 

the recipient’s insurance and that the 

recipient’s ability to obtain health, 

disability, or life insurance may be 

affected; (7) organ donor risk factors that 

could affect the success of the graft or 

the health of the patient, including, but 

not limited to, the donor’s history, 

condition or age of the organs used or 

the patient’s potential risk of contracting 

the human immunodeficiency virus and 

other infectious diseases if the disease 

cannot be detected in an infected donor; 

and (8) his or her right to refuse 

transplantation. 

We proposed that transplant centers 

must implement a written living donor 

informed consent process that informs 

prospective living donors of all aspects 

of living donation and potential 

outcomes from living donation. We 

proposed that transplant centers must 

ensure that prospective living donors 

are fully informed about the following: 

(1) The fact that communication 

between the donor and the transplant 

center will remain confidential in 

accordance with the requirements at 45 

CFR parts 160 and 164; (2) the 

evaluation process; (3) the surgical 

procedure, including post-operative 

treatment; (4) availability of alternative 

treatments for the transplant recipient; 

(5) potential medical and psychosocial 

risks to the donor; (6) national and 

transplant center-specific outcomes for 

both donors and recipients; (7) 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; and(8) the donor’s right to opt 

out of donation at any time during the 

donation process. 

We proposed that a transplant center 

must notify its waiting list patients of 

information about the center that could 

impact the patient’s ability to receive a 

transplant should an organ become 

available, and the procedures that are in 

place to ensure the availability of a 

transplant team. 

We proposed that a transplant center 

served by a single transplant surgeon or 

physician would be required to inform 

its waiting list patients of the potential 

unavailability of the transplant surgeon 

or physician and whether the center had 

a mechanism to provide an alternate 

transplant surgeon or transplant 

physician that meets the hospital’s 

credentialing policies. 

We proposed that at least 30 days 

before a center’s Medicare approval was 

terminated, whether voluntarily or 

involuntarily, the center would have to 

inform the patients on the waiting list 

of this fact, and must provide assistance 

to patients who choose to transfer to 

another Medicare-approved center, 

without loss of the patient’s time 

accrued on the waiting list. 

We also proposed that if a transplant 

center were terminated, such transplant 

center would have to inform Medicare 

beneficiaries on the center’s waiting list 

that Medicare would no longer pay for 

transplants performed at the center after 

the effective date of the center’s loss of 

approval. 

We requested comments on the 

proposed requirement for a transplant 

center to inform patients of potential 

organ donor risk factors that could affect 

the success of the graft or the health of 

the patient, including, but not limited 

to, the donor’s history; condition or age 

of the organs used; or the patient’s 

possible risk of contracting the human 

immunodeficiency virus and other 

infectious diseases if the disease could 

not be detected in an infected donor. We 

also solicited comments regarding our 

proposed informed consent 

requirements for living donors, 

including those requirements we 

proposed adopting from the Secretary’s 

Advisory Committee on Transplantation 

(ACOT) recommendations, and whether 

we would need to establish additional 

criteria for transplant centers 

performing living donor transplants. 

Following are summaries of the 

comments we received and our 

responses. 

Comment: Some commenters said that 

all kidney transplant centers should be 


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exempt from initial approval 

requirements (such as the requirement 

to perform 9 transplants) because a 

lengthy initial approval process would 

delay access to the new kidney center’s 

transplantation services for Medicare 

beneficiaries. 

Response: We share the commenters’

concern that a lengthy approval process 

for kidney centers, particularly a 

requirement to perform 10 transplants 

prior to approval, may disadvantage 

Medicare beneficiaries who need kidney 

transplants by limiting their access to 

transplantation services at new kidney 

transplant centers. Under section 

1861(s)(2)(J) of the Act, almost all ESRD 

transplant candidates must have their 

transplant surgery and follow-up care 

provided by a center that is already 

Medicare-certified in order for their 

immunosuppressant drugs to be paid for 

under Part B of Medicare as part of the 

Medicare transplantation services. 

Therefore, we are concerned that some 

new kidney centers may offer to provide 

free kidney transplants to Medicare 

beneficiaries in order to meet the 

Medicare clinical experience 

requirements and thus obtain Medicare 

approval expeditiously. These 

prospective kidney transplant 

candidates may not be aware of the 

implications for such free transplants 

that Medicare only pays for prescription 

drugs used in immunosuppressive 

therapy under Medicare Part B if the 

transplant was performed in a Medicareapproved facility. 

Therefore, we have added a 

requirement under the CoP for Patient 

and Living Donor Rights at 

§§ 482.102(a)(8) and 482.102(b)(9) that a 

transplant center must inform Medicare 

beneficiaries who are prospective 

transplant recipients and their 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 

for under Medicare Part B. See further 

discussion of this requirement in this 

preamble under ‘‘Centers With Current 

Medicare Approval.’’

Comment: A commenter 

recommended that the OPTN 

incorporate ACOT recommendations on 

transplant patient and living donor 

rights into its policies and monitor 

transplant center compliance. Another 

commenter suggested that we or the 

OPTN should provide transplant centers 

with sample education materials to 

educate donors about their rights. 

Response: The OPTN has published a 

variety of transplant education 

brochures for centers to distribute to 

patients and living donors; the list of 

resources is available at 

www.transplantliving.org. Although the 

OPTN does not have any publications 

specific to living donation (with the 

exception of some limited information 

published in the booklet titled ‘‘What 

Every Patient Needs to Know’’) it has 

posted extensive living donation 

information on its Web site. Suggestions 

that the OPTN adopt ACOT 

recommendations are beyond the scope 

of this rule. 

Informed Consent 

We are removing the proposed 

requirement that transplant centers 

inform transplant candidates of ‘‘the fact 

that future health problems related to 

the transplantation may not be covered 

by the recipient’s insurance, and that 

the recipient’s ability to obtain health, 

disability, or life insurance may be 

affected.’’ This language was included 

in the proposed rule in the standard for 

informed consent for transplant patients 

at § 482.102(a)(6); similar language was 

included in the standard for informed 

consent for living donors at 

§ 482.102(b)(7). It was intended to apply 

only to living donors. Thus, it has been 

removed at § 482.102(a)(6). 

Comment: Many commenters 

supported the requirement for informed 

consent to protect patient rights. 

However, some commenters supported 

the adoption of the ACOT 

recommendations in their entirety, 

rather than the limited number of 

specific informed consent elements that 

we proposed. One commenter 

recommended that we require a 

standardized informed consent process 

for all transplant centers. 

Response: We have chosen not to 

adopt the ACOT recommendations in 

their entirety because they are 

extensively detailed and go beyond 

what we perceive as necessary for 

Medicare approval. Instead, we have 

adopted the ACOT recommendations 

that are directly related to transplant 

patient and living donor rights. We have 

not included other recommendations 

that address organ donation, organ 

allocation, and organ procurement 

organizations. This final rule does not 

require a standardized informed consent 

process because such a requirement 

would deprive transplant centers of the 

flexibility we believe they need to 

develop informed consent policies that 

best serve their needs. 

Comment: A few commenters stated 

that the proposed informed consent 

provisions for transplant patients and 

living donors are too prescriptive and 

not a standard practice in medicine. The 

commenters said that a transplant 

center’s only legal obligation is to 

provide patients and living donors with 

sufficient information to make an 

informed decision. A few commenters 

said that the requirement for a written 

informed consent process is 

burdensome and unnecessary since 

hospitals already have informed consent 

policies that may be applicable to 

transplants. 

Response: As a standard practice for 

any type of surgical procedure, a 

hospital has the obligation to provide 

patients with sufficient information to 

make informed decisions. We believe 

the elements of informed consent that 

we proposed and that we require under 

this final rule are the minimum 

necessary to ensure transplant patients 

and living donors can make an informed 

decision. (See § 482.102(a).) We believe 

this basic information should be 

provided to patients and living donors 

by all transplant centers. 

We recognize that a transplant 

center’s informed consent process may 

overlap with the hospital’s informed 

consent process. A transplant center 

may choose to integrate the required 

elements for the transplant center 

informed consent process into the 

hospital informed consent process. We 

note, however, 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. 

In their recommendation, ACOT 

endorsed two ethical principles: (1) 

Equipoise; that is, the benefits to both 

the donor and the recipient outweigh 

the risks associated with the donation 

and transplantation of the live donor 

organ; and (2) that the potential donor’s 

participation is completely voluntary 

and may be withdrawn at any time. We 

believe transplant centers should base 

their informed consent policies and 

procedures on these principles and 

implement them scrupulously. We 

made no changes based on these 

comments. 

Comment: A commenter stated that 

once a transplant center documents in 

medical records that a patient’s 

informed consent was obtained 

(including the specifics that were 

discussed), it should be sufficient 

evidence that an informed consent 

policy exists. 


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Response: We disagree. We expect a 

transplant center to have informed 

consent policies that include a written 

informed consent process and 

documentation that informed consent 

was given. Therefore, the 

documentation of informed consent 

alone would not be sufficient to 

substitute for a written informed 

consent policy. 

Comment: Some commenters 

suggested eliminating the prescriptive 

informed consent language. One 

commenter stated that the requirement 

for a transplant center to inform patients 

about the patient evaluation process is 

too prescriptive. 

Response: We believe the information 

in the elements of informed consent that 

we proposed and that are set forth in 

this final rule are necessary for patients 

to make an informed decision about 

transplantation. We also believe it is 

important for transplant candidates to 

understand how they will be evaluated 

for placement on the waiting list, how 

their readiness for transplant will be 

ascertained while they are awaiting 

transplantation (for example, through 

periodic blood tests), and what factors 

could require their removal from the 

waiting list. 

Comment: Some commenters said that 

a transplant center should be required to 

use a patient education checklist to 

educate patients about transplant risks. 

One commenter asked how patient 

informed consent should be 

documented to comply with this 

requirement. 

Response: A transplant center may 

use any patient education tools, such as 

a patient education checklist, to educate 

patients about transplant risks, as long 

as the center includes the required 

elements. A transplant center may 

choose to document the discussion of 

informed consent in any format as long 

as the discussion is documented in the 

patient’s medical record. 

Comment: One commenter stated that 

a last-minute discussion of potential 

donor risk with a transplant recipient 

would be extremely difficult because 

the window of time between organ 

procurement and transplantation is very 

short. The commenter said that it is 

unrealistic to require centers to repeat 

the extensive informed consent process 

at the time of transplantation and 

suggested that the discussion with 

transplant candidates about potential 

risks should be done well before an 

actual organ offer takes place. The 

commenter recommended that the 

informed consent process be limited to 

the point in time when a patient is 

placed on a transplant waiting list. 

Response: We agree with the 

commenter. Our expectation is that 

discussion of potential donor risk 

factors should occur well before an 

organ is offered, for example, when the 

patient is first placed on the waiting list, 

and the information should be reviewed 

with the patient from time to time. We 

agree with the commenters that the time 

period between organ procurement and 

the offer of an organ may be too short 

for a thorough discussion of informed 

consent with patients. We do not expect 

a transplant center to rush through a 

detailed discussion of potential donor 

risk factors with transplant candidates 

just prior to transplantation. 

Comment: Some commenters 

expressed concern that it could be 

impossible for transplant centers to 

discuss all potential organ donor risk 

factors with transplant candidates. 

Another commenter stated that 

requiring a transplant center to provide 

a written explanation of organ-specific 

risk factors to patients would be 

burdensome. 

Response: Although it may not be 

possible for transplant centers to discuss 

every single potential organ donor risk 

factor with patients on their waiting 

lists, we expect centers to cover, at a 

minimum, the factors listed in the text 

of this final rule, that is, donor history; 

condition or age of the organs used; and 

the patient’s risk of contracting the 

human immunodeficiency virus and 

other infectious diseases if the disease 

cannot be detected in an infected donor. 

Providing this information should 

ensure that patients understand before 

they make transplant decisions that 

certain factors may affect the success of 

their transplant. Transplant centers 

certainly have the flexibility to discuss 

other risk factors beyond those we have 

delineated in this final rule. 

The requirement for transplant 

centers to have a written informed 

consent process does not mean that 

centers must provide a written 

explanation of organ-specific risk factors 

to transplant patients. As proposed, this 

final rule requires only that a transplant 

center inform patients of organ and 

organ donor risk factors. 

Comment: A commenter 

recommended that we require 

transplant centers to provide some 

minimal information for patients 

contemplating acceptance of an 

extended criteria donor (ECD) kidney as 

follows: (1) The increased likelihood of 

delayed graft function; (2) decreased 

graft survival compared to a non-ECD 

kidney; (3) increased longevity 

compared to remaining on dialysis; (4) 

the potential for decreased waiting time 

for a donated kidney; and (5) the benefit 

of receiving a transplant prior to 

beginning dialysis, which may cause 

related morbidity and mortality. 

Response: We agree with the 

commenter that these factors should be 

discussed with patients contemplating 

acceptance of an ECD kidney. As 

discussed in our previous comment, the 

fact that transplantation of certain types 

of organs (such as ECD or DCD organs) 

may have an effect on patient or graft 

survival must be discussed with 

transplant candidates, as appropriate. 

Thus, if a kidney transplant center 

transplants organs from ECDs, they 

should include all relevant facts about 

ECD organs in their discussion of organ 

donor risk factors with patients who are 

candidates for transplantation with an 

ECD organ, especially information about 

patient morbidity and mortality on 

dialysis versus transplantation with an 

ECD organ. 

Comment: A commenter suggested 

letting the transplant surgeon decide 

based on OPTN guidelines whether the 

organ donor risk factors are significant 

enough to warrant a discussion with a 

patient. 

Response: We agree with the 

commenter that the transplant surgeon 

should be responsible for taking the lead 

in discussing potential organ donor risk 

factors with the patient. At a minimum, 

we expect the transplant surgeon to 

discuss the potential organ donor risk 

factors described at § 482.102(a). The 

transplant surgeon also should decide 

whether other factors should be 

discussed. Although currently, there are 

no universal guidelines for organ donor 

risk factors, we believe surgeons should 

be able to reference current practices in 

their discussions with patients. 

Comment: Some commenters objected 

to the proposed requirement to inform 

patients of national and center-specific 

transplantation outcomes, as indicated 

in the SRTR reports. The commenters 

stated that expected survival rates 

indicated in the SRTR do not reflect the 

potential compromise of outcomes 

resulting from the use of ECD/DCD 

organs by some centers. 

In addition, the commenters were 

concerned that some patients may not 

have adequate knowledge to interpret 

the expected survival data properly. 

Response: The national and centerspecific outcomes as indicated in the 

SRTR reports are already publicly 

available at http:// 

www.ustransplant.org. The SRTR has 

added ECD as one of the risk-adjustment 

factors used in calculating expected 

survival rates. The OPTN may consider 

including DCD organs as one of the riskadjustment factors when more data are 

available. 


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Some patients may not be able to fully 

comprehend the SRTR reports. 

Nonetheless, we expect a transplant 

center to provide guidance to patients 

and families in finding and interpreting 

the SRTR reports in relation to the 

center’s own patient outcomes. At a 

minimum, we expect a transplant center 

to provide prospective transplant 

recipients, their families, and 

prospective living donors with 

information from the most recent SRTR 

center-specific report, including (but not 

limited to) the transplant center’s 

observed and expected 1-year patient 

and graft survival, national 1-year 

patient and graft survival, and 

notification about all Medicare outcome 

requirements not being met by the 

transplant center. 

Comment: Many commenters 

supported establishing requirements for 

an informed consent process for living 

donors. Some commenters noted that 

informed consent for living donors 

protects the donor and reduces legal 

liability for the transplant team. Many 

commenters said that they specifically 

supported incorporating the ACOT 

recommendations into Medicare 

requirements. In fact, one commenter 

was concerned that we had not adopted 

all of ACOT’s initial recommendations 

related to living donation. 

Response: We agree that protections 

for living donors are essential. 

Therefore, as proposed, we are adopting 

the ACOT recommendations that 

address the health and safety of living 

donors. 

Although we have not adopted the 

ACOT recommendations for living 

donors in this final rule in their entirety, 

because some of them fall outside the 

purview of this rule, we recommend 

that transplant centers that perform 

living donor transplants consider them 

when developing informed consent 

policies for living donors. 

Comment: A commenter stated that 

there is no compelling reason why the 

proposed informed consent process for 

living donors should go beyond the 

OPTN requirements. 

Response: 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. 

Further, as we have stated in our 

responses to previous comments 

including these requirements in 

regulations provides us with the 

authority for oversight and enforcement. 

Comment: A commenter stated that 

the requirement for transplant centers to 

model the ACOT recommendations for 

informed consent for living liver donors 

is overbearing and noted that it should 

not apply to living kidney donors as 

living kidney donation is a more 

simplified procedure requiring fewer 

informed consent details. 

Response: We did not propose 

requiring hospitals to adopt the ACOT 

recommendations for informed consent 

for living liver or kidney donors. We 

cited the documents in the preamble to 

the proposed rule only to provide 

guidance for transplant centers 

developing informed consent polices for 

living donors. However, all living 

donors deserve the same level of 

protection. Although individuals 

contemplating living donation of 

different organ types may need different 

information, all living donors should be 

provided with sufficient information on 

which to make a fully informed 

decision. 

Comment: A commenter requested 

clarification on the requirement for 

documentation of informed consent for 

living donors, and the commenter asked 

if separate informed consent forms are 

needed for living donors. 

Response: A transplant center may 

choose to document the discussion of 

informed consent with living donors in 

any manner it chooses. The center may 

document every discussion in detail or 

use a checklist or any other tool of its 

choice to indicate that all the core 

components were covered. 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. 

Comment: A commenter noted that 

the presentation of the elements of 

informed consent to potential recipients 

and living donors should be easy to 

understand and consistent with each 

patient’s native language and 

educational level. The commenter said 

that adequate time should be given to 

donors to make a donation decision that 

is free from coercion and noted that 

New York State law gives living donors 

2 weeks to make a decision. 

Response: We agree with the 

commenter’s observations. Nevertheless, 

we have not specified requirements in 

this final rule for educational level or 

language for informed consent 

documents, nor have we specified a 

standard period of time prospective 

living donors be given to make a 

donation decision. We have avoided 

such prescriptive requirements 

throughout this final rule to provide 

transplant centers with the maximum 

flexibility to implement the rule’s 

requirements according to their needs 

and the needs of their patient 

populations. Although we have not 

incorporated the commenter’s 

suggestions into this final rule, we 

would urge transplant centers to 

consider the suggestions as they develop 

their informed consent process. 

Comment: Some commenters 

supported the concept of informing 

living donors of short and long-term 

risks but suggested eliminating the 

requirement because providing this 

information would require the 

availability of a living donor registry 

that tracks these risks. A commenter 

recommended that the Secretary pursue 

action to establish a living donor 

registry. 

Response: Currently, there is no 

official living donor registry. However, 

collection of living donor outcome 

metrics by the OPTN is ongoing, and the 

follow-up data period for live donors 

has been extended from 1 year to 2 years 

post-transplant. The OPTN is reevaluating living donor follow-up forms, 

developing strategies to improve their 

completeness, and considering the 

development of a living donor registry. 

Once data for national and transplant 

center-specific outcomes for living 

donors are readily available to 

transplant centers, centers must begin 

providing the data to living donors to 

assist them in making a decision 

whether to donate. In the interim, each 

center must provide whatever data are 

available on its own living donor 

outcomes to prospective living donors. 

Should national living donor data 

become available in the future, 

transplant centers must provide this 

information to prospective living 

donors. Thus, we have added language 

at § 482.102(b)(6) that specifies living 

donors must be informed about national 

and center-specific outcomes for living 

donors, as data are available. 

Notification to Patients 

Note that we have removed the phrase 

‘‘that meets the hospital’s credentialing 

policies’’ from the end of the sentence 

‘‘whether or not the center has a 

mechanism to provide an alternate 

transplant surgeon or transplant 

physician that meets the hospital’s 

credentialing policies’’ in 

§ 482.102(c)(1)(ii) of the proposed rule. 

A hospital where a transplant center is 

located should have a process for 

credentialing of its staff as required by 

§ 482.22. Therefore, a requirement for an 

alternate transplant surgeon or 

transplant physician ‘‘that meets the 

hospital’s credentialing policies’’ is 

unnecessary. 


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Comment: Some commenters 

supported the requirement for a 

transplant center to notify patients of 

information that could impact the 

patients’ ability to receive an organ. 

Such information would include 

informing patients of the possibility that 

a center’s sole transplant team might be 

unavailable when an organ becomes 

available and whether the center has a 

mechanism to provide an alternate 

transplant surgeon or transplant 

physician. However, other commenters 

said that the requirement would be 

burdensome. They stated that a 

requirement to notify patients about 

short-term absences (for example, 

sickness, vacation, and conferences) 

would be unrealistic. The commenters 

suggested that a requirement to notify 

waiting list patients of the unavailability 

of the transplant surgeon or physician 

for more than 30 days would be 

realistic. 

Response: We did not propose nor do 

we require in this final rule that 

transplant centers notify waiting list 

patients about specific absences as they 

occur. Instead, we are requiring a 

transplant center served by a single 

transplant surgeon or physician to 

inform each waiting list patient of the 

possibility that the center’s transplant 

surgeon(s) or physician(s) may not be 

available at the time an organ becomes 

available. We also require a transplant 

center to tell each waiting list patient 

whether the center has a mechanism to 

provide an alternate transplant surgeon 

or physician. 

Comment: A commenter suggested 

that in the context of termination under 

§ 482.102(c)(2), which requires a 

transplant center whose Medicare 

approval is terminated to inform waiting 

list patients at least 30 days prior to the 

termination, we should modify the 30- 

day requirement by adding ‘‘and 

following the exhaustion of all appeals 

provided pursuant to [part] 498 * * *.’’

Response: The general provisions 

under 42 CFR part 498 provide for an 

administrative judicial review of 

administrative determinations, for 

providers facing termination of 

Medicare approval. Thus, if a transplant 

center appeals a termination of 

Medicare approval under 42 CFR, part 

498, the termination will not occur until 

the appeals process, if any, is 

completed. Therefore, there is no need 

to incorporate the commenter’s 

suggested language. 

Comment: A commenter stated that 

the proposed rule does not address how 

care would be provided for patients on 

the waiting list of a transplant center 

whose Medicare approval was 

terminated. 

Response: We disagree. Sections 

482.102(c)(2)(i) and (ii) of both the 

proposed rule and this final rule 

provide that at least 30 days before a 

center’s Medicare approval is 

terminated, whether voluntarily or 

involuntarily, the center must inform 

patients on the center’s waiting list. The 

transplant center also must provide 

assistance to waiting list patients who 

choose to transfer to the waiting list of 

another Medicare-approved transplant 

center without loss of time accrued on 

the waiting list. Further, the transplant 

center must inform Medicare 

beneficiaries on the center’s waiting list 

that Medicare will no longer pay for 

transplants performed at the center after 

the effective date of the center’s loss of 

Medicare approval. 

This final rule adds a requirement at 

§ 482.102(c)(3) for patient notification if 

a transplant center voluntarily 

inactivates. We require that as soon as 

possible, prior to a transplant center’s 

inactivation, the center must inform 

patients on the center’s waiting list and, 

as directed by the Secretary, provide 

assistance to waiting list patients who 

choose to transfer to the waiting list of 

another Medicare-approved transplant 

center without loss of time accrued on 

the waiting list. As we stated earlier, we 

intend to monitor transplant center 

inactivity closely. 

Condition of Participation: Additional 

Requirements for Kidney Transplant 

Centers (Proposed § 482.104) 

We proposed to delete some sections 

from part 405, subpart U and move 

some of the sections in subpart U to this 

final rule. 

We proposed that kidney transplant 

centers be required to furnish: (a) 

Transplantation and other medical and 

surgical specialty services required for 

the care of ESRD patients; and (b) 

inpatient dialysis services, directly or 

under arrangement. We proposed that 

such kidney dialysis centers or units 

must meet the conditions for coverage of 

suppliers of ESRD services contained in 

part 405, subpart U. 

We proposed that kidney transplant 

centers would be required to cooperate 

with the ESRD Network designated for 

its geographic area in fulfilling the terms 

of the network’s current statement of 

work. 

Following are summaries of the 

comments we received and our 

responses. Note that based on public 

comments summarized earlier in this 

preamble, we have added a requirement 

at § 482.104(a) that a kidney transplant 

center must have written policies and 

procedures for ongoing communication 

with dialysis patients’ local dialysis 

facilities. 

Comment: A commenter requested 

clarification about the extent to which a 

dialysis facility providing acute services 

to transplant recipients must meet the 

requirements of a chronic dialysis 

facility under the ESRD rule. Another 

commenter suggested deleting the 

proposed requirement for transplant 

centers that furnish inpatient dialysis 

services to meet the conditions for 

coverage for suppliers of ESRD Services 

contained in part 405 Subpart U. A 

commenter recommended that we add a 

new condition of participation for 

inpatient dialysis units to provide 

regulatory guidance for providers of 

inpatient dialysis services in acute care 

settings. 

Response: Based on these comments 

and further analysis of our proposal, we 

have concluded that it is unnecessary to 

require transplant centers that provide 

inpatient dialysis services to kidney 

transplant patients to comply with the 

Conditions for Coverage for Suppliers of 

ESRD Services in part 405 subpart U. 

Kidney transplant centers are located 

inside hospitals that must comply with 

the Medicare hospital CoPs, which 

include quality standards that apply to 

all services provided by hospitals. Since 

inpatient dialysis services furnished 

either directly by kidney transplant 

centers or under arrangement are subject 

to the requirements in the hospital 

CoPs, we see no need to regulate 

inpatient dialysis services separately. 

Therefore, we have removed the 

proposed requirement at § 482.104(b) 

that inpatient kidney dialysis centers or 

units must meet the Conditions for 

Coverage, part 405, subpart U for 

suppliers of ESRD services. We have 

retained in this final rule only the 

requirement that kidney transplant 

centers must furnish inpatient dialysis 

services directly or under arrangement. 

However, a kidney transplant center 

that furnishes outpatient dialysis 

services directly or under arrangement 

in dialysis centers or units is required 

to meet the Conditions for Coverage for 

Suppliers of ESRD Services contained in 

part 405, subpart U. 

Comment: A commenter suggested 

requiring transplant centers performing 

pediatric kidney transplants to provide 

inpatient pediatric dialysis services 

with appropriate pediatric equipment 

and nursing expertise. 

Response: We expect both pediatric 

and adult transplant centers to provide 

staffing, equipment, and other resources 

appropriate to the needs of their specific 

patient population. Since providing 

inpatient dialysis services to pediatric 

patients may require specialized 


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pediatric equipment and specific 

pediatric nursing expertise, we believe 

transplant centers should have the 

flexibility to determine how they will 

provide these services. We have made 

no changes in this final rule based on 

this comment. 

Comment: A few commenters 

supported the requirement for kidney 

transplant centers to remain associated 

with the ESRD Network. However, one 

commenter stated that the proposed 

requirement for participation in network 

activities is duplicative of 42 CFR part 

405, subpart U and requested 

clarification. 

Response: Existing §§ 405.2110 

through 405.2112 contain provisions 

that relate to the designation and 

functions of the ESRD networks. These 

provisions focus primarily on the role 

and responsibilities of the ESRD 

networks. Although we do not believe 

the role and responsibilities of the 

networks need to be included in this 

final rule, we believe that kidney 

transplant centers must continue to 

share information and collaborate with 

the networks. Thus, under § 482.104(c), 

we are finalizing our proposal that 

kidney transplant centers must 

cooperate with the ESRD network 

designated for their geographical area in 

fulfilling the terms of the network’s 

current statement of work. 

Deeming Authority (§ 488.6) 

Under § 1865 of the Act and § 488.5 

of the regulations, hospitals that are 

accredited by the Joint Commission on 

Accreditation of Healthcare 

Organizations (JCAHO) or the American 

Osteopathic Association (AOA) are not 

routinely surveyed by the State survey 

agencies for compliance with the CoPs. 

Instead, they are deemed to meet the 

requirements based on either their 

JCAHO or AOA accreditation. In order 

to receive this deemed status, hospitals 

as well as other providers and suppliers, 

which are accredited by JCAHO, AOA, 

or other national accreditation programs 

with deeming authority under § 488.6 of 

the regulations (see part 488, Survey 

and Certification Procedures), must 

meet requirements that are at least as 

stringent as the Medicare CoPs. 

Therefore, an accreditation organization 

could apply for and receive approval of 

deeming authority for the transplant 

center CoPs if the accreditation 

organization demonstrates that its 

requirements for transplant centers are 

at least as stringent as those in this final 

rule. In this final rule, we are amending 

§ 488.6, as described at 42 CFR part 488, 

subpart A, to include transplant centers, 

except for kidney transplant centers, 

among those providers and suppliers 

that are eligible to receive deemed status 

based on such an accreditation. A 

transplant center can choose to meet the 

requirements through the accreditation 

process or through a State survey. As a 

designee of CMS, an accrediting 

organization or a State survey agency 

must survey each transplant center’s 

compliance with the clinical 

experience, outcome, data submission, 

and process requirements. In either 

case, the special procedures for 

transplant centers, as described under 

§ 488.61, will ultimately guide the 

survey process. 

Special Procedures for Approval and 

Re-Approval of Organ Transplant 

Centers (Proposed § 488.61) 

We proposed utilizing the survey, 

certification, and enforcement 

procedures described at 42 CFR part 

488, subpart A, including the periodic 

review of compliance and approval 

contained in § 488.20. We would retain 

§ 488.60 to apply exclusively to ESRD 

facilities. Following are summaries of 

the comments we received and our 

responses. 

(a) Initial Approval Procedures 

We proposed that a transplant center 

would be permitted to submit a letter of 

request to us for Medicare approval at 

any time. We proposed that the letter, 

signed by a person authorized to 

represent the center, would have to 

include the hospital’s Medicare 

provider I.D. number, name(s) of the 

designated primary transplant surgeon 

and primary physician, and a statement 

from the OPTN that the center had 

complied with all data submission 

requirements. 

We proposed that we or our designee 

would determine a transplant center’s 

compliance with the data submission 

and outcome requirements proposed at 

§ 482.80(b) and (c). We or our designee 

would review the 1-year patient and 

graft survival data contained in the 

SRTR’s most recent center-specific 

reports. 

We proposed that, if both of the 

conditions in § 482.80(b)(4) applied, the 

center could ask the SRTR to prepare a 

customized report of the center’s 1- 

month patient and graft survival data for 

the previous 1-year period. We or our 

designee would determine compliance 

with the outcome requirements 

contained at § 482.80(b) using the data 

contained in these customized reports. 

We proposed that if we or our 

designee determined that a transplant 

center met the data submission and 

outcome requirements of § 482.80, we or 

our designee would conduct a survey 

and review the center’s compliance with 

the conditions of participation 

contained at § 482.68 through § 482.76 

and § 482.90 through § 482.104, using 

the procedures described at 42 CFR part 

488, subpart A. 

We proposed that if a transplant 

center seeking Medicare approval was 

found to be in compliance with all 

conditions of participation at § 482.68 

through § 482.104, except for § 482.82 

(Re-approval requirements), we would 

notify the transplant center in writing of 

the effective date of its Medicare 

approval or notify the transplant center 

in writing if it were not approved. We 

proposed that we would grant initial 

approval to a transplant center for 3 

years. 

(b) Re-Approval Procedures 

We proposed that once Medicareapproved, a transplant center would 

have to be in compliance with all 

conditions of participation for 

transplant centers at § 482.68 through 

§ 482.104, except for § 482.80 (Initial 

approval requirements) throughout the 

3-year approval period. 

We proposed that at least 180 days 

before the end of the 3-year approval 

period, we or our designee would 

review the transplant center’s data in 

making re-approval determinations. 

We proposed that: (1) To determine 

compliance with the data submission 

requirements at § 482.82(a), we or our 

designee would request data submission 

data from the OPTN for the previous 3 

calendar years; and (2) to determine 

compliance with the outcome 

requirements at § 482.82(c), we or our 

designee would review the data 

contained in the most recent SRTR 

center-specific reports. 

We proposed that if we or our 

designee determined that a transplant 

center met the data submission and 

outcome requirements at § 482.82, the 

transplant center would be re-approved 

for 3 years. 

We proposed that if we or our 

designee determined that a transplant 

center failed to meet the data 

submission or outcome requirements 

contained at § 482.82, the transplant 

center would be surveyed for 

compliance with § 482.68 through 

§ 482.76 and § 482.90 through § 482.104, 

using the procedures described at 42 

CFR part 488, subpart A. 

We proposed that we or our designee 

would notify the transplant center in 

writing if it were re-approved or if its 

approval were being revoked. If reapproved, we or our designee would 

notify the transplant center of the 

effective date of the re-approval. 


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(c) Loss of Medicare Approval 

We proposed that centers that lost 

their Medicare approval would be 

permitted to seek re-entry into the 

program at any time, using the 

procedures described at § 488.61(a). We 

proposed that a center that lost its 

Medicare approval would be required to 

be in compliance with §§ 482.68 

through 482.104, except for § 482.82 

(Re-approval procedures), at the time of 

the request for Medicare approval. We 

proposed that a center seeking to reenter the Medicare program would be 

required to submit a report documenting 

any changes or corrective actions the 

center took as a result of the loss of its 

Medicare approval status. 

We proposed that transplant centers 

with current Medicare approval would 

be permitted to continue to provide 

transplant services until we notified 

them whether they were approved 

under the new CoPs for transplant 

centers. For clarity we are adding the 

words ‘‘OPTN Data Report’’ to the 

regulation text for this section to 

describe the source of the data we will 

review to determine compliance with 

the clinical experience requirements. 

Following are summaries of the 

comments we received and our 

responses. 

Initial Approval Procedures for New 

Transplant Centers 

Comment: Some commenters 

disagreed with the proposed process for 

initial approval of transplant centers, 

specifically, that if a center did not meet 

the data submission and/or outcome 

requirements, the center would not be 

considered for approval. Some 

commenters stated that data submission 

and outcome measures should be used 

only as indicators and not as pass/fail 

tests to approve centers. Other 

commenters suggested that the initial 

approval procedures should be similar 

to the proposed re-approval procedures, 

so that centers failing to meet the data 

and outcome requirements would not be 

denied Medicare approval automatically 

but would be surveyed to determine 

whether they should be approved. 

Response: In view of the public 

comments, as well as the potential 

disruption for Medicare beneficiaries if 

a large number of currently approved 

centers are denied initial approval 

under the requirements of this final 

rule, we will not deny initial approval 

to a transplant center automatically as 

we proposed at § 488.61, if it fails to 

meet the data, clinical experience, or 

outcome requirements at § 482.80. 

Instead, we will take a flexible approach 

to our initial approval of transplant 

centers, as described at § 488.61 in this 

final rule. For the initial approval 

process, we will conduct a follow-up 

survey in all instances at currently 

Medicare-approved transplant centers if 

the center has not met the clinical 

experience and/or outcome 

requirements. We will exercise our 

discretion for new applications to the 

Medicare program. CMS will prioritize 

the scheduling of follow-up surveys 

based on the center’s volume and 

outcome measurements and the 

program’s history. CMS will survey 

these centers for the remaining 

conditions of participation and develop 

plans of correction for any condition or 

standard that is not met. If a center has 

‘‘failed’’ the outcome measures, we will 

expect the plans of correction to include 

steps to improve these outcomes within 

a reasonable time frame (for example, by 

the next release of outcomes in the 

center-specific report). 

Thus, under this final rule at 

488.61(a)(3), if we determine that a 

transplant center, including a kidney 

transplant center, applying for initial 

approval has not met the data 

submission, clinical experience, or 

outcome requirements, we may deny the 

request for approval or we may review 

the center’s compliance with the 

conditions of participation at § 482.72 

through § 482.76 and § 482.90 through 

§ 482.104, using the procedures 

described at 42 CFR part 488, subpart A, 

to determine whether the center’s 

request should be approved. Our review 

may include a survey of the transplant 

center. We will notify the transplant 

center in writing whether its request has 

been approved and, if approved, the 

effective date of its approval. 

However, we will not grant initial 

approval unless: (1) The center has met 

or has come very close to meeting the 

data, clinical experience, and outcome 

requirements; and (2) the center is in 

compliance with all other conditions of 

participation. In the initial approval 

process, we will give the center an 

opportunity to correct any areas that do 

not meet the Conditions of Participation 

in a reasonable time period through a 

Plan of Correction that is developed by 

the Center, and approved and monitored 

by CMS. 

Following are examples of situations 

in which a transplant center applying 

for initial approval fails to meet the data 

submission, clinical experience, or 

outcome requirements and, for each 

example, an explanation of why we 

would or would not approve the center. 

Example 1: A large heart transplant center 

that is currently Medicare approved under 

the NCDs applies for initial approval under 

the new CoPs. The center consistently 

performs a large number of heart transplants 

annually and demonstrates superior 

performance on the outcome requirements. 

However, the transplant center has not met 

the data submission requirement by 

submitting 95 percent of the required data to 

the OPTN within 90 days of the due date. In 

fact, in the preceding 12 months, the 

transplant center submitted less than 90 

percent of its transplant data within 90 days 

of the due date. 

Because of the transplant center’s extensive 

clinical experience and superior outcomes, 

we perform a review of the center and 

determine that the center meets all 

conditions of participation other than the 

standard for data submission. The transplant 

center submits a plan of correction to us, 

demonstrating how it plans to come into 

compliance with the data submission 

requirement by hiring additional staff to 

collect transplant data and report it to the 

OPTN. We review and accept the plan of 

correction and approve the center. 

Example 2: A small, currently-approved 

liver transplant center applies for initial 

approval under the new CoPs. The center is 

the only liver center in a large western state 

that is primarily rural. The center meets the 

data submission requirement and its 

outcomes are acceptable. However, the center 

performed only 7 transplants in the 

preceding 12 months. Because the transplant 

center meets the data submission and 

outcome requirements and because it is the 

only liver transplant center in a largely rural 

state, we perform a review of the center and 

determine that it meets all the standards 

other than the clinical experience 

requirement. The center submits a plan of 

correction, detailing how it will attempt to 

meet the clinical experience requirement in 

the future (for example, by accepting more 

extended criteria organs for its patients). We 

accept the plan of correction and approve the 

center. 

Example 3: A small kidney center that is 

currently approved under the ESRD CfCs 

applies for approval under the new CoPs. 

The kidney center meets the data submission 

requirement. The center performed 2 of the 

10 transplants in the preceding 12 months 

and its outcomes are slightly below what is 

required under the CoPs. Although the center 

failed to meet both the clinical experience 

and the outcome requirements, we will 

review the transplant center’s compliance 

with the other conditions of participation 

before making a decision on its request for 

approval. However, it is unlikely that we will 

grant approval under such conditions. 

Example 4: A lung center located in a large 

city in the northeastern United States applies 

for Medicare approval under the 

requirements in the final rule. The lung 

center is currently Medicare approved. The 

center meets the data submission and clinical 

experience requirements. However, the 

center’s 1-year observed patient and 1-year 

observed graft survival has been considerably 

below its expected 1-year expected patient 

and 1-year expected graft survival for the 

entire 2.5 year cohort. The center’s outcomes 

show no sign of trending upward. We deny 

the center’s request for approval. The center 

is free to re-apply at any time. 


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In summary, the flexibility of the 

initial approval process in this final rule 

will permit us to survey and possibly 

approve transplant centers that fail to 

meet the data submission, clinical 

experience, or outcome requirements 

when there are mitigating circumstances 

or when a transplant center’s reported 

outcomes do not reflect the general high 

quality of its transplantation services. 

Based on the comments we received, 

§ 488.61(a)(3) has been revised to read 

‘‘If CMS determines that a transplant 

center has not met the data submission, 

clinical experience, and outcome 

requirements, CMS may deny the 

request for approval or may review the 

center’s compliance with the conditions 

of participation at § 482.72 through 

§ 482.76 and § 482.90 through § 482.104, 

using the procedures described at 42 

CFR part 488, subpart A, to determine 

whether the center’s request will be 

approved. CMS will notify the 

transplant center in writing whether it 

is approved and, if approved, the 

effective date of its approval.’’

Initial Approval Procedures For Centers 

With Current Medicare Approval 

Comment: Commenters objected to 

the proposed requirement that all 

transplant centers with current 

Medicare approval must apply for initial 

approval under the CoPs. 

Response: We do not believe it would 

be in the best interests of Medicare 

beneficiaries awaiting organ transplants 

to automatically approve centers with 

current Medicare approval because 

these centers were approved under 

NCDs for heart, liver, lung, and intestine 

centers or the ESRD CfCs for kidney 

transplant centers, which are different 

in many aspects from the CoPs in this 

final rule. For example, there are no 

outcome requirements for kidney 

transplant centers in the ESRD CfCs. 

Further, we know that some extra-renal 

transplant centers that were approved 

based on NCD criteria no longer meet 

those criteria. Therefore, automatically 

approving centers with current 

Medicare approval has the potential to 

permit a number of poor or marginal 

performers to continue to participate in 

Medicare. Based on these 

considerations, prior to approving 

currently approved transplant centers 

under our new requirements, we must 

first verify that they meet the CoPs in 

this final rule. The requirement for all 

currently-approved transplant centers to 

re-apply for initial approval under these 

new standards is consistent with our 

goals to increase transparency in the 

approval process and strengthen our 

oversight authority. 

We expect all transplant centers, 

including kidney transplant centers, 

that are Medicare approved as of the 

effective date of this final rule that wish 

to continue to provide services to 

Medicare beneficiaries to be in 

compliance with the CoPs at §§ 482.72 

through 482.104, as of the effective date 

of this final rule. Such transplant 

centers have 180 days from the effective 

date of this final rule to submit a request 

for Medicare approval under the CoPs at 

§§ 482.72 through 482.104, using the 

process described at § 488.61(b). 

CMS will consider mitigating factors, 

including (but not limited to) the 

following in considering approval of a 

transplant center that does not meet the 

conditions of participation: the extent to 

which outcome measures are met or 

exceeded, availability of Medicareapproved transplant centers in the area, 

and extenuating circumstances (e.g., 

natural disaster) that may have a 

temporary effect on meeting the 

conditions of participation. In addition, 

the transplant center must submit to 

CMS and implement a plan of 

correction to meet the conditions of 

participation. 

We will determine whether to 

approve the transplant center using the 

procedures described in paragraphs 

§ 488.61(a)(2) through (a)(5). Until we 

make a determination whether to 

approve the transplant center’s request 

for approval, the transplant center will 

continue to be approved under the 

ESRD CfCs (for kidney transplant 

centers) or the pertinent NCDs (for 

extra-renal transplant centers), as 

applicable. The transplant center will 

continue to be reimbursed for services 

provided to Medicare beneficiaries. 

Once we approve a kidney transplant 

center under the CoPs, the ESRD CFCs 

will no longer apply to the transplant 

center as of the date of its approval. 

Once we approve an extra-renal 

transplant center under the conditions 

of participation, the NCDs will no 

longer apply to the transplant center as 

of the date of its approval. (See 

§ 488.61(b).) Until we approve a 

currently approved transplant center 

under the CoPs in this final rule, the 

transplant center must continue to 

comply with the requirements in the 

NCDs or the ESRD CFCs, as applicable. 

If a transplant center that is Medicare 

approved as of the effective date of this 

final rule does not submit a request to 

us for Medicare approval under the 

CoPs at §§ 482.72 through 482.104 

within 180 days after the effective date 

of the final rule, or if the transplant 

center applies timely, but we do not 

approve the transplant center under the 

CoPs in this final rule, we will revoke 

the transplant center’s approval under 

the CfCs for kidney transplant centers or 

the NCDs for extra-renal transplant 

centers, as applicable, and the 

transplant center will no longer be 

reimbursed for services provided to 

Medicare beneficiaries. CMS will notify 

the transplant center in writing of the 

effective date of its loss of Medicare 

approval. 

Re-Approval Procedures 

We asked the public and the five peer 

reviewers to comment on the following 

re-approval issues: (1) The feasibility 

and utility of the alternative approach to 

re-approve transplant centers based on 

random surveys; (2) methodology for 

selecting a random sample for surveys; 

(3) the necessity of surveying all centers 

every 3 years, regardless of their 

compliance with data submission and 

outcome measure requirements; and (4) 

the appropriateness of making reapproval survey decisions based on 

OPTN information (that is desk review, 

on-site audits and action(s) taken since 

last Medicare approval). 

Following are the comments we 

received and our responses. 

(1) The Feasibility and Utility of the 

Alternative Approach To Re-Approve 

Transplant Centers Based on Random 

Surveys 

Comment: A peer reviewer agreed that 

a transplant center’s compliance with 

data submission and outcome measure 

requirements by itself is not sufficient 

evidence for CMS to grant Medicare reapproval. However, two peer reviewers 

did not agree with using random 

surveys to identify transplant programs 

with deficiencies and stated that 

random surveys would miss many 

programs whose performance may 

warrant a survey. One peer reviewer 

supported using random surveys to reapprove transplant centers and believed 

it to be a systematic approach to assess 

transplant centers. One peer reviewer 

stated that Medicare’s re-approval 

process should rely on the OPTN’s 

monitoring and oversight process for 

transplant centers. 

Many public commenters also agreed 

with our concern that a center’s 

compliance with data submission and 

outcome requirements may not 

necessarily indicate a center is also in 

compliance with the process 

requirements. These commenters 

supported targeted or random surveys to 

determine re-approval decisions. 

However, one commenter said that 

random surveys for re-approval are 

unnecessary if a center has 

demonstrated consistent compliance 

with the requirements. 


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Response: We recognize that 

transplant center performance varies 

greatly and random surveys of centers 

may not be able to identify all poor 

performers. After carefully evaluating 

all the comments and taking into 

consideration the results of our recent 

survey of transplant centers, we believe 

finite resources are best used to survey 

the poorest performers and centers with 

significant deficiencies. Therefore, we 

will not perform random surveys as part 

of the re-approval process for transplant 

centers. Instead, we will review centers 

that do not meet the data submission, 

clinical experience, and outcome 

requirements for compliance with the 

CoPs before making our re-approval 

decision. The review may include an 

on-site visit. Under the final rule at 

§ 488.61(c)(2), if we determine that a 

transplant center has not met the data 

submission, clinical experience, or 

outcome requirements at § 482.82, the 

transplant center will be reviewed for 

compliance with the conditions of 

participation at § 482.72 through 

§ 482.76 and § 482.90 through § 482.104, 

using the procedures described at 42 

CFR part 488, subpart A. Under the final 

rule at § 488.61(c)(3), if we determine 

that a transplant center has met the data 

submission, clinical experience, and 

outcome requirements at § 482.82, we 

may choose to review the transplant 

center for compliance with the 

conditions of participation at § 482.72 

through § 482.76 and § 482.90 through 

§ 482.104, using the procedures 

described at 42 CFR part 488, subpart A. 

CMS will consider mitigating factors, 

including (but not limited to) the 

following in considering approval of a 

transplant center that does not meet the 

conditions of participation: The extent 

to which outcome measures are met or 

exceeded, availability of Medicareapproved transplant centers in the area, 

and extenuating circumstances (e.g., 

natural disaster) that may have a 

temporary effect on meeting the 

conditions of participation. In addition, 

the transplant center must submit to 

CMS and implement a plan of 

correction to meet the conditions of 

participation. 

During the Medicare approval cycle, a 

transplant center will be reviewed at 

some point to ensure it is in compliance 

with the CoPs. The existing complaint 

investigation process and the use of 

relevant data, including the OPTN data, 

are good tools to identify centers with 

deficiencies. 

As stated earlier, the OPTN and CMS 

oversight have a different focus, and 

they compliment each other. Therefore, 

we disagree with the commenter that 

OPTN oversight can substitute for CMS 

oversight. Further, we do not have the 

statutory authority to delegate 

regulatory authority to the OPTN to 

regulate transplant centers. No changes 

have been made in this final rule based 

on this comment. 

(2) Methodology To Select a Random 

Sample for Surveys 

Comment: Most peer reviewers had 

no comments on this issue. One peer 

reviewer suggested that 5–10% of small 

and large organ-specific centers should 

be selected for random surveys. 

Response: We thank the peer reviewer 

for his suggestions. However, as stated 

in our responses earlier, we are not 

using random surveys to make reapproval decisions in this final rule. No 

changes have been made based on this 

comment. 

(3) Whether Centers Should Be 

Surveyed Once Every 3 Years, 

Regardless of Their Compliance With 

Data Submission and Outcome Measure 

Requirements 

Comment: A few commenters 

recommended surveying only centers 

that fail to comply with data submission 

and outcome measure requirements 

every 3 years. A commenter stated that 

all centers should be surveyed for 

compliance with the process 

requirements every 3 years, regardless of 

whether they are in compliance with 

data and outcome requirements. The 

commenter suggested allowing a plan of 

correction if a center is out of 

compliance with one or more conditions 

for coverage. Another commenter 

recommended that re-approval surveys 

be conducted only when a center has 

become an OPTN ‘‘member not in good 

standing’’ and only after exhaustion of 

all OPTN appeals processes and 

remedies. A commenter recommended 

that transplant centers be subject to only 

one survey every 3 years by either the 

OPTN or CMS but not both because 

surveys are burdensome, bureaucratic, 

and costly. 

Two peer reviewers supported routine 

periodic survey of transplant centers for 

the purposes of: (1) Validating the 

timeliness and accuracy of data 

submission, (2) enhancing transplant 

centers’ self-assessment process, and (3) 

sharing best practices to improve 

performance. A peer reviewer 

recommended surveying only centers 

that fail to comply with data submission 

and outcome measure requirements 

every 3 years. One peer reviewer stated 

that routine surveys are burdensome for 

centers that are performing well. 

Response: We agree with the 

commenters and peer reviewers that 

transplant centers’ data submission and 

outcome performance should be 

reviewed regularly to ensure they are in 

compliance with all of our 

requirements, even if they are 

consistently in compliance with data 

submission and clinical experience 

requirements. Nonetheless, we are also 

mindful of the potential burden on 

centers that are in compliance with the 

CoPs. Therefore, we will minimize the 

burden for transplant centers by 

conducting targeted re-approval 

surveys. For example, a center that 

barely meets the outcome requirements 

may be surveyed every 3 years, while a 

center that consistently has superior 

outcomes may be surveyed less often. 

As stated previously, transplant 

centers will be subject to the same 

remediation process, including plans of 

correction, used for nearly all other 

Medicare providers and suppliers. 

Also, we disagree with the 

commenter’s suggestion to use the 

OPTN membership status of ‘‘not in 

good standing’’ as a trigger for surveys 

because the OPTN may designate a 

member as ‘‘not in good standing’’ for 

reasons that have nothing to do with the 

center’s compliance with CMS’s 

regulatory requirements (for example, 

OPTN organ allocation policies). If a 

transplant center were to become an 

OPTN ‘‘member not in good standing,’’

we most likely would treat the 

member’s status with the OPTN as a 

complaint and conduct a survey of the 

center to determine its compliance with 

our regulatory requirements. If a 

Medicare provider is substantially out of 

compliance with our conditions of 

participation, we must take independent 

action promptly to oversee the 

provider’s development and 

implementation of a plan of correction. 

We must base our decision whether to 

review or survey a center on issues that 

directly relate to the requirements in 

this final rule. Therefore, no changes 

have been made based on this comment. 

Comment: Some commenters 

supported the re-approval procedures 

for Medicare-approved transplant 

centers and the 3-year re-approval cycle. 

However, some commenters suggested 

extending the approval cycle to 5 or 6 

years. 

Response: We agree with the 

commenters that centers should be 

monitored and re-approved every 3 

years. Ongoing evaluation is critical to 

ensure that after Medicare approval, a 

center continues to meet Medicare 

requirements. Frequent, active oversight 

of transplants centers helps to ensure 

that Medicare beneficiaries continue to 

receive high quality transplantation 

services. We disagree that 5 or 6 years 

is an appropriate time period for reVerDate Aug<31>2005 19:11 Mar 29, 2007 Jkt 211001 PO 00000 Frm 00050 Fmt 4701 Sfmt 4700 E:\FR\FM\30MRR2.SGM 30MRR2

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approval. Given rapid changes in the 

field of transplantation, a center’s 

performance may change radically in 5 

or 6 years from its initial Medicare 

approval. 

Comment: A peer reviewer requested 

clarification on whether CMS will rely 

on the OPTN’s Membership and 

Professional Standards Committee’s 

(MPSC) extensive method to flag centers 

for further review or develop a similar 

method for this scrutiny. 

Response: We plan to convene a 

technical expert panel to develop a 

similar methodology for targeting 

transplant centers for survey. However, 

we expect to minimize burden for 

transplant centers by conducting 

targeted re-approval surveys. 

Comment: A peer reviewer favored a 

periodic ‘‘self-study’’ report by all 

programs regarding the state of their 

compliance with process requirements. 

A robust self-study process could 

potentially eliminate the need for, or 

reduce the frequency of, on-site surveys. 

Response: We welcome the idea of 

transplant centers performing periodic 

‘‘self-study’’ to assess their compliance 

with the process requirements. We urge 

transplant centers to consider 

incorporating a robust self-study process 

to enhance their preparedness for 

surveys. No changes have been made 

based on this comment. 

(4) Use of OPTN Information To Identify 

Centers That Need To Be Surveyed 

Comment: Many commenters agreed 

that it would be appropriate to make 

survey decisions based on OPTN 

information since it is widely accepted 

by U.S. health care payers. Nonetheless, 

a peer reviewer cautioned that routine 

use of OPTN information may alter the 

generally collegial responses that the 

OPTN receives from transplant 

programs. Transplant centers may 

become less open, less responsive, and 

more guarded. The peer reviewer said 

that this possibility should be carefully 

considered if the OPTN informationbased survey approach is taken. The 

peer reviewer also recommended that 

we clearly define the thresholds for 

passing OPTN information to CMS. 

Another peer reviewer was concerned 

that the sharing of OPTN data with CMS 

jeopardizes the confidentiality of 

transplant centers’ data submissions to 

the OPTN under applicable laws and 

regulations protecting peer review 

processes employed by the OPTN 

committees. The reviewer 

recommended adding language to note 

that nothing in the final rule changes 

existing OPTN rules and policies with 

respect to confidentiality of data 

obtained from centers, as part of its 

oversight and compliance obligations. 

Response: We agree that the use of 

OPTN information for survey decisions 

is appropriate since it is transparent, 

acceptable to the transplant community, 

and is publicly available. We will use 

relevant information such as OPTN data 

to prioritize survey decisions. 

We do not believe the sharing of 

OPTN data with us jeopardizes the 

confidentiality of transplant centers’

data under applicable laws and 

regulations because the OPTN final rule 

at 42 CFR part 121, states in 

§ 121.11(b)(1)(iii) that the OPTN and the 

SRTR, as appropriate, shall provide to 

the Secretary any data that the Secretary 

requests. Because of the language in part 

121, we do not see a need to add 

clarifying language with respect to 

confidentiality of data obtained from 

centers. We expect the OPTN/MPSC to 

continue its review process to flag 

centers for further review and we expect 

that centers will continue to maintain 

their collegial relationships with the 

OPTN. 

Comment: A public commenter asked 

whether CMS or some other agency or 

organization will monitor transplant 

center’s compliance with the outcome 

requirements. One commenter 

recommended that CMS consult with 

the OPTN. 

A peer reviewer stated that we need 

to delineate the methodology we will 

use to survey transplant centers, 

identify the designated organization that 

will perform the surveys, and provide 

assurance that the organization has the 

experience and expertise to perform 

transplant center surveys. 

Response: Although we have not yet 

determined which entity will monitor 

extra-renal transplant centers, we will 

inform them as soon as possible. Kidney 

transplant centers will not be monitored 

by any of the national accrediting 

bodies. Pursuant to sections 1865(b)(1) 

and 1881(b) of the Act, kidney 

transplant centers cannot be deemed by 

a national accreditation body to meet 

the Medicare conditions of 

participation. If a national accrediting 

organization applies for deeming 

authority for any of the extra-renal 

transplant centers, we will assess its 

expertise and review its application. If 

an accrediting organization is approved 

for deeming authority the transplant 

centers will be routinely reviewed 

(which could include surveys) by the 

accrediting organization. We will 

continue to have oversight 

responsibility for complaint surveys and 

validation surveys and will work closely 

with the accrediting organization on an 

ongoing basis. Most transplant centers 

are located in accredited hospitals and 

surveys of the transplant center may be 

combined with the routine survey of the 

hospital which may allow for a more 

efficient review since some of the 

transplant center documentation and 

records will be combined with the 

hospital records. We will include 

information about how transplant center 

surveys will be performed in the 

Interpretive Guidelines that we will 

develop following publication of the 

final rule. Under this final rule, we will 

monitor transplant center compliance 

with the clinical experience and 

outcome requirements. We will 

continue to work with the OPTN 

through HRSA on transplant center 

issues. 

Accreditation, Corrective Actions, 

Appeal Process and Loss of Medicare 

Approval 

We requested comments on whether 

transplant centers should be regarded as 

providers or as suppliers for the purpose 

of appealing adverse approval and reapproval decisions. 

Comment: A commenter suggested 

that transplant centers should be 

identified as a provider in the 

regulations for accreditation and 

appeals purposes. One commenter 

suggested that the part 498 appeals 

process is an appropriate mechanism for 

transplant center appeals. Another 

commenter requested that we state 

clearly that the denial of initial approval 

and re-approval is a determination that 

triggers appeal rights under part 498. 

Response: We agree with the 

commenter that transplant centers 

should have provider status for 

accreditation and appeals purposes 

because transplant centers are located 

within hospitals, which are considered 

providers under the Medicare program. 

Therefore, we have added transplant 

centers to the list of providers in 42 CFR 

498.2 that have the right to appeal 

decisions that affect their participation 

in the Medicare program. Additionally, 

we have added transplant centers to the 

list of providers and suppliers in 42 CFR 

488.6 that can receive deemed status 

through an accrediting organization. 

Transplant centers that apply for and 

are denied Medicare approval, as well 

as Medicare-approved transplant centers 

that are terminated from the Medicare 

program may appeal these decisions 

under part 498. 

Comment: A few commenters 

recommended that a center should be 

allowed to continue Medicare 

participation pending exhaustion of any 

appeals, provided that its treatment of 

Medicare beneficiaries does not 

jeopardize their health and safety. 


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Response: In most cases, Medicare 

providers and suppliers are permitted to 

continue to participate in Medicare 

while an appeal is pending, unless the 

deficiency is such that the health and 

safety of patients is in immediate 

jeopardy. 

Comment: Many commenters asked 

us to clarify whether transplant centers 

that do not meet the data and outcome 

requirements in the initial approval and 

re-approval process will have an 

opportunity for corrective action. A 

commenter suggested that we should 

provide a process of remediation and 

corrective actions for centers that fail to 

comply with the data submission and 

outcome requirements that is like the 

process for hospitals that face 

termination from the Medicare program. 

A commenter recommended 180 days 

for centers to submit acceptable plans of 

correction and correct deficiencies 

through the use of an acceptable QAPI 

program. Another commenter stated that 

we should consult with the OPTN 

before denying re-approval of Medicareapproved centers. A commenter 

suggested that we should review a 

center for potential termination of 

Medicare approval only when the 

Secretary has been notified of an OPTN 

decision to take adverse action against 

the center. A commenter recommended 

that we adopt the OPTN remediation 

process for centers failing to meet 

outcome requirements. 

Response: Once approved under the 

requirements of this final rule, 

transplant centers will be subject to the 

same remediation process used for 

nearly all other Medicare providers and 

suppliers. Under the process for reapproval, a transplant center found to be 

out of compliance with one or more 

CoPs, including the CoP for data 

submission, clinical experience, and 

outcome requirements, will have an 

opportunity to come back into 

compliance once it has submitted an 

acceptable plan of correction. Generally, 

the transplant center will be permitted 

to continue to provide services to 

Medicare beneficiaries while we 

monitor implementation of the plan of 

correction. We also will use this process 

if we find, during a complaint 

investigation, that a transplant center is 

out of compliance with one or more 

conditions of participation. We do not 

have a remediation or corrective action 

process for entities that apply for initial 

Medicare certification or approval under 

this final rule and fail to meet the 

requirements. However, a transplant 

center that is not approved may re-apply 

for initial approval at any time. 

We will include additional details 

about the processes for initial approval 

and re-approval, plans of correction, 

and other matters related to survey and 

certification of transplant centers in 

Interpretive Guidelines for surveyors 

and manual instructions that will be 

published following the effective date of 

this final rule. 

III. Provisions of the Final Rule 

In the final rule, we are adopting the 

provisions as set forth in the February 

4, 2005 proposed rule with the 

following revisions: 

Amend § 482.70, ‘‘Definitions,’’ by—

• Revising the term ‘‘adverse event.’’

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 or 

serious medical complications due to 

living donation of any living donor 

should be investigated as an adverse 

event. The proposed definition also 

listed another example of an adverse 

event as ‘‘transplantation of organs of 

mismatched blood types due to failure 

to validate the donor and recipient’s 

vital information.’’ We have revised this 

example to now read ‘‘unintentional 

transplantation of organs of mismatched 

blood types’’ in order to further clarify 

this term. 

• Removing the term ‘‘intestinal’’

wherever it appears, when referring to 

such transplants and transplant centers, 

and adding in its place the term 

‘‘intestine.’’

Amend § 482.72, ‘‘Condition of 

participation: OPTN membership,’’ by—

• Revising the beginning of the last 

sentence in the condition statement by 

changing it from ‘‘No transplant hospital 

***’’ to ‘‘No hospital that provides 

transplantation services * * *’’

Amend § 482.74, ‘‘Condition of 

participation: Notification to CMS,’’

by—

• Redesignating the proposed 

introductory text as paragraph (a) and 

proposed paragraphs (a) and (b) as 

paragraphs (a)(1) and (a)(2) respectively. 

• Revising the newly redesignated 

paragraph (a) to read ‘‘A transplant 

center must notify CMS immediately of 

any significant changes related to the 

center’s transplant program or changes 

that could affect its compliance with the 

conditions of participation. Instances in 

which CMS should receive information 

for follow up, as appropriate, include, 

but are not limited to: * * *’’

• Redesignating § 482.100(b) as 

§ 482.74(a)(3) and revising newly 

designated paragraph (a)(3). 

• Adding a new paragraph (a)(4) to 

clarify that a transplant center must 

notify CMS immediately of its 

inactivation. 

• Adding a new paragraph (b) to 

specify the actions CMS will take to 

follow-up with a transplant center that 

notifies us of significant changes in their 

program. 

Amend § 482.76, ‘‘Condition of 

participation: Pediatric transplants,’’

by—

• Removing the word ‘‘wishes’’ and 

adding in its place ‘‘seeks Medicare 

approval’’ in the condition statement to 

clarify that it is only those centers 

seeking Medicare approval to perform 

pediatric transplants that must submit a 

request for this specific purpose. 

• Adding the phrase ‘‘in a 12-month 

period’’ after ‘‘A center that performs 50 

percent or more of its transplants,’’ at 

proposed § 482.76(b) to clarify that a 

center that performs predominately 

adult transplants must be approved to 

perform adult transplants in order to be 

approved to perform pediatric 

transplants. 

• Adding the phrase ‘‘in a 12-month 

period’’ after ‘‘A center that performs 50 

percent or more of its transplants’’ at 

proposed § 482.76(c) to clarify that a 

center that performs predominately 

pediatric transplants must be approved 

to perform pediatric transplants in order 

to be approved to perform adult 

transplants. 

• Revising proposed § 482.76(c)(3) to 

read ‘‘A center that performs 50 percent 

or more of its transplants on pediatric 

patients in a 12-month period is not 

required to meet the clinical experience 

requirements prior to its request for 

approval as a pediatric transplant 

center. 

• Adding the citation of ‘‘Omnibus 

Budget and Reconciliation Act (OBRA) 

1987 criteria in section 4009(b) (Pub. L. 

100–203)’’ at paragraph (d) to clarify 

that the alternate criteria for Medicare 

approval of heart transplant centers 

providing transplantation services to 

pediatric heart patients are mandated by 

statute, and in paragraph (d)(1) changing 

the word ‘‘center’’ to ‘‘hospital’’ to 

conform with the language in OBRA 

1987. 

Amend § 482.80, ‘‘Condition of 

participation: Data submission and 

outcome requirements for initial 

approval of transplant centers,’’ by—

• Adding the phrase ‘‘clinical 

experience’’ to the CoP section heading 

and to the condition statement to clarify 

that there is a clinical experience 

requirement, and so that the heading 

now reads ‘‘Data submission, clinical 

experience, and outcome requirements 

for initial approval of transplant 


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centers.’’ (The appropriate revisions 

regarding the clinical experience 

requirements for approval and reapproval, including the special 

procedures for approval and re-approval 

described at § 488.61, have been made 

throughout the final rule.) 

• Revising the condition statement. 

Throughout the proposed rule the terms 

‘‘outcome measure’’ and ‘‘outcome 

measure standards’’ are used. We have 

replaced both terms with ‘‘outcome 

requirements’’ here and throughout the 

final rule in order to clarify, through the 

use of a uniform term throughout, that 

these are requirements and not 

measures or standards. We have done 

this, along with our removal of the 

reference to waivers in the proposed 

rule, in order to further clarify that 

centers not meeting the data 

submission, clinical experience, and 

outcome requirements may be reviewed 

to augment CMS’s approval decisions. 

• Removing in paragraph (a) 

‘‘transplant recipient registration, and 

recipient follow-up’’ and adding in its 

place the words ‘‘transplant recipient 

registration and follow-up.’’ In addition, 

adding at the end of paragraph (a) ‘‘and 

living donor registration and follow-up’’

to clarify that they are part of the 

required data submissions. 

• Adding a new paragraph (b), 

Standard: Clinical Experience 

requirements. An organ-specific 

transplant center generally must 

perform 10 transplants over a 12-month 

period. 

• Re-designating proposed § 482.80 

paragraph (b) as paragraph (c) and 

revising the paragraph heading to now 

read ‘‘(c) Standard: Outcome 

requirements.’’ All references to this 

paragraph have been amended 

accordingly. 

• Revising proposed § 482.80 

paragraph (b)(1) (now (c)(1)) by 

removing the words ‘‘ as long as the 

center has 1-year post-transplant followup on at least 9 transplants of the 

appropriate organ type.’’

• Revising proposed § 482.80 

paragraph (b)(2) (now (c)(2)) by 

removing the words ‘‘The 9’’ and adding 

in its place the words ‘‘The required 

number of’’ so that the paragraph now 

reads: ‘‘The required number of 

transplants must have been performed 

during the time frame reported in the 

most recent SRTR center-specific 

report.’’

• Removing proposed § 482.80 

paragraphs (b)(4), (b)(5), and (b)(6) to 

clarify that a center may not request 

CMS to review its 1-month patient and 

graft survival outcomes for all 

transplants performed in the previous 

1-year period in lieu of 1-year patient 

and graft survival outcomes if certain 

conditions are met. We are not 

finalizing the proposed review of 

1-month post-transplant data of new 

centers seeking Medicare approval. 

• Re-designating proposed § 482.80 

paragraph (c) as paragraph (d) with the 

heading continuing to read 

‘‘Exceptions.’’ All references to this 

paragraph have been amended 

accordingly. 

• Revising newly re-designated 

paragraph (d)(1) to clarify that heartlung transplant centers are not required 

to meet the clinical experience 

requirements or the outcome 

requirements for heart-lung transplants 

performed at the center. 

• Revising newly re-designated 

paragraph (d)(2) to clarify that intestine 

transplant centers are not required to 

meet the outcome requirements for 

intestine, combined liver-intestine, or 

multivisceral transplants performed at 

the center. 

• Revising newly re-designated 

paragraph (d)(3) to clarify that pancreas 

transplant centers are not required to 

meet the clinical experience 

requirements or the outcome 

requirements for pancreas and kidneypancreas transplants performed at the 

center. 

• Removing in newly re-designated 

paragraph (d)(4) the words ‘‘perform a 

minimum number of pediatric 

transplants’’ and adding in its place the 

words ‘‘comply with the clinical 

experience requirements in paragraph 

(b)’’ to clarify that a center requesting 

initial Medicare approval to perform 

pediatric transplants does not have to 

comply with the clinical experience 

requirements prior to its request for 

approval as a pediatric transplant 

center. 

• Adding paragraph (d)(5) to state 

that ‘‘a kidney transplant center that is 

not Medicare-approved on the effective 

date of this final rule is required to 

perform at least 3 transplants over a 12- 

month period prior to its request for 

initial approval.’’

Amend § 482.82 ‘‘Condition of 

participation: Data submission and 

outcome requirements for re-approval of 

transplant centers’’ by—

• Adding the phrase ‘‘clinical 

experience’’ to the CoP section heading 

and to the condition statement to clarify 

that there is a clinical experience 

requirement, and so that the heading 

now reads ‘‘Data submission, clinical 

experience, and outcome requirements 

for re-approval of transplant centers.’’

• In paragraph (a), revising 

‘‘transplant recipient registration, and 

recipient follow-up’’ to read ‘‘transplant 

recipient registration and follow-up.’’ In 

addition, adding the words ‘‘and living 

donor registration and follow-up’’ at the 

end of paragraph (a) to clarify that they 

are part of the required data submission. 

• Adding a new paragraph (b), 

Standard: Clinical experience 

requirements. An organ-specific 

transplant center must generally 

perform an average of 10 transplants per 

year during the re-approval period. 

• Re-designating proposed paragraph 

(b) as paragraph (c) and revising the 

paragraph heading to now read ‘‘(c) 

Standard: Outcome requirements.’’ All 

references to this paragraph have been 

amended accordingly. 

• Revising proposed paragraph (b)(1) 

(now (c)(1)) by removing the phrase ‘‘as 

long as the center has 1-year posttransplant follow-up on at least 9 

transplants of the appropriate organ 

type.’’

• Revising proposed § 482.82 

paragraph (b)(2) (now (c)(2)) by 

removing the words ‘‘The 9’’ and adding 

in its place the words ‘‘The required 

number of’’ so that it now reads: ‘‘The 

required number of transplants must 

have been performed during the time 

frame reported in the most recent SRTR 

center-specific report.’’

• Re-designating proposed § 482.82 

paragraph (c) as paragraph (d) with the 

paragraph heading continuing to read 

‘‘Exceptions.’’ All references to this 

paragraph have been amended 

accordingly. 

• Revising newly re-designated 

paragraph (d)(1) to clarify that heartlung transplant centers are not required 

to meet the clinical experience 

requirements or the outcome 

requirements for heart-lung transplants 

performed at the center. 

• Revising newly re-designated 

paragraph (d)(2) to clarify that intestine 

transplant centers are not required to 

meet the outcome requirements for 

intestine, combined liver-intestine, or 

multivisceral transplants performed at 

the center. 

• Revising newly re-designated 

paragraph (d)(3) to clarify that pancreas 

transplant centers are not required to 

meet the clinical experience 

requirements or the outcome 

requirements for pancreas and kidneypancreas transplants performed at the 

center. 

• Revising newly re-designated 

paragraph (d)(4) by removing the phrase 

‘‘perform a minimum number of 

pediatric transplants’’ and adding in its 

place the words ‘‘comply with the 

clinical experience requirements in 

paragraph (b)’’ in order to clarify that a 

center does not have to comply with the 

clinical experience requirements to be 

re-approved. 


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Amend § 482.90 ‘‘Condition of 

participation: Patient and living donor 

selection’’ by—

• Removing the word ‘‘waitlist’’ and 

adding in its place the words ‘‘waiting 

list’’ in the condition statement and 

throughout the requirements where 

applicable. 

• Removing proposed paragraph 

(a)(1) and re-designating paragraphs 

(a)(2), (a)(3), and (a)(4) as paragraphs 

(a)(1), (a)(2), and (a)(3). 

• Revising newly re-designated 

paragraph (a)(1) by adding the words, 

‘‘if possible’’ at the end of the sentence 

to allow transplant centers the 

discretion to give psychosocial 

evaluation to prospective transplant 

candidates. 

• Adding the words ‘‘transplant 

patient’’ to paragraph (a)(4) which reads 

‘‘A transplant center must provide a 

copy of its patient selection criteria to 

a transplant patient or dialysis facility, 

if requested by such transplant patient 

or facility.’’

• Removing the words ‘‘transplant 

candidate’s’’ in proposed paragraph 

(b)(2) so that the transplant center is 

only required to document the living 

donor’s suitability for donation in the 

living donor’s medical record. 

Revise § 482.92 ‘‘Condition of 

participation: Organ recovery and 

receipt’’ by—

• Revising the first line of the 

condition statement to read ‘‘Transplant 

centers must have written protocols for 

validation of donor-recipient blood type 

and other vital data for the deceased 

organ recovery, organ receipt, and living 

donor organ transplantation process.’’

• Adding the phrase ‘‘When the 

identity of an intended transplant 

recipient is known and the transplant 

center sends a team to recover organ(s),’’

at the beginning of paragraph (a) to 

clarify that if the intended recipient for 

the organ being recovered is known, the 

transplant center’s recovery team must 

review and compare the donor data with 

the recipient blood type and other vital 

data before organ recovery takes place. 

• Adding the phrase ‘‘a licensed 

health care professional’’ to paragraph 

(b) to clarify that this individual must be 

present for the verification of donor’s 

blood type and vital data when an organ 

arrives at the transplant center. 

Amend § 482.94 ‘‘Condition of 

participation: Patient and living donor 

management’’ by—

• Removing the word ‘‘pretransplant’’ in the condition statement 

and in paragraph (a)(1) to clarify that a 

transplant center is not required to 

provide the care of a multidisciplinary 

patient care team coordinated by a 

physician in the pre-transplant phase of 

transplantation. 

• Removing the words ‘‘on an 

ongoing basis’’ in paragraph (b)(1) and 

adding them to paragraph (b) 

introductory text to clarify that 

transplant centers must keep their 

waiting lists up to date on an ongoing 

basis. 

• Adding the phrase ‘‘(and in the case 

of a kidney patient, the patient’s usual 

dialysis facility)’’ in paragraph (c)(1) to 

clarify that the dialysis facility of the 

kidney transplant patients must also be 

notified of the patient’s transplant 

status’’. 

• Adding the phrase ‘‘(and in the case 

of a kidney patient, the patient’s usual 

dialysis facility)’’ in paragraph (c)(2) to 

clarify that the dialysis facility of the 

kidney transplant patients must also be 

notified of the kidney patient’s removal 

from the waiting list for any reason 

other than death or transplantation no 

later than 10 days after the date the 

patient was removed from the waiting 

list. 

• Removing the requirement in 

proposed (c)(2)(i)that once a patient is 

placed on a center’s waiting list, the 

center must document in the patient’s 

record that the patient is notified of his 

or her placement status at least once a 

year, even if there is no change in the 

patient’s placement status. We are not 

finalizing this proposed requirement. 

• Re-designating the proposed 

paragraph (c)(2)(ii) as paragraph (c)(2). 

• Removing proposed paragraph 

(c)(3). 

• Revising proposed paragraph 

(c)(4)(i) to replace the word ‘‘pretransplant’’ with ‘‘transplant.’’

• Re-designating proposed paragraph 

(c)(4) as paragraph (c)(3). 

• Revising proposed paragraph (d) to 

now define a qualified social worker as 

‘‘an individual who meets licensing 

requirements in the State in which he or 

she practices; 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) Is working 

as a social worker in a transplant center 

as of the effective date of this final rule 

and has served for at least 2 years as a 

social worker, 1 year of which was in a 

transplantation program, and has 

established a consultative relationship 

with a social worker who is qualified 

under § 482.94(d)(1) of this paragraph. 

• Revising proposed paragraph (e) by 

removing paragraphs (e)(1) and (e)(2), 

and now defining a qualified dietitian as 

an individual who meets practice 

requirements in the State in which he/ 

she practices and who is a registered 

dietitian with the Commission on 

Dietetic Registration. 

Amend § 482.96 ‘‘Condition of 

participation: Quality assessment and 

performance improvement (QAPI)’’ by—

• Adding in paragraph (a) the word 

‘‘requirements’’ after the words ‘‘OPTN 

waitlist (now waiting list)’’ in order to 

further clarify this example of a QAPI 

program activity. 

• Adding in paragraph (a) the words 

‘‘patient education’’ to clarify that this 

is one of the included QAPI activities 

and outcomes. 

Amend § 482.98 ‘‘Condition of 

participation: Human resources’’ by—

• Revising proposed paragraph (a)(1) 

to read: ‘‘Coordinating with the hospital 

in which the transplant center is located 

to ensure adequate training of nursing 

staff and clinical transplant coordinators 

in the care of transplant patients and 

living donors’ to further clarify the 

responsibilities of the Director of a 

transplant center. 

• Revising paragraph (a)(3), to clarify 

that the director of the transplant center 

is responsible for ensuring that surgery 

is performed ‘‘by, or under the direct 

supervision of, a qualified transplant 

surgeon.’’

• Adding the phrase ‘‘and who are 

immediately available to provide 

transplantation services when an organ 

is offered for transplantation’’ at the end 

of the sentence at paragraph (b) to 

clarify that a transplant surgeon and 

physician must be immediately 

available to perform a transplant when 

an organ is offered. 

• Removing in paragraph (c), the 

portion of the definition of a qualified 

clinical transplant coordinator, which 

requires an individual to be certified by 

the American Board of Transplant 

Coordinators, and adding in its place an 

expanded one that states ‘‘The clinical 

transplant coordinator must be a 

registered nurse or other licensed 

clinician who has experience and 

knowledge of transplantation and living 

donation issues. The clinical transplant 

coordinator’s responsibilities must 

include, but are not limited to, the 

following: (1) Ensuring the coordination 

of the clinical aspects of transplant 

patient and living donor care; and (2) 

Acting as a liaison between a kidney 

transplant center and dialysis facilities, 

as applicable.’’

• Adding a new standard at 

paragraph (d) titled ‘‘Independent living 

donor advocate or living donor advocate 

team.’’ This new requirement states 

‘‘The transplant center that performs 

living donor transplantation must 

identify either an independent living 

donor advocate or an independent 

living donor advocate team to ensure 


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protection of the rights of living donors 

and prospective living donors.’’ As 

noted below, this new standard also has 

three new provisions contained within 

it. 

• Requiring under the new paragraph 

(d)(1) that the living donor advocate or 

living donor advocate team must not be 

involved in transplantation activities on 

a routine basis. 

• Requiring under the new paragraph 

(d)(2) that these independent advocates 

or advocate teams must demonstrate: (i) 

Knowledge of living organ donation, 

transplantation, medical ethics, and 

informed consent; and (ii) 

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. 

• Requiring under the new paragraph 

(d)(3) that the independent living donor 

advocate’s or living donor advocate 

team’s responsibilities include: (i) 

Representing and advising the donor; 

(ii) protecting and promoting the 

interests of the donor; and (iii) 

respecting the donor’s decision and 

ensuring that the donor’s decision is 

informed and free from coercion. 

• Re-designating proposed § 482.98 

paragraph (d) as paragraph (e) with 

heading continuing to read ‘‘Standard: 

Transplant team.’’ All references to this 

paragraph have been amended 

accordingly. 

• Re-designating proposed § 482.98 

paragraph (e) as paragraph (f) with 

heading continuing to read ‘‘Standard: 

Resource commitment.’’ All references 

to this paragraph have been amended 

accordingly. 

• Adding the words ‘‘patient 

education’’ in newly re-designated 

paragraph (f) to clarify that this is one 

of the areas of expertise that a transplant 

center is required to have available 

under its resources. 

Amend § 482.100 ‘‘Condition of 

Participation: Organ procurement’’ by—

• Removing the paragraph 

designation ‘‘(a)’’ and combining the 

text with the condition statement. 

• Re-designating proposed paragraph 

(b) as § 482.74(a)(3) and revising newly 

designated § 482.74(a)(3) to read 

‘‘Termination of an agreement between 

the hospital in which the transplant 

center is located and an OPO for the 

recovery and receipt of organs;’’. 

Amend § 482.102 ‘‘Condition of 

participation: Patient and living donor 

rights’’ by—

• Adding the words ‘‘Patient rights’’

to the condition statement to clarify that 

§ 482.13 is the Patients rights CoP. 

• Revising proposed § 482.102 

paragraph (a) to read ‘‘Transplant 

centers must implement written 

transplant patient informed consent 

policies that inform each patient of: 

***’’

• Amending paragraph (a)(5) to 

specify that information provided to 

patients includes (but is not limited to) 

information from the most recent SRTR 

center-specific report, including (but not 

limited to) the transplant center’s 

observed and expected 1-year patient 

and graft survival, national 1-year 

patient and graft survival, and 

notification about all Medicare outcome 

requirements not being met by the 

transplant center. 

• Removing the text of proposed 

paragraph (a)(6); 

• Re-designating the proposed (a)(7) 

as (a)(6). 

• Re-designating the proposed (a)(8) 

as (a)(7). 

• Adding a new paragraph (a)(8) to 

read ‘‘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 for 

under Medicare Part B.’’

• Revising proposed § 482.102 

paragraph (b) to read ‘‘Transplant 

centers must implement written living 

donor informed consent policies that 

inform ***.’’

• Adding paragraph (b)(9) to read 

‘‘The fact that if a 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.’’

• Deleting the phrase ‘‘that meets the 

hospital’s credentialing policies’’ from 

proposed § 482.102 paragraph (c)(1)(ii) 

in order to clarify this provision. 

• Revising proposed § 482.102 

paragraph (c)(2)(ii) to read: ‘‘Inform 

Medicare beneficiaries on the center’s 

waiting list that Medicare will no longer 

pay for transplants performed at the 

center after the effective date of the 

center’s termination of approval.’’

• Adding a new provision at 

§ 482.102(c)(3) that reads ‘‘As soon as 

possible prior to a transplant center’s 

voluntary inactivation, the center must 

inform patients on the center’s waiting 

list and, as directed by the Secretary, 

provide assistance to waiting list 

patients who choose to transfer to the 

waiting list of another Medicareapproved transplant center without loss 

of time accrued on the waiting list.’’

Amend § 482.104 ‘‘Condition of 

participation: Additional requirements 

for kidney transplant centers’’ by—

• Revising proposed § 482.104 

paragraph (a) by adding a new line that 

reads ‘‘A kidney transplant center must 

have written policies and procedures for 

ongoing communications with dialysis 

patients’ local dialysis facilities.’’

• Removing the requirement at 

proposed § 482.104 paragraph (b) that 

kidney dialysis centers or units in 

kidney transplant centers providing 

dialysis services to inpatients directly or 

under arrangement must meet the 

Conditions of Coverage of Suppliers of 

ESRD Services contained in part 405 

subpart U of this chapter. We are not 

finalizing this proposed requirement in 

the final rule. 

Amend § 488.6 ‘‘Other national 

accreditation programs for hospitals’’

by—

• Revising paragraph (a), first 

sentence, by inserting the words 

‘‘transplant centers except for kidney 

transplant centers;’’ after the words 

‘‘psychiatric hospitals;’’. 

Amend § 488.61 ‘‘Special procedures 

for approval and re-approval of organ 

transplant centers’’ by—

• Revising the heading to paragraph 

(a) to read ‘‘Initial approval procedures 

for transplant centers that are not 

Medicare-approved as of June 28, 2007.’’

• Revising paragraph (a) to clarify 

that a transplant center, including 

kidney transplant centers, may submit a 

request to CMS for Medicare approval at 

any time. 

• Revising proposed § 488.61 

paragraph (a)(2) to include provisions 

from proposed paragraph (a)(3) to read 

‘‘To determine compliance with the 

clinical experience and outcome 

requirements at § 482.80(b) and (c), CMS 

will review the data contained in the 

most recent OPTN Data Report and 1- 

year patient and graft survival data 

contained in the most recent Scientific 

Registry of Transplant Recipient (SRTR) 

center-specific report.’’

• Deleting proposed paragraph (a)(3) 

and redesignating proposed paragraph 

(a)(4) as (a)(3). We revised proposed 

paragraph (a)(4), now (a)(3) to read: If 

CMS determines that a transplant center 

has not met the data submission, 

clinical experience, or outcome 

requirements, CMS may deny the 

request for approval or may review the 

center’s compliance with the conditions 

of participation at § 482.72 through 

§ 482.76 and § 482.90 through § 482.104 

of this chapter, using the procedures 

described at 42 CFR part 488, subpart A, 

to determine whether the center’s 

request will be approved. CMS will 

notify the transplant center in writing 

whether it is approved and, if approved, 

of the effective date of its approval. 

• Adding a new paragraph (a)(4) to 

describe mitigating factors CMS will 

consider in determining initial approval 


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or re-approval of a transplant center that 

does not meet the data submission, 

clinical experience, outcome 

requirements and other conditions of 

participation. 

• Revising paragraph (a)(5) to outline 

the initial Medicare approval review 

process and approval period, and to 

specify how transplant centers will be 

notified of approval. 

• Deleting proposed paragraph (a)(6) 

and including its content in proposed 

paragraph (a)(4) (now (a)(3)). 

• Adding a new paragraph (a)(6) to 

state that a kidney center may submit a 

request for initial approval after 

performing at lease 3 transplants over a 

12-month period. 

• Revising proposed paragraph (a)(7) 

for clarity. 

All references to these paragraphs 

have been amended accordingly. 

• Redesignating proposed paragraph 

(b) as paragraph (c). 

• Adding a new paragraph (b) to 

clarify that all transplant centers, 

including kidney transplant centers, 

approved as of the effective date of this 

final rule that want to continue to be 

Medicare approved must submit a 

request to CMS for Medicare approval 

under the conditions of participation by 

December 26, 2007, using the process 

described in paragraph (a)(1) of the 

section. CMS will determine whether to 

approve a transplant center using the 

procedures described in paragraphs 

(a)(2) through (a)(5) of the section. 

• Revising proposed paragraph (b) 

(now (c)), for clarity. 

• Revising proposed § 488.61 

paragraph (b)(1)(ii) (now (c)(1)(ii)) to 

read ‘‘To determine compliance with 

the clinical experience and outcome 

requirements at § 482.82(b) and (c), CMS 

will review the data contained in the 

most recent OPTN Data Report and 1- 

year patient and graft survival data 

contained in the most recent Scientific 

Registry of Transplant Recipient (SRTR) 

center-specific report.’’

• Revising proposed 488.61 

paragraph (b)(4) (now (c)(1)) to read 

‘‘Prior to the end of the 3-year approval 

period, CMS will review the transplant 

center’s data in making re-approval 

determinations.’’

• Adding a new paragraph (c)(4) to 

describe mitigating factors CMS will 

consider in determining re-approval of a 

transplant center that does not meet the 

data submission, clinical experience, 

outcome requirements and other 

conditions of participation. 

• Revising proposed § 488.61 

paragraph (b)(4) (now (c)(5)) to read: 

‘‘CMS will notify the transplant center 

in writing if its approval is being 

revoked and of the effective date of the 

revocation.’’

• Adding the phrase ‘‘including 

kidney transplant centers’’ to paragraph 

(c) to clarify that all transplant centers 

must be in compliance with all the CoPs 

for transplant center at § 482.72 through 

§ 482.104, except for § 482.80 (Initial 

approval requirements) throughout the 3 

year approval period. 

• Adding a new transplant center 

inactivity requirement at paragraph (e) 

to state that a transplant center may 

inactivate its program for a period not 

to exceed 12 months during the 3-year 

approval cycle. A transplant center must 

notify CMS upon its voluntary 

inactivation as required by 

§ 482.74(a)(4). 

IV. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

(PRA) of 1995, we are required to 

provide 30-day notice in the Federal 

Register and solicit public comment 

before a collection of information 

requirement is submitted to the Office of 

Management and Budget (OMB) for 

review and approval. In order to fairly 

evaluate whether an information 

collection should be approved by OMB, 

section 3506(c)(2)(A) of the PRA of 1995 

requires that we solicit comments on the 

following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We solicited public comments on 

each of these issues for the sections of 

this document that contain information 

collection requirements (ICRs). 

General Comments 

Comment: Some commenters said 

they were concerned that CMS generally 

underestimated the total burden hours 

and/or total estimated costs that this 

regulation would impose on transplant 

centers. Other commenters felt that 

some of the data used in the proposed 

rule were inaccurate. 

Response: After further analysis of the 

tasks needed for the paperwork 

requirements in this final rule and 

review of more recent financial data, we 

agree with the commenters that for 

certain requirements, we 

underestimated the total burden hours 

(and in the economic impact analysis, 

the total estimated costs) associated 

with the paperwork requirements in the 

proposed rule. Therefore, we have 

increased our estimate of total burden 

hours and/or total costs for some of the 

conditions of participation. These 

changes are discussed below for each 

relevant condition of participation. 

Comment: Some commenters said that 

many of the requirements in the 

proposed rule would be unnecessary 

because some of the proposed 

requirements are similar or identical to 

either current OPTN or JCAHO 

requirements. 

Response: The commenters are 

correct; however, we disagree that these 

requirements are unnecessary. For these 

requirements to be enforceable by us 

through our oversight and survey and 

certification process, they must be 

promulgated as regulations. 

Also, some commenters stated that 

the regulation would increase posttransplant health care costs. However, 

this final rule regulates only inpatient 

transplant services and will not increase 

the cost of providing post-transplant 

care once patients are discharged from 

the hospital. 

Section 482.74 Condition of 

Participation: Notification to CMS 

Section 482.74 requires a transplant 

center to notify us immediately of any 

significant changes related to the 

center’s transplant program or changes 

that could affect its compliance with the 

CoPs. The instances in which a 

transplant center must notify us 

include, but are not limited to: any 

change in key staff members of the 

transplant team; a decrease in the 

number of the center’s transplants or 

survival rates that could result in the 

center being out of compliance with 

§ 482.82, Condition of participation: 

Data submission, clinical experience, 

and outcome requirements for reapproval of transplant centers; 

termination of an agreement between 

the hospital in which the transplant 

center is located and an OPO for the 

recovery and receipt of organs; and 

inactivation of the transplant center. 

In the proposed rule, we estimated 

that the burden associated with this 

section would be the time required to 

notify us of significant changes. We 

estimated that there would be three 

occasions annually per center requiring 

notification. For each occasion, we 

estimated that it would take 5 minutes 

to notify us. Therefore, we estimated 

that it would take no more than 15 

minutes annually for each center to 

notify us of any significant changes. We 

said that since there were approximately 

900 transplant centers, we estimated 

that the total burden hours for 


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complying with this section would be a 

total of 225 hours. The estimate of 900 

transplant centers included nonMedicare approved transplant centers. 

However, our analysis will only concern 

Medicare-approved centers. 

Comment: One commenter said that 

we significantly underestimated the 

burden required for transplant centers to 

comply with this requirement. The 

commenter noted that notifying us of 

these changes required the involvement 

of the program’s medical director, an 

administrator, and appropriate clerical/ 

support staff. The commenter opined 

that large centers would have a 

significant number of changes per year, 

perhaps as many as 6–12, and that each 

change would require 15–30 minutes of 

time for each of the individuals 

involved or approximately one and onehalf to two hours per change. 

Response: We agree that we 

underestimated the burden of this 

requirement. We agree that reporting a 

significant change to us would require 

more than 5 minutes and would involve 

senior staff and management. After 

further analysis of the tasks involved in 

complying with this section and the 

personnel that generally would be 

involved. 

TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST ESTIMATE FOR SUBMITTING SIGNIFICANT CHANGES TO CMS 

Position Hourly wage Hours required 

per report 

Total cost 

estimate for 

each report 

Total annual 

burden hours 

per center 

(for 3 reports) 

Total annual 

cost estimate 

per center 

(for 3 reports 

per year per 

center) 

Medical Director ................................................................. $116.60 .50 $58.30 1 .5 $174.90 

Senior Administrator .......................................................... 92.31 .50 46.16 1 .5 138.46 

Transplant Coordinator ...................................................... 43.87 .75 32.90 2 .25 98.71 

Secretary ............................................................................ 21.81 .25 5.45 .75 16.36 

Totals .......................................................................... ........................ 2.00 142.81 6 .0 428.43 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com. 

Section 482.76 Condition of 

Participation: Pediatric Transplants 

Section 482.76 states that a transplant 

center that seeks Medicare approval to 

provide transplantation services to 

pediatric patients must submit to CMS 

a request specifically for Medicare 

approval to perform pediatric 

transplants using the procedures at 

§ 488.61, Special procedures for 

approval and re-approval of organ 

transplant centers. The center 

requesting Medicare approval to 

perform pediatric transplants must meet 

all the conditions of participation in 

§§ 482.72 through 482.74 and §§ 482.80 

through 482.104, with respect to its 

pediatric patients. 

The burden associated with this 

requirement would be the time required 

to prepare and submit the required 

information and data to us. Since 

pediatric centers must comply with the 

procedures at § 488.61, the burden for 

pediatric centers to request Medicare 

approval will be analyzed under that 

section. 

In lieu of meeting all of the 

requirements in those sections noted 

above, § 482.76(d) provides that a heart 

transplant center that wishes to provide 

transplantation services to pediatric 

heart patients may be approved to 

perform pediatric heart transplant by 

meeting the OBRA 1987 criteria in 

section 4009(b) (Pub. L. 100–203) as 

follows: 

(1) The center’s pediatric transplant 

program must be operated jointly by the 

hospital and another facility that is 

Medicare-approved; 

(2) The unified program shares the 

same transplant surgeons and quality 

improvement program (including 

oversight committee, patient protocol, 

and patient selection criteria); and 

(3) The center must demonstrate to 

the satisfaction of the Secretary that it 

is able to provide specialized facilities, 

services, and personnel that are required 

by pediatric heart transplant patients. 

The burden associated with this 

requirement is the time required for 

heart transplant centers that choose to 

use the alternative criteria under 

§ 482.76(d) to prepare and submit the 

required information to us. We believe 

that it would require additional time to 

apply using the alternative criteria in 

this section. However, we also believe 

that the additional burden would be 

minimal. 

In addition, we believe that fewer 

than 10 entities would choose to apply 

for Medicare approval using the 

alternative criteria in this section in any 

given year. There are currently seven 

Medicare-approved pediatric heart 

transplant centers. Even if we should 

receive requests for Medicare approval 

from the equivalent of 50 percent of the 

currently approved centers, we would 

receive only about 4 requests. Under 5 

CFR 1320.3(c), a ‘‘collection of 

information’’ does not include 

requirements imposed on fewer than ten 

entities. Therefore, the requirements 

under § 482.76(d) are not subject to the 

PRA. 

Section 482.80 Condition of 

Participation: Data Submission, Clinical 

Experience, and Outcome Measure 

Requirements for Initial Approval of 

Transplant Centers 

Section 482.80 requires that, except as 

specified in paragraph (d) of that section 

and at 488.61, transplant centers must 

generally meet all data submission, 

clinical experience, and outcome 

requirements to be granted initial 

approval by us. Section 482.80(a) 

requires transplant centers to submit to 

the OPTN at least 95 percent of the 

required data on all transplants 

(deceased and living donors) no later 

than 90 days after the date established 

by the OPTN. The required data 

submissions include, but are not limited 

to, submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration and follow-up, and living 

donor registration and follow-up. 

The burden associated with this 

requirement is the amount of time it 

would take the transplant center to 

submit the required data. In the 

proposed rule, we stated that we 

believed that these requirements 

reflected usual and customary business 

practice and would be followed even if 

there were no Medicare requirements. 

Thus, we said that the burden for these 

requirements would be exempt under 5 

CFR 1320.3(b)(2). 

Comment: A national organization 

that represents professionals in the 

transplant community commented that 

the data submission requirements 


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necessary for OPTN compliance have 

had a huge financial impact on 

transplant centers. The commenter 

noted that multiple forms are required 

for each patient, from the time of 

registration on the OPTN waiting list to 

several years post-transplant. They 

noted that the analysis did not account 

for the additional resources needed to 

complete and submit these forms. 

Response: Although we appreciate 

that the data submission requirements 

necessitate significant resources from 

the transplant centers, we would point 

out that OPTN policies require 

transplant hospitals as a condition of 

membership to submit these required 

data to the OPTN. The final rule 

governing the operation of the OPTN (42 

CFR 121.11) also imposes this 

requirement by Federal regulation. 

Further, existing Medicare regulations 

require that if a hospital performs 

transplants, it must be a member of the 

OPTN and provide organ-transplantrelated data, as requested, to the OPTN, 

SRTR, and the OPOs. (See 42 CFR 

482.45(b).) Therefore, complying with 

this section imposes little additional 

burden on the transplant centers and 

constitutes usual and customary 

business practice. 

Under 5 CFR 1320.3(b)(2), if the 

activities that are needed to comply 

with an ICR constitute usual and 

customary business practices, those 

activities should be excluded from the 

burden analysis. Thus, these activities 

will not be included in the burden 

analysis for this final rule. 

Section 482.82 Condition of 

Participation: Data Submission, Clinical 

Experience, and Outcome Measure 

Requirements for Re-Approval of 

Transplant Centers 

Section 482.82 provides that, except 

as specified in paragraph (d) of this 

section and at 488.61, transplant centers 

must meet all the data submission, 

clinical experience, and outcome 

requirements to be re-approved. Section 

482.82(a) requires that no later than 90 

days after the due date established by 

the OPTN, a transplant center must 

submit to the OPTN at least 95 percent 

of the required data submissions on all 

transplants (deceased and living donors) 

it has performed over the 3-year 

approval period. The required data 

submissions include, but are not limited 

to, submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration and follow up, and living 

donor registration and follow up. 

The burden associated with this 

requirement is the time it would take 

the transplant center to submit the 

required data. As discussed above under 

§ 482.80, we already require hospitals in 

which transplant centers are located to 

belong to the OPTN, and the OPTN 

requires that these hospitals submit data 

to the OPTN. (See § 482.45(b).) 

Thus, complying with this section 

imposes little additional burden on the 

transplant centers and constitutes usual 

and customary business practice. Under 

5 CFR 1320.3(b)(2), if the activities that 

are needed to comply with an ICR 

constitute usual and customary business 

practices, those activities should be 

excluded from the burden analysis. 

Therefore, these activities will not be 

included in this final rule’s burden 

analysis. 

Section 482.90 Condition of 

Participation: Patient and Living Donor 

Selection 

Section 482.90 requires transplant 

centers to use written patient selection 

criteria in determining a patient’s 

suitability for placement on the waiting 

list or a patient’s suitability for 

transplant. If a center performs living 

donor transplants, the center must also 

use written donor selection criteria in 

determining the suitability of candidates 

for donation. 

Section 482.90(a) states that before a 

transplant center places a transplant 

candidate on its waiting list, the 

candidate’s medical record must contain 

documentation that the candidate’s 

blood type has been determined. When 

a patient is placed on a center’s waiting 

list or is selected to receive a transplant, 

the center must document in the 

patient’s medical record the patient 

selection criteria that were used. Section 

482.90(b) states that a transplant center 

also must document in the living 

donor’s medical records the living 

donor’s suitability for donation and that 

the living donor has given informed 

consent, as required under § 482.102(b). 

Comment: Some commenters said that 

the patient selection criteria 

requirements would be burdensome. For 

example, one commenter said that it 

would take at least 30 minutes of staff 

time to document the patient selection 

criteria in the file of each patient or 

living donor. 

Response: We disagree. Each center 

has the flexibility to determine the most 

expedient way to satisfy this 

requirement. Centers should be able to 

reduce the resources needed to 

document individual potential 

transplant recipient and living donor 

medical records significantly by using 

electronic formats, forms, or checklists. 

Therefore, complying with this 

requirement constitutes a minimal 

burden to the transplant centers. 

Comment: One commenter said that 

we did not address the recordkeeping 

burden for this requirement. 

Response: For the reasons discussed 

immediately below, we do not believe a 

burden analysis of this requirement 

should be included in this PRA 

analysis. 

The burden associated with 

complying with this section is the time 

to develop the transplant recipient and 

living donor selection criteria and 

document each potential transplant 

recipient’s and living donor’s medical 

record. We expect that all transplant 

centers have policies regarding selection 

criteria for potential transplant 

recipients and living donors (if they 

perform living donor transplants). In 

addition, it is standard medical practice 

to document in the medical record of a 

hospital patient undergoing surgery 

whether the patient meets the hospital’s 

criteria for surgery. Thus, we believe 

that the activities required by this 

section constitute usual and customary 

business practices for transplant centers. 

Therefore, pursuant to 5 CFR 

1320.3(b)(2), we will not include these 

activities in the burden analysis for this 

final rule. 

Section 482.92 Condition of 

Participation: Organ Recovery and 

Receipt 

Transplant centers must have written 

protocols to validate donor-recipient 

matching of blood types and other vital 

data for deceased organ recovery, organ 

receipt, and living donor transplantation 

process. 

The burden associated with this 

section is the time required to develop 

these written protocols. We believe that 

developing written protocols for critical 

functions such as those required by this 

section reflect usual and customary 

business practice for transplant centers. 

Therefore, the burden of these 

requirements is exempt under 5 CFR 

1320.3(b)(2). 

Section 482.94 Condition of 

Participation: Patient and Living Donor 

Management 

Transplant centers must have written 

patient management policies for the 

transplant and discharge phases of 

transplantation. If a transplant center 

performs living donor transplants, the 

center also must have written donor 

management policies for the donor 

evaluation, donation, and discharge 

phases of living organ donation. 

The burden associated with these 

requirements is the time it takes to 

develop written patient management 

policies. We believe that it is usual and 

customary business practice for 


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transplant centers, as it would be for 

any major health care facility, to have 

written patient management policies. 

Thus, under 5 CFR 1320.3(b)(2), these 

activities should be excluded from any 

burden analysis. 

In addition, § 482.94(b) requires that 

transplant centers must keep their 

waiting lists up to date on an ongoing 

basis, including: 

(1) Updating of waiting list patients’

clinical information; 

(2) Removing patients from the 

center’s waiting list if a patient receives 

a transplant or dies, or if there is any 

other reason that the patient should no 

longer be on a center’s waiting list; and 

(3) Notifying the OPTN no later than 

24 hours after a patient’s removal from 

the center’s waiting list. 

Section 482.94(c) requires transplant 

centers to maintain up-to-date and 

accurate patient management records for 

each patient who receives an evaluation 

for placement on a center’s waiting list 

and who is admitted for organ 

transplantation. 

Section 482.94(c)(1) states that for 

each patient who receives an evaluation 

for placement on a center’s waiting list, 

the center must document in the 

patient’s record that the patient (and in 

the case of a kidney patient, the 

patient’s usual dialysis facility) has been 

informed of his or her transplant status, 

including notification of: (i) The 

patient’s placement on the center’s 

waiting list; (ii) The center’s decision 

not to place the patient on its waiting 

list; or (iii) The center’s inability to 

make a determination regarding the 

patient’s placement on its waiting list 

because further clinical testing or 

documentation is needed. 

Section 482.94(c)(2) states that if a 

patient on the waiting list is removed 

from the waiting list for any reason 

other than death or transplantation, the 

transplant center must document in the 

patient’s record that the patient (and in 

the case of a kidney patient, the 

patient’s usual dialysis facility) was 

notified of his or her removal from the 

waiting list no later than 10 days after 

the date the patient was removed from 

the center’s waiting list. 

Section 482.94(c)(3) states that in the 

case of patients admitted for organ 

transplants, transplant centers must 

maintain written records of 

multidisciplinary patient care planning 

during the transplant period and 

multidisciplinary discharge planning for 

post-transplant care. 

The burden associated with this 

section, except for notifying dialysis 

facilities, is the time required for a 

transplant center to document all the 

necessary information and maintain the 

waiting list. As described above, all 

transplant centers must already follow 

OPTN requirements for notification of 

patients and maintenance of their 

waiting lists. We believe that most, if 

not all, transplant centers have business 

practices that already comply with this 

section. For the remainder of centers, 

compliance should require only a 

minimal burden. 

Under 5 CFR 1320.3(b)(2), if the 

activities that are needed to comply 

with an ICR constitute usual and 

customary business practices, those 

activities should be excluded from the 

burden analysis. Since the activities that 

are required to satisfy this section 

constitute usual and customary business 

practices, the burden associated with 

them will not be included in our PRA 

analysis for this final rule. 

Section 482.94(c)(1) and (2) require 

kidney transplant centers, in the case of 

dialysis patients, to document in the 

patient’s record that both the patient 

and the patient’s usual dialysis facility 

have been notified of the patient’s 

transplant status and all changes in the 

patient’s transplant status as required 

under § 482.94(c)(1). Since this is not a 

requirement for OPTN members, we do 

not believe that all kidney transplant 

centers are currently notifying dialysis 

facilities. 

The burden associated with this 

requirement is the time it would take for 

the transplant center to notify the 

various dialysis facilities of the status of 

their patients on the transplant center’s 

waiting list. Rather than notifying 

dialysis facilities on an individual basis, 

we believe that transplant centers would 

chose to periodically notify the dialysis 

centers about their patients’ status. 

Thus, for the purposes of determining 

the burden for this requirement, we will 

assume quarterly notifications by the 

transplant centers to the dialysis 

facilities. Note that this final rule does 

not establish a time frame transplant 

centers must use to notify dialysis 

centers about patient status. We are 

using quarterly notification only to 

estimate an economic impact for this 

notification requirement. 

According to UNOS, as of December 

31, 2005, there were 64,848 individuals 

awaiting kidney transplants. Currently, 

there are approximately 4,649 dialysis 

facilities and approximately 243 

Medicare-approved kidney transplant 

centers. Therefore, the average 

transplant center will have to notify 19 

dialysis clinics about the waiting list 

status of their patients (4,649 dialysis 

facilities divided by 243 Medicareapproved kidney transplant centers = 

19.13 dialysis centers). Since there are 

64,848 patients waiting for kidney 

transplants and 4,649 dialysis facilities, 

there are an average of 14 patients on 

the waiting list for kidneys at each 

dialysis facility (64,848 patients divided 

by 4,649 dialysis facilities = 13.9). Thus, 

for each of the 243 kidney transplant 

centers, there are about 267 waiting list 

patients (64,848 patients divided by 243 

transplant centers = 266.86 or 14 

patients per dialysis facility × 19 

dialysis facilities = 266). Therefore, on 

average, each transplant center would 

have to determine the status of about 

267 patients and notify an average of 19 

dialysis facilities about the status of 

these patients 4 times a year. 

Based upon our past experience, we 

believe that this notification would 

require the involvement of the 

transplant coordinator and appropriate 

support/clerical staff. We would 

anticipate that the transplant centers 

would utilize modern technology to 

minimize the burden of satisfying this 

requirement. 


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TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST ESTIMATE TO NOTIFY DIALYSIS FACILITIES OF THEIR

PATIENTS’ WAITING LIST STATUS

Position Hourly wage Burden hours 

per event* 

Cost estimate 

per event* 

Total annual 

hours required 

(for 4 events) 

Total annual 

cost estimate 

(for 4 events) 

Transplant Coordinator ........................................................ $ 43.87 2.00 $87.74 8.0 $350.96 

Secretary .............................................................................. 21.81 .50 10.90 2.0 43.62 

Totals ............................................................................ ........................ 2.50 98.64 10.0 394.58 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com. 

*Each notification is an ‘‘event.’’

Thus, we anticipate that the burden 

hours for each time a transplant center 

notifies the relevant dialysis centers of 

the status of their patients on the 

center’s waiting list would require 2.5 

burden hours and the cost estimate 

would be $98.64. With the transplant 

centers conducting these notifications 

on a quarterly basis, that is, 4 

notifications per year for each kidney 

center, the total annual burden hours for 

each center would be 10 and the total 

annual cost estimate would be $394.58. 

Since there are currently 243 current 

Medicare-approved kidney transplant 

centers, their total burden hours would 

be 2,430 (243 centers × 10 hours = 

2,430) and the total cost complying with 

this ICR is $95,882.94 (243 centers × 

$394.58 = $95,882.94). 

Section 482.96 Condition of 

participation: Quality assessment and 

performance improvement (QAPI) 

Section 482.96 requires transplant 

centers to develop, implement, and 

maintain a written, comprehensive, 

data-driven QAPI program designed to 

monitor and evaluate performance of all 

transplantation services, including 

services provided under contract or 

arrangement. 

Section 482.96(b) requires transplant 

centers to establish and implement 

written policies to address and 

document adverse events that occur 

during any phase of an organ 

transplantation case. These policies 

must address, at a minimum, the 

process for the identification, reporting, 

analysis, and prevention of adverse 

events. When an adverse event is 

identified, the transplant center must 

conduct a thorough analysis of and 

document any adverse event. 

The burden associated with this rule 

is the time required to develop these 

policies and document each adverse 

event. In the proposed rule, we 

estimated that it would take 8 hours on 

a 1-time basis to comply with this 

requirement. 

Comment: Some commenters 

disagreed with our analysis and said 

that we underestimated the time and 

staff hours required to comply with this 

section. One commenter stated that a 

large center would require one full-time 

equivalent (FTE) to comply with this 

requirement. Another commenter 

indicated that it took 160 staff hours to 

develop and establish the QAPI program 

at his or her hospital and 1.25 FTEs to 

maintain the program. This commenter 

indicated that eight hours would only 

be a ‘‘start’’ in complying with this 

requirement. 

Response: We agree with the 

commenters that 8 hours is insufficient 

to develop the policies necessary to 

comply with this section. However, 

since all transplant centers are located 

in Medicare hospitals and Medicare 

hospitals are required to have a QAPI 

program (see 42 CFR 482.21), we believe 

that each center will have sufficient 

resources available to develop its own 

QAPI program in considerably fewer 

than 160 burden hours. 

We believe that the typical transplant 

center would already have established a 

QAPI program as part of its usual and 

customary business practices and, thus, 

would not incur any additional 

associated burden. Therefore, since the 

activities required to comply with this 

section constitute usual and customary 

business practices, any burden 

associated with this requirement is 

exempt from the burden analysis under 

5 CFR 1320.3(b)(2). 

Section 482.98 Condition of 

Participation: Human Resources 

Section 482.98(b) requires transplant 

centers to identify to the OPTN a 

primary transplant surgeon and a 

transplant physician with the 

appropriate training and experience to 

provide transplantation services who 

are immediately available to provide 

transplantation services when an organ 

is offered for transplantation. 

The burden associated with this 

requirement is the time it will take to 

compile this information and forward it 

to the OPTN. Since this same 

information is required for the letter 

requesting initial approval for the 

transplant center at § 488.61(a), each 

transplant center will only need to 

notify the OPTN of the two individuals 

it has designed as its primary transplant 

surgeon and transplant physician. This 

could be done electronically or by a 

simple form, depending upon OPTN 

requirements. Thus, notifying the OPTN 

of the same information should not 

result in any additional appreciable 

burden to the transplant centers. 

Section 482.100 Condition of 

Participation: Organ Procurement 

Section 482.100 requires a transplant 

center to ensure that the hospital in 

which it operates has a written 

agreement for the receipt of organs with 

an OPO designated by the Secretary that 

identifies specific responsibilities for 

the hospital and for the OPO with 

respect to organ recovery and organ 

allocation. 

The burden associated with this rule 

is the time required to draft a mutually 

acceptable agreement between the 

transplant center and the designated 

OPO for the receipt of organs. Section 

121.9 of the Department’s regulations 

governing the OPTN requires transplant 

centers to have letters of agreement or 

contracts with an OPO. However, such 

a letter of agreement or contract will not 

satisfy the requirements of this section 

if it does not identify specific 

responsibilities for the hospital and the 

OPO with respect to organ recovery and 

organ allocation. Thus, we believe that 

approximately 50 percent, or 252, 

transplant centers will need to re-draft 

the letters of agreement or contracts 

between themselves and their 

designated OPOs that identify specific 

responsibilities for the hospital and for 

the OPO with respect to organ recovery 

and organ allocation. 

Based upon our experience with 

transplant centers, as well as other 

health care organizations, agreements of 

this type would require the involvement 

of the transplant center’s attorney, 

medical director, administrator, 

transplant coordinator, and appropriate 

clerical/support staff. We believe that it 

would require a total of approximately 


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11 hours to negotiate and draft a 

mutually acceptable agreement that 

would be signed by both the transplant 

center and OPO. 

TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST ESTIMATE TO DEVELOP AN AGREEMENT BETWEEN A

TRANSPLANT CENTER AND AN OPO CONCERNING ORGAN RECOVERY AND ORGAN ALLOCATION

Position Hourly wage Total annual 

hours required 

Total annual 

cost estimate 

General Counsel or Attorney ....................................................................................................... $176.86 4.0 $707.44 

Medical Director ........................................................................................................................... 116.60 2.0 233.20 

Senior Administrator .................................................................................................................... 92.31 2.0 184.62 

Transplant Coordinator ................................................................................................................ 43.87 2.0 87.74 

Secretary ...................................................................................................................................... 21.81 1.0 21.81 

Totals .................................................................................................................................... ........................ 11.00 1,234.81 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com. 

Thus, for each transplant center to 

negotiate and draft an agreement with 

its designated OPO concerning organ 

recovery and organ allocation, the total 

annual burden hours would be 11 and 

the total cost estimate would be 

$1,234.81. For 252 transplant centers to 

negotiate and draft these agreements, 

the total burden hours would be 2772 

(11 annual burden hours × 252 

transplant centers = 2,268) and the total 

cost estimate would be $311.172.12 (252 

transplant centers × $1,073.30). 

Section 482.102 Condition of 

Participation: Patient and Living Donor 

Rights 

Section 482.102 requires transplant 

centers to implement written transplant 

patient informed consent policies. The 

policies must inform each patient of: (1) 

The evaluation process; (2) the surgical 

procedure; (3) alternative treatments; (4) 

potential medical or psychosocial risks; 

(5) national and transplant centerspecific outcomes; (6) organ donor risk 

factors that could affect the success of 

the graft or the health of the patient, 

including, but not limited to, the 

donor’s history, condition or age of the 

organs used, or the patient’s potential 

risk of contracting the human 

immunodeficiency virus and other 

infectious diseases if the disease cannot 

be detected in an infected donor; (7) his 

or her right to refuse transplantation; 

and (8) 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. 

Section 482.102(b) also requires 

transplant centers to implement written 

living donor informed consent policies 

that inform the prospective living donor 

of all aspects of, and potential outcomes 

from, living donation. Each transplant 

center must ensure that the prospective 

living donor is fully informed about the 

following: (1) The fact that 

communication between the donor and 

the transplant center will remain 

confidential; (2) the evaluation process; 

(3) the surgical procedure, including 

post-operative treatment; (4) the 

availability of alternative treatments for 

the transplant recipient; (5) the potential 

medical or psychosocial risk to the 

donor; (6) the national and transplant 

center-specific outcomes for recipients; 

and national and center-specific 

outcomes for living donors, as data are 

available; (7) 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; (8) the 

donor’s right to opt out of donation at 

any time during the donation process; 

and (9) the fact that if a 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. 

We expect that nearly all transplant 

centers currently have written policies 

regarding informed consent. Therefore, 

there would be no additional burden on 

them, as these policies are usual and 

customary business practices. Therefore, 

the burden of these requirements is 

exempt under 5 CFR 1320.3(b)(2) and 

will not be included in our PRA 

analysis for this final rule. 

Section 482.102(c) requires each 

transplant center to notify patients 

placed on its waiting list of information 

about the center that could impact the 

patient’s ability to receive a transplant 

should an organ become available, and 

what procedures are in place to ensure 

the availability of a transplant team. 

Section 482.102(c)(1) specifically 

requires a transplant center served by a 

single transplant surgeon or physician 

to inform patients placed on the center’s 

waiting list of the potential 

unavailability of the transplant surgeon 

or physician and whether the center has 

a mechanism to provide an alternative 

transplant surgeon or transplant 

physician. 

Comment: One commenter pointed 

out that complying with this 

requirement would entail the drafting of 

a letter by an administrator, approval by 

the surgeon, searching a database to 

identify appropriate patients, clerical or 

support resources to prepare and mail 

the letters, and the expense associated 

with actually mailing the letters. The 

commenter pointed out that this would 

be an extensive and unrealistic use of 

resources for short-term unavailability 

issues, such as the absence of the 

transplant surgeon. 

Response: As discussed earlier in this 

preamble, this provision does not 

require transplant centers to inform 

waiting list patients on an ongoing basis 

about the short-term unavailability of a 

transplant surgeon, for example, when a 

transplant surgeon is on vacation. The 

provision simply requires that, at the 

time a patient is placed on the waiting 

list, the patient is informed about 

circumstances that could impact the 

patient’s ability to receive a transplant 

should an organ become available and 

what procedures the transplant center 

has in place to address these 

circumstances. Clearly, this requirement 

is particularly important when a 

transplant center is served by a single 

transplant surgeon or transplant 

physician. We expect that most 

transplant centers already provide this 

information to patients when they are 

placed on the waiting list. 

Therefore, the burden associated with 

this requirement is exempt under 5 CFR 

1320.3(b)(2). The burden of these 

activities will not be included in our 

PRA analysis for this final rule. 

Section 482.102(c)(2) states that at 

least 30 days before a transplant center’s 

Medicare approval is terminated, 

whether voluntarily or involuntarily, 


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the center must inform patients on the 

center’s waiting list of this fact and 

provide assistance to waiting list 

patients who choose to transfer to the 

waiting list of another Medicareapproved transplant center without loss 

of time accrued on the waiting list. The 

transplant center must also inform 

Medicare beneficiaries on the center’s 

waiting list that Medicare will no longer 

pay for transplants performed at the 

center after the effective date of the 

center’s loss of Medicare approval at 

least 30 days before their Medicare 

approval is terminated. In addition, 

§ 482.102(c)(3) requires that as soon as 

possible prior to a transplant center’s 

voluntary inactivation, the center must 

inform patients on the center’s waiting 

list and, as directed by the Secretary, 

provide assistance to waiting list 

patients who choose to transfer to the 

waiting list of another Medicareapproved transplant center without the 

loss of time accrued on the waiting list. 

The burden associated with this 

section would be the time required of a 

transplant center to draft a letter 

notifying patients on its waiting list of 

the loss of the program’s Medicare 

approval status and, by mail or 

otherwise, provide the letter to all 

patients on the center’s waiting list. We 

estimate that it would require an 

administrator approximately 30 minutes 

to draft the letter. It would then require 

a secretary or other support staff person 

2.5 hours to copy and/or mail these 

letters to the individuals on the center’s 

waiting list(s). Based on our estimate, 

complying with this section would 

require three burden hours and the total 

cost would be $100.69. 

TOTAL BURDEN HOURS AND TOTAL COST ESTIMATE FOR NOTIFYING PATIENTS ON A CENTER’S WAITING LIST OF A

TRANSPLANT CENTER’S LOSS OF MEDICARE APPROVAL

Position Hourly wage Hours required Total cost estimate 

Senior Administrator .................................................................................................................... $92.31 .50 $46.16 

Secretary ...................................................................................................................................... 21.81 2.50 54.53 

Totals .................................................................................................................................... ........................ 3.00 100.69 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com. 

As discussed in more detail below 

under section § 488.61, we believe that, 

based upon the requirements contained 

in this final rule, up to two percent of 

transplant centers or approximately 10 

centers may lose their Medicareapproved status annually. If 10 centers 

annually lost their Medicare-approved 

status, either voluntarily or 

involuntarily, then the total annual 

burden hours would be 30 (10 

transplant centers × 3 burden hours = 30 

total burden hours) and the total annual 

cost estimate would be $1,006.90 

($100.69 cost estimate × 10 transplant 

centers = $1,006.90). 

Section 482.104 Condition of 

Participation: Additional Requirements 

for Kidney Transplant Services 

Section 482.104(a) states that a kidney 

transplant center must have written 

policies and procedures for ongoing 

communications with dialysis patients’

local dialysis facilities. 

The burden associated with this 

requirement is the time and effort it 

would take for a kidney transplant 

center to develop the written policies 

and procedures for such 

communication. Under this final rule, 

one of the responsibilities of the clinical 

transplant coordinator is to act as a 

liaison between a kidney transplant 

center and dialysis facilities. (See 

§ 482.98(c)(2).) We believe that most 

centers currently use their clinical 

transport coordinators in this role. Most 

centers will be able to meet this 

requirement by putting their current 

practice into writing. This will probably 

be done by the clinical transplant 

coordinators. Since they are 

memorializing their current practices, 

we believe it can be accomplished in a 

very short time. We believe that this 

communication policy and procedures 

will be straightforward and can be 

accomplished quickly by the 

coordinators. In addition, many centers 

may already have such policies and 

procedures in writing. Thus, complying 

with this requirement will constitute a 

minimal burden to the centers. 

Section 488.61 Special Procedures for 

Approval And Re-Approval of Organ 

Transplant Centers 

Section 488.61(a) requires transplant 

centers that are not Medicare-approved 

as of June 28, 2007 to submit a request 

to CMS for Medicare approval. Section 

488.61(b) requires transplant centers, 

including kidney transplant centers, 

that are Medicare approved as of June 

28, 2007 to submit a request for 

Medicare approval no later than 

December 26, 2007. The process for 

making the request for Medicare 

approval is the same for both types of 

transplant centers. (See § 488.61(b)(1).) 

The request for Medicare approval must 

be signed by a person authorized to 

represent the center (for example, a 

chief executive officer). The request 

must include the hospital’s Medicare 

provider identification (I.D.) number; 

the name(s) of the designated primary 

transplant surgeon and primary 

transplant physician; and a statement 

from the OPTN that the center has 

complied with all data submission 

requirements. 

The burden associated with this 

section would be the time required to 

prepare and submit this letter to us. In 

addition, the center would have to 

obtain a statement from the OPTN that 

the center had complied with all data 

submission requirements to submit with 

the letter. 

In the proposed rule, we estimated 

that each hospital would spend 

approximately 15 minutes to prepare 

and submit the letter requesting 

Medicare approval to us. We did note 

that a hospital may have multiple 

transplant centers and, therefore, could 

be submitting more than one request for 

approval. 

Comment: We received public 

comments on the proposed rule that 

said we had underestimated the time 

required for a transplant center to apply 

for Medicare approval. One commenter 

emphasized that transplantation centers 

take applying for Medicare approval 

very seriously. The commenter also 

indicated that the preparation, approval, 

and submission of the request for 

Medicare approval could take days at 

many large institutions. 

Response: After further analysis of the 

tasks and the personnel that would be 

involved in applying for Medicare 

approval, we agree with the commenters 

that 15 minutes significantly 

underestimates the time required to 

prepare, obtain the required center 

approval(s), obtain the statement from 


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the OPTN, and submit the request for 

Medicare approval to us. However, we 

disagree with the commenter that said it 

could take ‘‘days’’ to accomplish all of 

the required tasks. Our analysis of the 

total burden hours and total cost 

estimate are discussed in detail below. 

We now believe that accomplishing 

all of the tasks necessary for complying 

with § 488.61(a) would involve the 

transplant program’s medical director, 

an administrator, a transplant 

coordinator, and appropriate support/ 

administrative staff. We estimate that it 

would take these individuals 

approximately the same amount of time 

as it would take the transplant center to 

notify us of a significant change in their 

program or approximately 2 burden 

hours. 

TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST FOR A TRANSPLANT CENTER TO APPLY FOR MEDICARE

APPROVAL

Position Hourly wage Hours required Total cost 

estimate 

Medical Director ........................................................................................................................... $116.60 .50 $58.30 

Senior Administrator .................................................................................................................... 92.31 .50 46.16 

Transplant Coordinator ................................................................................................................ 43.87 .75 32.90 

Secretary ...................................................................................................................................... 21.81 .25 5.45 

Totals .................................................................................................................................... ........................ 2.00 142.81 

All salary information is from the salary.com Web site athttp://hrsalarycenter.salary.com. 

This final rule requires all transplant 

centers that are currently Medicareapproved to apply for initial approval 

under the requirements in this final 

rule. There are currently approximately 

504 Medicare-approved transplant 

centers. We believe that all 504 

transplant centers will submit requests 

to us to retain their Medicare approval. 

In addition, based on our previous 

experience, we believe that 

approximately 10 new centers a year 

may apply for Medicare approval. Thus, 

we anticipate 514 transplant centers 

will be applying for Medicare approval 

of their transplant programs in the first 

year following the effective date of this 

final rule. 

For the first year after the effective 

date of this final rule, the total burden 

hours would be 1,028 (514 transplant 

centers × 2 burden hours = 1,028 total 

burden hours), and the total cost 

estimate would be $73,404.34 (514 

transplant centers × $142.81 = 

$73,404.34). For subsequent years, we 

anticipate that about 10 transplant 

centers will request initial Medicare 

approval. For those subsequent years, 

the total burden hours are 20 (10 

transplant centers × 2 burden hours = 20 

total burden hours) and the total cost 

estimate would be $1,428.10 (10 

transplant centers × $142.81 = 

$1,428.10). 

Section 488.61(d) allows transplant 

centers that have lost their Medicare 

approval to seek re-entry into the 

Medicare program at any time. A center 

that has lost its Medicare approval must: 

(1) Request initial approval using the 

procedures at § 488.61(a); 

(2) Be in compliance with §§ 482.72 

through 482.104, except for § 482.82 

(Re-approval Requirements), at the time 

of the request for Medicare approval; 

and 

(3) Submit a report to us documenting 

any changes or corrective action(s) taken 

by the center as a result of the loss of 

its Medicare approval status. 

The burden associated with this 

section would be the time required to 

prepare and submit the request for 

approval to us pursuant to § 488.61(a) 

and the time to prepare and submit a 

report to CMS documenting any changes 

or corrective actions taken by the center 

as a result of the loss of its Medicare 

approval status. After further analysis of 

the tasks that would be involved and the 

personnel that would be needed, we 

believe that developing and submitting 

the required plan would involve the 

transplant program’s medical director, 

an administrator, a transplant 

coordinator, and appropriate support/ 

administrative staff. 

In the proposed rule, we said that we 

believed no more than 9 entities would 

be affected by this requirement which 

made it exempt from the PRA, in 

accordance with 5 CFR 1320.3(c). This 

was based on our previous experience 

with transplant centers. Previously, only 

five centers had voluntarily terminated 

their Medicare approval. 

However, this final rule has minimum 

clinical experience, outcome, and 

process requirements that transplant 

centers must meet to obtain initial 

Medicare approval and to stay in the 

program. Considering these 

requirements, we anticipate that more 

centers may voluntarily terminate their 

Medicare approval status in order to 

give themselves time to correct any 

problems they may have in meeting 

these requirements. In addition, it may 

become more common for transplant 

centers to be involuntarily terminated. 

Therefore, we estimate that up to two 

percent or approximately 10 of the 

currently Medicare-approved centers 

may lose their status at some point in 

any given year and later seek to re-enter 

the program. 

We believe that accomplishing all of 

the tasks necessary for complying with 

§ 488.61(d) would require the same staff 

as needed for § 488.61(a) and (b). 

However, we also believe that the center 

requesting re-entry into the Medicare 

program will spend more time preparing 

the request due to the preparation of the 

report documenting any changes or 

corrective action taken by the center as 

a result of the loss of its Medicare 

approval status. Thus, we believe that a 

transplant center complying with this 

sub-section’s requirements would 

require a total of 5 burden hours and 

have a total cost estimate of $329.50. In 

any given year, we anticipate as many 

as 10 centers may seek to re-enter the 

Medicare program. For these 10 centers, 

the total burden hours would be 50 (10 

centers × 5 burden hours to re-apply = 

50 total burden hours) and the total cost 

estimate would be $3,295.00($329.50 

per center to re-apply × 10 centers = 

$3,295.00). 


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TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST FOR TRANSPLANT CENTERS SEEKING RE-ENTRY INTO THE

MEDICARE PROGRAM AFTER LOSS OF MEDICARE APPROVAL

Position Hourly wage Hours required Total cost 

estimate 

Medical Director ........................................................................................................................... $116.60 1.00 $116.60 

Senior Administrator .................................................................................................................... 92.31 1.00 92.31 

Transplant Coordinator ................................................................................................................ 43.87 2.50 109.68 

Secretary ...................................................................................................................................... 21.81 .50 10.91 

Totals .................................................................................................................................... ........................ 5.00 329.50 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com. 

Thus, for all of the PRA requirements 

in this rule, the total burden hours for 

the first year are 8,830, and the total cost 

estimate is $659,989.50. For subsequent 

years the total burden hours are 5,554 

and the total cost estimate is 

$317,541,66. The burden hours and cost 

estimate are detailed in the chart below. 

All of the PRA requirements noted in 

this chart constitute new collections of 

information. 

SUMMARY OF PRA REQUIREMENTS FOR TRANSPLANT CENTERS (TCS) IN THE FIRST YEAR OF THIS FINAL RULE

PRA requirement 

Total annual 

cost estimate 

per TC 

Total annual 

burden hours 

(BHs) 

per TC 

Total annual cost estimate for ‘‘X’’

TCs 

Total annual burden hours (BHs) 

for ‘‘X’’ TCs 

§ 482.74—Notification to CMS of 

Significant Changes.

$428.43 6.0 $215,928.72 for 504 TCs (currently 

there are 504 Medicare approved TCs).

3,024 BHs for 504 TCs (currently 

there are 504 Medicare approved TCs). 

§ 482.94(c)(3)—Notification to Dialysis Facilities of Patients’ Waiting List Status.394.58 10.0 $95,882.94 for 243 TCs (currently 

there are 243 Medicare-approved kidney TCs).

2,430 BHs for 243 TCs (currently 

there are 243 Medicare-approved kidney TCs). 

§ 482.100—Development of Agreement Between T.C. and Each 

OPO on Organ Recovery and Allocation 1.

1,234.81 11.0 $311,172,12 for 252 TCs (we estimate that about 50 percent, or 

252, TCs will need to re-draft 

letters of agreements of contracts between themselves and 

their designated OPOs).

2,772 BHs for 252 TCs (we estimate that about 50 percent, or 

252, TCs will need to re-draft 

letters of agreements of contracts between themselves and 

their designated OPOs). 

§ 482.102(c)(2)—Notification of Patients on Waiting List of Loss of 

Medicare Approval.

100.69 3.0 $1,006.90 for 10 TCs (we estimate 

that about 10 TCs would lose 

their Medicare Approval each 

year).

30 BHs for 10 TCs (we estimate 

that about 10 TCs would lose 

their Medicare Approval each 

year). 

§ 488.61(a)—Application for Medicare Approval 2.142.81 2.0 $73,404.34 for 514 TCs (first 

year—all 504 currently Medicare-approved TCs would need 

to apply and we estimate that 10 

new TCs would also apply for a 

total of 514 TCs applying for 

Medicare approval in the first 

year).

1,028 BHs for 514 TCs (first 

year—all 504 currently Medicare-approved TCs would need 

to apply and we estimate that 10 

new TCs would also apply for a 

total of 514 TCs applying for 

Medicare approval in the first 

year). 

§ 488.61(d)—Application to ReEnter Medicare Program.329.50 5.0 $3,295.00 for 10 TCs (we estimate 

that 10 TCs who had lost their 

Medicare approved status would 

seek to re-enter the Medicare 

Program each year)..

50 BHs for 10 TCs (we estimate 

that 10 TCs who had lost their 

Medicare approved status would 

seek to re-enter the Medicare 

Program each year). 

Totals ....................................... 2,630.82 37.0 700,690.02 ..................................... 9,334 BHs. 

1These estimates are for the first year of implementation only. After the first year, we estimate that fewer than 10 transplant centers will need 

to comply with this requirement. Therefore, in subsequent years, this requirement would not be subject to the PRA. 2This estimate is for the first year only. In subsequent years, we estimate that only 10 new transplant centers will apply for Medicare approval 

each year. Thus, for subsequent years, the estimated burden hours will be 20 (2 BHs × 10 TCs) and the cost estimate will be $1,428.10 

($142.81 × 10 TCs). 

If you comment on these information 

collection and record keeping 

requirements, please mail copies 

directly to the following: 

Centers for Medicare & Medicaid 

Services, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attn.: Melissa Musotto, CMS–3835–F, 

Room C5–14–03, 7500 Security 

Boulevard, Baltimore, MD 21244–

1850. 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 

20503, Attn: Carolyn Lovett, CMS 

Desk Officer, CMS–3835–F, 

carolyn_lovett@omb.eop.gov. Fax 

(202) 395–6974. 

V. Regulatory Impact Statement 

A. Overall Impact 

We have examined the impact of this 

final rule as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review), the 


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Regulatory Flexibility Act (RFA) 

(September 16, 1980 Public Law 96–

354), Section 1102(b) of the Social 

Security Act, the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4), and 

Executive Order 13132. 

Executive Order 12866 (as amended 

by Executive Order 13258, which 

merely reassigns responsibilities of 

duties) directs agencies to assess all 

costs and benefits of available regulatory 

alternatives and, if new regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). We 

estimate the overall economic impact of 

this final rule to be a cost of $28,420,259 

and a benefit of $1,257,516 in the first 

year. The social benefits that should 

result from implementation of this final 

rule are significant. However, we have 

no reasonably accurate method of 

quantifying those social benefits. Thus, 

we do not believe that this final rule is 

economically significant. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, nonprofit organizations, government 

agencies, and small governmental 

jurisdictions. Most hospitals and most 

other providers and suppliers are small 

entities, either by non-profit status or by 

having revenues of $29 million or less 

in any 1 year (65 FR 69432). Individuals 

and states are not included in the 

definition of a small entity. We believe 

this rule will not have a significant 

impact on a substantial number of small 

businesses because most of the 

requirements in this final rule are 

already part of the transplant centers’

standard practices. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area 

(superseded by Core Based Statistical 

Areas) and has fewer than 100 beds. We 

believe this final rule will not have a 

significant impact on small rural 

hospitals since small rural hospitals do 

not have the resources to perform organ 

transplants. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule that may result in expenditure in 

any 1 year by state, local or tribal 

governments, in the aggregate, or by the 

private sector, of $110 million or more. 

We do not believe that this rule will 

have an effect on state, local or tribal 

governments, or the private sector, that 

could create an unfunded mandate 

greater than $110 million annually. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

requirement costs on state and local 

governments, preempts state law, or 

otherwise has Federalism implications. 

This rule does not impose substantial 

direct requirement costs on state or local 

governments and does not preempt state 

law or have other Federalism 

implications. We have determined that 

this final rule will not significantly 

affect the rights, roles, and 

responsibilities of states. 

This final rule will affect all facilities 

that perform, or are planning to perform, 

organ transplants and may have an 

effect on the ability of those facilities to 

compete. Thus, while we do not believe 

the requirements will have a significant 

economic impact on these facilities, we 

believe it is desirable to inform the 

public of the likely effect of this final 

rule on those facilities. Thus, we have 

prepared the following analysis, which 

in combination with the other sections 

of this final rule, is intended to conform 

to the objectives of the RFA and section 

1102(b) of the Act. 

B. Anticipated Effects 

Our intent in developing and 

implementing these CoPs for transplant 

centers is to ensure Medicare-covered 

transplants are performed in an 

effective, efficient manner and that high 

quality transplantation services are 

provided to Medicare beneficiaries. This 

is critical due to the scarcity of 

transplantable organs for the individuals 

on organ transplant waiting lists. This 

final rule also serves to keep Medicare 

requirements current with the best 

practices in transplantation. We believe 

that adherence to these outcomes and 

process requirements will result in 

reduced organ wastage and, as a 

consequence, fewer graft failures and retransplantations. We do not anticipate 

that the changes in our requirements for 

transplant centers will affect the number 

of organ transplants performed because 

this final rule will have no effect on the 

number of organs available for 

transplantation. 

This final rule will establish CoPs for 

transplant centers that perform organ 

transplants. The final rule will maintain 

many of the same requirements that are 

in the current National Coverage 

Decisions (NCDs) for heart, liver, lung, 

and intestine transplants, and 

conditions for coverage (CfCs) for 

kidney transplant centers in 42 CFR, 

Part 405, subpart U. Some of the 

requirements in this final rule could 

result in additional costs for some 

centers. Although we do not believe the 

requirements in this final rule will have 

a substantial economic impact on a 

significant number of transplant centers, 

we believe it is desirable to inform the 

public of our projections of the likely 

effects of this final rule. There are two 

reasons this final rule will have a 

minimal economic effect. 

As of October 1, 2006, 504 Medicareapproved transplant centers potentially 

will be affected by the requirements in 

this final rule to a greater or lesser 

degree. However, we believe the 

majority of the transplant centers have 

already put into practice most of the 

process requirements contained in this 

final rule. Since these requirements, for 

the most part, reflect advances in 

transplantation technology, we believe 

they are routine or standard practices 

for most transplant centers. 

Furthermore, although this final rule 

requires a large amount of data to be 

submitted, transplant centers are 

already submitting these data to the 

OPTN. 

General Comments 

In the public comments to the 

proposed rule, some commenters said 

that CMS had underestimated the 

impact the requirements in the 

proposed rule would have on transplant 

centers. They stated that the number of 

hours and the costs associated with 

some requirements were either 

inaccurate or were underestimated. 

We agree with the commenters that in 

certain instances the economic impact 

was underestimated in the proposed 

rule. We have performed further 

analysis of the tasks and resources 

required to satisfy the CoPs in this final 

rule, and we have reviewed more recent 

economic data. Based on this further 

analysis, we have adjusted our estimate 

of the economic impact for the final 

rule. These adjustments are discussed 

below for each relevant condition of 

participation. 

Some commenters said that some of 

the CoPs in the proposed rule were 

unnecessary because some of the 

requirements are similar or even 

identical to either current OPTN or 

JCAHO requirements. We agree that 


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some of the CoPs are similar or perhaps 

even identical to OPTN or JCAHO 

requirements. However, for these 

requirements to be mandatory and 

enforceable by CMS through our survey 

and certification process, they must be 

promulgated as regulations. 

Some commenters expressed concern 

that these new requirements would 

increase costs. One commenter noted 

that increased costs could result in 

increased organ acquisition fees and 

subsequent increased expenses to the 

Medicare program and could also 

reduce access to transplantation services 

for some individuals. The commenter 

speculated that hospitals could have 

difficulty contracting with managed care 

organizations due to the increased costs. 

As we stated above, we do not believe 

this rule will have a significant 

economic impact on most transplant 

centers because most of the 

requirements are routine practice in the 

majority of centers. In addition, all 

transplant centers are located in 

hospitals and thus, already have access 

to resources that should minimize the 

additional costs needed to satisfy the 

requirements in this final rule. Only the 

costs associated with the donor 

advocate or donor advocate team 

requirements will affect organ 

acquisition fees. We estimate that in the 

first year of its implementation, the 

requirements in this final rule will 

increase the cost of a transplant by 

approximately $1,071 per transplant 

($28,420,256 total first year costs 

divided by 26,539 total transplants in 

2004 = $1,070.88 or about $1,071). 

However, in subsequent years, the 

increase will drop to approximately 

$360 per transplant (about 9,566,291 

implementation costs in subsequent 

years divided by 26,539 total transplants 

in 2004 = $360.46 or approximately 

$360). In light of the fact that the total 

first-year cost of an organ transplant 

(including both hospital and physician 

charges) varies from about $175,000 for 

a kidney transplant to nearly $400,000 

for a heart transplant, the impact of this 

rule will be negligible. Thus, hospitals 

should have no difficulty contracting 

with managed care organizations due to 

the requirements in this final rule. 

Section 482.72 Condition of 

Participation: OPTN Membership 

Section 482.72 requires each 

transplant center to be located in a 

transplant hospital that is a member of 

and abides by the rules and 

requirements of the Organ Procurement 

and Transplantation Network (OPTN). 

Under § 482.45(b)(1) of the hospital 

CoPs, all transplant centers that are 

currently Medicare-approved are 

required to be located in hospitals that 

are members of the OPTN and that abide 

by the OPTN’s rules. Thus, there is no 

additional burden or economic impact 

associated with this condition to centers 

that currently have Medicare approval. 

Since this final rule requires centers to 

perform a certain number of transplants 

prior to applying for Medicare approval, 

new centers also will be members of the 

OPTN. Thus, there is no economic 

impact from this requirement to centers 

that will be applying for Medicare 

approval after the effective date of this 

rule. 

Section 482.74 Condition of 

Participation: Notification to CMS 

Section 482.74 requires a transplant 

center to notify us immediately of any 

significant changes related to the 

center’s transplant program or changes 

that could affect its compliance with the 

applicable CoPs. Instances in which 

CMS should be notified include, but are 

not limited to, changes in key staff 

members of the transplant team; a 

decrease in the center’s number of 

transplants or survival rates that could 

result in the center being out of 

compliance with § 482.82; termination 

of an agreement between the hospital in 

which the transplant center is located 

and an OPO for the recovery and receipt 

of organs; and inactivation of the 

transplant center. 

We believe that satisfying this 

requirement would require the 

involvement of the program’s medical 

director, an administrator, a transplant 

coordinator, and appropriate support or 

administrative staff. Based upon our 

previous experience with transplant 

centers, we believe that three significant 

changes per year per center is an 

appropriate estimate. We also believe 

that it would take the above described 

personnel approximately 2 hours to 

comply with this section. 

Thus, each time a transplant center is 

required to report a significant change to 

us, the total economic impact or cost 

estimate is $142.81. For the estimated 

three significant changes per transplant 

center per year, the total cost estimate 

would be $428.43. Since there are 

currently approximately 504 Medicareapproved transplant centers, the total 

annual cost estimate for complying with 

this section is $215,928.72 ($428.43 

annual cost estimate per center × 504 

transplant centers = $215,928.72). 

Section 482.76 Condition of 

Participation: Pediatric Transplants 

Section 482.76 requires transplant 

centers that want Medicare approval to 

provide transplant services to pediatric 

patients to submit to us a request 

specifically for Medicare approval to 

perform pediatric transplants using the 

procedures described in § 488.61, 

Special procedures for approval and reapproval of organ transplant centers. 

Section 482.76(d) allows heart 

transplant centers that want to provide 

transplantation services to pediatric 

heart patients to be approved to perform 

pediatric heart transplants by meeting 

the OBRA 1987 criteria in section 

4009(b) (Pub. L. 100–203) as follows: (1) 

The center’s pediatric transplant 

program must be operated jointly by the 

hospital and another facility that is 

Medicare-approved; (2) the unified 

program shares the same transplant 

surgeons and quality improvement 

program (including oversight 

committee, patient protocol, and patient 

selection criteria); and (3) the center 

demonstrates to the satisfaction of the 

Secretary that it is able to provide 

specialized facilities, services, and 

personnel that are required by pediatric 

heart transplant patients. 

We believe that most transplant 

centers that want to obtain Medicare 

approval to do pediatric transplants will 

use the procedures at § 488.61. 

Therefore, the economic impact for 

centers requesting approval to do 

pediatric transplants will be discussed 

under that section. For those centers 

that want to request approval using the 

alternative criteria, we believe there will 

be some impact, but it will be minimal 

and should affect very few centers. 

Currently, there are approximately 13 

pediatric heart centers; 6 of these 

centers are Medicare approved. Based 

on these figures, we expect that no more 

than one pediatric heart center will 

apply for Medicare approval per year. 

Section 482.80 Condition of 

Participation: Data Submission, Clinical 

Experience, and Outcome Requirements 

for Initial Approval of Transplant 

Centers 

Section 482.80 requires that 

transplant centers must generally meet 

all data submission, clinical experience, 

and outcome requirements to be granted 

initial approval by CMS. Section 

482.80(a) states that no later than 90 

days after the due date established by 

the OPTN, a transplant center must 

submit to the OPTN at least 95 percent 

of the required data on all transplants, 

(deceased and living donors) it has 

performed. The required data 

submissions include, but are not limited 

to, submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration and follow-up, and living 

donor registration and follow-up. 

However, transplant centers already 


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submit these data to the OPTN, using 

the time frame specified by the OPTN, 

as required by 42 CFR 121.11, which 

regulates transplant hospitals’

submission of data to the OPTN. 

Therefore, there is no additional cost to 

transplant centers from the data 

submission requirement in this final 

rule. Section 482.80(b) establishes a 

clinical experience requirement of 10 

transplants in a 12-month period for 

initial Medicare approval for heart, 

intestine, kidney, liver, and lung 

transplant centers. The clinical 

experience requirement for initial 

approval for kidney centers is 3 

transplants in a 12-month period. (See 

§ 482.80(d)(5).) 

Current national coverage decisions 

require 10 transplants for intestine and 

lung centers and 12 transplants for liver 

and heart centers. Current conditions for 

coverage for kidney transplant centers 

require 15 or more kidney transplants 

annually for a center to have 

unconditional status. Thus, all currently 

approved transplant centers should be 

performing the minimum number of 

transplants required. 

Furthermore, even if a center does not 

meet the clinical experience 

requirements, we may grant the center 

initial Medicare approval based on a 

review of the center’s compliance with 

the relevant conditions of participation 

at § 482.72 through § 482.76 and 

§ 482.90 through § 482.104. (See 

§ 488.61(a)(3).) 

Nevertheless, some centers may not 

be granted Medicare approval due to 

their failure to satisfy the clinical 

experience requirements. Loss of 

Medicare approval is likely to result in 

the center losing patients. If a center 

with current Medicare approval applies 

for and is denied Medicare approval 

under this final rule, it has the option 

to leave the Medicare program 

voluntarily until it can satisfy the 

requirements. 

Although we believe the economic 

impact of the clinical experience 

requirements will be minimal, we are 

not aware of any research that quantifies 

the cost or benefit to a hospital of 

having a transplant center. Anecdotal 

information indicates that some 

hospitals with a transplant center lose 

money or break even but that some 

hospitals experience a financial benefit. 

Whether a transplant center is a benefit 

or a cost to a hospital may depend at 

least in part on the type of organ 

transplanted, the volume of transplants 

performed, and the center’s operational 

efficiency. 

We also recognize that there may be 

benefits and/or costs to Medicare 

beneficiaries and other patients on the 

waiting lists of centers that lose 

Medicare approval, although we do not 

believe it is possible to quantify the 

benefits or costs. Benefits would include 

improved patient safety and better 

outcomes for patients who transfer to 

the waiting lists of transplant centers 

that furnish higher quality 

transplantation services. Costs could 

include increased cost for transportation 

to a center that is farther from a waiting 

list patient’s home and an increase in 

the time until an organ becomes 

available, with the potential for 

increased morbidity and mortality. 

Section 482.80(c) states that CMS will 

review outcomes for all transplants 

performed at a center, including 

outcomes for living donor transplants, if 

applicable. Except for lung transplants, 

CMS will review adult and pediatric 

outcomes separately when a center 

requests Medicare approval to perform 

both adult and pediatric transplants. 

Outcome data must be available for 

review. CMS will compare each 

transplant center’s observed number of 

patient deaths and graft failures 1 year 

post-transplant to the center’s expected 

number of patient deaths and graft 

failures 1-year post-transplant using the 

data contained in the most recent SRTR 

center-specific reports. (See 

§ 488.61(d)(1).) The required number of 

transplants must have been performed 

during the time frame reported in the 

most recent SRTR center-specific report. 

(See § 488.61(c)(2).) CMS will not 

consider a center’s patient and graft 

survival rates to be acceptable if: (1) A 

center’s observed patient survival rate or 

observed graft survival rate is lower 

than its expected patient survival rate or 

expected graft survival rate; and (2) all 

three of the following thresholds are 

crossed over: (A) the one-sided p-value 

is less than 0.05, (B) the number of 

observed events (patient deaths or graft 

failures) minus the number of expected 

events is greater than 3, and (C) the 

number of observed events divided by 

the number of expected events is greater 

than 1.5. (See § 488.61(c)(3).) 

Current national coverage decisions 

for heart, liver, lung, and intestine 

transplants already contain outcome 

requirements. However, those outcome 

requirements only concern patient (not 

graft) survival rates. The outcome 

requirements associated with § 482.80(c) 

are more comprehensive because they 

include graft survival. We believe that 

more centers may have difficulty in 

meeting these new standards. However, 

under § 488.61(a)(3), CMS, as an option, 

may approve a center that does not meet 

the patient and graft survival if a survey 

of the center demonstrates that the 

center was in compliance with § 482.72 

through § 482.76 and § 482.90 through 

§ 482.104. In addition, a center also may 

choose to withdraw voluntarily from the 

Medicare program and seek re-entry 

after it has corrected any problems. (See 

42 CFR § 488.61(d).) Thus, we believe 

the economic impact from the new 

outcome measures will be minimal. 

Section 482.82 Condition of 

Participation: Data Submission, Clinical 

Experience, and Outcome Measure 

Requirements for Re-Approval of 

Transplant Centers 

Section 482.82 provides that 

transplant centers must generally meet 

all data submission, clinical experience, 

and outcome requirements in order to 

be re-approved. The data submission, 

clinical experience, and outcome 

requirements and exceptions to those 

requirements generally are identical to 

those in § 482.80, which contains the 

requirements for initial approval. 

However, in this section, the review will 

cover the 3-year approval period. 

The economic impact of this section 

is the same as the economic impact of 

§ 482.80, except that transplant centers 

will have to comply with these 

requirements for the entire time they 

have Medicare approval. Thus, the 

economic impact associated with this 

section constitutes an annual economic 

impact for all of the centers with 

Medicare approval. However, we 

believe the economic impact will be 

minimal. 

Section 482.90 Condition of 

Participation: Patient and Living Donor 

Selection 

Section 482.90 requires transplant 

centers to use written patient selection 

criteria in determining a patient’s 

suitability for placement on the waiting 

list or a patient’s suitability for 

transplant. If a center performs living 

donor transplants, the center also must 

use written donor selection criteria in 

determining the suitability of candidates 

for donation. 

Section 482.90(a) requires that before 

a prospective transplant candidate is 

placed on a center’s waiting list, each 

prospective transplant candidate shall 

receive a psychosocial evaluation, if 

possible. In addition, the candidate’s 

medical record must contain 

documentation that the candidate’s 

blood type has been determined. When 

a patient is placed on a center’s waiting 

list or is selected to receive a transplant, 

the center must document in the 

patient’s medical record the patient 

selection criteria used. A transplant 

center must provide a copy of its patient 

selection criteria to a transplant patient, 


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or a dialysis facility, as requested by the 

patient or the dialysis facility. 

In our experience, all or nearly all 

transplant centers conduct psychosocial 

evaluations of transplant candidates. 

Such evaluations are performed 

routinely so that centers can evaluate 

how well a prospective candidate will 

do after transplantation (for example, 

whether the patient is likely to be 

compliant with the immunosuppressive 

medications needed to prevent graft 

failure). Thus, we expect no economic 

impact from this requirement for most 

transplant centers. 

In the public comments we received 

on the proposed rule, some commenters 

said that the patient selection criteria 

requirements would be burdensome. For 

example, one commenter said that it 

would take at least 30 minutes of staff 

time to document the patient selection 

criteria in the file of each patient or 

living donor. Some commenters 

indicated that the patient selection 

criteria would need constant updating. 

They also noted that the proposed rule 

did not contain an analysis of the 

economic impact for this requirement. 

We disagree that the requirement to 

have written patient selection criteria 

would have a significant impact on 

transplant centers. We expect that heart, 

liver, and lung transplant centers 

already have patient selection criteria 

because current NCDs require these 

centers to have such criteria. Further, 

Medicare coverage of pancreas and 

intestine transplants is based on specific 

clinical indicators. Although there are 

no current requirements for kidney 

transplant centers to have patient 

selection criteria, based on our 

experience, we expect that all or nearly 

all centers already have such criteria 

because many kidney transplant centers 

provide their patient selection criteria to 

local dialysis facilities. Therefore, 

complying with this requirement should 

have no additional impact on heart, 

liver, and lung centers and only a 

minimal impact on other transplant 

centers. 

We believe that transplant centers 

should be able to document the patient 

selection criteria in a patient’s medical 

record in considerably less than 30 

minutes. Generally, documenting the 

patient selection criteria in a patient’s 

medical record should involve no more 

than tracking the patient’s primary 

diagnosis and any co-morbid conditions 

to the appropriate patient selection 

criteria. Under this final rule, each 

center has the flexibility to determine 

the most expedient way to satisfy this 

requirement. Centers should be able to 

significantly reduce the resources 

needed to document the required 

information in the potential transplant 

recipient and living donor medical 

records by using electronic formats, 

forms, or checklists. 

In addition, it is standard medical 

practice to document in the medical 

record of a hospital patient undergoing 

surgery whether the patient meets the 

hospital’s criteria for surgery. Although 

we do not know how many prospective 

transplant candidates would be 

interested in requesting a copy of a 

transplant center’s patient selection 

criteria, we believe that the activities 

required by this section would have a 

minimal economic impact on transplant 

centers. Supplying a copy of patient 

selection criteria to a dialysis facility at 

its request can be done electronically 

and should require only minimal effort. 

Thus, we believe that the activities 

required by this section would require 

no additional staff and have only a 

minimal economic impact on transplant 

centers. 

Section 482.90(b) provides that 

transplant centers performing living 

donor transplants must ensure that each 

prospective living donor receives a 

medical and psychosocial evaluation 

prior to donation and must document in 

the living donor’s medical records both 

the living donor’s suitability for 

donation and that the living donor has 

given informed consent, as required 

under § 482.102. 

We expect the economic impact of 

these living donor requirements to be 

minimal, as they are similar to the 

requirements for transplant patients 

discussed previously. Due to the 

potential risks associated with donation, 

we expect that every transplant center 

that performs living donor transplants 

already has criteria for the selection of 

living donors, as well as protocols that 

require a medical and psychosocial 

evaluation of the donor. In addition, as 

with any other surgical procedure, 

documenting a living donor’s informed 

consent should be standard practice for 

any transplant center. Thus, we believe 

that these activities would constitute a 

minimal economic burden to centers 

that perform living donor transplants. 

Section 482.92 Condition of 

Participation: Organ Recovery and 

Receipt 

Transplant centers must have written 

protocols for validation of donorrecipient blood type and other vital data 

for the deceased organ recovery, organ 

receipt, and living donor organ 

transplantation processes. There are also 

specific requirements related to each of 

these processes, such as a requirement 

that the transplanting surgeon and 

another licensed health care 

professional at the transplant center 

must verify that the donor’s blood type 

and other vital data are compatible with 

transplantation of the intended recipient 

prior to transplantation. (See 

§ 482.90(b).) 

We expect that all transplant centers 

already have written protocols for 

critical functions addressed within this 

section. Although some centers’

protocols may need to be reviewed and 

revised so that they satisfy the 

requirements in this section, the 

economic impact will be negligible. 

Section 482.94 Condition of 

Participation: Patient and Living Donor 

Management 

Transplant centers must have written 

patient management policies for the 

transplant and discharge phases of 

transplantation. If a transplant center 

performs living donor transplants, the 

center also must have written donor 

management policies for the donor 

evaluation, donation, and discharge 

phases of living organ donation. 

We expect that it is standard practice 

for transplant centers to have written 

policies for the evaluation, transplant, 

and discharge phases of transplantation. 

Thus, developing written policies for 

these areas should have no economic 

impact on most transplant centers. 

However, we acknowledge that some of 

the centers’ written policies may need to 

be revised to satisfy the individual 

standards in this section. Thus, the 

economic impact of individual 

standards will be discussed below. 

Section 482.94(a) states that a 

transplant center’s patient and donor 

management policies must ensure that 

each transplant patient is under the care 

of a multidisciplinary patient care team 

coordinated by a physician throughout 

the transplant and discharge phases of 

transplantation. If the center performs 

living donor transplants, the same 

patient care requirement applies for 

living donors throughout the donor 

evaluation, donation, and discharge 

phases of donation. 

We believe that it is a standard 

practice for hospitals to have patient 

management policies that cover both the 

in-patient stay and discharge planning. 

Thus, we expect that transplant centers 

already have patient and donor 

management policies for the transplant 

and the discharge phases of 

transplantation. Due to the potential 

risks to living donors, we expect that 

every transplant center that performs 

living donor transplants already has 

written policies that cover the 

evaluation of living donors. We 

acknowledge that publication of this 

final rule may cause some centers to 


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review or revise their policies to ensure 

that they are in compliance. However, 

the economic impact on these transplant 

centers will be minimal. 

Section 482.94(b) requires that 

transplant centers must keep their 

waiting lists up to date on an ongoing 

basis, including: (1) Updating of waiting 

list patients’ clinical information; (2) 

removing patients from the center’s 

waiting list if a patient receives a 

transplant or dies, or if there is any 

other reason why the patient should no 

longer be on a center’s waiting list; and 

(3) notifying the OPTN no later than 24 

hours after a patient’s removal from the 

center’s waiting list. 

We believe these activities are 

standard practice for most transplant 

centers. Transplant centers must keep 

their patients’ clinical information 

updated to ensure that organ offers are 

made for patients appropriately, based 

on their clinical status. Further, the 

OPTN requires transplant centers to: (1) 

Remove a patient from the waiting list 

if the patient receives a transplant or 

dies; and (2) notify the OPTN within 24 

hours of the patient’s transplantation or 

death. Thus, there should be no 

economic impact on transplant centers 

from this requirement. 

Section 482.94(c) requires transplant 

centers to maintain up-to-date and 

accurate patient management records for 

each patient who receives an evaluation 

for placement on a center’s waiting list 

and who is admitted for organ 

transplantation. 

Section 482.94(c)(1) states that for 

each patient who receives an evaluation 

for placement on a center’s waiting list, 

the center must document in the 

patient’s record that the patient has 

been informed of his or her transplant 

status, including notification of the 

patient’s placement on the center’s 

waiting list, the center’s decision not to 

place the patient on its waiting list, or 

the center’s inability to make a 

determination regarding the patient’s 

placement on its waiting list because 

further clinical testing or documentation 

is needed. 

Section 482.94(c)(2) states that if a 

patient on the center’s waiting list is 

removed for any reason other than death 

or transplantation, the center must 

document in the patient’s record that 

the patient was notified no later than 10 

days after the date the patient was 

removed from the center’s waiting list. 

Section 482.94(c)(4) states that in the 

case of patients admitted for organ 

transplants, transplant centers must 

maintain written records of 

multidisciplinary patient care planning 

during the transplant period and 

multidisciplinary discharge planning for 

post-transplant care. 

All transplant centers must follow 

OPTN requirements regarding 

notification of patients and maintenance 

of their waiting lists. If a patient on the 

waiting list is removed from the waiting 

list for any reason other than death or 

transplantation, § 482.94(c)(2) requires 

the transplant center to document in the 

patient’s record that the patient was 

notified not later than 10 days after the 

date the patient was removed from the 

waiting list. The OPTN already requires 

this notification, and documentation of 

the patient’s record would be usual and 

customary business practice. Since we 

expect that all transplant centers are 

already complying with this 

requirement, there should be no 

economic impact on transplant centers 

from this requirement of the final rule. 

Thus, we believe that transplant centers 

already comply with the requirements 

in § 482.94(c), with the exception of the 

requirement for notification of dialysis 

facilities. Therefore, there is no 

economic impact on transplant centers 

from these requirements. 

Sections 482.94(c)(1) and (2) require 

kidney transplant centers, in the case of 

dialysis patients, to notify the patients’

usual dialysis facility. Since this is not 

an OPTN requirement, we do not 

believe that all transplant centers 

currently notify dialysis facilities about 

this information. When a kidney 

transplant center must notify a patient 

within 10 days about a change in status, 

the transplant center could choose to 

inform the dialysis facility at the same 

time it notifies the patient. If it did, we 

believe the burden of complying with 

this requirement would be minimal. 

However, the transplant center also 

could choose to notify the dialysis 

facilities periodically about other 

changes in status. 

For the purpose of estimating the 

economic impact, we will assume that 

rather than notifying dialysis facilities 

on a flow basis for each patient, 

transplant centers will update dialysis 

centers periodically about the status of 

all patients. Thus, for the purposes of 

determining the burden for this 

requirement, we will assume quarterly 

notifications by transplant centers to 

dialysis facilities. 

According to the OPTN, as of 

December 31, 2005, there were 64,848 

individuals awaiting kidney transplants. 

Currently, there are 4,649 dialysis 

facilities in the United States. Since the 

number of patients at these facilities 

varies greatly, the following analysis 

will use the average number of dialysis 

patients at a facility. There are currently 

approximately 243 Medicare-approved 

kidney transplant centers. Therefore, 

each transplant center has patients on 

its kidney transplant waiting list from 

an average of 19 (4,649 dialysis facilities 

divided by 243 Medicare-approved 

kidney transplant centers = 19.13) 

dialysis centers. Since there are 64,848 

patients waiting for kidney transplants 

and 4,649 dialysis facilities, each 

transplant center has an average of 14 

kidney waiting list patients at each 

dialysis facility (64,848 patients divided 

by 4,649 dialysis facilities = 13.9). For 

each of the 243 kidney transplant 

centers, there are about 267 patients 

(64,848 patients divided by 243 

transplant centers = 266.86 or 14 

patients per dialysis facility × 19 

dialysis facilities = 266). Thus, on 

average, each transplant center will 

have to determine the status of about 

267 patients and notify an average of 19 

dialysis facilities about the status of 

these patients 4 times per year. 

Based upon our past experience, we 

believe that this notification will require 

the involvement of the transplant 

coordinator and appropriate support/ 

clerical staff. We anticipate that 

transplant centers will utilize modern 

technology to minimize the burden of 

satisfying this requirement. 

TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST ESTIMATE TO NOTIFY DIALYSIS FACILITIES OF THEIR

PATIENTS’ WAITING LIST STATUS

Position Hourly wage Burden hours 

per event 

Cost estimate 

per event 

Total annual 

hours required 

(for 4 events) 

Total annual 

cost estimate 

for 4 events) 

Transplant coordinator ......................................................... $43.87 2.00 $87.74 8.0 $350.96 

Secretary .............................................................................. 21.81 .50 10.90 2.0 43.62 


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TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST ESTIMATE TO NOTIFY DIALYSIS FACILITIES OF THEIR

PATIENTS’ WAITING LIST STATUS—Continued 

Position Hourly wage Burden hours 

per event 

Cost estimate 

per event 

Total annual 

hours required 

(for 4 events) 

Total annual 

cost estimate 

for 4 events) 

Total .............................................................................. ........................ 2.50 98.64 10.00 394.58 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com. 

Thus, we anticipate that each 

quarterly notification will cost about 

$98.64. With the transplant centers 

conducting these notifications on a 

quarterly basis (that is, 4 notifications 

per year for each kidney center), the 

total annual economic impact to each 

kidney transplant center would be 

$394.58. Since there are currently about 

243 Medicare-approved kidney 

transplant centers, the total economic 

impact from this requirement will be 

$95,882.94 annually (243 transplant 

centers × $394.58 = $95,882.94). 

Section 482.94(d) states that a 

transplant center must make social 

services, furnished by qualified social 

workers, available to transplant patients, 

living donors, and their families. A 

qualified social worker is an individual 

who meets licensing requirements in the 

State in which he or she practices 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) is working as a social worker in a 

transplant center as of the effective date 

of this final rule and has served for at 

least 2 years as a social worker, 1 year 

of which was in a transplantation 

program, and has established a 

consultative relationship with a social 

worker who is qualified under 

§ 482.94(d)(1). 

Current policies for heart, liver, and 

lung transplants require facility 

commitment at all levels, including 

social service resources. We believe 

nearly all transplant centers already 

have a qualified social worker to 

provide social services. Further, we 

have been careful to retain an exception 

for bachelor’s-prepared social workers 

so that transplant centers that employ 

these social workers do not have to 

replace them with master’s-prepared 

social workers, if they were employed as 

social workers in the transplant center 

as of the effective date of this final rule 

and served for at least 2 years as a social 

worker, 1 year of which was in a 

transplantation program, and has 

established a consultative relationship 

with a social worker who is qualified 

under § 482.94(d)(1). Thus, satisfying 

this requirement would constitute a 

minimal economic impact for most, if 

not all, centers. 

Section 482.94(e) states that 

transplant centers must make 

nutritional assessments and diet 

counseling services, furnished by a 

qualified dietician, available to all 

transplant patients and living donors. A 

qualified dietician is an individual who 

meets practice requirements in the State 

in which he or she practices, and is a 

registered dietician with the 

Commission on Dietetic Registration. 

Some commenters said that this 

requirement was too expensive and 

burdensome. We disagree. Kidney 

transplant centers are required by ESRD 

CfCs at § 405.2171(c) to ensure patients 

receive nutritional services from a 

qualified dietician. Thus, all kidney 

centers currently should be providing 

these services to transplant patients and 

living donors. We expect that most 

extra-renal transplant centers provide 

nutritional services to transplant 

patients, because these patients have 

very specific nutritional needs. Some 

liver, lung, and intestine centers that 

transplant organs from living donors 

may need to obtain a dietician’s services 

for their living donors if they do not 

already provide these services. 

However, since the number of living 

liver, lung, and intestine donors in 2004 

totaled fewer than 400, we believe liver, 

lung, and intestine centers can obtain 

nutritional services for their living 

donors from dieticians already 

employed by the hospitals in which the 

centers are located at little cost to the 

center. Thus, we expect the economic 

impact to be minimal. 

Section 482.96 Condition of 

Participation: Quality Assessment and 

Performance Improvement (QAPI) 

Section 482.96 requires transplant 

centers to develop, implement, and 

maintain a written, comprehensive, 

data-driven QAPI program designed to 

monitor and evaluate performance of all 

transplantation services, including 

services provided under contract or 

arrangement. 

Section 482.96(a) states that the 

transplant center’s QAPI program must 

use objective measures to evaluate the 

center’s performance with regard to 

transplantation activities and outcomes. 

Outcomes may include, but are not 

limited to, patient and donor selection 

criteria, accuracy of the waiting list in 

accordance with the OPTN waiting list 

requirements, accuracy of donor and 

recipient matching, patient and donor 

management, techniques for organ 

recovery, consent practices, patient 

education, patient satisfaction, and 

patient rights. The transplant center 

must take actions that result in 

performance improvements and track 

performance to ensure that 

improvements are sustained. 

Section 482.96(b) requires transplant 

centers to establish and implement 

written policies to address and 

document adverse events that occur 

during any phase of an organ 

transplantation case. These policies 

must address, at a minimum, the 

process for identification, reporting, 

analysis, and prevention of adverse 

events. When an adverse event is 

identified, the transplant center must 

conduct a thorough analysis of and 

document any adverse event. The center 

must then use this analysis to effect 

changes in its policies and practices in 

order to prevent repeat incidents. 

In the proposed rule, we estimated 

that only a minority of centers did not 

already have a data-driven QAPI 

program. For those centers that would 

need to develop a QAPI program that 

would satisfy this requirement, we 

estimated that a center would likely 

utilize an experienced individual from 

its hospital QAPI staff. We used the 

salary of a registered nurse (RN) to 

estimate the economic impact, since 

many QAPI coordinators are RNs. We 

noted that the 2002 mean annual 

income of an RN was $42,730 and 

requested comments addressing 

whether transplant centers would be 

able to utilize individuals from the 

hospital’s existing QAPI staff to develop 

and implement a QAPI program specific 

to the transplant center or whether 

transplant centers would need to hire 

additional staff in order to comply with 

this proposed requirement. We did not 

make a specific estimate of the 

economic burden; however, we 

estimated the PRA burden to be 8 hours 


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on a one-time basis to comply with this 

requirement. 

Comment: Some commenters 

disagreed with the resources we 

believed would be required to satisfy 

this requirement. One commenter stated 

that a large center would require one 

FTE to comply with this requirement. 

Another commenter indicated that it 

took 160 staff hours to develop and 

establish the QAPI program at their 

hospital and 1.25 FTEs to maintain the 

program. This commenter indicated that 

8 hours would be only a ‘‘start’’ in 

complying with this requirement. 

Others noted that the establishment, 

implementation, and maintenance of 

such a QAPI program would be much 

more complex and would require more 

resources. 

Other commenters disagreed with our 

use of the 2002 mean annual RN salary 

of $42,730. One commenter noted that 

a budget of $42,000 would not cover 

their projected expenses to satisfy this 

requirement. Another commenter also 

noted that this was insufficient. They 

noted the nursing shortage and that 

most of the clinical coordinators who 

would be doing this work were 

generally both highly experienced and 

trained, and held either a bachelor’s or 

master’s degree. One commenter 

explicitly said that the average annual 

national RN salary was not the 

appropriate salary to use in estimating 

the burden associated with the QAPI 

requirement. 

Another commenter cautioned us 

about assuming that the hospital’s QAPI 

program would satisfy this requirement. 

The commenter stated that although a 

hospital QAPI program may be able to 

support a single transplant center, the 

scope and complexity of multiple 

transplant centers would require more 

resources. 

Response: We acknowledge that we 

underestimated the economic impact of 

the QAPI requirement in the proposed 

rule. It clearly will take more than 8 

hours to develop and implement the 

policies necessary to comply with this 

section. We also agree that the use of the 

2002 mean annual national RN salary is 

inadequate. However, while we agree 

that a hospital QAPI program may be 

inadequate to fully support its 

transplant center, particularly if a 

hospital has multiple transplant centers, 

we believe that the hospital’s QAPI 

program would be a substantial resource 

for the staff responsible for the 

transplant center’s QAPI program. 

We believe that many centers have 

already established and implemented a 

QAPI program that satisfies this final 

rule’s QAPI requirement. However, 

some of the centers may need to review 

and revise their programs. We believe 

this will constitute only a minimal 

economic impact to those centers. 

Some centers may need to develop 

and implement a QAPI program. 

Beginning in 2003, hospitals are 

required to have hospital-wide QAPI 

programs that involve all hospital 

departments. (See 42 CFR 482.20.) 

Therefore, we believe that no more than 

20 percent of the 504 currently 

Medicare-approved centers (101 centers) 

will need either to develop and 

implement a QAPI program or 

substantially revise an existing program. 

We also believe that no more than 40 

percent of the centers (202 centers) will 

need to perform moderate revisions to 

their programs so that they will satisfy 

the QAPI requirements in this final rule. 

However, since each center is located in 

a hospital, we believe that centers will 

have substantial resources to draw upon 

in developing their QAPI programs. 

Based on our past experience, we 

believe it is likely that centers will 

utilize an experienced staff person, 

possibly an experienced RN with some 

knowledge of the transplant program. 

An individual with this experience 

would likely be paid approximately the 

same as a transplant nurse coordinator 

or about $91,456 annually. We have 

considerable experience providing 

guidance to OPOs in developing 

comprehensive QAPI programs, which 

has provided us with knowledge of how 

many staff resources are needed to 

implement or modify a data-driven 

QAPI program. We believe it will 

require 1 FTE for each one of the 101 

centers that will need either to develop 

a QAPI program or perform substantial 

revision to an existing QAPI program. 

We believe it will require half of an FTE 

for each one of the 202 centers that will 

need to perform at least moderate 

revisions to their programs. The cost to 

the 101 centers that need 1 FTE would 

be $9,237,056 ($91,456 × 101 = 

$9,237,056), and the cost to the 202 

centers that need a half FTE would be 

$9,237,056 ($91,456 divided by 2 = 

$45,728 and $45,728 × 202 centers = 

$9,237,056). The total economic impact 

of this requirement on the transplant 

centers would be $18,474,112 

($9,237,056 + $9,237,056 = 

$18,474,112). 

This section also requires the centers 

to maintain their QAPI programs. We 

believe that having and maintaining a 

QAPI program should be considered 

standard practice by the transplant 

centers. Once the center’s QAPI program 

is developed and implemented, we 

believe that maintaining it would have 

a minimal economic impact on the 

transplant centers. 

Section 482.98 Condition of 

Participation: Human Resources 

Section 482.98 states that transplant 

centers must ensure that all individuals 

who provide services and/or supervise 

services at the center, including 

individuals furnishing services under 

contract or arrangement, are qualified to 

provide or supervise such services. 

Section 482.98(a) requires each 

transplant center to be under the general 

supervision of a qualified transplant 

surgeon or qualified physician-director. 

This director need not serve full time 

and may also serve as the center’s 

primary transplant surgeon or transplant 

physician. Section 482.98(b) requires 

transplant centers to identify to the 

OPTN a primary transplant surgeon and 

a transplant physician with appropriate 

training and experience to provide 

transplantation services, who are 

immediately available to provide 

transplantation services when an organ 

is offered for transplantation. 

Any economic impact associated with 

these requirements should be minimal. 

The current regulations for kidney 

transplant centers already require renal 

transplant centers to be supervised by a 

qualified transplantation surgeon or 

qualified physician-director, and we 

expect most extra-renal transplant 

centers have a director who would be 

considered qualified under this final 

rule. The OPTN requires transplant 

centers to have transplant surgeons and 

physicians with specific qualifications, 

training, and experience, and we believe 

that in most transplant centers, the 

primary transplant surgeon and 

transplant physician are immediately 

available to provide transplantation 

services when an organ is offered for a 

patient. 

Section 482.98(c) requires transplant 

centers to have a clinical transplant 

coordinator who is either a registered 

nurse or other licensed clinician who 

has experience and knowledge of 

transplantation and living donation 

issues. Based on our experience with 

transplant centers, we believe that all or 

nearly all centers already have a clinical 

transplant coordinator on staff to 

coordinate all patient care and 

management activities. Therefore, we do 

not believe that this requirement will 

constitute any additional burden for 

transplant centers. 

Section 482.98(d) states that 

transplant centers that perform living 

donor transplantation must identify 

either an independent living donor 

advocate or an independent living 

donor advocate team to ensure the 

protection of the rights of living donors 

and prospective living donors. This 


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individual(s) must not be involved in 

transplantation activities on a routine 

basis. 

Due to the potential risks living 

donors face, we believe it is crucial that 

living donors have an independent 

living donor advocate or advocate team. 

In addition, due to their growing 

numbers, there is an urgent need to 

provide this type of service for these 

living donors. According to the 2005 

OPTN/SRTR Annual Report, in 2003, 

there were a total of 6,820 living donors. 

In 2004, there were a total of 7,002 

living donors, of which 6,645 were 

living kidney donors, 323 were living 

liver donors, 28 were living lung 

donors, and 6 were living intestine 

donors. 

In determining an economic impact 

for this requirement, it is important to 

note that the number of living donors at 

a particular transplant center varies 

greatly. In order to estimate the 

economic impact, we have determined 

the annual average number of living 

donors per center, based on the annual 

number of living kidney and living liver 

donors. Since there are so few living 

lung and intestine donors, we have not 

estimated the impact of this requirement 

on lung or intestine transplant centers. 

There are currently about 243 

Medicare-approved kidney transplant 

programs. However, 31 of those centers 

perform only pediatric kidney 

transplants. Based on our review of data 

from the SRTR, pediatric kidney centers 

transplant very few kidneys from living 

donors. However, nearly all of the 212 

adult kidney transplant centers perform 

living kidney transplants. There are 

currently 90 Medicare-approved liver 

transplant centers. However, in 2005 

only about 36 percent or about 32 of 

those centers performed living liver 

transplants. We expect that at least half 

of the kidney and liver centers that 

perform living donor transplants already 

have a donor advocate or donor 

advocate team that fulfills the 

requirements of this final rule. Thus, we 

will determine an estimate of the 

economic impact for this requirement 

based on 106 kidney transplant centers 

(half the number of currently Medicareapproved kidney transplant centers) and 

16 liver transplant centers (half the 

number of currently Medicare-approved 

liver transplant centers that perform 

living transplants). 

Although some centers may choose to 

develop an independent living donor 

advocate team, we believe that most 

centers will choose to have an 

independent living donor advocate. 

Most centers will probably choose either 

an RN or a social worker to fill this 

position. We believe that the total 

annual compensation for this position 

would be approximately $81,124, which 

is the median annual total 

compensation for a renal dialysis staff 

nurse. Due to the number of living 

kidney donors, we believe that on 

average each center will need to have 1 

FTE for the independent living donor 

advocate position. Thus, the total 

annual economic impact to kidney 

transplant centers would be $8,599,144 

($81,124 × 106 transplant centers = 

$8,599,144). However, there are far 

fewer living liver transplants performed 

per transplant center. Although each 

center will vary in the number of 

transplants performed, we estimate that 

on average each center will need about 

half FTE for an independent living 

donor advocate. Thus, the total annual 

economic impact to the liver transplant 

centers will be $648,992 ($81,124 × .5 = 

$40,562 × 16 centers = $648,992). Thus, 

the total economic impact for this 

requirement is $9,248,136 ($8,599.144 + 

$648,992 = $9,248,136). 

Section 482.98(e) states that 

transplant centers must identify a 

multidisciplinary transplant team and 

describe the responsibilities of each 

member of the team. The team must be 

composed of individuals with the 

appropriate qualifications, training, and 

experience in the relevant areas of 

medicine, nursing, nutrition, social 

services, transplant coordination, and 

pharmacology. 

Current NCDs for heart, liver, and 

lung transplant centers require them to 

have multi-disciplinary transplant 

teams, and current CfCs for kidney 

transplant centers require them to have 

both social workers and dieticians. We 

believe that all transplant centers have 

identified their multidisciplinary 

transplant teams and described the 

responsibilities of each member of that 

team. Thus, we do not anticipate that 

this requirement will have any 

economic impact on centers. 

Section 482.98(f) states that each 

transplant center must demonstrate 

availability of expertise in internal 

medicine, surgery, anesthesiology, 

immunology, infectious disease control, 

pathology, radiology, blood banking, 

and patient education as related to the 

provision of transplantation services. 

Current NCDs for heart, liver, and lung 

transplant centers have similar 

requirements. Since every transplant 

center is part of a larger hospital, we 

expect that all transplant centers already 

have access to expertise in all of these 

areas. Therefore, this requirement will 

result in no additional economic 

impact. 

Section 482.100 Condition of 

Participation: Organ Procurement 

Section 482.100 requires a transplant 

center to ensure that the hospital in 

which it operates has a written 

agreement for the receipt of organs with 

an OPO designated by the Secretary that 

identifies specific responsibilities for 

the hospital and for the OPO with 

respect to organ recovery and organ 

allocation. 

Therefore, we expect that all centers 

have some type of written agreement or 

contract with an OPO. However, these 

agreements may not satisfy the 

requirements of this section. Thus, we 

believe that approximately 50 percent of 

the 504 centers or 252 centers would 

need to revise the agreements between 

themselves and their designated OPOs 

for the receipt of organs that identify 

specific responsibilities for the hospital 

and for the OPO with respect to organ 

recovery and organ allocation. 

TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST ESTIMATE TO DEVELOP AN AGREEMENT BETWEEN A

TRANSPLANT CENTER AND AN OPO CONCERNING ORGAN RECOVERY AND ORGAN ALLOCATION

Position Hourly wage Total annual 

hours required 

Total annual 

cost estimate 

General Counsel or Attorney ....................................................................................................... $176.86 4.0 $707.44 

Medical Director ........................................................................................................................... 116.60 2.0 233.20 

Senior Administrator .................................................................................................................... 92.31 2.0 184.62 

Transplant Coordinator ................................................................................................................ 43.87 2.0 87.74 

Secretary ...................................................................................................................................... 21.81 1.0 21.81 

Totals .................................................................................................................................... ........................ 11.00 1,234.81 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com 


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Based on our experience with health 

care organizations, agreements of this 

type would require the involvement of 

the hospital’s attorney and an 

administrator. It would also involve the 

transplant center’s director, transplant 

coordinator, and appropriate clerical/ 

support staff. We believe that it would 

require a total of approximately 11 

hours to negotiate and draft a mutually 

acceptable agreement that would be 

signed by both the transplant center and 

the OPO. 

For each hospital in which one of the 

252 transplant centers is located, the 

total cost estimate to negotiate and draft 

an organ recovery and organ allocation 

agreement with its designated OPO is 

$1,234.81. The total cost estimate is 

$311,172.12 (252 transplant centers × 

$1,234.81 = $311,172.12). 

Section 482.102 Condition of 

Participation: Patient and Living Donor 

Rights 

Section 482.102 requires transplant 

centers to implement written transplant 

patient informed consent policies that 

inform each patient about: (1) The 

evaluation process; (2) the surgical 

procedure; (3) alternative treatments; (4) 

potential medical or psychosocial risks; 

(5) national and transplant centerspecific outcomes; (6) organ donor risk 

factors that could affect the success of 

the graft or the health of the patient, 

including, but not limited to, the 

donor’s history, condition or age of the 

organs used, or the patient’s potential 

risk of contracting the human 

immunodeficiency virus and other 

infectious diseases if the disease cannot 

be detected in an infected donor; (7) his 

or her right to refuse transplantation; 

and (8) the fact that if a 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. 

Section 482.102(b) also requires 

transplant centers to implement written 

living donor informed consent policies 

that inform the prospective living donor 

of all aspects of, and potential outcomes 

from, living donation. The centers must 

ensure that the prospective living donor 

is fully informed about: (1) The fact that 

communication between the donor and 

the transplant center will remain 

confidential; (2) the evaluation process; 

(3) the surgical procedure, including 

post-operative treatment; (4) the 

availability of alternative treatments for 

the transplant recipient; (5) the potential 

medical or psychosocial risk to the 

donor; (6) the national and transplant 

center-specific outcomes for recipients; 

and the national and center-specific 

outcomes for living donors, as data are 

available; (7) 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; and (8) the 

donor’s right to opt out of donation at 

any time during the donation process; 

and (9) the fact that if a 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. 

We believe that all transplant centers 

currently have policies regarding 

informed consent. Although we 

acknowledge that some centers may 

need to review and revise their 

informed consent policies to satisfy the 

requirements for this section, we believe 

that the economic impact will be 

minimal. 

Section 482.102(c) requires a 

transplant center to notify patients 

placed on the center’s waiting list of 

information about the center that could 

impact the patient’s ability to receive a 

transplant should an organ become 

available, and what procedures are in 

place to ensure the availability of a 

transplant team. Section 482.102(c)(1) 

specifically requires a transplant center 

served by a single transplant surgeon or 

physician to inform patients placed on 

the center’s waiting list of the potential 

unavailability of the transplant surgeon 

or physician and to indicate whether or 

not the center has a mechanism to 

provide an alternate transplant surgeon 

or transplant physician. 

In the public comments we received 

to the proposed rule, one commenter 

pointed out that complying with this 

requirement would entail the drafting of 

a letter by an administrator, approval by 

the surgeon, searching a database to 

identify appropriate patients, clerical or 

support resources to prepare and mail 

the letters, and the expense associated 

with actually mailing the letters. The 

commenter pointed out that this would 

be an extensive and unrealistic use of 

resources for short-term unavailability 

issues, such as the absence of the 

transplant surgeon. 

As discussed earlier in this preamble, 

this provision does not require that 

transplant centers inform waiting list 

patients on an ongoing basis about the 

short-term unavailability of a transplant 

surgeon, such as, when a transplant 

surgeon is on vacation. The provision 

simply requires that at the time a patient 

is placed on the waiting list, the patient 

must be informed about circumstances 

that could impact the patient’s ability to 

receive a transplant and what 

procedures the transplant center has in 

place to address these circumstances. 

Clearly, this requirement is particularly 

important when a transplant center is 

served by a single surgeon. We expect 

that most transplant centers already 

provide this information to patients 

when they are placed on the waiting 

list. Thus, the economic impact for this 

requirement is minimal. 

Section 482.102(c)(2) requires that, at 

least 30 days before a transplant center’s 

Medicare approval is terminated, either 

voluntarily or involuntarily, the center 

must inform patients on its waiting list 

of this fact and provide assistance to 

waiting list patients who choose to 

transfer to the waiting list of another 

Medicare-approved transplant center 

without loss of time accrued on the 

waiting list. The transplant center must 

also inform Medicare beneficiaries on 

the center’s waiting list that Medicare 

will no longer pay for transplants 

performed at the center after the 

effective date of the center’s loss of 

Medicare approval. 

Section 482.102(c)(3) requires that as 

soon as possible prior to a transplant 

center’s voluntary inactivation, the 

center must inform patients on its 

waiting list and, as directed by the 

Secretary, provide assistance to waiting 

list patients who choose to transfer to 

the waiting list of another Medicareapproved transplant center without loss 

of time accrued on the waiting list as 

soon as possible. 

We expect that transplant centers 

would inform waiting list patients by 

mail. We estimate that it would require 

an administrator approximately 30 

minutes to draft a letter. A secretary or 

other support staff person would copy 

and mail these letters to the individuals 

on the center’s waiting list. Based on 

our estimate, the economic impact of 

performing these tasks would be 

$100.69 for each center. 


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TOTAL BURDEN HOURS AND TOTAL COST ESTIMATE FOR NOTIFYING PATIENTS ON A CENTER’S WAITING LIST OF A

TRANSPLANT CENTER’S LOSS OF MEDICARE APPROVAL

Position Hourly wage Hours required Total cost 

estimate 

Senior Administrator .................................................................................................................... $ 92.31 .50 $ 46.16 

Secretary ...................................................................................................................................... 21.81 2.50 54.53 

Totals .................................................................................................................................... ........................ 3.00 100.69 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com 

In addition, the transplant center 

would incur costs for paper, envelopes, 

and postage. We estimate these costs to 

total $.55 per mailing. On average, each 

transplant center has 112 patients, so 

the total cost of mailing the letter to 

each waiting list patient would be 

approximately $61.60 (112 patients × 

$.55 = $61.60). 

As discussed in more detail below 

under § 488.61, we believe that based 

upon the requirements contained in this 

final rule, up to two percent of 

transplant centers or approximately 10 

centers may lose their Medicare 

approved status annually. If 10 centers 

annually lost their Medicare approved 

status, either voluntarily or 

involuntarily, the total cost estimate 

would be $1,622.90 ($100.69 salary cost 

estimate + $61.60 materials/postage cost 

estimate x 10 transplant centers = 

$1,622.90). 

Section 482.104 Condition of 

Participation: Additional Requirements 

for Kidney Transplant Centers 

Section 482.104(a) requires kidney 

transplant centers to directly furnish 

transplantation and other medical and 

surgical specialty services required for 

the care of ESRD patients. The centers 

must have written policies and 

procedures for ongoing communications 

with the dialysis patients’ local dialysis 

facilities. Section 482.104(b) states that 

the kidney transplant centers must also 

furnish inpatient dialysis services 

directly or under arrangement. In 

addition, Section 482.104(c) states that 

the centers must cooperate with the 

ESRD network designated for their 

geographic area, in fulfilling the terms 

of the Network’s current statement of 

work. 

We believe that these requirements 

constitute standard practice for 

transplant centers. Thus, the activities 

required to comply with this section 

constitute a minimal economic impact. 

Section 488.61 Special Procedures for 

Approval and Re-Approval of Organ 

Transplant Centers 

Section 488.61(a) requires transplant 

centers that are not Medicare-approved 

as of June 28, 2007 to submit a request 

to CMS for Medicare approval. Section 

488.61(b) requires transplant centers, 

including kidney transplant centers, 

that are Medicare approved as of June 

28, 2007 to submit a request for 

Medicare approval no later than 

December 26, 2007. The process for 

making the request for Medicare 

approval is the same for both types of 

transplant centers. (See § 488.61(b)(1).) 

The request for Medicare approval must 

be signed by a person authorized to 

represent the center (for example, a 

chief executive officer). The request 

must include the hospital’s Medicare 

provider identification (I.D.) number; 

the name(s) of the designated primary 

transplant surgeon and primary 

transplant physician; and a statement 

from the OPTN that the center has 

complied with all data submission 

requirements. 

In the proposed rule, we estimated 

that each hospital would spend 

approximately 15 minutes to prepare 

and submit the request for Medicare 

approval to CMS. We did note that a 

hospital may have multiple transplant 

centers and, therefore, could be 

submitting more than one request for 

approval. 

We received public comments on the 

proposed rule that said we had 

underestimated the time required for a 

transplant center to apply for Medicare 

approval. One commenter emphasized 

that transplant centers regard applying 

for Medicare approval very seriously. 

The commenter also indicated that the 

preparation, approval, and submission 

of the request for Medicare approval 

could take days at many large 

institutions. After further analysis of the 

tasks and the personnel that would be 

involved in applying for Medicare 

approval, we agree with the commenters 

that 15 minutes significantly 

underestimates the time required to 

prepare the request, obtain the required 

center approval(s), and submit the 

request for Medicare approval to CMS. 

However, we disagree with the 

commenter that said it could take 

‘‘days’’ to accomplish all of the required 

tasks. Our analysis of the total cost 

estimate is discussed in detail below. 

We believe that accomplishing all of 

the tasks necessary for complying with 

Section 488.61(a) would involve the 

transplant program’s medical director, 

an administrator, a transplant 

coordinator, and appropriate support/ 

administrative staff. We estimate that it 

would take these individuals 

approximately the same amount of time 

as it would take the transplant center to 

notify CMS of a significant change in 

their program or approximately 2 

burden hours. 

TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST FOR A TRANSPLANT CENTER TO APPLY FOR MEDICARE

APPROVAL

Position Hourly wage Hours required Total cost 

estimate 

Medical Director ........................................................................................................................... $116.60 .50 $58.30 

Senior Administrator .................................................................................................................... 92.31 .50 46.16 

Transplant Coordinator ................................................................................................................ 43.87 .75 32.90 

Secretary ...................................................................................................................................... $21.81 .25 $5.45 

Totals .................................................................................................................................... ........................ 2.00 142.81 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com 


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This final rule requires all currentlyapproved transplant centers that want to 

continue to provide services to 

Medicare beneficiaries to apply for 

initial approval. There are currently 

approximately 504 Medicare-approved 

transplant centers. We believe that all 

504 transplant centers will submit 

letters requesting initial approval under 

the requirements of this final rule. In 

addition, based on our experience, we 

believe that approximately 10 new 

centers a year may apply for Medicare 

approval. Thus, we anticipate that 514 

transplant centers will apply for 

Medicare in the first year following the 

effective date of this final rule. 

For the first year after the effective 

date of this final rule, the total cost 

estimate would be $73,404.34 (514 

transplant centers × $142.81 = 

$73,404.34). For subsequent years, we 

anticipate that about 10 transplant 

centers will request initial Medicare 

approval. For those subsequent years, 

the total cost estimate would be 

$1,428.10 (10 transplant centers × 

$142.81 = $1,428.10). 

Section 488.61(d) allows transplant 

centers that have lost their Medicare 

approval to seek re-entry into the 

Medicare program at any time. If a 

center chooses to seek Medicare 

approval after losing it, the center must: 

(1) request initial approval using the 

procedures at § 488.61(a); (2) be in 

compliance with §§ 482.72 through 

482.104, except for § 482.82 (Reapproval Requirements), at the time of 

the request for Medicare approval; and 

(3) submit a report to CMS documenting 

any changes or corrective action taken 

by the center as a result of the loss of 

its Medicare approval status. 

A transplant center would utilize 

resources to prepare and submit a 

request for approval to CMS pursuant to 

§ 488.61(a) and to prepare and submit a 

report to CMS documenting any changes 

or corrective action taken by the center 

as a result of the loss of its Medicare 

approval status. After further analysis of 

the tasks that would be involved and the 

personnel that would be needed, 

developing and submitting the requests 

and the report would involve the 

transplant program’s medical director, 

an administrator, a transplant 

coordinator, and appropriate support or 

administrative staff. We also believe that 

it will require more time to request reentry into the Medicare program due to 

the development of the report 

documenting any changes or corrective 

action taken by the center as a result of 

the loss of its Medicare approval status. 

During 2005 and 2006, only six 

centers voluntarily terminated their 

Medicare approval. Transplant centers 

have rarely had their Medicare approval 

status revoked involuntarily. However, 

this final rule has outcome 

requirements, clinical experience 

requirements, and process requirements 

that transplant centers must generally 

meet to obtain initial Medicare approval 

and to retain their approval. 

Considering these requirements, we 

anticipate that more centers may 

voluntarily terminate their Medicare 

approval status in order to give 

themselves time to correct any problems 

they may have in meeting these 

requirements. In addition, it may 

become more common for transplant 

centers to be involuntarily terminated 

from the Medicare program. Therefore, 

we estimate that, in any given year, up 

to two percent, or approximately 10, of 

the currently 504 Medicare-approved 

centers may lose their status annually 

and later seek to re-enter the program. 

Based on the above, we estimate that 

a transplant center complying with the 

requirements to apply for initial 

approval would incur a total cost of 

$329.50. In any given year, we 

anticipate that as many as 10 centers 

may seek to re-enter the Medicare 

program. For these 10 centers, the total 

cost estimate would be $ 3,295.00 

($329.50 per center to re-apply × 10 

centers = $ 3,295.00). 

TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST FOR TRANSPLANT CENTERS SEEKING RE-ENTRY INTO THE

MEDICARE PROGRAM AFTER LOSS OF MEDICARE APPROVAL

Position Hourly wage Hours required Total cost 

estimate 

Medical Director ........................................................................................................................... $116.60 1.00 $116.60 

Senior Administrator .................................................................................................................... 92.31 1.00 92.31 

Transplant Coordinator ................................................................................................................ 43.87 2.50 109.68 

Secretary ...................................................................................................................................... 21.81 .50 10.91 

Totals .................................................................................................................................... ........................ 5.00 329.50 

All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com 

Thus, the estimated total economic 

impact for this section in the first year 

after this final rule becomes effective is 

$73,404.34 (514 transplant centers × 

$142.81 = $73,404.34). For subsequent 

years, the estimated annual total 

economic impact is $4,723.10 

($1,428.10 + $3,295.00 = $4,723.10). 

Our estimate of the first-year 

economic impact on transplant centers 

to meet the requirements in this final 

rule are as follows: 

• $215,928 for notification to CMS of 

significant changes to the center’s 

transplant program. 

• $95,882 annually for kidney 

transplant centers to notify dialysis 

facilities’ of their patients’ waiting list 

status. 

• $311,172 to revise agreements with 

OPOs. 

• $18,474,112 to develop and 

implement a QAPI program. 

• $9,248,136 to provide a living 

donor advocate in those centers that 

perform living donor transplantations. 

• $1,622 for centers that have lost 

their Medicare approval status to notify 

the patients on their waiting list. 

• $73,404 in the first year of 

implementation of this final rule to 

apply for Medicare approval. 

Summary of Direct Cost 

The overall first year economic 

impact of implementing the 

requirements in this final rule will be 

approximately $28,420,256, and the first 

year cost to each of the transplant 

centers will be an average of about 

$56,389 per transplant center. This 

figure includes the total compensation 

for all of the staff hours that were 

calculated. 

Benefits and Effects of This Final Rule 

The primary economic benefit of this 

final rule lies with its potential to 

improve Medicare-approved transplant 

centers’ effectiveness and efficiency and 

thus reduce the number of patient 

deaths and graft failures for patients 

who receive transplants at Medicareapproved facilities. We believe that 

implementing the requirements in this 

final rule will result in a decrease in 

patient deaths and graft failures. 


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However, it is difficult to estimate the 

percentage of that decrease. For some 

transplant centers, most of the 

requirements in this final rule are 

already standard practice. Other centers 

will need to make only minor 

improvements to their current processes 

and practices. And, some transplant 

centers will need to make substantial 

modifications to their processes and 

practices to be in compliance. In 

addition, while some requirements will 

probably have only a minor, if any, 

effect on patient outcomes, there are 

certain requirements that we believe 

have the potential to substantially 

improve patient outcomes. For example, 

§ 482.72(a) requires transplant centers to 

submit to the OPTN at least 95 percent 

of the required data on all transplants it 

has performed no later than 90 days 

after the due date established by the 

OPTN. Since this is already a 

requirement of the OPTN and the 

hospitals in which transplant centers 

are located must already belong to the 

OPTN, we do not anticipate that this 

requirement in the final rule will have 

any effect on patient outcomes. 

However, other requirements could 

have a substantial effect. Section 482.96 

requires that transplant centers must 

develop, implement, and maintain a 

written, comprehensive, data-driven 

quality assessment and performance 

improvement (QAPI) program designed 

to monitor and evaluate performance of 

all transplantation services. These types 

of QAPI programs have the potential to 

substantially improve patient outcomes. 

Centers that do not have such QAPI 

programs currently could experience 

substantial improvements in their 

patient outcomes. However, since some 

centers are already complying with the 

QAPI requirement, as well as the other 

requirements in the final rule, we do not 

believe that the increase in 

improvement for all transplant centers 

will be substantial. Due to the current 

diversity in processes and procedures 

existing in transplant centers, we cannot 

calculate any percentage of decrease in 

patient deaths or graft failures to any 

degree of reasonable certainty. Thus, we 

will not be able to quantify the social 

benefits we believe will result from 

implementation of this final rule. 

The social benefits from the 

implementation of this regulation will 

result from both the lives saved and the 

decrease in graft failures. Organ failure 

is usually fatal within a short period of 

time. Patients with ESRD are an 

exception. Some ESRD patients can 

survive for many years on dialysis and 

many of those patients can do quite 

well. However, dialysis is quite 

demanding and requires a substantial 

commitment on the part of these 

patients and their families. Therefore, 

kidney transplantation offers these 

patients a substantially increased 

quality of life. In addition, graft failures 

for very seriously ill patients often 

require re-transplantation for the patient 

to survive for more than a short length 

of time. And, considering the significant 

shortage of transplantable organs, it is 

crucial for transplant centers to operate 

efficiently and provide the best quality 

of care to transplant recipients to 

optimize the use of the transplantable 

organs that are available. 

In addition to a decrease in patient 

deaths and graft failures, many of the 

requirements in this regulation should 

contribute to a higher quality of care for 

both transplant recipients and living 

donors. This increase in the quality of 

care will result in substantial social 

benefits. For example, the requirements 

for informed consent, donor 

management, a living donor advocate or 

living donor advocate team, and 

psychosocial evaluations of both 

potential transplant recipients and 

living donors should all lead to an 

improvement in the quality of care 

received by both transplant recipients 

and living donors. Based upon the 

above, we believe that the social 

benefits from the implementation of this 

final rule include: 

• Increase in years of life gained. 

• Improvements in quality of life, 

particularly for chronic kidney disease 

patients who can terminate dialysis. 

• Resumption of work/volunteerism/ 

productivity for some patients. 

• An increase in the number of 

taxpayers (patients who return to work). 

• An increase in family stability due 

to the life saved and improved health of 

a family member. 

• An increase in access to dialysis as 

more patients receive kidney 

transplants. 

• An increase in the number of 

patients who are transplanted due to the 

reduction in patients who need to be retransplanted due to graft failures. 

• Improved quality of care for both 

potential and actual transplant 

recipients and living donors. 

Effects on the Medicare Program 

In addition to the social benefits 

discussed above, we can estimate a 

monetary benefit from a reduction in the 

number of kidney graft failures, which 

forces kidney transplant patients to 

return to dialysis for treatment. 

Medicare pays for kidney dialysis for 

the vast majority of dialysis patients in 

the United States. 

In 2003 (the most recent year for 

which complete data are available), 

there were 15,722 kidney (deceased or 

living donor) and kidney-pancreas 

transplants. Of the approximately 

15,722 patients who received these 

transplants, 1-year graft survival data 

show that 1288 (less than 10 percent) of 

kidney grafts failed. We do not have 

data to show how many of the 

transplants were performed at Medicareapproved facilities, but since all or 

nearly all kidney transplant centers are 

Medicare approved, we will assume that 

all 2003 kidney and kidney-pancreas 

transplants were performed at Medicareapproved transplant centers. As stated 

above, we believe that the improvement 

in the number of graft failures will be 

modest. We estimate that the 

improvement could be from 1 to 3 

percent. A 1 to 3 percent decrease in 

kidney graft failures would result in 

approximately 13 to 39 fewer graft 

failures in the first year after 

implementation of this regulation. 

Based on the median decrease of 2 

percent, we can estimate that there 

could be as many as 26 fewer kidney 

graft failures. 

The 2003 average per person per year 

primary payer cost for dialysis patients 

was $63,723, while the cost for endstage renal disease patients with a 

functioning kidney graft was $15,357 

(United States Renal Data System 

(USRDS): 2005 Annual Data Report: 

Atlas of End-Stage Renal Disease in the 

United States pages 674 and 680). 

Therefore, net health care cost savings 

would be $48,366 annually per patient 

and the cost savings for 26 patients 

would be $1,257,516 (26 patients × 

$48,366 cost savings per patient = 

$1,257,516). 

It is important to note that retransplantation of a kidney patient who 

experiences graft failure prevents a 

patient on the kidney waiting list from 

receiving a kidney and, thus, ending 

dialysis treatment. It is also important to 

note that while fewer graft failures will 

result in more patients receiving a first 

transplant (rather than a re-transplant), 

we estimate that the number of organs 

available for transplantation will remain 

the same. Thus, we do not anticipate 

that Medicare will face increased costs 

because the number of transplants 

should remain approximately the same. 

We expect that the procedures for 

approval and re-approval contained in 

this final rule will have some economic 

impact on the Medicare program 

because CMS will need to survey all 504 

transplant centers that are currently 

approved by Medicare if they wish to 

continue to provide services to 

Medicare beneficiaries. Furthermore, 


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under this final rule, all transplant 

centers must be re-approved every 3 

years, and some centers will be 

surveyed as part of our re-approval 

process. Thus, this final rule is likely to 

increase survey costs. 

Nevertheless, to the extent possible, 

we will minimize costs by prioritizing 

surveys based on transplant centers 

performance on the outcome 

requirements and by conducting surveys 

in the most efficient way possible. For 

example, all transplant centers located 

in the same hospital will be surveyed at 

the same time. 

In addition, since Medicare 

reimbursement rates are either directly 

or indirectly influenced by a hospital’s 

costs, we may eventually increase 

Medicare reimbursement to transplant 

centers to cover some of the costs of 

their extra responsibilities. Medicare 

pays hospitals on a cost basis for certain 

‘‘organ acquisition costs’’. Costs related 

to the requirement to have a donor 

advocate or donor advocate team are 

organ acquisition costs. 

Medicare generally reimburses 

hospitals for organ transplant costs for 

beneficiaries using diagnosis related 

groups (DRGs) in all States, except for 

Maryland. DRG payments are 

periodically re-weighted in a budget 

neutral fashion to increase payments for 

procedures that have costs that are 

growing at a faster rate than most other 

procedures. Therefore, it is possible that 

DRGs for organ transplants will increase 

and therefore offset some of the 

hospitals’ costs under the various 

transplant DRGs. 

Conclusion 

We believe that the requirements in 

this final rule will ensure that the organ 

transplants made available to patients 

are provided in a safe and effective 

manner. We also believe that this final 

rule will ensure that living donors 

receive the guidance and care that they 

deserve. We estimate that the first year 

cost of implementing this final rule is 

$28,420,256. The cost of 

implementation in subsequent years is 

estimated to be $9,566,291 annually. 

List of Subjects 

42 CFR Part 405 

Administrative practice and 

procedure, Health facilities, Health 

professions, Kidney diseases, Medical 

devices, Medicare, Reporting and 

recordkeeping requirements, Rural 

areas, X-rays. 

42 CFR Part 482 

Grant programs-health, Hospitals, 

Medicare, reporting and recordkeeping 

requirements. 

42 CFR Part 488 

Administrative practice and 

procedure, Health facilities, Medicare, 

reporting and recordkeeping 

requirements. 

42 CFR Part 498 

Administrative practice and 

procedure, Health Facilities, Health 

professions, Medicare, reporting and 

recordkeeping requirements. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

chapter IV as set forth below: 

PART 405—FEDERAL HEALTH 

INSURANCE FOR THE AGED AND 

DISABLED 

Subpart U—Conditions for Coverage of 

Suppliers of End-Stage Renal Disease 

(ESRD) Services 

■ 1. The authority citation for part 405, 

Subpart U continues to read as follows: 

Authority: Secs. 1102, 1138, 1861, 1862(a), 

1871, 1874, and 1881 of the Social Security 

Act (42 U.S.C. 1302, 1320b–8, 1395x, 

1395y(a), 1395hh, 1395kk, and 1395rr), 

unless otherwise noted. 

§ 405.2102 [Amended] 

■ 2. Section 405.2102 is amended by—

■ A. Removing the definitions for 

‘‘histocompatibility testing’’ and ‘‘organ 

procurement’’. 

■ B. Amending the definition of ‘‘ESRD 

facility’’ by removing paragraph (a) and 

by re-designating paragraphs (b) through 

(e) as paragraphs (a) through (d). 

■ C. Amending the definition of ‘‘ESRD 

service’’ by removing paragraph (a) and 

by re-designating paragraphs (b) and (c) 

as paragraphs (a) and (b). 

■ D. Amending the definition of 

‘‘Qualified personnel’’ by removing 

paragraph (g). 

§§ 405.2120 through 405.2124 [Removed] 

■ 3. Sections 405.2120 through 

405.2124 are removed. 

§ 405.2130 [Removed] 

■ 4. Section 405.2130 is removed. 

§§ 405.2170 and 405.2171 [Removed] 

■ 5. Section 405.2170 and 405.2171 are 

removed. 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

■ 6. The authority citation for part 482 

is revised to read as follows: 

Authority: Secs. 1102, 1871 and 1881 of 

the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr), unless otherwise noted. 

■ 7. Part 482 is amended by revising 

subpart E to read as follows: 

Subpart E—Requirements for Specialty 

Hospitals 

Sec. 

482.68 Special requirements for transplant 

centers. 

482.70 Definitions. 

General Requirements for Transplant 

Centers 

482.72 Condition of participation: OPTN 

Membership. 

482.74 Condition of participation: 

Notification to CMS. 

482.76 Condition of participation: Pediatric 

Transplants. 

Transplant Center Data Submission, Clinical 

Experience, and Outcome Requirements 

482.80 Condition of participation: Data 

submission, clinical experience, and 

outcome requirements for initial 

approval of transplant centers. 

482.82 Condition of participation: Data 

submission, clinical experience, and 

outcome requirements for re-approval of 

transplant centers. 

Transplant Center Process Requirements 

482.90 Condition of participation: Patient 

and living donor selection. 

482.92 Condition of participation: Organ 

recovery and receipt. 

482.94 Condition of participation: Patient 

and living donor management. 

482.96 Condition of participation: Quality 

assessment and performance 

improvement (QAPI). 

482.98 Condition of participation: Human 

resources. 

482.100 Condition of participation: Organ 

procurement. 

482.102 Condition of participation: Patient 

and living donor rights. 

482.104 Condition of participation: 

Additional requirements for kidney 

transplant centers. 

Subpart E—Requirements for Specialty 

Hospitals 

§ 482.68 Special requirements for 

transplant centers. 

A transplant center located within a 

hospital that has a Medicare provider 

agreement must meet the conditions of 

participation specified in § 482.72 

through § 482.104 in order to be granted 

approval from CMS to provide 

transplant services. 

(a) Unless specified otherwise, the 

conditions of participation at § 482.72 

through § 482.104 apply to heart, heartlung, intestine, kidney, liver, lung, and 

pancreas centers. 

(b) In addition to meeting the 

conditions of participation specified in 

§ 482.72 through § 482.104, a transplant 

center must also meet the conditions of 

participation specified in § 482.1 

through § 482.57. 


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§ 482.70 Definitions. 

As used in this subpart, the following 

definitions apply: 

Adverse event means an untoward, 

undesirable, and usually unanticipated 

event that causes death or serious 

injury, or the risk thereof. As applied to 

transplant centers, examples of adverse 

events include (but are not limited to) 

serious medical complications or death 

caused by living donation; 

unintentional transplantation of organs 

of mismatched blood types; 

transplantation of organs to unintended 

recipients; and unintended transmission 

of infectious disease to a recipient. 

End-Stage Renal Disease (ESRD) 

means that stage of renal impairment 

that appears irreversible and permanent, 

and requires a regular course of dialysis 

or kidney transplantation to maintain 

life. 

ESRD Network means all Medicareapproved ESRD facilities in a designated 

geographic area specified by CMS. 

Heart-Lung transplant center means a 

transplant center that is located in a 

hospital with an existing Medicareapproved heart transplant center and an 

existing Medicare-approved lung center 

that performs combined heart-lung 

transplants. 

Intestine transplant center means a 

Medicare-approved liver transplant 

center that performs intestine 

transplants, combined liver-intestine 

transplants, or multivisceral transplants. 

Network organization means the 

administrative governing body to the 

network and liaison to the Federal 

government. 

Pancreas transplant center means a 

Medicare-approved kidney transplant 

center that performs pancreas 

transplants alone or subsequent to a 

kidney transplant as well as kidneypancreas transplants. 

Transplant center means an organspecific transplant program (as defined 

in this rule) within a transplant hospital 

(for example, a hospital’s lung 

transplant program may also be referred 

to as the hospital’s lung transplant 

center). 

Transplant hospital means a hospital 

that furnishes organ transplants and 

other medical and surgical specialty 

services required for the care of 

transplant patients. 

Transplant program means a 

component within a transplant hospital 

(as defined in this rule) that provides 

transplantation of a particular type of 

organ. 

General Requirements for Transplant 

Centers 

§ 482.72 Condition of participation: OPTN 

membership. 

A transplant center must be located in 

a transplant hospital that is a member of 

and abides by the rules and 

requirements of the Organ Procurement 

and Transplantation Network (OPTN) 

established and operated in accordance 

with section 372 of the Public Health 

Service (PHS) Act (42 U.S.C. 274). The 

term ‘‘rules and requirements of the 

OPTN’’ means those rules and 

requirements approved by the Secretary 

pursuant to § 121.4 of this title. No 

hospital that provides transplantation 

services shall be deemed to be out of 

compliance with section 1138(a)(1)(B) of 

the Act or this section unless the 

Secretary has given the OPTN formal 

notice that he or she approves the 

decision to exclude the transplant 

hospital from the OPTN and also has 

notified the transplant hospital in 

writing. 

§ 482.74 Condition of participation: 

Notification to CMS. 

(a) A transplant center must notify 

CMS immediately of any significant 

changes related to the center’s 

transplant program or changes that 

could affect its compliance with the 

conditions of participation. Instances in 

which CMS should receive information 

for follow up, as appropriate, include, 

but are not limited to: 

(1) Change in key staff members of the 

transplant team, such as a change in the 

individual the transplant center 

designated to the OPTN as the center’s 

‘‘primary transplant surgeon’’ or 

‘‘primary transplant physician;’

(2) A decrease in the center’s number 

of transplants or survival rates that 

could result in the center being out of 

compliance with § 482.82; 

(3) Termination of an agreement 

between the hospital in which the 

transplant center is located and an OPO 

for the recovery and receipt of organs as 

required by section 482.100; and 

(4) Inactivation of the transplant 

center. 

(b) Upon receiving notification of 

significant changes, CMS will follow up 

with the transplant center as 

appropriate, including (but not limited 

to): 

(1) Requesting additional information; 

(2) Analyzing the information; or 

(3) Conducting an on-site review. 

§ 482.76 Condition of participation: 

Pediatric Transplants. 

A transplant center that seeks 

Medicare approval to provide 

transplantation services to pediatric 

patients must submit to CMS a request 

specifically for Medicare approval to 

perform pediatric transplants using the 

procedures described at § 488.61 of this 

chapter. 

(a) Except as specified in paragraph 

(d) of this section, a center requesting 

Medicare approval to perform pediatric 

transplants must meet all the conditions 

of participation at § 482.72 through 

§ 482.74 and § 482.80 through § 482.104 

with respect to its pediatric patients. 

(b) A center that performs 50 percent 

or more of its transplants in a 12-month 

period on adult patients must be 

approved to perform adult transplants 

in order to be approved to perform 

pediatric transplants. 

(1) Loss of Medicare approval to 

perform adult transplants, whether 

voluntary or involuntary, will result in 

loss of the center’s approval to perform 

pediatric transplants. 

(2) Loss of Medicare approval to 

perform pediatric transplants, whether 

voluntary or involuntary, may trigger a 

review of the center’s Medicare 

approval to perform adult transplants. 

(c) A center that performs 50 percent 

or more of its transplants in a 12-month 

period on pediatric patients must be 

approved to perform pediatric 

transplants in order to be approved to 

perform adult transplants. 

(1) Loss of Medicare approval to 

perform pediatric transplants, whether 

voluntary or involuntary, will result in 

loss of the center’s approval to perform 

adult transplants. 

(2) Loss of Medicare approval to 

perform adult transplants, whether 

voluntary or involuntary, may trigger a 

review of the center’s Medicare 

approval to perform pediatric 

transplants. 

(3) A center that performs 50 percent 

or more of its transplants on pediatric 

patients in a 12-month period is not 

required to meet the clinical experience 

requirements prior to its request for 

approval as a pediatric transplant 

center. 

(d) Instead of meeting all conditions 

of participation at § 482.72 through 

§ 482.74 and § 482.80 through § 482.104, 

a heart transplant center that wishes to 

provide transplantation services to 

pediatric heart patients may be 

approved to perform pediatric heart 

transplants by meeting the Omnibus 

Budget Reconciliation Act of 1987 

criteria in section 4009(b) (Pub. L. 100–

203), as follows: 

(1) The center’s pediatric transplant 

program must be operated jointly by the 

hospital and another facility that is 

Medicare-approved; 

(2) The unified program shares the 

same transplant surgeons and quality 


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improvement program (including 

oversight committee, patient protocol, 

and patient selection criteria); and 

(3) The center demonstrates to the 

satisfaction of the Secretary that it is 

able to provide the specialized facilities, 

services, and personnel that are required 

by pediatric heart transplant patients. 

Transplant Center Data Submission, 

Clinical Experience, and Outcome 

Requirements 

§ 482.80 Condition of participation: Data 

submission, clinical experience, and 

outcome requirements for initial approval of 

transplant centers. 

Except as specified in paragraph (d) of 

this section, and § 488.61 of this 

chapter, transplant centers must meet 

all data submission, clinical experience, 

and outcome requirements to be granted 

initial approval by CMS. 

(a) Standard: Data submission. No 

later than 90 days after the due date 

established by the OPTN, a transplant 

center must submit to the OPTN at least 

95 percent of required data on all 

transplants (deceased and living donor) 

it has performed. Required data 

submissions include, but are not limited 

to, submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration and follow-up, and living 

donor registration and follow-up. 

(b) Standard: Clinical experience. To 

be considered for initial approval, an 

organ-specific transplant center must 

generally perform 10 transplants over a 

12-month period. 

(c) Standard: Outcome requirements. 

CMS will review outcomes for all 

transplants performed at a center, 

including outcomes for living donor 

transplants, if applicable. Except for 

lung transplants, CMS will review adult 

and pediatric outcomes separately when 

a center requests Medicare approval to 

perform both adult and pediatric 

transplants. 

(1) CMS will compare each transplant 

center’s observed number of patient 

deaths and graft failures 1-year posttransplant to the center’s expected 

number of patient deaths and graft 

failures 1-year post-transplant using the 

data contained in the most recent 

Scientific Registry of Transplant 

Recipients (SRTR) center-specific 

report. 

(2) The required number of 

transplants must have been performed 

during the time frame reported in the 

most recent SRTR center-specific report. 

(3) CMS will not consider a center’s 

patient and graft survival rates to be 

acceptable if: 

(i) A center’s observed patient 

survival rate or observed graft survival 

rate is lower than its expected patient 

survival rate or expected graft survival 

rate; and 

(ii) All three of the following 

thresholds are crossed over: 

(A) The one-sided p-value is less than 

0.05, 

(B) The number of observed events 

(patient deaths or graft failures) minus 

the number of expected events is greater 

than 3, and 

(C) The number of observed events 

divided by the number of expected 

events is greater than 1.5. 

(d) Exceptions. (1) A heart-lung 

transplant center is not required to 

comply with the clinical experience 

requirements in paragraph (b) of this 

section or the outcome requirements in 

paragraph (c) of this section for heartlung transplants performed at the 

center. 

(2) An intestine transplant center is 

not required to comply with the 

outcome performance requirements in 

paragraph (c) of this section for 

intestine, combined liver-intestine or 

multivisceral transplants performed at 

the center. 

(3) A pancreas transplant center is not 

required to comply with the clinical 

experience requirements in paragraph 

(b) of this section or the outcome 

requirements in paragraph (c) of this 

section for pancreas transplants 

performed at the center. 

(4) A center that is requesting initial 

Medicare approval to perform pediatric 

transplants is not required to comply 

with the clinical experience 

requirements in paragraph (b) of this 

section prior to its request for approval 

as a pediatric transplant center. 

(5) A kidney transplant center that is 

not Medicare-approved on the effective 

date of this rule is required to perform 

at least 3 transplants over a 12-month 

period prior to its request for initial 

approval. 

§ 482.82 Condition of participation: Data 

submission, clinical experience, and 

outcome requirements for re-approval of 

transplant centers. 

Except as specified in paragraph (d) of 

this section, and § 488.61 of this 

chapter, transplant centers must meet 

all data submission, clinical experience, 

and outcome requirements in order to 

be re-approved. 

(a) Standard: Data submission. No 

later than 90 days after the due date 

established by the OPTN, a transplant 

center must submit to the OPTN at least 

95 percent of the required data 

submissions on all transplants 

(deceased and living donor) it has 

performed over the 3-year approval 

period. Required data submissions 

include, but are not limited to, 

submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration and follow-up, and living 

donor registration and follow-up. 

(b) Standard: Clinical experience. To 

be considered for re-approval, an organspecific transplant center must generally 

perform an average of 10 transplants per 

year during the re-approval period. 

(c) Standard: Outcome requirements. 

CMS will review outcomes for all 

transplants performed at a center, 

including outcomes for living donor 

transplants if applicable. Except for lung 

transplants, CMS will review adult and 

pediatric outcomes separately when a 

center requests Medicare approval to 

perform both adult and pediatric 

transplants. 

(1) CMS will compare each transplant 

center’s observed number of patient 

deaths and graft failures 1-year posttransplant to the center’s expected 

number of patient deaths and graft 

failures 1-year post-transplant using 

data contained in the most recent SRTR 

center-specific report. 

(2) The required number of 

transplants must have been performed 

during the time frame reported in the 

most recent SRTR center-specific report. 

(3) CMS will not consider a center’s 

patient and graft survival rates to be 

acceptable if: 

(i) A center’s observed patient 

survival rate or observed graft survival 

rate is lower than its expected patient 

survival rate and graft survival rate; and 

(ii) All three of the following 

thresholds are crossed over: 

(A) The one-sided p-value is less than 

0.05, 

(B) The number of observed events 

(patient deaths or graft failures) minus 

the number of expected events is greater 

than 3, and 

(C) The number of observed events 

divided by the number of expected 

events is greater than 1.5. 

(d) Exceptions. (1) A heart-lung 

transplant center is not required to 

comply with the clinical experience 

requirements in paragraph (b) of this 

section or the outcome requirements in 

paragraph (c) of this section for heartlung transplants performed at the 

center. 

(2) An intestine transplant center is 

not required to comply with the 

outcome requirements in paragraph (c) 

of this section for intestine, combined 

liver-intestine, and multivisceral 

transplants performed at the center. 

(3) A pancreas transplant center is not 

required to comply with the clinical 

experience requirements in paragraph 

(b) of this section or the outcome 


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requirements in paragraph (c) of this 

section for pancreas transplants 

performed at the center. 

(4) A center that is approved to 

perform pediatric transplants is not 

required to comply with the clinical 

experience requirements in paragraph 

(b) of this section to be re-approved. 

Transplant Center Process 

Requirements 

§ 482.90 Condition of participation: Patient 

and living donor selection. 

The transplant center must use 

written patient selection criteria in 

determining a patient’s suitability for 

placement on the waiting list or a 

patient’s suitability for transplantation. 

If a center performs living donor 

transplants, the center also must use 

written donor selection criteria in 

determining the suitability of candidates 

for donation. 

(a) Standard: Patient selection. Patient 

selection criteria must ensure fair and 

non-discriminatory distribution of 

organs. 

(1) Prior to placement on the center’s 

waiting list, a prospective transplant 

candidate must receive a psychosocial 

evaluation, if possible. 

(2) Before a transplant center places a 

transplant candidate on its waiting list, 

the candidate’s medical record must 

contain documentation that the 

candidate’s blood type has been 

determined. 

(3) When a patient is placed on a 

center’s waiting list or is selected to 

receive a transplant, the center must 

document in the patient’s medical 

record the patient selection criteria 

used. 

(4) A transplant center must provide 

a copy of its patient selection criteria to 

a transplant patient, or a dialysis 

facility, as requested by a patient or a 

dialysis facility. 

(b) Standard: Living donor selection. 

The living donor selection criteria must 

be consistent with the general principles 

of medical ethics. Transplant centers 

must: 

(1) Ensure that a prospective living 

donor receives a medical and 

psychosocial evaluation prior to 

donation, 

(2) Document in the living donor’s 

medical records the living donor’s 

suitability for donation, and 

(3) Document that the living donor 

has given informed consent, as required 

under § 482.102. 

§ 482.92 Condition of participation: Organ 

recovery and receipt. 

Transplant centers must have written 

protocols for validation of donorrecipient blood type and other vital data 

for the deceased organ recovery, organ 

receipt, and living donor organ 

transplantation processes. The 

transplanting surgeon at the transplant 

center is responsible for ensuring the 

medical suitability of donor organs for 

transplantation into the intended 

recipient. 

(a) Standard: Organ recovery. When 

the identity of an intended transplant 

recipient is known and the transplant 

center sends a team to recover the 

organ(s), the transplant center’s recovery 

team must review and compare the 

donor data with the recipient blood type 

and other vital data before organ 

recovery takes place. 

(b) Standard: Organ receipt. After an 

organ arrives at a transplant center, 

prior to transplantation, the 

transplanting surgeon and another 

licensed health care professional must 

verify that the donor’s blood type and 

other vital data are compatible with 

transplantation of the intended recipient 

(c) Standard: Living donor 

transplantation. If a center performs 

living donor transplants, the 

transplanting surgeon and another 

licensed health care professional at the 

center must verify that the living 

donor’s blood type and other vital data 

are 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. 

Transplant centers must have written 

patient management policies for the 

transplant and discharge phases of 

transplantation. If a transplant center 

performs living donor transplants, the 

center also must have written donor 

management policies for the donor 

evaluation, donation, and discharge 

phases of living organ donation. 

(a) Standard: Patient and living donor 

care. The transplant center’s patient and 

donor management policies must ensure 

that: 

(1) Each transplant patient is under 

the care of a multidisciplinary patient 

care team coordinated by a physician 

throughout the transplant and discharge 

phases of transplantation; and 

(2) If a center performs living donor 

transplants, each living donor is under 

the care of a multidisciplinary patient 

care team coordinated by a physician 

throughout the donor evaluation, 

donation, and discharge phases of 

donation. 

(b) Standard: Waiting list 

management. Transplant centers must 

keep their waiting lists up to date on an 

ongoing basis, including: 

(1) Updating of waiting list patients’

clinical information; 

(2) Removing patients from the 

center’s waiting list if a patient receives 

a transplant or dies, or if there is any 

other reason the patient should no 

longer be on a center’s waiting list; and 

(3) Notifying the OPTN no later than 

24 hours after a patient’s removal from 

the center’s waiting list. 

(c) Standard: Patient records. 

Transplant centers must maintain up-todate and accurate patient management 

records for each patient who receives an 

evaluation for placement on a center’s 

waiting list and who is admitted for 

organ transplantation. 

(1) For each patient who receives an 

evaluation for placement on a center’s 

waiting list, the center must document 

in the patient’s record that the patient 

(and in the case of a kidney patient, the 

patient’s usual dialysis facility) has been 

informed of his or her transplant status, 

including notification of: 

(i) The patient’s placement on the 

center’s waiting list; 

(ii) The center’s decision not to place 

the patient on its waiting list; or 

(iii) The center’s inability to make a 

determination regarding the patient’s 

placement on its waiting list because 

further clinical testing or documentation 

is needed. 

(2) If a patient on the waiting list is 

removed from the waiting list for any 

reason other than death or 

transplantation, the transplant center 

must document in the patient’s record 

that the patient (and in the case of a 

kidney patient, the patient’s usual 

dialysis facility) was notified no later 

than 10 days after the date the patient 

was removed from the waiting list. 

(3) In the case of patients admitted for 

organ transplants, transplant centers 

must maintain written records of: 

(i) Multidisciplinary patient care 

planning during the transplant period; 

and 

(ii) Multidisciplinary discharge 

planning for post-transplant care. 

(d) Standard: Social services. The 

transplant center must make social 

services available, 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 in which he or 

she practices; and 

(1) Completed a course of study with 

specialization in clinical practice and 

holds a master’s degree from a graduate 

school of social work accredited by the 

Council on Social Work Education; or 

(2) Is working as a social worker in a 

transplant center as of the effective date 

of this final rule and has served for at 


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least 2 years as a social worker, 1 year 

of which was in a transplantation 

program, and has established a 

consultative relationship with a social 

worker who is qualified under (d)(1) of 

this paragraph. 

(e) Standard: Nutritional services. 

Transplant centers must make 

nutritional assessments and diet 

counseling services, furnished by a 

qualified dietitian, available to all 

transplant patients and living donors. A 

qualified dietitian is an individual who 

meets practice requirements in the State 

in which he or she practices and is a 

registered dietitian with the 

Commission on Dietetic Registration. 

§ 482.96 Condition of participation: Quality 

assessment and performance improvement 

(QAPI). 

Transplant centers must develop, 

implement, and maintain a written, 

comprehensive, data-driven QAPI 

program designed to monitor and 

evaluate performance of all 

transplantation services, including 

services provided under contract or 

arrangement. 

(a) Standard: Components of a QAPI 

program. The transplant center’s QAPI 

program must use objective measures to 

evaluate the center’s performance with 

regard to transplantation activities and 

outcomes. Outcome measures may 

include, but are not limited to, patient 

and donor selection criteria, accuracy of 

the waiting list in accordance with the 

OPTN waiting list requirements, 

accuracy of donor and recipient 

matching, patient and donor 

management, techniques for organ 

recovery, consent practices, patient 

education, patient satisfaction, and 

patient rights. The transplant center 

must take actions that result in 

performance improvements and track 

performance to ensure that 

improvements are sustained. 

(b) Standard: Adverse events. A 

transplant center must establish and 

implement written policies to address 

and document adverse events that occur 

during any phase of an organ 

transplantation case. 

(1) The policies must address, at a 

minimum, the process for the 

identification, reporting, analysis, and 

prevention of adverse events. 

(2) The transplant center must 

conduct a thorough analysis of and 

document any adverse event and must 

utilize the analysis to effect changes in 

the transplant center’s policies and 

practices to prevent repeat incidents. 

§ 482.98 Condition of participation: Human 

resources. 

The transplant center must ensure 

that all individuals who provide 

services and/or supervise services at the 

center, including individuals furnishing 

services under contract or arrangement, 

are qualified to provide or supervise 

such services. 

(a) Standard: Director of a transplant 

center. The transplant center must be 

under the general supervision of a 

qualified transplant surgeon or a 

qualified physician-director. The 

director of a transplant center need not 

serve full-time and may also serve as a 

center’s primary transplant surgeon or 

transplant physician in accordance with 

§ 482.98(b). The director is responsible 

for planning, organizing, conducting, 

and directing the transplant center and 

must devote sufficient time to carry out 

these responsibilities, which include 

but are not limited to the following: 

(1) Coordinating with the hospital in 

which the transplant center is located to 

ensure adequate training of nursing staff 

and clinical transplant coordinators in 

the care of transplant patients and living 

donors. 

(2) Ensuring that tissue typing and 

organ procurement services are 

available. 

(3) Ensuring that transplantation 

surgery is performed by, or under the 

direct supervision of, a qualified 

transplant surgeon in accordance with 

§ 482.98(b). 

(b) Standard: Transplant surgeon and 

physician. The transplant center must 

identify to the OPTN a primary 

transplant surgeon and a transplant 

physician with the appropriate training 

and experience to provide 

transplantation services, who are 

immediately available to provide 

transplantation services when an organ 

is offered for transplantation. 

(1) The transplant surgeon is 

responsible for providing surgical 

services related to transplantation. 

(2) The transplant physician is 

responsible for providing and 

coordinating transplantation care. 

(c) Standard: Clinical transplant 

coordinator. The transplant center must 

have a clinical transplant coordinator to 

ensure the continuity of care of patients 

and living donors during the pretransplant, transplant, and discharge 

phases of transplantation and the donor 

evaluation, donation, and discharge 

phases of donation. The clinical 

transplant coordinator must be a 

registered nurse or clinician licensed by 

the State in which the clinical 

transplant coordinator practices, who 

has experience and knowledge of 

transplantation and living donation 

issues. The clinical transplant 

coordinator’s responsibilities must 

include, but are not limited to, the 

following: 

(1) Ensuring the coordination of the 

clinical aspects of transplant patient and 

living donor care; and 

(2) Acting as a liaison between a 

kidney transplant center and dialysis 

facilities, as applicable. 

(d) Standard: Independent living 

donor advocate or living donor advocate 

team. The transplant center that 

performs living donor transplantation 

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. 

(1) The living donor advocate or 

living donor advocate team must not be 

involved in transplantation activities on 

a routine basis. 

(2) The independent living donor 

advocate or living donor advocate team 

must demonstrate: 

(i) Knowledge of living organ 

donation, transplantation, medical 

ethics, and informed consent; and 

(ii) 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. 

(3) The independent living donor 

advocate or living donor advocate team 

is responsible for: 

(i) Representing and advising the 

donor; 

(ii) Protecting and promoting the 

interests of the donor; and 

(iii) Respecting the donor’s decision 

and ensuring that the donor’s decision 

is informed and free from coercion. 

(e) Standard: Transplant team. The 

transplant center must identify a 

multidisciplinary transplant team and 

describe the responsibilities of each 

member of the team. The team must be 

composed of individuals with the 

appropriate qualifications, training, and 

experience in the relevant areas of 

medicine, nursing, nutrition, social 

services, transplant coordination, and 

pharmacology. 

(f) Standard: Resource commitment. 

The transplant center must demonstrate 

availability of expertise in internal 

medicine, surgery, anesthesiology, 

immunology, infectious disease control, 

pathology, radiology, blood banking, 

and patient education as related to the 

provision of transplantation services. 

§ 482.100 Condition of participation: 

Organ procurement. 

The transplant center must ensure 

that the hospital in which it operates 

has a written agreement for the receipt 

of organs with an OPO designated by 

the Secretary that identifies specific 


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responsibilities for the hospital and for 

the OPO with respect to organ recovery 

and organ allocation. 

§ 482.102 Condition of participation: 

Patient and living donor rights. 

In addition to meeting the condition 

of participation ‘‘Patients rights’’

requirements at § 482.13, the transplant 

center must protect and promote each 

transplant patient’s and living donor’s 

rights. 

(a) Standard: Informed consent for 

transplant patients. Transplant centers 

must implement written transplant 

patient informed consent policies that 

inform each patient of: 

(1) The evaluation process; 

(2) The surgical procedure; 

(3) Alternative treatments; 

(4) Potential medical or psychosocial 

risks; 

(5) National and transplant centerspecific outcomes, from the most recent 

SRTR center-specific report, including 

(but not limited to) the transplant 

center’s observed and expected 1-year 

patient and graft survival, national 1- 

year patient and graft survival, and 

notification about all Medicare outcome 

requirements not being met by the 

transplant center; 

(6) Organ donor risk factors that could 

affect the success of the graft or the 

health of the patient, including, but not 

limited to, the donor’s history, 

condition or age of the organs used, or 

the patient’s potential risk of contracting 

the human immunodeficiency virus and 

other infectious diseases if the disease 

cannot be detected in an infected donor; 

(7) His or her right to refuse 

transplantation; and 

(8) 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 for 

under Medicare Part B. 

(b) Standard: Informed consent for 

living donors. Transplant centers must 

implement written living donor 

informed consent policies that inform 

the prospective living donor of all 

aspects of, and potential outcomes from, 

living donation. Transplant centers 

must ensure that the prospective living 

donor is fully informed about the 

following: 

(1) The fact that communication 

between the donor and the transplant 

center will remain confidential, in 

accordance with the requirements at 45 

CFR parts 160 and 164. 

(2) The evaluation process; 

(3) The surgical procedure, including 

post-operative treatment; 

(4) The availability of alternative 

treatments for the transplant recipient; 

(5) The potential medical or 

psychosocial risks to the donor; 

(6) The national and transplant 

center-specific outcomes for recipients, 

and the national and center-specific 

outcomes for living donors, as data are 

available; 

(7) 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; 

(8) The donor’s right to opt out of 

donation at any time during the 

donation process; and 

(9) The fact that if a 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 

for under Medicare Part B. 

(c) Standard: Notification to patients. 

Transplant centers must notify patients 

placed on the center’s waiting list of 

information about the center that could 

impact the patient’s ability to receive a 

transplant should an organ become 

available, and what procedures are in 

place to ensure the availability of a 

transplant team. 

(1) A transplant center served by a 

single transplant surgeon or physician 

must inform patients placed on the 

center’s waiting list of: 

(i) The potential unavailability of the 

transplant surgeon or physician; and 

(ii) Whether the center has a 

mechanism to provide an alternate 

transplant surgeon or transplant 

physician. 

(2) At least 30 days before a center’s 

Medicare approval is terminated, 

whether voluntarily or involuntarily, 

the center must: 

(i) Inform patients on the center’s 

waiting list and provide assistance to 

waiting list patients who choose to 

transfer to the waiting list of another 

Medicare-approved transplant center 

without loss of time accrued on the 

waiting list; and 

(ii) Inform Medicare beneficiaries on 

the center’s waiting list that Medicare 

will no longer pay for transplants 

performed at the center after the 

effective date of the center’s termination 

of approval. 

(3) As soon as possible prior to a 

transplant center’s voluntary 

inactivation, the center must inform 

patients on the center’s waiting list and, 

as directed by the Secretary, provide 

assistance to waiting list patients who 

choose to transfer to the waiting list of 

another Medicare-approved transplant 

center without loss of time accrued on 

the waiting list. 

§ 482.104 Condition of participation: 

Additional requirements for kidney 

transplant centers. 

(a) Standard: End stage renal disease 

(ESRD) services. Kidney transplant 

centers must directly furnish 

transplantation and other medical and 

surgical specialty services required for 

the care of ESRD patients. A kidney 

transplant center must have written 

policies and procedures for ongoing 

communications with dialysis patients’

local dialysis facilities. 

(b) Standard: Dialysis services. 

Kidney transplant centers must furnish 

inpatient dialysis services directly or 

under arrangement. 

(c) Standard: Participation in network 

activities. Kidney transplant centers 

must cooperate with the ESRD Network 

designated for their geographic area, in 

fulfilling the terms of the Network’s 

current statement of work. 

PART 488—SURVEY, CERTIFICATION, 

AND ENFORCEMENT PROCEDURES 

Subpart A—General Provisions 

■ 8. The authority citation for part 488 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh) unless otherwise noted). 

§ 488.6 [Amended] 

■ 9. Section 488.6(a) is amended by 

adding ‘‘transplant centers, except for 

kidney transplant centers;’’ after 

‘‘psychiatric hospitals;’’ but before 

‘‘SNFs.’’

Subpart B—Special Requirements 

■ 10. Section 488.61 is added to subpart 

B to read as follows: 

§ 488.61 Special procedures for approval 

and re-approval of organ transplant centers. 

For the purposes of this subpart, the 

survey, certification, and enforcement 

procedures described at 42 CFR part 

488, subpart A apply to transplant 

centers, including the periodic review of 

compliance and approval described at 

§ 488.20. 

(a) Initial approval procedures for 

transplant centers that are not 

Medicare-approved as of June 28, 2007. 

A transplant center, including a kidney 

transplant center, may submit a request 

to CMS for Medicare approval at any 

time. 

(1) The request, signed by a person 

authorized to represent the center (for 

example, a chief executive officer), must 

include: 

(i) The hospital’s Medicare provider 

I.D. number; 


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(ii) Name(s) of the designated primary 

transplant surgeon and primary 

transplant physician; and, 

(iii) A statement from the OPTN that 

the center has complied with all data 

submission requirements. 

(2) To determine compliance with the 

clinical experience and outcome 

requirements at § 482.80(b) and 

§ 482.80(c), CMS will review the data 

contained in the most recent OPTN Data 

Report and 1-year patient and graft 

survival data contained in the most 

recent Scientific Registry of Transplant 

Recipient (SRTR) center-specific report. 

(3) If CMS determines that a 

transplant center has not met the data 

submission, clinical experience, or 

outcome requirements, CMS may deny 

the request for approval or may review 

the center’s compliance with the 

conditions of participation at § 482.72 

through § 482.76 and § 482.90 through 

§ 482.104 of this chapter, using the 

procedures described at 42 CFR part 

488, subpart A, to determine whether 

the center’s request will be approved. 

CMS will notify the transplant center in 

writing whether it is approved and, if 

approved, of the effective date of its 

approval. 

(4) CMS will consider mitigating 

factors, including (but not limited to) 

the following in considering initial 

approval of a transplant center that does 

not meet the data submission, clinical 

experience, outcome requirements and 

other conditions of participation: 

(i) The extent to which outcome 

measures are met or exceeded; 

(ii) Availability of Medicare-approved 

transplant centers in the area; and 

(iii) Extenuating circumstances (e.g., 

natural disaster) that may have a 

temporary effect on meeting the 

conditions of participation. 

(iv) CMS will not approve any 

program with a condition-level 

deficiency. However, CMS may approve 

a program with a standard-level 

deficiency upon receipt of an acceptable 

plan of correction. 

(5) If CMS determines that a 

transplant center has met the data 

submission, clinical experience, and 

outcome requirements, CMS will review 

the center’s compliance with the 

conditions of participation contained at 

§ 482.72 through § 482.76 and § 482.90 

through § 482.104 of this chapter using 

the procedures described at 42 CFR part 

488, subpart A. If the transplant center 

is found to be in compliance with all the 

conditions of participation at § 482.72 

through § 482.104, except for § 482.82 of 

this chapter (Re-approval 

Requirements), CMS will notify the 

transplant center in writing of the 

effective date of its Medicare-approval. 

CMS will notify the transplant center in 

writing if it is not Medicare-approved. 

(6) A kidney transplant center may 

submit a request for initial approval 

after performing at least 3 transplants 

over a 12-month period. 

(7) Transplant centers will be 

approved for 3 years. 

(b) Initial approval procedures for 

transplant centers, including kidney 

transplant centers, that are Medicare 

approved as of June 28, 2007. 

(1) A transplant center that wants to 

continue to be Medicare approved must 

be in compliance with the conditions of 

participation at §§ 482.72 through 

482.104 as of June 28, 2007 and submit 

a request to CMS for Medicare approval 

under the conditions of participation no 

later than December 26, 2007, using the 

process described in paragraph (a)(1) of 

the section. 

(2) CMS will determine whether to 

approve the transplant center, using the 

procedures described in paragraphs 

(a)(2) through (a)(5) of this section. Until 

CMS makes a determination whether to 

approve the transplant center under the 

conditions of participation at §§ 482.72 

through 482.104, the transplant center 

will continue to be Medicare approved 

under the end stage renal disease 

(ESRD) conditions for coverage (CfCs) in 

part 405, subpart U of this chapter for 

kidney transplant centers or the 

pertinent national coverage decisions 

(NCDs) for extra-renal organ transplant 

centers, as applicable, and the 

transplant center will continue to be 

reimbursed for services provided to 

Medicare beneficiaries. 

(3) Once CMS approves a kidney 

transplant center under the conditions 

of participation, the ESRD CfCs no 

longer apply to the center as of the date 

of its approval. Once CMS approves an 

extra-renal organ transplant center 

under the conditions of participation, 

the NCDs no longer apply to the center 

as of the date of its approval. 

(4) If a transplant center that is 

Medicare approved as of June 28, 2007 

submits a request for approval under the 

CoPs at §§ 482.72 through 482.104 of 

this chapter but CMS does not approve 

the transplant center, or if the transplant 

center does not submit its request to 

CMS for Medicare approval under the 

CoPs by December 26, 2007, CMS will 

revoke the transplant center’s approval 

under the conditions for coverage for 

kidney transplant centers or the national 

coverage decisions for extra-renal 

transplant centers, as applicable, and 

the transplant center will no longer be 

reimbursed for services provided to 

Medicare beneficiaries. CMS will notify 

the transplant center in writing of the 

effective date of its loss of Medicare 

approval. 

(c) Re-approval procedures. Once 

Medicare-approved, transplant centers, 

including kidney transplant centers, 

must be in compliance with all the 

conditions of participation for 

transplant centers at § 482.72 through 

§ 482.104 of this chapter, except for 

§ 482.80 (initial approval requirements) 

throughout the 3-year approval period. 

(1) Prior to the end of the 3-year 

approval period, CMS will review the 

transplant center’s data in making reapproval determinations. 

(i) To determine compliance with the 

data submission requirements at 

§ 482.82(a) of this chapter, CMS will 

request data submission data from the 

OPTN for the previous 3 calendar years. 

(ii) To determine compliance with the 

clinical experience and outcome 

requirements at § 482.82(b) and 

§ 482.82(c) of this chapter, CMS will 

review the data contained in the most 

recent OPTN Data Report and 1-year 

patient and graft survival data contained 

in the most recent SRTR center-specific 

reports. 

(2) If CMS determines that a 

transplant center has not met the data 

submission, clinical experience, or 

outcome requirements at § 482.82, the 

transplant center will be reviewed for 

compliance with § 482.72 through 

§ 482.76 and § 482.90 through § 482.104 

of this chapter, using the procedures 

described at 42 CFR part 488, subpart A. 

(3) If CMS determines that a 

transplant center has met the data 

submission, clinical experience, and 

outcome requirements at § 482.82, CMS 

may choose to review the transplant 

center for compliance with § 482.72 

through § 482.76 and § 482.90 through 

§ 482.104 of this chapter, using the 

procedures described at 42 CFR part 

488, subpart A. 

(4) CMS will consider mitigating 

factors, including (but not limited to) 

the following in considering re-approval 

of a transplant center that does not meet 

the data submission, clinical 

experience, outcome requirements and 

other conditions of participation: 

(i) The extent to which outcome 

measures are met or exceeded; 

(ii) Availability of Medicare-approved 

transplant centers in the area; and 

(iii) Extenuating circumstances (e.g., 

natural disaster) that may have a 

temporary effect on meeting the 

conditions of participation. 

(iv) CMS will not approve any 

program with a condition-level 

deficiency. However, CMS may reapprove a program with a standard-level 

deficiency upon receipt of an acceptable 

plan of correction. 


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(5) CMS will notify the transplant 

center in writing if its approval is being 

revoked and of the effective date of the 

revocation. 

(d) Loss of Medicare Approval. 

Centers that have lost their Medicare 

approval may seek re-entry into the 

Medicare program at any time. A center 

that has lost its Medicare approval must: 

(1) Request initial approval using the 

procedures described in § 488.61(a); 

(2) Be in compliance with §§ 482.72 

through 482.104 of this chapter, except 

for § 482.82 (Re-approval 

Requirements), at the time of the request 

for Medicare approval; and 

(3) Submit a report to CMS 

documenting any changes or corrective 

actions taken by the center as a result of 

the loss of its Medicare approval status. 

(e) Transplant Center Inactivity. A 

transplant center may remain inactive 

and retain its Medicare approval for a 

period not to exceed 12 months during 

the 3-year approval cycle. A transplant 

center must notify CMS upon its 

voluntary inactivation as required by 

§ 482.74(d) of this chapter. 

PART 498—APPEALS PROCEDURES 

FOR DETERMINATIONS THAT AFFECT 

PARTICIPATION IN THE MEDICARE 

PROGRAM AND FOR 

DETERMINATIONS THAT AFFECT THE 

PARTICIPATION OF ICFs/MR AND 

CERTAIN NFs IN THE MEDICAID 

PROGRAM 

■ 11. The authority citation for part 498 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart A—General Provisions 

§ 498.2 [Amended] 

■ 12. In § 498.2, the definition of 

‘‘provider’’ is amended by adding 

‘‘transplant center’’ after ‘‘hospital’’ the 

first time it appears. 

(Catalog of Federal Domestic Assistance 

Program No. 13.773 Medicare—Hospital 

Insurance Program; and No. 13.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 7, 2006. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: December 12, 2006. 

Michael O. Leavitt 

Secretary. 

Editorial Note: This document was 

received at the Office of the Federal Register 

on March 20, 2007. 

[FR Doc. 07–1435 Filed 3–22–07; 4:00 pm] 

BILLING CODE 4120–01–P 


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