Friday,

February 4, 2005

Part III

Department of 

Health and Human 

Services

Centers for Medicare & Medicaid Services 

42 CFR Parts 405, 482, and 488 

Medicare Program; Hospital Conditions of 

Participation: Requirements for Approval 

and Re-Approval of Transplant Centers 

To Perform Organ Transplants; Proposed 

Rule

6140 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

42 CFR Parts 405, 482, and 488 

[CMS–3835–P] 

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 and 

Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule would set 

forth the requirements that heart, heartlung, intestine, kidney, lung, and 

pancreas transplant centers must meet 

to participate as Medicare-approved 

transplant centers. These proposed 

revised requirements focus on an organ 

transplant center’s ability to perform 

successful transplants and deliver 

quality patient care as evidenced by 

good outcomes and sound policies and 

procedures. We are proposing that 

approval, as determined by a center’s 

compliance with the proposed data 

submission, outcome, and process 

requirements would be granted for 3 

years. Every 3 years, approvals would be 

renewed for transplant centers that 

continue to meet these requirements. 

We are proposing these revised 

requirements to ensure that transplant 

centers continually provide high-quality 

transplantation services in a safe and 

efficient manner.

DATES: We will consider comments if 

we receive them at the appropriate 

address, as provided below, no later 

than 5 p.m. on April 5, 2005.

ADDRESSES: In commenting, please refer 

to file code CMS–3835–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. You may submit 

comments in one of three ways (no 

duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments. (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By mail. You may mail written 

comments (one original and two copies) 

to the following address ONLY: Centers 

for Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3835–P, PO 

Box 8013, Baltimore, MD 21244–8013.

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

9994 in advance to schedule your 

arrival with one of our staff members.

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 

7500 Security Boulevard, Baltimore, MD 

21244–1850.

(Because access to the interior of the 

HHH Building is not readily available 

to persons without Federal 

Government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is 

available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the 

comments being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by mailing 

your comments to the addresses 

provided at the end of the ‘‘Collection 

of Information Requirements’’ section in 

this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Eva 

Fung (410) 786–7539. Marcia Newton 

(410) 786–5265. Jeannie Miller (410) 

786–3164. Rachael Weinstein (410) 786–

6775.

SUPPLEMENTARY INFORMATION:

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–3835–P 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. CMS posts all electronic 

comments received before the close of 

the comment period on its public 

website as soon as possible after they 

have been received. Hard copy 

comments received timely will be 

available for public inspection as they 

are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

A. Key Statutory Provisions

The Medicare statute contains specific 

authority for prescribing the health and 

safety requirements for facilities 

furnishing end stage renal disease 

(ESRD) care to beneficiaries, including 

renal transplant centers, pursuant to 

section 1881(b)(1) of the Social Security 

Act (the Act). Section 1102 of the Act 

(42 U.S.C. 1302) 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.’’ In 

2003, 13,278 donors (deceased and 

living) provided organs in the U.S., and 

25,468 transplants (deceased and living 

donor) were performed, yet 83,731 

patients waited for a transplant at the 

end of 2003. Given the relative scarcity 

of donated organs compared to the 

number of people on transplant waitlists 

and the critical need to use these 

limited resources efficiently, we believe 

the proposed conditions of participation 

(CoPs) for transplant centers are 

necessary to: (1) Protect other potential 

Medicare beneficiaries who are waiting 

for organs for transplantation; (2) 

establish sufficient quality and 

procedural standards to ensure that 

transplants are performed in a safe and 

efficient manner; and (3) reduce 

Medicare expenses by decreasing the 

likelihood that a transplant will fail. 

Section 1864 of the Act authorizes the 

use of State agencies to determine 

providers’ compliance with the CoPs. 

Responsibilities of 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,

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6141

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. In order to receive 

deemed status, hospitals accredited by 

the JCAHO, the AOA, or 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.) Therefore, an 

accreditation organization could apply 

for and receive approval of deeming 

authority for the proposed hospital CoPs 

for transplant centers if the 

accreditation organization demonstrates 

that it has requirements for transplant 

centers that are at least as stringent as 

the proposed CoPs. 

B. Department Activities Related to 

Organ Donation and Transplantation 

1. Department Commitment To 

Increasing Organ Donation and 

Transplantation 

At the end of 2003, there were 83,731 

Americans waiting for organ 

transplants. About 25,468 patients on 

the waitlist received organ transplants 

(deceased and living donor), and 

approximately 6,879 persons died 

waiting for an organ to become 

available. Promotion of organ donation, 

which would increase the number of 

transplant recipients by increasing 

organ availability, is of paramount 

importance to the Department of Health 

and Human Services (the Department). 

On April 17, 2001, Secretary Tommy 

Thompson launched his ‘‘Gift of Life 

Donation Initiative,’’ a multi-level 

approach to increasing organ, tissue, 

and marrow donation. The Secretary has 

directed agencies within the Department 

to make organ, tissue, and marrow 

donation a top priority. The Secretary’s 

initiative focuses on 5 elements: (1) A 

model donor card program, (2) a 

national forum on donor registries, (3) a 

national ‘‘Gift of Life’’ medal to honor 

donor families, (4) a model curriculum 

on organ donation for drivers’ education 

classes, and (5) the ‘‘Workplace 

Partnership for Life’’ program, which 

involves collaboration with companies 

and employer groups to make 

information on organ donation available 

to all employees. We are revising the current Medicare 

requirements for heart, intestine, 

kidney, liver, and lung centers and 

adding new Medicare requirements for 

heart-lung and pancreas centers by 

proposing transplant center hospital 

conditions of participation. The 

proposed CoPs would ensure that all 

Medicare-approved transplant centers 

provide quality transplantation services 

so that organs, once recovered, are not 

wasted. This proposed rule would not 

apply to the Medicaid program. 

2. Transplantation Criteria Town Hall 

Meeting 

We held a Town Hall Meeting on 

December 1, 1999 (See 64 FR 58419) to 

discuss current medical and scientific 

evidence regarding potential criteria for 

approval of transplant centers for 

Medicare coverage. Approximately 150 

people attended the meeting. Attendees 

included representatives from the Organ 

Procurement and Transplantation 

Network (OPTN), staff from transplant 

centers, health policy and clinical 

researchers, transplant recipients and 

their families, physicians and other 

clinicians, and government officials. The format for the meeting included 

four subject-related panel presentations 

followed by an opportunity for 

comments from the attendees. The panel 

topics included: (1) Aspects of facilities 

linked to coverage, (2) methodologies 

for measuring outcomes, (3) data used 

for approving centers, and (4) thresholds 

for approving centers. In addition to the 

planned panel topics, the meeting 

provided for an open forum during 

which ideas not covered in the topic 

panels could be shared. To 

accommodate the views of those who 

could not attend the meeting, we 

provided an opportunity for members of 

the community to share their views in 

writing. Comments from the Town Hall 

Meeting expressed widely divergent 

views. However, the ideas shared during 

this meeting and the written public 

comments were considered seriously 

and significantly influenced the 

development of this proposed rule. Our 

staff has also attended meetings, 

conferences and training to stay abreast 

of the latest advancement and issues 

associated with transplantation. 

C. Current Medicare Policy Regarding 

Transplantation 

1. Kidney Transplant Centers 

Section 1881 of the Act authorizes 

benefits for individuals who have been 

determined to have ESRD, including 

dialysis and transplantation services. 

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

provides an explicit direction to the 

Secretary of Health and Human Services 

to develop requirements for kidney 

(renal) transplantation services under 

the Medicare program. We fulfilled this 

responsibility through regulations 

published on June 3, 1976 (41 FR 

22511). These requirements are codified 

at 42 CFR part 405, Subpart U. Under 

the Conditions for ESRD coverage, renal 

transplant centers must meet all 

appropriate conditions of coverage, 

which address issues such as 

compliance with applicable Federal, 

State, and local laws and regulations; 

Governing body; Patient long-term 

program and patient care plan; Patients’

rights; Medical records; and Physical 

environment. In addition, the 

conditions of coverage include the 

following criteria specifically for kidney 

or renal transplant centers: 

• Minimum utilization rates. The 

regulations classify renal transplant 

centers that meet all the other 

conditions for coverage of ESRD 

services at 42 CFR 405, Subpart U into 

the following 4 categories according to 

the center’s minimum utilization rates 

(annual volume): (1) Unconditional 

status, (2) conditional status, (3) 

exception status, and (4) not eligible for 

reimbursement for that ESRD service. 

(See 42 CFR 405.2122.) Unconditional 

status is assigned to a center that 

performs 15 or more transplants per 

year. Conditional status is assigned to a 

center that performs 7 to 14 transplants 

per year. (See 42 CFR 405.2130.) If a 

center does not meet the minimum 

utilization rate for unconditional or 

conditional status, it may, under certain 

circumstances, be approved for a timelimited exception status. A center that 

does not meet the requirements for 

conditional or unconditional status and 

is not granted an exception status under 

§ 405.2122(b) is not eligible for 

reimbursement for that ESRD service. 

(See 42 CFR 405.2122.) 

• Director of Renal Transplantation.

Renal transplant centers must be under 

the direction of a qualified transplant 

surgeon or a physician who is 

responsible for: (1) Participating in the 

selection of suitable treatment 

modalities for each ESRD patient; (2) 

ensuring adequate training of nurses in 

the care of transplant patients; (3) 

ensuring tissue typing and organ 

procurement services are available 

either directly or under arrangement; 

and (4) ensuring transplantation surgery 

is performed under the direct 

supervision of a qualified transplant 

surgeon (See 42 CFR 405.2170).

• Minimal Service Requirements. 

Renal transplant centers must meet the 

following minimal service requirements: 

(1) Be part of a Medicare-approved and 

participating hospital; (2) be under the 

supervision of the hospital 

administrator and medical staff; (3)

6142 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

participate in a patient registry program 

with an OPO for patients who are 

awaiting deceased donor 

transplantation; (4) utilize a qualified 

social worker to evaluate transplant 

patients’ psychosocial needs, participate 

in care planning of the patients and 

identify community resources to assist 

the patient and family; (5) utilize a 

qualified dietitian who will, in 

consultation with the attending 

physician, assess the nutritional and 

dietetic needs of each patient, 

recommend therapeutic diets, provide 

diet counseling to patients and their 

families, and monitor adherence and 

response to a prescribed diet; (6) utilize 

a laboratory that is approved under 42 

CFR Part 493 and that can perform 

cross-matching of recipient serum and 

donor lymphocytes for pre-formed 

antibodies by an acceptable technique 

on a 24-hour emergency basis, and (7) 

utilize the services of an organ 

procurement organization (OPO) to 

obtain deceased donor organs, and have 

a written agreement covering the 

services (See 42 CFR 2171). 

Even though the ESRD conditions of 

coverage contained at 42 CFR part 405, 

subpart U include some kidney 

transplant center provisions, the 

proliferation of patient and living donor 

issues and our desire to standardize 

requirements for transplant centers 

necessitate a broader regulatory 

framework for the oversight of kidney 

transplant centers. Therefore, we have 

concluded that it is logical for us to 

replace the requirements contained in 

Part 405, Subpart U that pertain solely 

to renal transplant centers with 

approval and re-approval requirements 

for kidney transplant centers in these 

proposed hospital CoPs for organ 

transplant centers. Specifically, we 

propose to delete § 405.2120 through 

§ 405.2134, § 405.2170 through 

§ 405.2171, and the definitions for 

‘‘histocompatibility testing,’’ ‘‘ESRD 

Network,’’ ‘‘Network organization,’’

‘‘organ procurement,’’ ‘‘renal 

transplantation center,’’

‘‘transplantation service,’’ and 

‘‘transplantation surgeon’’ contained in 

§ 405.2102. The proposed transplant 

center CoPs are both outcome and 

process-based and would collectively 

ensure that transplantation services 

furnished in all types of transplant 

centers are safe and efficient. 

Generally, the provisions contained in 

the proposed transplant center CoPs are 

applicable to all types of transplant 

centers. However, kidney 

transplantation differs from other types 

of organ transplants in some ways. For 

example, section 1881(b)(1)(A) of the 

Act explicitly provides for Medicare 

kidney transplants while coverage of 

most transplant services are provided 

under the general ‘‘reasonable and 

necessary’’ authority of section 1862. 

Also, whereas organ transplantation is 

the only treatment option for patients 

with end-stage heart, liver, lung or 

intestinal failure, dialysis is an 

alternative treatment for ESRD patients 

when transplantation is not feasible. To 

underscore the distinct nature of kidney 

transplants and kidney transplant 

centers, we have included some 

provisions that are specific only to 

kidney transplant centers in the 

proposed hospital CoPs for transplant 

centers. The following proposed CoPs 

for approval and re-approval of 

transplant centers contain provisions 

that are specific only to kidney 

transplant centers (see Section II. 

Provisions of the Proposed Regulation 

for further discussion of the 

requirements): 

• Condition of participation: Patient 

and living donor selection (proposed 

§ 482.90(a)(1));

• Condition of participation: Patient 

and living donor management (proposed 

§ 482.94(c)(3)); and 

• Condition of participation: 

Additional requirements for kidney 

transplant centers (proposed § 482.104). 

2. Extra-renal Organ Transplant Centers 

Beginning in 1987, we published 

several notices in the Federal Register

delineating our coverage policies 

regarding various organ transplants. On 

April 6, 1987, the Health Care Financing 

Administration (HCFA), now known as 

CMS, published a ruling (52 FR 10935) 

(HCFAR 87–1) announcing Medicare’s 

national coverage policy on heart 

transplants. On April 12, 1991, we 

published a final notice (56 FR 15006) 

announcing Medicare’s national 

coverage decision on liver transplants in 

adults. On February 2, 1995, we 

published a notice with comment (60 

FR 6537) announcing Medicare’s 

national coverage decision on lung 

transplants. 

In these notices, we stated that the 

transplants in adults were medically 

reasonable and necessary and covered 

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

42 U.S.C. 1395y(a)(1), when performed 

on carefully selected patients in centers 

that meet certain criteria. As discussed 

in these notices, we based these policies 

on research carried out by the Battelle 

Human Affairs Research Center (heart) 

and the Public Health Service’s Center 

for Health Care Technology (liver and 

lung). The specified center criteria for 

heart, liver, and lung transplant centers 

included the following: 

• Patient selection. A center must 

have specific written patient selection 

criteria for each organ type and an 

implementation plan. 

• Patient management. A center must 

have adequate patient management 

plans and protocols that include 

therapeutic and evaluative procedures 

for the waiting period, in-hospital 

period, and post-transplant phases of 

treatment. 

• Commitment. The center must 

make a sufficient commitment of 

resources and planning of the transplant 

center to demonstrate the importance of 

the center at all levels. Indications of 

this commitment must be broadly 

evident throughout the center. The 

center must use a multidisciplinary 

team that includes representatives with 

expertise in the appropriate organ 

specialty (e.g., hepatology, cardiology, 

or pulmonology) and the following 

general areas: Vascular surgery, 

anesthesiology, immunology, infectious 

diseases, pathology, radiology, nursing, 

blood banking, and social services. 

• Facility plans. The center must 

have facility plans, commitments, and 

resources for a program that ensures a 

reasonable concentration of experience. 

• Maintenance of data. The center 

must agree to maintain and, when 

requested, submit data to CMS. 

• Organ procurement. The center 

must be located in a hospital that is a 

member of the OPTN as a transplant 

hospital, and abide by its approved 

rules. The center must also have an 

agreement with an OPO. 

See Section II Provisions of the 

Proposed Regulations (Proposed Section 

482.72) for further discussion of the 

OPTN rules. 

• Laboratory services. The center 

must make available, either directly or 

under arrangements, laboratory services 

to meet the needs of patients. 

• Billing. The center must agree to 

submit claims to Medicare only for 

transplants performed on individuals 

who have Medicare-covered conditions.

• Experience and survival rates. The 

center must demonstrate experience and 

success with organ transplants. The 

center staff must have performed a 

specified volume of transplants for each 

organ type (12 or more adult heart or 

liver transplants or 10 or more lung 

transplants) for covered conditions in 

each of the two preceding 12-month 

periods. Additionally, the center must 

demonstrate a minimum actuarial 1-year 

and 2-year survival rate. Heart 

transplant centers must demonstrate 

actuarial survival rates of 73 percent for 

1 year and 65 percent for 2 years. Liver 

centers must demonstrate a 1-year 

actuarial survival rate of 77 percent and

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6143

a 2-year actuarial survival rate of 60 

percent for adult patients. Lung 

transplant centers must demonstrate a 1-

year actuarial survival rate of 69 percent 

and a 2-year actuarial survival rate of 62 

percent. 

On July 26, 2000, we issued a national 

coverage decision (http://

www.cms.hhs.gov/mcd/

viewdecisionmemo.asp?id=75), which 

was implemented in a program 

memorandum (See Program 

Memorandum AB–00–95, http://

www.cms.hhs.gov/manuals/pm_trans/

2000/memos/comm_date_dsc.asp) with 

an effective date of October 11, 2000. 

This decision announced a revision to 

the volume criterion for transplant 

centers to require 12 transplants over a 

12-month period for heart and liver 

transplant centers, and 10 transplants 

over a 12-month period for lung 

transplant centers and to eliminate the 

2-year minimum experience 

requirement. The memorandum was 

issued in response to concerns raised by 

hospitals that open a new transplant 

center staffed by an experienced team 

that has transferred from another 

Medicare-approved center. The 

hospitals stated that a new center, 

staffed with an experienced team, 

should receive immediate Medicare 

approval rather than wait at least 2 years 

until the center was able to demonstrate 

that it had performed the required 

volume of transplants. In response to 

these concerns, we solicited scientific 

evidence from the transplant 

community on the relationship between 

low-volume centers, transplantation 

team experience, and outcomes. Our 

analysis of the scientific literature and 

the information we received indicated 

that center volume could serve as a 

proxy for the 2-year minimum 

experience requirement. In other words, 

the evidence we reviewed pointed to the 

fact that volume is a more accurate 

indicator of outcome than time (see 

CAG–00061, http://cms.hhs.gov/ncdr/

memo.asp?id=75, for summary of 

relevant clinical literature). Thus, new 

centers staffed with an experienced 

team that perform a high volume of 

transplants could be expected to 

produce satisfactory outcomes. 

As of July 1, 1999, Medicare covers 

whole organ pancreas transplantation 

for diabetic patients, when it is 

performed simultaneously with or after 

a kidney transplant. (See sections 35–82 

of Coverage Issues Manual.) Effective for 

services provided on or after April 1, 

2001, Medicare covers isolated 

intestinal transplant, combined liverintestinal transplant, and multivisceral 

transplant. Coverage for all three types 

of intestinal transplants is limited to 

patients who have irreversible intestinal 

failure and who have failed total 

parenteral nutrition (TPN). To be 

Medicare-approved, an intestinal 

transplant center must have an annual 

volume of 10 transplants with a 1-year 

actuarial patient survival rate of 65 

percent (See Program Memorandum 

AB–01–58). 

D. Living Donors 

Since 1990, living donation has 

become the fastest growing source of 

kidneys for kidney transplants and, 

more recently, of livers for liver 

transplants. In 2001, the number of 

living donors exceeded the number of 

deceased donors for the first time. There 

were 12,591 organ donors in the U.S. in 

2001; 6,510 were living donors and 

6,081 were deceased donors. In 2003, 

the number of living donors continued 

to exceed the number of deceased 

donors. In 2003, there were 13,278 

organ donors in the U.S.; 6,821 were 

living donors and 6,457 were deceased 

donors. Living donor transplantation 

provides an alternative to deceased 

donor transplantation for a growing 

number of waitlist patients. Of the 

25,468 transplants performed in the U.S. 

in 2003, 6,811 were living donor 

transplants, which is a 3.0 percent 

increase from the 6,616 living donor 

transplants performed in 2002. 

Meanwhile, the number of deceased 

donor transplants rose by 2.0 percent 

from 18,292 in 2002 to 18,657 in 2003.

As living donor transplantation 

increases, there is growing concern over 

the safety of living donors. Most of the 

living donor transplant data reported are 

for kidney and liver transplants. Other 

types of living donor transplants are rare 

and data are scarce. For example, among 

the 6,811 living donor transplants 

performed in 2003, 6,468 were kidney 

transplants, 321 liver transplants, 15 

lung transplants, 0 pancreas transplant, 

and 4 intestinal transplant. 3 kidneypancreas transplants were performed. 

The risk of donor death for living 

kidney donors has been very low. In the 

46-year history of living donor kidney 

transplantation, the risk of donor death 

is estimated to be approximately 0.03 

percent. 

For example, if we look at the 6,468 

living donor kidney transplants 

performed in 2003 (out of a total of 

15,138 living and deceased kidney 

transplants performed in the U.S. in 

2003), we estimate that fewer than 2 of 

those transplants would result in donor 

death. Although there is a relatively low 

risk of donor death for living kidney 

donors, recent research seems to 

indicate that living kidney donation 

may increase the donor’s morbidity. For 

example, a United Network for Organ 

Sharing (UNOS) study indicated that a 

total of 56 previous living donors were 

identified as having been listed for 

transplantation. It is unknown if more 

living kidney donors had suffered from 

renal failure as well (Ellison MD, 

McBride MA, Taranto SE, Delmonico 

FL, Kauffman HM. ‘‘Living Kidney 

Donors in Need of Kidney Transplants: 

A Report From the Organ Procurement 

and Transplantation Network. 

Transplantation, 2002 November 15; 

74(9): 1349–51). Living renal donation 

has long-term risks that may not be 

apparent in the short term, which leads 

us to believe that potential donors 

should be informed of these long-term 

risks. 

The risk of donor death for living liver 

donors is higher than the risk of donor 

death for living kidney donors. In the 

13-year history of living donor liver 

transplants (LDLTs), the risk of donor 

death has been estimated to be 

approximately 1 percent. Living liver 

donors face a higher risk of morbidity 

and mortality than living kidney donors 

due in part to complications from blood 

clotting, bile duct leakage, and 

infections. Furthermore, the rapid 

growth of adult LDLT as an alternative 

to deceased transplantation has resulted 

in great variation in surgical techniques, 

center volumes and recipient and donor 

selection criteria. 

In addition to concerns over donor 

morbidity and mortality, there is also 

growing concern about the lack of 

standard guidelines governing living 

donor selection and post-operative care. 

For example, in 2002, a living liver 

donor death was reported in a 

transplant hospital in New York. The 

New York Department of Health 

launched an investigation into the 

donor’s death and found that the 

donor’s post-operative care was 

inadequate and fragmented. The New 

York Department of Health’s 

investigation report concluded that 

inadequate staffing was a contributing 

factor in the donor’s death (‘‘NY 

Department of Health charges 

inadequate staffing a factor in live 

donor’s death at Mt. Sinai Hospital,’’

Transplant News, March 15, 2002, at 5.). 

Accurate physical and psychosocial 

assessments of the suitability of 

prospective donors are imperative to 

reduce the likelihood of harm to healthy 

donors. In the absence of national 

guidelines for donor selection, it is 

difficult to ensure that living donations 

are performed safely. Currently, there 

are few worldwide registries to track 

living donor outcomes. The OPTN, 

however, gathers 1-year post-donation 

6144 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

follow-up data on living donors in the 

US.

Section 1881(d) of the Act entitles any 

individual who donates a kidney for 

transplant surgery to Medicare benefits 

under parts A and B with respect to 

such donation. Medicare does not have 

a national coverage determination 

regarding extra-renal living donor 

transplants. In the absence of a national 

coverage determination, however, 

Medicare contractors may make local 

coverage determinations either on a 

claim-by-claim basis or through local 

medical review policies. We have some 

concerns about the lack of standardized 

recipient and donor selection criteria, 

best practices in living donation 

procedures, a national outcomes 

database of donors’ long-term follow-up 

and the variability in surgical expertise, 

volumes and center resources given the 

growth in living donor transplants. 

More systematic data collection and 

reporting of donor and recipient 

mortality and morbidity are needed to 

further assess the risk of death for living 

donors and the benefit for recipients. 

Generally, we believe living donation is 

a very promising medical practice. 

Therefore, in order to protect the safety 

of living donors and guarantee the more 

efficient use of human organs, we have 

proposed some minimal requirements 

for transplant centers performing living 

donor transplants that would apply to 

all Medicare-approved centers that 

perform living donor transplants. In 

accordance with our authority to 

establish standards necessary for the 

health and safety of individuals 

furnished services in hospitals, we 

believe we possess sufficient authority 

to prescribe rules for this practice. We 

invite public comments on these 

proposed requirements for living donor 

selection and living donor rights (see

Section II. Provisions of the Proposed 

Regulations for a detailed discussion of 

these proposed requirements). We also 

request comments on whether we need 

to establish additional criteria for 

transplant centers performing living 

donor transplants.

[If you choose to comment on this issue, 

please include the caption ‘‘CRITERIA 

FOR CENTERS PERFORMING LIVING 

DONOR TRANPLANT’’ at the beginning 

of your comments.] 

E. Why We Are Proposing New CoPs for 

Transplant Centers 

Our current Medicare coverage 

policies for extra-renal organs are based 

on the ‘‘reasonable and necessary’’

provision, Section 1862(a)(1)(A) of the 

Act. (‘‘[N]o payment may be made under 

part A or part B for any expenses 

incurred for items or services—(1)(A) 

which * * * are not reasonable and 

necessary for the diagnosis or treatment 

of illness or injury or to improve the 

functioning of a malformed body 

member.’’) Generally a medical 

procedure will be covered if its safety 

and efficacy have been adequately 

demonstrated by scientific evidence and 

the medical community has generally 

accepted the procedure. In the Federal 

Register notices announcing the 

Medicare coverage policies for heart, 

liver, and lung transplants, we stated 

that organ transplants in adults were 

reasonable and necessary when 

performed on carefully selected patients 

in facilities that meet certain criteria. 

In the past decade, however, the 

medical community has made 

remarkable strides in organ 

transplantation, and data on successful 

transplant outcomes are compelling. 

Organ transplantation is generally very 

effective and successful. Patients who 

have received transplants benefit 

substantially from these life-saving 

procedures in terms of improved quality 

of life and longer lifetime. Aided by 

ongoing evolution in pharmacology and 

transplant technology, organ 

transplantation is no longer regarded as 

an experimental procedure by the 

medical community and most health 

insurance companies. Instead, 

transplantation has become the 

mainstream operation for many patients 

who are in the end stage of organ 

failure. 

Furthermore, cutting-edge medical 

technology and pharmacology have 

raised graft and patient survivals 

significantly, such that we recognize 

that the survival standards that we had 

established previously for heart, liver, 

and lung centers may be too low. The 

national mean 1-year patient survival 

rates for heart, liver, and lung 

transplants performed in all transplant 

centers are much higher than the 1-year 

patient survival thresholds we 

established in our earlier national 

coverage decisions for Medicare 

approval of heart, liver, and lung 

transplant centers. 

Furthermore, the current 

requirements for heart, liver, and lung 

centers established threshold 

requirements for Medicare 

reimbursement but do not include 

criteria for re-evaluating the ongoing 

performance of approved heart, liver 

and lung centers. Since organ 

transplantation is a medical procedure 

that depends completely on organs 

donated from an appropriate donor, any 

potential outcome failure should be 

minimized to minimize organ wastage. 

Ongoing evaluation of a transplant 

center’s outcomes would serve as a 

valuable oversight tool for guaranteeing 

that donated organs are used efficiently. 

By establishing criteria for data 

submission, outcome measures, and 

process requirements, we can assume 

that Medicare-approved transplant 

centers would continue to provide a 

sufficient quality of transplantation so 

that organ wastage due to transplant 

failure would be decreased.

We believe it is important to 

promulgate regulations that will allow 

CMS to take advantage of advances in 

medical technology and establish 

standards for facilities that will ensure 

that Medicare beneficiaries receiving 

care at Medicare-approved transplant 

centers receive quality transplantation 

services. We are proposing rules that 

will encourage centers to seek approval 

to perform transplants on patients and 

that will include reasonable 

requirements necessary to produce a 

high probability of success. We believe 

these rules will lead to more efficient 

usage of donated organs and enhance 

effective administration of the Medicare 

program. We are proposing to codify the 

requirements for the approval and reapproval of transplant centers as an 

option for hospitals under part 482, 

Subpart E. These regulations would 

apply to heart, heart-lung, intestine, 

kidney, liver, lung, and pancreas 

centers. For purposes of this regulation, 

intestine centers are those Medicareapproved liver transplant centers that 

perform intestinal transplants, 

combined liver-intestinal 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 perform kidney-pancreas 

transplants. 

The requirements for Medicareapproved transplant centers have been 

published over the years in the Federal 

Register, the Coverage Issues Manual, 

and 42 CFR part 405, subpart U. 

Locating the Medicare requirements for 

different organ types has proven 

difficult for hospitals desiring to become 

Medicare-approved transplant centers. 

Therefore, we are proposing to include 

the criteria for all of the organ transplant 

types (i.e., heart, heart-lung, intestine, 

kidney, liver, lung, and pancreas) in the 

same CFR part: 42 CFR part 482. 

Although we received some comments 

during the Town Hall Meeting in 

December 1999 expressing the view that 

kidney transplant center criteria should 

remain with the ESRD facility 

conditions, we believe it will facilitate 

ease of reference and understanding if 

all the transplant center criteria are 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6145

consolidated into a specific set of 

hospital policies. 

Entities that request approval as a 

Medicare transplant center must first 

meet all of the hospital CoPs in 42 CFR 

part 482; however, inclusion of the 

organ transplant center criteria in the 

hospital CoPs does not imply that every 

hospital must meet the criteria in order 

to participate in Medicare. Rather, the 

transplant criteria represent an optional 

status based on conditions that are 

applicable only to hospitals that choose 

to apply for Medicare approval as a 

transplant center. Each type of organ 

transplant center would be approved 

separately, so only the approval of the 

individual organ-specific transplant 

center would be threatened if it were 

found non-compliant with the CoPs for 

transplant centers. That is, the hospital 

would not face the automatic loss of its 

Medicare approval as a hospital (or the 

loss of Medicare approval for other 

transplant centers) if one transplant 

center in the hospital were found to be 

noncompliant with the CoPs for that 

type of transplant center. 

II. Provisions of the Proposed 

Regulations 

For the reasons discussed previously, 

we propose to set forth new hospital 

CoPs for the approval and re-approval of 

transplant centers at part 482, subpart E 

of this chapter. Following is a 

discussion of the specific requirements 

contained in the proposed conditions. 

Special Requirements for Transplant 

Centers (Proposed Section 482.68) 

The requirements for approval and reapproval of transplant centers contained 

in this proposed rule represent special 

requirements that a transplant center 

must meet in order to receive Medicare 

approval as an organ-specific transplant 

center. Therefore, we propose a hospital 

that has a Medicare provider agreement 

must meet the CoPs specified in 

§ 482.70 through § 482.104 in order to 

be granted approval from CMS and to 

receive reimbursement for providing 

transplant services. We propose that 

unless we specify otherwise, the CoPs 

specified in § 482.70 through § 482.104 

apply to all transplant centers addressed 

in this proposed rule (i.e., heart, heartlung, intestine, kidney, liver, lung, and 

pancreas transplant centers).

We also propose that transplant 

centers seeking Medicare approval meet 

the hospital conditions of participation 

specified in § 482.1 through § 482.57. In 

other words, if the hospital in which a 

transplant center operates is terminated 

from Medicare, the transplant center 

would also lose its Medicare approval. 

However, loss of a transplant center’s 

approval status would not automatically 

lead to termination of the hospital’s 

provider agreement. 

Definitions (Proposed § 482.70) 

For clarity, we propose standardizing 

the usage of certain terms by proposing 

definitions for ‘‘transplant hospital,’’

‘‘transplant program,’’ and ‘‘transplant 

center.’’ Sometimes CMS has used the 

term ‘‘transplant center’’

interchangeably with the term 

‘‘transplant hospital’’ and sometimes it 

has used it interchangeably with the 

term ‘‘transplant program.’’ We propose 

defining ‘‘transplant hospital’’ as a 

hospital that furnishes organ transplants 

and other medical and surgical specialty 

services required for the care of 

transplant patients. A transplant 

hospital may have one or more types of 

organ transplant programs operating 

within the same hospital. Based on the 

definition of ‘‘transplant program’’ set 

forth at 42 CFR 121.2, we propose 

defining a ‘‘transplant program’’ as a 

component within a transplant hospital 

that provides transplantation of a 

particular organ type. Under the 

proposed definitions for ‘‘transplant 

hospital’’ and ‘‘transplant program’’, we 

propose to use ‘‘transplant center’’

interchangeably with ‘‘transplant 

program’’ in this proposed rule. 

We propose to delete the definitions 

for ‘‘histocompatibility testing,’’ ‘‘ESRD 

Network,’’ ‘‘network organization,’’

organ procurement,’’ ‘‘renal 

transplantation center,’’

‘‘transplantation service,’’ and 

‘‘transplantation surgeon’’ contained in 

§ 405.2102. To emphasize the distinct 

statutory requirements that kidney 

transplant centers have to meet and to 

clarify usage of three terms in the 

proposed CoPs for transplant centers, 

we propose to retain in § 482.70 the 

definitions for ‘‘ESRD,’’ ‘‘ESRD 

network,’’ and ‘‘network organization’’

from § 405.2102.

We propose adding a definition for 

‘‘adverse event’’ because we propose 

requiring a center to establish a written 

policy to address adverse events that 

occur during any phase of an organ 

transplantation case. The proposed 

definition for ‘‘adverse event’’ is derived 

from the JCAHO definition of an 

‘‘adverse event’’ and provides examples 

of adverse events that may occur in a 

transplant center. 

To reduce confusion, we also propose 

definitions for the particular types of 

organ transplant centers addressed in 

this proposed rule that perform multiorgan transplants. We propose including 

definitions for ‘‘heart-lung transplant 

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

and ‘‘intestinal transplant center’’ as 

they are used in this proposed rule. 

These definitions, as we propose to 

include them, are contained in the 

regulatory text at proposed § 482.70. 

Proposed General Requirements for 

Transplant Centers 

Condition of Participation: OPTN 

Membership (Proposed section 482.72) 

The OPTN was established under 

section 372 of the Public Health Service 

(PHS) Act, as enacted by the National 

Organ Transplant Act of 1984 (Pub. L. 

98–507), and amended by Public Law 

100–607 and Public Law 101–616. 

Section 372 of the PHS Act requires the 

Secretary to provide, by contract, for the 

establishment and operation of the 

OPTN to manage the national organ 

allocation system, to increase the supply 

of donated organs, and to perform 

related activities. Since 1986, the Health 

Resources and Services 

Administration’s (HRSA) Division of 

Transplantation (DoT) has administered 

a contract with UNOS to operate the 

OPTN. On October 20, 1999, HRSA 

published regulations governing the 

operation of the OPTN at 42 CFR Part 

121 (64 FR 56650). 

The primary functions of the OPTN 

are (1) to ensure that critically-ill and 

medically-qualified patients have 

equitable access to organs; (2) to ensure 

the safe and efficient recovery and use 

of scarce vital organs; and (3) to collect, 

maintain, and track information on all 

transplants and transplant patients from 

the time of surgery until graft failure or 

patient death. Although the OPTN 

regulations referred to above include 

some provisions that apply to OPTN 

members, including transplant centers, 

the OPTN regulations at § 121.4 also 

require the OPTN to establish policies 

for its members in order to achieve the 

goals of the OPTN. As required by the 

OPTN regulations at § 121.4, policies are 

established concerning organ 

procurement and transplantation for 

OPTN members. These policies 

established by the OPTN are legally 

enforceable against OPTN members if 

the Secretary approves them and they 

are published in the Federal Register in 

accordance with § 121.4. The Secretary 

enforces the OPTN policies, or rules, 

pursuant to the procedure laid out at 

§ 121.10. To date, no OPTN policies 

have been approved by the Secretary. 

Until enactment of the Omnibus 

Budget Reconciliation Act (OBRA) of 

1986 (Pub. L. 99–509), membership in 

the OPTN was voluntary. However, 

section 9318 of the OBRA of 1986 added 

section 1138(a)(1)(B) to the Act to 

require hospitals that perform organ 

6146 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

transplants to be members of and abide 

by the rules and requirements of the 

OPTN as a condition for participation in 

the Medicare and Medicaid programs. In 

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

the Act, the hospital condition of 

participation for organ, tissue, and eye 

procurement at § 482.45(b)(1) requires 

that a hospital in which organ 

transplants are performed must be a 

member of the OPTN and abide by the 

OPTN rules that have been approved by 

the Secretary. We propose that 

transplant centers 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 in 

§ 482.45(b)(1), which are enforceable 

under § 121.10. We propose that no 

transplant hospital would be considered 

to be out of compliance with section 

1138(a)(1)(B) of the Act, or with the 

proposed rule, unless the Secretary had 

given the OPTN formal notice that he or 

she approved the decision to exclude 

the transplant hospital from the OPTN 

and had notified the center in writing.

Condition of Participation: Notification 

to CMS (Proposed section 482.74) 

The current requirements for coverage 

of heart, liver and lung transplants 

require a Medicare-approved transplant 

center to report immediately to CMS 

any events or changes that would affect 

its approved status. Specifically, a 

center is required to report to us, within 

a reasonable period of time, any 

significant decrease in its experience 

level (for example, volume) or survival 

rates, the departure of key members of 

the transplant team or any other major 

changes that could affect the 

performance of heart, liver or lung 

transplants at the facility. There are no 

requirements for kidney transplant 

centers to report significant changes to 

CMS. We are proposing to require each 

transplant center to report immediately 

to CMS information on any significant 

changes that would affect its approval, 

such as an unusually large number of 

patient deaths during or shortly after 

transplant that could impact the center’s 

1-year patient survival rates or a change 

in key staff members, such as the 

individual the transplant center 

designates to the OPTN as the center’s 

‘‘primary transplant surgeon’’ or 

‘‘primary transplant physician.’’ This 

would be a new requirement for kidney, 

pancreas, heart-lung, and intestine 

transplant centers. We believe this 

requirement is necessary for all 

transplant centers to ensure that each 

transplant center maintains the 

resources and commitment needed to 

safely and efficiently perform 

transplants throughout its approval 

period. 

Condition of Participation: Pediatric 

Transplants (Proposed Section 482.76) 

Section 4009(b) of the Omnibus 

Budget Reconciliation Act of 1987 

(OBRA 1987) (Pub. L. 100–203) 

indicates that pediatric heart transplant 

centers are Medicare-approved heart 

transplant centers if they meet certain 

criteria. Public Law 100–203 specified 

the following criteria: (1) The hospital’s 

pediatric heart transplant center is 

operated jointly by the hospital and 

another facility that is Medicareapproved; (2) the unified program 

shares the same transplant surgeons and 

quality assurance program (including 

oversight committee, patient protocol, 

and patient selection criteria); and (3) 

the hospital 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 

(See Section 35–87 of the Coverage 

Issues Manual). We currently use 

criteria for pediatric liver and lung 

transplant centers similar to the criteria 

that were specified by Congress for 

pediatric heart transplant centers. (See 

Section 35–53.1 of the Coverage Issues 

Manual for liver transplants and 60 FR 

6537 for lung transplants.) 

Since many centers that perform 

pediatric transplants are not jointly 

operated by another facility that is 

Medicare-approved, we propose to 

require all transplant centers, adult and 

pediatric, that wish to be reimbursed for 

pediatric transplants performed on 

Medicare beneficiaries to specifically 

request Medicare approval to perform 

pediatric transplants. We would 

approve and re-approve the center to 

perform pediatric transplants using the 

procedures described in proposed 

§ 488.61. A center that wishes to be 

approved to perform pediatric 

transplants would have to meet the 

conditions of participation contained in 

§ 482.68 through § 482.74 and § 482.80 

through § 482.104 with respect to its 

pediatric patients. However, given 

Congress’s intent that pediatric heart 

centers could participate in Medicare if 

they meet the requirements described in 

section 4009(b) of OBRA 1987, we are 

proposing to retain the statutory criteria 

as an option for heart transplant centers 

that wish to become Medicare-approved 

to perform pediatric heart transplants. 

In other words, a center that wishes to 

be approved to perform pediatric heart 

transplants may be approved by meeting 

the data submission, outcome, and 

process requirements proposed in this 

regulation, or the center may be 

approved by meeting the criteria in 

section 4009(b) of OBRA 1987. 

Although all transplant centers that 

wish to be reimbursed for transplants 

performed on pediatric Medicare 

beneficiaries would have to request 

Medicare approval to perform pediatric 

transplants, we believe it is necessary to 

distinguish between two different types 

of centers that may provide pediatric 

transplantation services. In some 

centers, patients are predominantly 

adults (i.e., 18 years or older) and only 

a few pediatric transplants are 

performed. In other centers, pediatric 

transplant programs are separate from 

the adult programs and may be operated 

by departments of pediatrics or 

children’s hospitals where a majority of 

transplants are performed on pediatric 

patients (i.e., patients younger than 18). 

We propose that in centers where 

patients are predominantly (≤50 

percent) adult patients, the center 

would need to have Medicare approval 

to perform both adult and pediatric 

transplants in order to be reimbursed for 

transplants performed on pediatric 

Medicare beneficiaries. Since few 

transplants are performed on children in 

such centers, we propose that loss of 

Medicare approval to perform adult 

transplants, whether voluntary or 

involuntary, would result in loss of 

Medicare approval to perform pediatric 

transplants. However, loss of Medicare 

approval to perform pediatric 

transplants would not affect the center’s 

Medicare approval to perform adult 

transplants.

Likewise, we propose that a center 

that predominantly (≥50 percent) 

provides transplantation services to 

pediatric patients (i.e., a pediatric 

center) would need to have Medicare 

approval to perform both pediatric and 

adult transplants in order to be 

reimbursed for transplants performed on 

adult Medicare beneficiaries. In this 

case, however, loss of Medicare 

approval to perform adult transplants 

would not impact the center’s Medicare 

approval to perform pediatric 

transplants while loss of Medicare 

approval to perform pediatric 

transplants, whether voluntary or 

involuntary, would result in loss of 

Medicare approval to perform adult 

transplants. Usually, centers that 

predominantly serve pediatric patients 

will transplant only a few young adults 

(18 or 19 years old) who wish to 

maintain continuity of care but have 

aged beyond the pediatric patient 

classification. Because of the occasional 

adult patients being transplanted at the 

pediatric centers and the relatively few 

pediatric transplants in general, we are 

not requiring a minimum number of

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6147

transplants (adult or pediatric) for 

pediatric centers. We are requesting 

comments on our proposed 

methodology for approving and reapproving centers that perform pediatric 

transplants.

[If you choose to comment on this issue, 

please include the caption ‘‘CENTERS 

PERFORMING PEDIATRIC 

TRANSPLANTS’’ at the beginning of 

your comments.] 

Proposed Transplant Center Data 

Submission and Outcome Requirements 

Condition of Participation: Data 

Submission and Outcome Measure 

Requirements for Initial Approval of 

Transplant Centers (Proposed section 

482.80)

[If you choose to comment on this 

section, please include the caption 

‘‘OUTCOME MEASURE 

REQUIREMENTS’’ at the beginning of 

your comments.] 

A. Overview

Our intent in promulgating this rule is 

to establish quality standards for 

approval and re-approval of transplant 

centers participating in Medicare. We 

intend to focus regulations on the actual 

care being furnished and the outcomes 

of that care, rather than solely on the 

underlying policies and procedures. 

The Institute of Medicine (IOM) 

highlighted the importance of focusing 

on outcomes in its report (‘‘Organ 

Procurement and Transplantation: 

Assessing Current Policies and the 

Potential Impact of the DHHS Final 

Rule’’), published on July 22, 1999. In 

its recommendation on Federal 

oversight, the IOM articulated its view 

that the Department should include 

greater use of patient-centered, 

outcome-oriented performance 

measures for OPOs, transplant centers, 

and the OPTN. 

Some representatives from the 

transplant community that attended the 

CMS Town Hall Meeting held in 

December 1999 also voiced a similar 

opinion that transplant center 

performance should be assessed using 

patient-centered outcome measures. 

However, there was no consensus on 

how to design an outcome-oriented 

system for evaluating center 

performance. 

We recognize the fact that transplant 

outcomes and practices can be assessed 

from multiple perspectives, and there is 

no one single criterion that can 

adequately evaluate the performance of 

a transplant center. Therefore, we are 

proposing to evaluate a center’s 

performance by measuring a center’s 

outcomes and experience, in 

combination with some specific process 

requirements we believe will ensure the 

quality of the transplant center. 

In developing a proposed framework 

for the initial approval of transplant 

centers, we have included criteria of 

significance to an outcome-based 

evaluation system. We are proposing 

criteria for timely and complete data 

submission, patient survival, and graft 

survival. 

B. Data Submission Requirements for 

Initial Approval of Transplant Centers 

1. Current Medicare Data Submission 

Requirements 

Under current transplant policies for 

heart, liver, and lung centers and the 

current regulations for renal transplant 

centers, centers applying for Medicare 

approval are required to supply data to 

CMS. As appropriate, these applicants 

must report every heart and liver 

transplant performed since 1982, every 

lung transplant performed since January 

1, 1990, or every kidney transplant 

performed during the most recent year 

of operation and during each of the 

preceding 2 calendar years. The current 

criteria for approval of heart, liver, and 

lung transplant centers require centers 

to agree to maintain and routinely 

submit to CMS, in a prescribed standard 

format, summary data about patients 

selected, protocols used, and short- and 

long-term outcomes on Medicare and 

non-Medicare patients undergoing 

transplantation. 

2. Data Collection and the OPTN 

In addition to supplying transplant 

data to CMS, transplant centers also 

collect and submit transplant data to the 

OPTN. Under the Department’s Health 

Information Privacy Rules at 45 CFR 

164.512, which implement the privacy 

provisions of the Health Insurance 

Portability and Accountability Act 

(HIPAA), covered entities are permitted 

to use and disclose protected health 

information to OPOs or other 

organizations engaged in the 

procurement, banking, or 

transplantation of organs, eyes, or 

tissues from deceased donors. 

Therefore, data submission to the OPTN 

is an exception under HIPAA with 

respect to organ transplants. The OPTN 

database utilizes electronic submission, 

review, and modification features 

through a secure, encrypted web-based 

system. Under contract with HRSA, the 

OPTN develops policies concerning 

data submission as well as policies 

concerning organ procurement and 

transplantation.

The OPTN requires its members to 

submit organ-specific data electronically 

to the OPTN through the use of 

standardized forms. There are a total of 

26 different organ-specific forms 

containing more than 3,500 data fields. 

Transplant centers are responsible for 

submitting the appropriate organspecific forms for each center using six 

form types. The OPTN also specifies 

time frames in which each form must be 

submitted to the OPTN. Below is a 

description of the six forms for which 

transplant centers are responsible and 

the due dates established by the OPTN 

for each form: 

• Transplant Candidate Registration 

Form includes waitlist data as well as 

other clinical and organ-specific 

information collected prior to 

transplant. There is a form for each 

organ type: Kidney-pancreas, kidney, 

pancreas, liver, intestine, heart, lung, 

and heart-lung. The OPTN requires 

transplant centers to submit the organspecific Transplant Candidate 

Registration Form to the OPTN within 

30 days of the form generation date. 

• Transplant Recipient Registration 

Form includes the patient status at 

discharge, pre- and post-transplant 

clinical information, as well as 

treatment data. The form is generated 

when the patient receives a transplant 

and is removed from the waitlist. There 

is a form for each organ type: kidneypancreas, kidney, pancreas, liver, 

intestine, and thoracic (i.e., heart, lung, 

and heart-lung). The OPTN requires 

transplant centers to complete the 

organ-specific Transplant Recipient 

Registration Form when the transplant 

recipient is discharged from the hospital 

or six weeks following the transplant 

date, whichever is first. The OPTN also 

requires transplant centers to submit the 

organ-specific Transplant Recipient 

Registration Form to the OPTN within 

60 days of the form generation date. 

• Transplant Recipient Follow-up 

Form is generated six months posttransplant (excluding thoracic) and on 

the transplant anniversary for every 

living organ recipient with a functioning 

graft. It includes patient status, clinical, 

and treatment information. There is a 

form for each organ type: Kidneypancreas, kidney, pancreas, liver, 

intestine, and thoracic. The OPTN 

requires transplant centers to submit the 

organ-specific Transplant Recipient 

Follow-up Form to the OPTN within 30 

days of the form generation date unless 

the transplant recipient dies or 

experiences a graft failure. In such 

circumstances, the OPTN specifies that 

transplant centers are required to submit 

the organ-specific Transplant Recipient 

Follow-up Form to the OPTN within 14 

days of the recipient’s death or graft 

failure. 

6148 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

• Post Transplant Malignancy Form

is generated after a malignancy has been 

reported on the Transplant Recipient 

Follow-up Form. The OPTN requires 

transplant centers to submit the Post 

Transplant Malignancy Form to the 

OPTN within 30 days of the form 

generation date. 

• Living Donor Registration Form

collects data for all living organ donors. 

The OPTN requires transplant centers to 

submit the Living Donor Registration 

Form to the OPTN within 30 days of the 

form generation date. 

• Living Donor Follow-up Form

includes patient status and clinical 

information collected on the living 

donor at intervals of six months and one 

year post-transplant. The OPTN requires 

transplant centers to submit the Living 

Donor Follow-up Form to the OPTN 

within 30 days of the form generation 

date. 

The OPTN also includes a data 

submission standard that requires, 

among other things, 95 percent of the 

required forms to be completed within 

90 days of their due date. 

3. The Scientific Registry of Transplant 

Recipients (SRTR) and the CenterSpecific Reports

Once the OPTN collects the required 

data, the SRTR, which is run by the 

University Renal Research Education 

Association (URREA) under contract 

with HRSA, analyzes the OPTN data 

and creates national and center-specific 

reports. Regulations at 42 CFR 121.11 

require the SRTR to make centerspecific information on the performance 

of transplant centers available over the 

Internet and requires the SRTR to 

update these data at least every 6 

months. URREA updates the centerspecific reports every January and July, 

and makes the center-specific reports 

available over the Internet at http://

www.ustransplant.org.

The SRTR center-specific reports 

contain a variety of statistical tables 

based on the transplants performed at 

each center in the US. The centerspecific reports contain information on 

each center’s performance; including 

statistics on each center’s waitlist 

activity, deceased and living donor 

transplant recipient characteristics and 

outcomes (including patient and graft 

survival), and donor characteristics. The 

SRTR also prepares national summary 

reports of these topics by center. Below, 

we provide a more detailed description 

of some of the statistics available in the 

center-specific reports. 

The most important outcome for a 

lifesaving technology such as 

transplantation is whether the patient 

survives the procedure. Currently, the 

SRTR center-specific reports provide 

observed and expected patient survival 

rates for adult and pediatric patients at 

the 1-month, 1-year, and 3-year 

reporting time point for each center. For 

calculation of the 1-month, 1-year, and 

3-year patient survival statistics, the 

SRTR center-specific reports use 

transplants that occurred during a 2.5-

year interval before a report is 

published. In order to maximize followup of patients that were transplanted 

towards the end of the 2.5-year interval, 

there may be a significant lag between 

the time that the last transplant in the 

2.5-year period occurred and the time 

that patient survival statistics are 

reported. For example, the July 2003 

center-specific reports contain 1-month 

and 1-year patient survival statistics for 

abdominal transplants (for example, 

kidney, kidney-pancreas, intestine, 

liver, and pancreas transplants) that 

were performed at a center between 

January 1, 2000 and June 30, 2002 and 

for thoracic transplants (for example, 

heart, heart-lung, and lung transplants) 

that were performed between January 1, 

2000 and June 30, 2002. In the future, 

the SRTR plans to calculate 1-month 

and 1-year survival statistics using 2.5-

year cohorts for all organs. The 3-year 

patient survival statistics include 

transplants performed between January 

1, 1998 and December 31, 1999. 

Additionally, the SRTR center-specific 

reports include adult patient survival 

rates and pediatric patient survival rates 

for deceased and living donor 

transplants. 

A center’s observed patient survival 

rate is an estimate of the fraction of 

patients in each cohort that would still 

be alive at the reporting time point had 

follow-up data been received up to that 

time. The SRTR uses the Kaplan-Meier 

method to calculate a center’s observed 

patient survival rate from the OPTN 

follow-up data and the Social Security 

Death Master File (SSDMF) data. The 

Kaplan-Meier method is a standard 

statistical technique for estimating 

survival at the reporting time point by 

assuming that the failure rate would 

have been the same for those patients 

lost to follow-up as was observed for 

patients with complete follow-up data. 

Recognizing that some patients are 

lost to follow-up for reasons beyond a 

transplant center’s control, such as a 

patient’s change of residence, change of 

providers, or unreported death, the 

SRTR began augmenting the OPTN data 

by tracking all transplant patients ‘‘lost 

to follow-up’’ through the SSDMF. 

Although there are some flaws in the 

SSDMF data, it has enhanced the 

SRTR’s ability to determine if patients 

‘‘lost to follow-up’’ had died or were 

still thought to be alive on a certain 

date. In addition to enhancing the 

accuracy of the SRTR’s center-specific 

reports, URREA has determined that the 

additional data obtained from the 

SSDMF seems to increase the reported 

survival rates of some centers.

A center’s expected patient survival 

rate is a risk-adjusted statistic that 

provides an estimate of the fraction of 

patients who would be expected to be 

alive at each reported time point based 

on the national experience for similar 

patients. The SRTR uses the Cox 

proportional hazards regression model 

to calculate each center’s expected 

patient survival rate. 

The Cox model is a statistical 

modeling technique that is widely used 

in the analysis of survival data. The Cox 

model is flexible in the types of data, 

event rate patterns, and covariates it can 

handle. It can model dependence of 

event rates on patient and donor 

characteristics in a variety of ways 

including time dependent proportional 

hazards (covariates), which are 

extremely useful for modeling the effect 

of current patient status on mortality 

and for modeling both short term and 

long term covariates effects on event 

rates. Information about the Cox model 

can be found on the Internet. For 

example, background on the Cox model 

can be found at http://

members.aol.com/johnp71/

prophaz.html.

The Cox model is designed to 

evaluate the outcomes among the 

recipients at one center, compared to 

what would be expected, had those 

same patients received a transplant at an 

‘‘average’’ center. One of the most 

important features of the Cox model is 

the identification of the adjustment 

factors that could affect transplant 

outcomes. These factors are chosen 

using clinical input supported by 

statistical analyses. The clinical input 

comes from the constant review of SRTR 

models by experts on the OPTN 

committees and the Secretary’s 

Advisory Committee on Organ 

Transplantation (ACOT). The Secretary 

established the ACOT to enhance organ 

donation, ensure the system of organ 

transplantation is grounded in the best 

available medical science, ensure the 

public that the system is as effective and 

equitable as possible, and thereby 

increase public confidence in the 

integrity and effectiveness of the 

transplantation system. Some nonstatistically significant factors are also 

included in the Cox models used to 

calculate expected patient survival in 

order to improve validity and public 

acceptance of the models. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6149

Historically, there have been more 

than 100 models fit for each centerspecific report release (e.g., models by 

organ, by age group, by living/deceased 

donor, by follow-up time period, by 

graft/patient survival). Currently, the 

models used to calculate 1-month and 1-

year patient survival are based on the 

same cohort of patients. The SRTR plans 

to begin to use a single model to 

calculate survival, as this would allow 

for more stable estimation of factors for 

the 1-month results, which currently are 

based on relatively few events. This will 

assure consistency in the expected 

values for the overall transplant 

population and the subpopulations of 

living and deceased donor recipients. 

The specific risk adjustment factors 

that affect transplant outcomes 

identified in the Cox model and their 

weights are subject to change with each 

updated analysis. Semi-annually (every 

January and July), the SRTR assesses the 

goodness of fit and stability of a survival 

model using the index of concordance. 

The index of concordance is a measure 

of a model’s ability to fit the mortality 

outcomes for each patient. In order to 

assess the stability of the models, for 

each center-specific report release, the 

models will be fit using the same list of 

covariates to a series of successive 

cohorts of transplant recipients. In 

addition, the values of the coefficients 

will be reported for each of the models 

while outcomes are evaluated relative to 

the norm, or the ‘‘average.’’ Significant 

changes in the index of concordance 

and the coefficients over a period of 

time will help to identify the factors that 

require closer evaluation in order to be 

sure that the models are as up to date 

as possible.

In the future, the SRTR plans to 

complete a table for each of the centerspecific report post-transplant models. 

The table will include the index of 

concordance, the coefficients, and pvalues for the coefficients when the 

model is fit for transplants during the 

2.5-year cohort used for the current 

center-specific report release as well as 

that for the two previous releases. This 

table will be posted publicly on the 

SRTR Web site (http://

www.ustransplant.org) at the time of the 

preview site, which is approximately 1 

month before the center-specific report 

public release date. It is intended to 

allow users to assess the stability of the 

models. If the fit of the models or the 

coefficients of the factors change 

markedly, one would be careful to 

evaluate the models to be sure that they 

are as up to date as possible. If the fit 

and coefficients do not change 

markedly, one could be assured that the 

models are stable. 

For purposes of example, the Cox 

models used in the July 2004 centerspecific reports to calculate expected 1-

year patient survival rates for deceased 

donor adult transplants contained the 

following factors. (Analytic 

Conventions—Guide to the CenterSpecific Reports, http://

www.ustransplant.org/programsreport.html). Factors for kidney 

transplants included: diagnosis, donor 

age, donor history of hypertension, 

donor meets expanded donor criteria for 

deceased kidney, donor race, donor 

serum creatinine, donor cause of death, 

human lymphocyte antigen (HLA) 

mismatch, peak panel reactive antibody 

(PRA), recipient age, recipient ethnicity, 

recipient medical condition, recipient 

race, and year of ESRD treatment. 

Factors for liver transplants included: 

diagnosis, ABO (i.e., blood types A, B, 

AB, and O) compatibility, donor 

Hispanic/Latino, donor age, donor and 

recipient in the same region but not the 

same OPO, donor and recipient not in 

same region or OPO, donor race, donor 

cause of death, non heart beating donor, 

recipient portal vein thrombosis, 

recipient age, recipient any previous 

transfusions, recipient ascites, recipient 

creatinine, recipient ethnicity, recipient 

height, recipient incidental tumor found 

at time of transplant, recipient insulin 

dependent diabetes, recipient medical 

condition, recipient on life support, 

recipient previous abdominal surgery, 

recipient race, and split or partial liver. 

Factors for heart transplants included: 

diagnosis, donor age, donor cause of 

death, ischemia time, recipient 

creatinine, recipient height, recipient 

medical condition, recipient on 

extracorporeal membrane oxygenation 

(ECMO), and recipient on ventilator. 

Factors for lung transplants included: 

cardiac index, diagnosis group B, 

diagnosis group C, diagnosis group D, 

diagnosis, donor age, donor body 

surface area, donor history of diabetes, 

donor race, donor cause of death, 

percent predicted forced vital capacity 

(FVC), ischemia time, New York Heart 

Association (NYHA) class, oxygen 

required at rest, recipient age, recipient 

creatinine, recipient female, recipient 

on ventilator, recipient race, and 

pulmonary artery (PA) hemodynamics 

mean by diagnosis interaction. 

As in patient survival, the SRTR also 

calculates observed and expected 1-

month, 1-year and 3-year graft survival 

statistics. Using the Kaplan-Meier 

method, the SRTR calculates observed 

graft survival rates for each of the 

reporting time points (i.e., 1-month, 1-

year, and 3-year) from OPTN and 

SSDMF data. Cox models are used to 

calculate expected graft survival 

statistics for each of the reporting time 

points. The factors predictive of graft 

survival models are generally similar to 

those predictive of patient survival 

models and generally include an 

indicator for whether or not this was the 

first transplant of this type. Again, 1-

month, 1-year, and 3-year graft survival 

statistics in the center-specific reports 

are stratified by age (i.e. adult or 

pediatric) and by donor type (i.e.

deceased or living) and are calculated 

using only transplants that occurred 

during a 2.5-year interval before a report 

is published.

4. Proposed Data Submission 

Requirements 

Since the SRTR center-specific reports 

contain a wealth of information about 

transplant center outcomes and the 

SRTR prepares its analytical reports 

from the data that transplant centers are 

already self-reporting to the OPTN, we 

propose that the SRTR’s center-specific 

reports could form the foundation for 

our outcome evaluation system. 

However, we need to be certain of the 

completeness of the data used to 

evaluate each center’s outcomes. 

In July 2001, an article that appeared 

in the Milwaukee Journal Sentinel

(‘‘Transplant Rate Reports Don’t Tell 

Whole Story,’’ http://www.jsonline.com/

alive/column/jul01/

marccol30072701.asp, July 27, 2001) 

questioned the data used by the SRTR 

to generate and publish the centerspecific reports. The article charged that 

some centers were getting away with 

reporting less than half of follow-up 

data required by the OPTN. Incomplete 

data can be attributed to several factors, 

including lost to follow-up. However, 

the article also alleged that some centers 

were purposely submitting incomplete 

data to skew their survival results. In 

order 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 

believe that it is important that we 

establish requirements for timely and 

complete reporting of data to the OPTN. 

As discussed earlier, the OPTN 

includes a data submission standard 

that requires, among other things, 95 

percent of the required forms to be 

completed within 90 days of their due 

date. We propose a similar data 

submission requirement. We propose, at 

§ 482.80(a) that no later than 90 days 

after the due date established by the 

OPTN, heart, heart-lung, intestine, 

kidney, liver, lung, and pancreas 

transplant centers must submit to the 

OPTN at least 95 percent of required 

data submissions on all transplants 

6150 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

(deceased and living donor) performed 

at the center. We believe it is important 

to maintain this 90-day grace period to 

ensure that transplant data collection 

and compilation are as complete and 

accurate as possible. 

We propose that required data 

submissions include, but not be limited 

to, the submission of the appropriate 

organ-specific OPTN forms for 

transplant candidate registration, 

transplant recipient registration, and 

recipient follow-up. Requiring timely 

and complete submission of data will 

ensure up-to-date and meaningful data.

C. Outcome Measure Requirements for 

Initial Approval of Transplant Centers 

1. Current Medicare Outcome Measure 

Requirements 

Under the current transplant policies, 

transplant centers applying for Medicare 

approval of a heart, liver or lung 

transplant center are required to report 

their 1-year and 2-year actuarial 

(unadjusted) patient survival rates using 

the modified Kaplan-Meier method. The 

modified Kaplan-Meier method 

estimates survival at the reporting time 

point by treating those patients lost to 

follow-up as dead on the day following 

the last ascertained survival. 

The current actuarial survival 

standards for heart transplants were 

developed in 1986. According to those 

standards, a center is required to 

demonstrate an actuarial survival rate of 

73 percent for 1 year and 65 percent for 

2 years for patients who have had heart 

transplants since January 1, 1982 at that 

center. Current criteria for approval as a 

liver transplant center were developed 

in 1991 and require an actuarial survival 

rate of 77 percent for 1 year and 60 

percent for 2 years for the time period 

the center is using to calculate survival. 

The criteria for lung transplants were 

published in our February 1995 notice 

of Medicare policy for lung transplants. 

The criteria require centers to maintain 

a 1-year actuarial survival rate of 69 

percent and a 2-year actuarial survival 

rate of 62 percent for all transplant cases 

occurring on or after January 1, 1990. 

The Medicare National Coverage 

Decision that we issued in October 2000 

requires intestinal centers to have a 1-

year actuarial survival rate of 65 percent 

for intestinal and multivisceral 

transplants. The required intestinal 

threshold is based on a weighted 

average of the national 1-year patient 

survival rates for small bowel 

transplantation, small bowel/liver 

transplantation, and multivisceral 

transplantation data from the literature 

reports on the international intestinal 

transplant registry. There are no 

survival standards in place for kidney, 

pancreas, and heart-lung transplant 

centers for Medicare approval. 

2. Appropriateness of Current Survival 

Criteria 

At the time the survival criteria for 

heart, liver and lung transplants were 

developed, organ transplants were 

largely viewed as experimental 

procedures and the survival criteria 

were designed to be high enough to 

ensure that Medicare-approved 

transplant centers were high-quality 

institutions but low enough to ensure 

that centers did not exclude high-risk 

patients. Aided by remarkable advances 

in medicine and cutting-edge 

technology, survival rates for heart, 

liver, and lung transplant patients have 

steadily increased since our criteria 

were established. For example, 

according to the 2003 OPTN/SRTR 

Annual Report, the unadjusted 1-year 

patient survival figures for transplants 

performed between 2000–2001 for 

deceased donor heart, liver, and lung 

transplantation were 86 percent, 86 

percent, and 78 percent, respectively. 

The recent national 1-year patient 

survival rates are considerably higher 

than the corresponding Medicare 1-year 

patient survival standards of 73 percent 

for heart, 77 percent for deceased donor 

liver, and 69 percent for lung 

transplantation. It seems clear that the 

Medicare survival criteria currently 

used for Medicare approval of heart, 

liver, and lung centers would not be 

appropriate under an outcome-oriented 

set of standards. 

We believe it is necessary for us to 

establish outcome measure 

requirements for transplant centers to 

protect patient safety and, given the 

scarcity of donor organs, to ensure that 

donor organs, once recovered, are 

transplanted effectively and are not 

wasted. In an effort to assure that 

transplant centers furnish 

transplantation services efficiently, we 

believe we need to establish a system for 

approval and re-approval of transplant 

centers that focuses on a center’s 

outcomes. A center’s outcomes serve as 

indicators of the center’s ability to 

furnish transplantation services 

successfully. Since we are proposing a 

system that focuses heavily on 

outcomes, it is critical that the outcome 

standards reflect current conditions. 

Consequently, we are proposing 

significant changes in the standards that 

would be applicable to Medicare 

approval. 

Moreover, we believe our 

responsibility to ensure that 

transplantation services are furnished 

safely and efficiently is no less 

important to those beneficiaries in need 

of kidney transplants than those in need 

of heart, liver, or lung transplants. 

Therefore, we are proposing to develop 

survival criteria for kidney transplant 

centers. 

3. Proposed Outcome Measure 

Requirements for Heart, Kidney, Liver, 

and Lung Centers 

It has been widely acknowledged by 

the transplant community that a 

transplant center’s performance should 

be measured on the basis of its 

outcomes. However, there is no 

consensus on how to develop an 

outcome-oriented evaluation system. In 

developing an outcome-oriented system 

for evaluating center performance, some 

issues we considered are what types of 

measures should be used, how many 

measures to include, and whether to 

include both short and long-term 

outcomes.

The transplant community considers 

post-transplant outcomes, such as 

patient and graft survival, to be the 

‘‘gold standard’’ for evaluating a 

transplant center’s performance. While 

post-transplant outcomes, which 

measure the outcomes of transplant 

recipients, are widely accepted as 

meaningful measures of transplant 

center performance, organ 

transplantation is both a short and longterm experience. 

We currently evaluate a center’s 

performance on the basis of a single 

outcome measure, patient survival. For 

the purposes of this proposed rule we 

considered continuing to evaluate a 

center’s performance on the basis of a 

single outcome measure. However, this 

approach could encourage centers to 

neglect other outcomes. For example, a 

kidney center might focus its efforts on 

ensuring that a kidney recipient 

survives to the detriment of the survival 

of the graft, since dialysis provides an 

alternative to death for kidney 

recipients with a failed graft. 

Additionally, we are concerned that 

use of patient survival rates alone would 

not paint a complete picture of the 

quality of transplants performed at a 

center. While patient survival rates 

measure patient mortality, patient 

survival rates do not measure patient 

morbidity or the success of the actual 

transplantation procedure. Therefore, 

we are not proposing to limit outcome 

criteria for initial approval to patient 

survival; we are proposing a graft 

survival criterion as well. 

We do not propose to use graft 

survival exclusively because patient 

survival is also an important measure 

for assessing a transplant center’s 

quality. For example, if a transplant 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6151

center lost grafts only due to patient 

deaths, its outcomes may not be poor 

with respect to graft survival. However, 

since patient deaths are supposed to 

occur less frequently than graft loss due 

to re-transplants and dialysis, this 

transplant center may have a 

significantly lower than expected 

patient survival. 

Therefore, we are proposing to use 

both graft and patient survival as 

outcome measures that would portray a 

center’s actual performance more 

accurately. The proposed outcome 

measure requirements, like the other 

proposed requirements for initial 

approval, serve as one of several 

requirements that transplant centers 

seeking initial approval would have to 

meet in order to begin furnishing 

transplantation services that are covered 

by Medicare.

We also considered looking at both 

short-term and long-term outcomes, 

such as the 2-year statistics we currently 

require. However, we realize that longterm outcomes are more susceptible to 

exogenous factors not directly related to 

the transplantation procedure. After 

careful analysis of these issues, we 

propose using 1-year patient survival 

and 1-year graft survival (and in certain 

circumstances, 1-month patient survival 

and 1-month graft survival in lieu of 1-

year patient survival and 1-year graft 

survival) as outcome measures for initial 

approval. We propose to require centers 

to meet both the 1-year patient survival 

and 1-year graft survival requirements 

separately. We propose to assess a 

transplant center’s 1-year patient and 

graft survival by comparing a transplant 

center’s expected 1-year patient and 

graft survival rate to its observed 1-year 

patient and graft survival rate for all 

transplants performed in the center, 

including living donor transplants if 

applicable. We propose to review a 

center’s observed patient and graft 

survival against its expected patient and 

graft survival using a methodology that 

was developed by the SRTR and used by 

the OPTN. (This methodology, 

including its development, is discussed 

in detail below.) We propose to review 

a center’s outcomes using the patient 

and graft survival data contained in the 

most recent SRTR center-specific report. 

We also propose to review adult and 

pediatric outcomes separately if a center 

other than a lung transplant center 

requests Medicare approval to perform 

pediatric transplants. For most organ 

types, the SRTR has developed separate 

Cox models for calculating expected 

patient and graft survival statistics for 

adult (18 and older) and pediatric 

(younger than 18) patients. For lung 

transplants, however, the SRTR 

stratifies recipient outcomes using other 

categories—(1) patients that are 12 and 

older or (2) patients that are less than 

12. Since most lung transplants 

performed on pediatric patients, which 

is traditionally defined as patients that 

are younger than 18 years old, are 

performed on older children, we 

propose to use the 1-year patient 

survival data on patients who are at 

least 12 years old to assess both adult 

and pediatric outcomes. 

a. Proposed Outcome Evaluation 

Methodology 

Some of the attendees in the CMS 

Town Hall Meeting expressed the view 

that transplant centers should be 

evaluated on the basis of risk-adjusted 

outcomes because risk adjustment can 

reduce the impact of patients’ diverse 

risk factors on survival rates. We agree 

that risk adjustment addresses the 

potential to inadvertently penalize 

centers for transplanting high-risk 

patients or using organs from extended 

criteria donors. We believe risk 

adjustment can level the playing field 

for all transplant centers. As such, we 

propose an evaluation system that relies 

on the SRTR’s risk-adjusted data. 

The SRTR methodology, which was 

adopted by the OPTN’s Board of 

Directors in June 2003, was designed to 

update deficiencies in prior OPTN 

methods. A discussion of prior methods 

used by the OPTN is available in the 

OPTN Proposal Archive, March 14, 

2003–32 Proposals (Proposed 

Modifications to OPTN/UNOS Bylaw 

Appendix B (Criteria for Institutional 

Membership), Section III (Transplant 

Programs) at http://www.optn.org/

policiesAndBylaws/publicComment/

proposalsArchive.asp. The current 

SRTR method, which is being proposed 

for use by CMS, uses a three-pronged 

approach that takes into consideration 

(1) statistical certainty; (2) the value of 

the finding for allocating resources to 

perform on-site surveys; and (3) the 

need for taking action. This threepronged approach provided the OPTN’s 

Membership and Professional Standards 

Committee (MPSC) with a balanced tool 

for assessing transplant center 

performance without creating excessive 

demand on the resources of the MPSC.

Specifically, the SRTR methodology 

compares observed outcomes to 

expected outcomes using three tests: (1) 

The p-value to test for statistical 

significance, (2) the number of observed 

events (i.e., patient deaths or graft 

failures) minus the number of expected 

events (O¥E), and (3) the number of 

observed events divided by the number 

of expected events (O/E). When a 

transplant center crosses over the 

thresholds for all three tests, it is 

identified for further review by the 

OPTN. 

The first prong of the three-pronged 

approach of the SRTR methodology is 

statistical certainty, which is based on 

assessing whether the difference 

between the observed number of deaths 

or graft failures is statistically 

significantly more than the expected 

number. Statistical tests often use pvalues to distinguish whether chance 

can or cannot be ruled out or chance is 

a likely or unlikely explanation for the 

differences documented between two 

observations. The p-value measures the 

statistical significance (or evidence) for 

testing a hypothesis. Usually, this 

hypothesis is either that two numbers 

are equal to each other or that a number 

is different from zero. A p-value of less 

than 0.5 (indicating that there is less 

than a 5 percent chance that any 

observed difference offered by random 

chance alone) is often considered 

‘‘statistically significant’’. Consequently, 

the p-value helps to identify centers 

where chance is an unlikely explanation 

for the differences between the center’s 

observed events and its expected events. 

A low p-value generally indicates that 

chance is an unlikely explanation for 

the differences between the actual and 

expected outcomes. The MPSC 

determined that a p-value less than 0.05 

would be adequate to assure the 

statistical certainty of the difference 

between the observed and expected 

number of deaths or graft failures. 

The second prong of the threepronged approach of the SRTR 

methodology is the value of the finding 

for allocating resources to perform onsite surveys. The number of observed 

events minus the number of expected 

events (that is, the number of patient 

deaths or graft failures a transplant 

center would expect to have based on its 

patient population) helps to identify 

centers with relatively large numbers of 

unexpected events. The OPTN uses the 

results of this test to determine how to 

allocate its limited resources available 

for the review of centers. This avoids 

allocation of resources to centers with 

only a small fraction of unexpected 

deaths. The SRTR proposed a threshold 

value for each test. The MPSC 

determined that the number ‘‘3’’ (that is, 

3 more patient deaths or graft failures 

than expected) would be adequate to 

assure that there was meaningful 

clinical information to assess for 

deficiencies in a transplant center 

(O¥E>3). Few smaller centers are 

expected to show statistical significance 

(i.e., show a p-value <0.05) because, 

from a statistical perspective, it hard to 

rule out chance when working with 

6152 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

small numbers. Therefore, one could 

expect that fewer small centers than 

large centers potentially would be 

identified using the SRTR methodology. 

The OPTN MPSC recognized that it 

would need to be able to appropriately 

flag smaller cohorts, especially since the 

center-specific reports separate adult 

and pediatric transplants. As such, in 

2001, the SRTR presented some 

analyses that would help the OPTN 

MPSC decide upon the minimum 

number of transplants needed in order 

for the SRTR methodology to flag 

smaller cohorts. Transplant centers that 

performed fewer transplants than this 

minimum number would not be 

reviewed using the SRTR methodology. 

Although a single death has a much 

greater impact on a center’s patient 

survival rate in a smaller center than in 

a larger center, the OPTN MPSC felt that 

the percentage difference when working 

with smaller cohorts was less useful 

from a clinical perspective because of 

the smaller numbers. For example, a 

transplant center that performs 10 

transplants and loses 1 graft has a 90 

percent survival rate whereas a center 

that performs 11 transplants and loses 2 

grafts has an 82 percent survival rate. 

Although the difference between 90 

percent and 82 percent may appear to be 

significant, when only 10 transplants 

have been performed, the absolute 

difference between the loss of 1 graft 

and 2 grafts is small. The MPSC felt that 

this type of difference was not sufficient 

to distinguish small cohorts. Therefore, 

the MPSC asked the SRTR to help them 

determine the minimum number of 

transplants required for the SRTR 

methodology to flag a transplant center 

and to have that ‘‘flag’’ be clinically 

appropriate.

In deciding upon the minimum 

number of transplants required for use 

of the SRTR methodology, the OPTN 

recognized that small transplant centers 

had to have a minimum excess of graft 

failures/deaths before there was 

adequate clinical information to 

evaluate for deficiencies in the 

transplant center. Since the minimum 

number of excess graft failures/deaths 

was determined to be 3, a transplant 

center would have to perform at least 4 

transplants in order to have an excess of 

3 deaths. However, performing 4 

transplants and having a 100% graft 

failure/death rate was not clinically 

acceptable. Therefore, the SRTR 

developed a scenario in which a 

transplant center’s expected graft 

failure/mortality rate was 10 percent, 

but its actual graft failure/mortality rate 

was 50 percent. Using this scenario, the 

SRTR methodology could flag cohorts as 

small as 8 transplants. Based on this 

finding, the OPTN MPSC decided to use 

the SRTR methodology on cohorts 

(adult or pediatric) of at least 9 

transplants. As the number of 

transplants increase, the clinical 

concordance of observed and expected 

mortality rates should also increase. 

The third prong of the approach of the 

SRTR methodology is the need for 

taking action. The MPSC determined 

that it would need to take action when 

it determined that the observed number 

of deaths or graft failures was 50 percent 

more than expected (O/E>1.5). 

We applaud the SRTR’s effort to strive 

for better ways to identify underperforming transplant centers. We have 

carefully reviewed and evaluated the 

SRTR’s methodology for flagging underperforming transplant centers. We 

believe the SRTR approach to handling 

small centers is reasonable. To address 

concerns that the methodology could be 

perceived as being more lenient towards 

smaller centers, we analyzed transplant 

center data from the most recent SRTR 

center-specific report and found that it 

flagged centers of all size ranges. Of the 

72 small centers (9–25 transplants), 15% 

were flagged.

ADULT PROGRAMS FLAGGED BASED ON CENTER SIZE

Center size 

Number of 

programs

(1) 

Number of 

programs 

flagged (patient/graft/both)

(2) 

Flagged/program

(2)/(1) 

<9 ................................................................................................................................................. 71 0 (0.0%) 0% 

9–25 ............................................................................................................................................. 72 11 (20.4%) 15.3% 

26–50 ........................................................................................................................................... 98 11 (20.4%) 11.2% 

51–100 ......................................................................................................................................... 121 13 (24.1%) 10.7% 

101–200 ....................................................................................................................................... 111 15 (27.8%) 13.5% 

201–500 ....................................................................................................................................... 60 3 (5.6%) 5.0% 

>500 ............................................................................................................................................. 8 1 (1.9%) 12.5% 

Total ...................................................................................................................................... 541 54 (100.0%) 

We believe that the analyses we 

conducted shows that the p-value test 

performs very well for centers with at 

least 9 transplants. Given the fact that 

an adult center has to have performed 

9 transplants in order to enable the 

SRTR methodology to capture 

differences during the 2.5 year cohort 

period, we believe the SRTR 

methodology can maintain a delicate 

balance between able to identify the 

outliers in both large and small centers. 

We are requesting comments on the 

appropriateness of proposing this 

approach. 

We propose adapting the general 

framework of the SRTR methodology to 

assess a heart, liver, lung, or kidney 

transplant center’s outcomes for our use. 

That is, we propose that if a transplant 

center’s observed 1-year patient survival 

rate and 1-year graft survival rate is 

lower than the expected 1-year patient 

survival rate and 1-year graft survival 

rate, respectively, we would use the 

three SRTR tests (p-value, O¥E, and O/

E) to determine whether a center’s 

observed survival rates were 

unacceptably low and whether thus the 

center would require CMS follow up. 

For each of the outcome measures we 

proposed for initial approval of heart, 

liver, lung, and kidney centers, we 

propose establishing minimum 

thresholds for the p-value, O¥E, and O/

E tests. One of the primary concerns 

expressed by beneficiaries at our Town 

Hall Meeting was access to their choice 

of transplant centers. Therefore, we 

want to establish a mechanism whereby 

all transplant centers that perform at or 

near their expected outcomes are able to 

obtain initial Medicare approval for 

transplantation. We recognize that the 

threshold we establish for each test 

would affect the quality of care, number 

and location of centers, and access to 

centers. It is our goal to establish 

thresholds to ensure access while 

ensuring that Medicare beneficiaries 

receive high quality organ 

transplantation services. After careful 

evaluation of SRTR’s analysis and 

OPTN’s reasoning, we propose to adopt 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6153

thresholds that mirror those adopted by 

the OPTN. 

Specifically, for each outcome 

measure, we propose considering the 

center’s patient and graft survival rate to 

be acceptable as long as the center’s 

observed patient and graft survival rate 

is higher than the center’s expected 

patient and graft survival rate. If a 

center’s observed patient and graft 

survival is lower than its expected 

patient or graft survival, we would still 

consider the center’s patient and graft 

survival rate to be acceptable, unless all 

three of the following thresholds are 

crossed over: 

• The one-sided p-value is less than 

0.05; 

• The number of observed events 

minus the number of expected events 

(O¥E) is greater than 3; and 

• The number of observed events 

divided by the number of expected 

events (O/E) is greater than 1.5. 

Our justification for these thresholds 

is the same as that of the OPTN when 

it adopted the thresholds in June 2003. 

A one-sided p-value less than 0.05 can 

loosely be interpreted to mean that there 

is a 95 percent probability that the 

difference between a center’s observed 

patient or graft survival rate cannot be 

explained by random fluctuations. 

Therefore, we believe that establishing 

the threshold for the p-value at 0.05 

provides us with reasonable assurance 

that a transplant center’s observed 

patient or graft survival rate truly cannot 

be attributed to external factors that may 

also influence patient or graft survival, 

as opposed to being the result of a 

random fluctuation (i.e. the difference 

between the observed and expected is 

statistically significant). A difference 

between the observed number of events 

(i.e., patient deaths or graft failures) and 

the number of expected events that is 

greater than 3 indicates that 3 or more 

of the observed events were unexpected. 

In establishing the threshold for the 

O¥E test at 3, our goal was to strike a 

balance between establishing a 

threshold that is high enough to avoid 

identifying centers where the absolute 

number of unexpected events is very 

small and establishing a threshold that 

is low enough to reflect that a nontrivial number of patients were affected. 

When the quotient of the number of 

observed events divided by the number 

of expected events is greater than 1.5, 

this indicates that a substantial fraction 

(more than 50 percent) of the observed 

events were unexpected. Therefore, the 

proposed thresholds for the O¥E and 

O/E tests help to identify centers in 

which a relatively large portion of the 

center’s transplants resulted in an 

unexpected adverse outcome (i.e., 

patient death or graft failure). 

For each outcome measure, we 

propose that only when a heart, liver, 

lung, or kidney center crosses over the 

thresholds established for all three tests, 

would we consider the center not to be 

in compliance with the requirements for 

that particular outcome measure. For 

example, we would consider a center 

that demonstrates a p-value of 1.00, 

O¥E of 5.0, and O/E of 2.0 based on the 

1-year patient survival data contained in 

the most recent SRTR center-specific 

report to meet the patient survival 

requirement because one of the three 

thresholds (that for the p-value test) was 

not crossed over. On the other hand, a 

center that demonstrates a p-value of 

0.01, O¥E of 5.0, and O/E of 1.9 for its 

patient survival data would cross over 

the thresholds for all three tests; 

therefore, we would not consider the 

patient survival requirement to be met.

Transplant centers would have to 

meet the requirements for each of the 

outcome measures (i.e., patient survival 

and graft survival) separately. In other 

words, a center that meets the 

requirements for patient survival but not 

for 1-year graft survival would not meet 

the proposed outcome measure 

requirements. By considering centers 

whose observed outcomes are lower 

than their expected outcomes to be 

acceptable unless they cross over the 

thresholds for all three tests, we believe 

that we can be reasonably assured that 

any center identified using this 

methodology will have both a 

statistically significant and non-trivial 

number of unexpected deaths or graft 

failures. Centers in which the number of 

unexpected events is relatively large but 

not statistically significant or in which 

the number of unexpected events is 

statistically significant but relatively 

small would not be inadvertently 

penalized under this proposed 

methodology. 

We are proposing that an adult 

transplant center requesting Medicare 

approval would have to have 1-year 

patient and 1-year graft survival followup data on at least 9 transplants of the 

appropriate organ type during the 2.5-

year period reported in the most recent 

center-specific report. In other words, 

centers that perform fewer than 9 

transplants generally would not be 

eligible for Medicare approval under our 

proposal. We are asking for comments 

as whether requiring the minimum 

number of 9 transplants during the 2.5-

year period is acceptable for this 

application of the SRTR methodology. 

CMS is cognizant that requiring a 

minimum number of transplants may 

appear to limit access to transplantation 

for Medicare beneficiaries. However, 

given that the proposed minimum 

number of transplants of 9 is lower than 

the current Medicare requirements (12 

transplants over a 12-month period for 

heart and liver transplant centers, and 

10 transplants over a 12-month period 

for lung and intestinal transplant 

centers), we do not believe this 

requirement would lessen current 

access to transplant centers. As stated 

earlier, our analysis of the most recent 

SRTR center-specific reports indicates 

that approximately 71 adult transplant 

centers performed fewer than 9 

transplants in the most recent 2.5-year 

period. It appears that the majority of 

the smaller cohorts involved pediatric 

cases, transplant centers at children’s 

hospitals, or centers in transition. After 

careful analyses, we found that 45 of 

those centers were the adult component 

of a pediatric center, which does not 

have to meet the proposed volume 

requirement. Of the remaining 26 

centers, only 11 are currently active 

according to the records of the OPTN. 

Of those 11 centers, there are 5 heart 

centers, 1 kidney center, 2 liver centers 

and 3 lung centers. Also, four centers 

have 7–8 transplants (and could easily 

reach 9 transplants); 2 centers are 

affiliated with a large transplant center; 

one center recently opened; and 2 

centers are located in cities with a 

nearby transplant center. 

OPTN requirements are similar to 

those we propose. The OPTN currently 

requires that heart, kidney and liver 

transplant centers perform a minimum 

of one transplant every 3 months, which 

equals approximately 9–10 transplants 

over the course of 2.5 years. Although 

lung transplant programs are required to 

perform a transplant only once every 6 

months, there were only 3 lung centers 

that did not perform at least 9 

transplants.

Given the very specialized care that 

needs to be provided to children, as 

well as the relatively few children who 

are Medicare beneficiaries, we did not 

want to restrict access to this group by 

setting a volume threshold that was 

inappropriately high. Although we have 

stated we would review pediatric 

outcomes separately if a transplant 

center requests Medicare approval to 

perform pediatric transplants, we 

propose not to require such centers to 

perform a minimum number of pediatric 

transplants prior to their request for 

approval. Most centers that would 

request Medicare approval to perform 

pediatric outcomes are likely to perform 

only 2 or 3 transplants per year. 

Analyses conducted by HRSA’s DoT 

staff indicate that a minimum volume 

requirement that would still allow the 

6154 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

SRTR’s methodology to flag poorperforming centers would preclude 

most children’s hospitals from being 

able to request Medicare approval. The 

OPTN, also recognizing the infrequency 

of pediatric transplantation, requires 

that only one transplant per year be 

performed to demonstrate that the 

pediatric center is functionally active. 

We request comments on this proposal. 

We recognize that there may be some 

concerns related to our proposed 

minimum number criterion because the 

current Medicare volume standards for 

heart, liver, lung, and intestinal centers 

are higher. Medicare currently requires 

heart and liver transplant centers to 

perform 12 transplants over a 12-month 

period, and lung and intestinal 

transplant centers to perform 10 

transplants over a 12-month period. 

Historically, we have used volume as a 

proxy for outcome. Since we now have 

risk-adjusted outcome measures, we 

believe it would be insufficient to 

propose a volume standard that would 

be viewed as arbitrary or unscientific. 

Instead, our volume requirement should 

only reflect the minimum number of 

transplants needed for the SRTR to be 

able to flag a poor-performing center, 

that is, 9 transplants performed during 

the reporting period. 

If a heart center is requesting 

Medicare approval in December 2004, 

we would rely on the 1-year patient and 

graft survival data contained in the July 

2004 SRTR center-specific report. Since 

the July 2004 report contains 1-year 

patient and graft survival data on 

transplants performed between January 

1, 2001 and December 31, 2002, we 

would expect that the July 2004 centerspecific report include 1-year patient 

and graft survival information on at 

least 9 heart transplants that were 

performed between January 1, 2001 and 

December 31, 2002. Meanwhile, a 

kidney transplant center that requests 

Medicare approval in December 2004 

would be expected to have 1-year 

patient and graft survival follow-up 

information on at least 9 kidney 

transplants that were performed 

between January 1, 2001 and June 30, 

2003, since the SRTR used a 2.5-year 

cohort in the July 2004 center-specific 

report to report patient and graft 

survival statistics for abdominal organs.

This lower volume criterion may also 

raise the concern that a center could 

perform 9 transplants quickly and then 

not perform a transplant for 12 months 

and yet become or remain Medicare 

approved. However, we believe this 

scenario is unlikely to occur because of 

additional oversight provided through 

the OPTN. In 1996, the MPSC of the 

OPTN proposed changes to the bylaws 

that would define a functionally 

inactive transplant center’s 

responsibility to patients on the waiting 

list. In order to identify such centers, 

the MPSC set forth criteria that would 

trigger further investigation of 

transplant center functional inactivity. 

Initially, the MPSC considered a 

transplant center to be functionally 

inactive if it did not perform a 

transplant within a 3-month period. As 

the MPSC has gained greater 

understanding of the impact of the 

organ procurement and allocation 

process on a center’s ability to perform 

transplants, it has revised the initial 

criteria for determining whether a center 

is functionally active: for heart, liver 

and kidney centers—a transplant every 

3 months; for lung centers—a transplant 

every 6 months; for children’s 

hospitals—a transplant once a year. In 

addition to these frequency standards, 

the MPSC also reviews organ offers and 

turndowns at centers that have not 

performed a transplant recently to 

determine whether the reason for 

inactivity is due to lack of suitable organ 

offers or inadequate resources at the 

transplant center. If the OPTN 

determines that a transplant center is 

functionally inactive, the transplant 

center is no longer eligible to receive 

organs for transplantation, and 

therefore, can no longer perform 

transplants. These OPTN reviews offer 

additional oversight to assure the public 

and Medicare that the organ transplant 

centers are truly functionally active at 

the time of Medicare approval and reapproval. We request comments on our 

proposal to focus more heavily on a 

center’s outcomes by eliminating 

volume as a separate standard and 

integrating volume into our outcomes 

assessment. 

b. Evaluation of Alternatives to the 

SRTR Methodology 

Based on our analysis of the July 2004 

SRTR center-specific reports, we believe 

that a majority of the heart, kidney, 

liver, and lung centers would be able to 

meet the proposed 1-year patient and 1-

year graft survival requirements. Using 

data from the July 2004 SRTR centerspecific reports, approximately 10.0 

percent of all heart, kidney, liver, and 

lung centers that perform adult 

transplants have observed outcomes that 

are lower than their expected outcomes 

and cross over the proposed thresholds 

for the three tests in terms of both 1-year 

patient survival and 1-year graft 

survival. In other words, if all heart, 

kidney, liver, and lung centers that 

perform adult transplants were to seek 

initial Medicare approval 

simultaneously, approximately 10.0 

percent of the 541 heart, kidney, liver, 

and lung centers that perform adult 

transplants would not be able to meet 

the proposed outcome measure 

requirements. Also, approximately 1.9 

percent of the 309 heart, liver, lung, and 

kidney centers that perform pediatric 

transplants have observed outcomes that 

are lower than their expected outcomes 

and meet the proposed thresholds for all 

three tests. We invite comments on the 

proposed outcome measures and their 

thresholds. We specifically solicit data 

and evidence that may support 

alternative thresholds, especially 

thresholds that may be specific to a 

particular organ transplant type. 

We also welcome comments on the 

methodology itself. We understand that 

the OPTN continuously reviews this 

methodology and may make 

modifications to the methodology or the 

thresholds for the three tests in the 

future. In the event that the OPTN 

decides to modify the methodology or 

any of the thresholds currently used, we 

would consider adopting the modified 

methodology or thresholds through 

notice and comment rulemaking.

In addition, we explored two options 

for applying the SRTR methodology. We 

would like to take this opportunity to 

welcome comments on these other 

options as well. In one option, a heart, 

kidney, liver, or lung center whose 

observed outcomes are lower than its 

expected outcomes would be considered 

to have unacceptable outcomes if it met 

the proposed thresholds for just two of 

the three tests (hereafter referred to as 

option 1. When we analyzed the data in 

the July 2004 SRTR center-specific 

reports, we discovered that option 1 

would identify approximately 15.7 

percent of the heart, kidney, liver, and 

lung centers that perform adult 

transplants and 4.2 percent of the heart, 

kidney, liver, and lung centers that 

perform pediatric transplants. 

A second option consists of 

considering a center’s outcomes to be 

unacceptable if its observed outcomes 

are lower than its expected outcomes 

and the center met the proposed 

threshold for just one of the three tests 

(hereafter referred to as option 2. If 

option 2 were selected, approximately 

41.6 percent of the heart, kidney, liver, 

and lung centers that perform adult 

transplants would fail to meet the 

proposed 1-year patient survival and 1-

year graft survival requirements and 

approximately 67.0 percent of the heart, 

kidney, liver, and lung centers that 

perform pediatric transplants would fail 

to meet the proposed 1-year patient 

survival and 1-year graft survival 

requirements. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6155

Considering a transplant center’s 

outcomes to be unacceptable when the 

center’s observed outcomes are lower 

than its expected outcomes and the 

center crosses over the proposed 

threshold for just one or two of the three 

tests is more stringent than our 

proposal. However, we are concerned 

that under this option, we would be 

conducting inspections on centers 

where the differences between the 

observed and expected events are 

relatively large but not statistically 

significant, thus diverting resources that 

should be expended surveying centers 

where the differences between the 

observed and expected events are both 

large and statistically significant. 

Therefore, we are proposing to consider 

a center’s outcomes to be unacceptable 

only when a center’s observed outcomes 

are lower than its expected outcomes 

and the center crosses over the proposed 

thresholds for all three tests. We are 

inviting comments on the merits of our 

proposed approach.

For comparison, we have summarized 

the results of our analysis of the effects 

of our proposal as well as options 1 and 

2 in the table below. We used data from 

the July 2004 center-specific reports to 

perform this analysis. We did not, 

however, screen out centers that 

performed fewer than 9 adult 

transplants when we conducted this 

analysis. Therefore, some of the centers 

that perform adult transplant that were 

identified using the proposed 

methodology or using option 1 or option 

2 may not be eligible to request 

Medicare approval because they did not 

perform 9 adult transplants during the 

2.5-year period reported in the July 2004 

center-specific reports.

NUMBER AND PERCENT OF CENTERS IDENTIFIED AS FAILING TO MEET PROPOSED OUTCOME MEASURE REQUIREMENTS

UNDER PROPOSAL AND OPTIONS 1 AND 2, BY ORGAN AND TRANSPLANT TYPE (ADULT OR PEDIATRIC) 

Organ type 

Number (n) and percent (%) of centers identified using: 

Adult transplants Pediatric transplants 

Proposal Option 1 Option 2 Proposal Option 1 Option 2 

n % n % n % n % n % n % 

Heart ......................................................... 11 8.7 20 15.9 45 35.7 0 0.0 3 4.4 18 26.5 

Liver .......................................................... 11 10.3 15 14.0 43 40.2 3 4.2 4 5.6 19 26.8 

Lung ......................................................... 7 10.0 8 11.4 25 35.7 0 0.0 0 0.0 10 100.0 

Kidney ...................................................... 25 10.5 42 17.6 112 47.1 3 1.9 6 3.8 160 100.0 

All Organs ......................................... 54 10.0 85 15.7 225 41.6 6 1.9 13 4.2 207 67.0 

c. Special Circumstances in Which 1-

Month Patient and 1-Month Graft 

Survival May Be Used in Lieu of 1-Year 

Patient and 1-Year Graft Survival 

We are also proposing that, under 

certain circumstances, we would review 

a center’s outcomes using 1-month posttransplant data in lieu of 1-year posttransplant data. We recognize that 

transplant teams sometimes move from 

one hospital to another to open a new 

transplant center. It is not uncommon 

for new centers staffed with an 

experienced team to have good 

outcomes. These new centers that 

request Medicare approval may not have 

1-year patient and graft survival data 

(including follow-up data from at least 

9 adult transplants performed during 

the 2.5-year period reported in the SRTR 

center-specific reports). At a minimum, 

1-month post-transplant data can 

demonstrate the success of the 

transplantation procedure as well as the 

skill of the transplantation team. We 

believe that in the absence of 1-year 

post-transplant outcomes, 1-month posttransplant outcomes can capture early 

graft and patient deaths due to poor 

transplantation skills and poor donor 

and/or recipient selection. These data 

are important in the assessment of a 

new transplant center. 

Therefore, we are proposing that a 

new transplant center may request 

initial approval using 1-month patient 

and 1-month graft survival data if 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 and if the 

transplant center’s team meets the 

human resources requirements at 

§ 482.98. If these specific conditions are 

not met, the new center must be 

reviewed using 1-year post-transplant 

patient and graft survival follow-up 

data. A new center with an experienced 

team requesting initial Medicareapproval that does not have 1-year 

patient and graft survival follow-up data 

(including 1-year follow-up data on at 

least 9 adult transplants for centers 

requesting Medicare approval to 

perform adult transplants) in the most 

recent SRTR center-specific report 

would have to ask the SRTR to generate 

a customized report of the center’s 1-

month patient and 1-month graft 

survival statistics for all transplants 

performed in the previous 1-year period. 

The SRTR would generate these 

customized reports using the same 

models as those used to generate the 

center-specific reports.

When 1-month post-transplant 

outcomes are used, we would review 

the center’s 1-month patient and graft 

survival rates for all transplants 

performed at the center during the 

previous 1-year period using 

customized reports. We would evaluate 

the center’s 1-month outcomes using the 

same SRTR methodology that we 

propose for evaluating transplant 

centers’ 1-year outcomes. The transplant 

center would need to have follow-up 

data on at least 9 transplants of the 

appropriate organ type. Instead of 1-year 

follow-up data on at least 9 transplants 

performed at the center during the 2.5-

year period reported in the SRTR centerspecific reports, however, the center 

would need a customized report with 1-

month follow-up data on at least 9 

transplants performed during the 

previous 1-year period. 

Centers which gain Medicare 

approval based on 1 month data would 

be reevaluated based on 1 year data 

when it became available. We are 

requesting comments on the frequency 

with which we should assess these 

centers after they are approved. 

If a center other than a lung transplant 

center requests Medicare approval to 

perform pediatric transplants on the 

basis of its 1-month patient and graft 

survival data, we would continue to 

review the adult and pediatric outcomes 

separately. We do not propose a volume 

criterion for approving centers to 

perform pediatric transplants when a 

center’s 1-year patient and graft survival 

data are used. Therefore, we do not 

propose a volume criterion for Medicare 

approval of a center to perform pediatric 

6156 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

transplants when 1-month patient and 

graft survival data are used. 

4. Proposed Outcome Measure 

Requirements for Heart-Lung, Intestine, 

and Pancreas Centers 

Due to the limited volume of heartlung, intestinal, and pancreas 

transplants performed nationwide, the 

OPTN has not been able to gather 

enough transplant data on these organ 

types for the SRTR to develop Cox 

models for calculating expected survival 

statistics for these types of transplants. 

We prefer not to gauge a transplant 

center’s performance on the basis of 

unadjusted data. Unadjusted data, or a 

center’s observed outcomes, do not take 

into account variation among transplant 

centers, such as differences in patient 

case-mix. We believe evaluating a 

transplant center on the basis of 

unadjusted data could potentially 

discourage centers from performing 

transplants on severely ill or high-risk 

patients. Therefore, for heart-lung, 

intestinal, and pancreas transplant 

centers, we propose no outcome 

measure requirements at this time. In 

the event that the SRTR develops riskadjustment models for heart-lung, 

intestinal, or pancreas transplant 

survival rates in the future, we will 

consider establishing outcome measure 

requirements for heart-lung, intestinal, 

or pancreas transplant centers through 

rulemaking. 

When the Medicare coverage criteria 

for heart transplants were published in 

1987, heart-lung transplants were 

considered to be experimental and were 

not covered by Medicare. When the 

Medicare coverage criteria for lung 

transplants were published in 1995, we 

stated that Medicare would cover heartlung transplants for beneficiaries with 

progressive end-stage cardiopulmonary 

disease when they were provided in a 

facility that was approved by Medicare 

for both heart and lung transplantation. 

Although Medicare began covering 

heart-lung transplants as well as single 

and double lung transplants, we did not 

establish separate survival criteria for 

heart-lung transplants. Instead, lung 

centers were required to have an 

aggregate 1-year survival rate of 69 

percent and an aggregate 2-year survival 

rate of 62 percent. In calculating its 

survival rates, centers were asked to 

include single and double lung 

transplants, as well as heart-lung 

transplants.

When the SRTR calculates statistics 

for lung transplants, however, the SRTR 

does not include heart-lung transplants 

because there is a separate category of 

data for heart-lung transplants. Even 

though the SRTR has a separate category 

for heart-lung transplant data, the data 

are not risk-adjusted. We propose that a 

heart-lung center, as defined in the 

proposed definition for a ‘‘heart-lung 

transplant center,’’ would need to meet 

just the proposed data submission 

requirements to be compliant with the 

proposed Data Submission and 

Outcome Requirements for Initial 

Approval of Transplant Centers CoP. In 

light of the proposed definition for 

‘‘heart-lung transplant center,’’ which 

requires heart-lung centers to be located 

in a hospital that has Medicare-approval 

to perform both heart and lung 

transplants, and the fact that only 33 

heart-lung transplants were performed 

in the U.S. in 2002, we believe that we 

would have reasonable assurance that 

the heart-lung center has sufficient 

expertise to perform heart-lung 

transplants successfully. We believe 

skill and expertise in both heart and 

lung transplantation are sufficient for 

ensuring that a center is able to perform 

high quality heart-lung transplants and 

that separate patient and graft survival 

rate criteria for heart-lung centers would 

not be necessary. Again, we request 

comments on the appropriateness of this 

approach for evaluating heart-lung 

transplant centers, as well as 

alternatives to this approach. 

The Medicare coverage decision for 

multivisceral and intestinal transplants 

was issued on October 4, 2000 and only 

covers services provided on or after 

April 1, 2001. Since only 299 intestinal 

transplants were performed from 2000 

through 2002, it is probable that the 

current Medicare 1-year patient survival 

threshold of 65 percent for intestinal 

transplants continues to be relevant. We 

are reluctant to establish outcome 

measure requirements on the basis of 

unadjusted data. Unlike heart-lung 

centers, intestinal centers do not have to 

be affiliated with any other type of 

center under current Medicare 

requirements. Historically, however, 

intestinal centers have evolved as an 

extension from the liver transplant 

centers. In 2002, there were 107 

intestinal transplants, of which only 44 

were intestine alone transplants. Given 

the historical affiliation of intestinal 

transplant centers with liver transplant 

centers and the very small number of 

intestinal transplants being performed, 

we are proposing that there not be any 

outcomes or volume criteria for 

intestinal transplantation. We believe 

that the proposed definition for 

‘‘intestinal transplant center,’’ which 

requires transplant centers to be located 

in a hospital that has Medicare approval 

to perform liver transplants, would be 

sufficient. Intestinal transplant centers 

would need to meet the proposed data 

submission requirements. We are 

requesting comment on the 

appropriateness of the proposal to 

approving intestinal transplant centers 

in light of the absence of risk-adjusted 

outcomes data for intestinal 

transplantation, the very low frequency 

of this type of procedure, and potential 

concerns that setting volume standards 

would further limit access to a rare 

procedure. 

Of the 1,369 deceased donor pancreas 

transplants performed in the United 

States in 2003, 502 were performed 

alone or subsequent to a kidney 

transplant and 867 were performed 

simultaneously with a kidney transplant 

(i.e., kidney-pancreas transplants). 

According to the July 2003 SRTR 

national summary report, the national 

mean 1-year patient survival rate for 

adult pancreas transplants performed 

alone or subsequent to a kidney 

transplant is 96.01 percent and the 

national mean 1-year graft survival rate 

is 78.34 percent. Since the number of 

pancreas transplants performed alone or 

subsequent to a kidney transplant is 

very small, the outcomes are generally 

very good, and the SRTR has not 

established a risk-adjustment model for 

pancreas transplants performed alone or 

subsequent to a kidney transplant, we 

do not propose any outcome measure 

requirements for pancreas transplant 

centers. We believe that the proposed 

definition for ‘‘pancreas transplant 

center,’’ which requires transplant 

centers to be located in a hospital that 

has Medicare approval to perform 

kidney transplants, would be sufficient. 

As with heart-lung and intestinal 

transplant centers, a pancreas transplant 

center would still need to meet the data 

submission requirements to be in 

compliance with the proposed Data 

Submission or Outcome Requirements 

for Initial Approval of Transplant 

Centers CoP at § 482.80. We request 

comments on the appropriateness of this 

approach to evaluating pancreas 

transplant centers in light of the lack of 

risk-adjusted data for pancreas 

transplants that are performed alone or 

subsequent to a kidney transplant. 

We note that these standards would 

not apply to infusions of pancreatic islet 

cells, a procedure sometimes termed 

‘‘islet cell transplantation’’. Under 

section 733 of the Medicare 

Prescription, Drug Improvement, and 

Modernization Act (MMA) (Pub. L. 108–

173), Medicare pays for some 

investigational islet transplantation 

procedures. Our pancreas standards 

would be inappropriate for these islet 

procedures which do not involve a 

whole organ or require the same skills 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6157

1Each transplant center must submit data on all 

transplants performed at the center, including 

living donor transplants if applicable, because CMS 

will review outcomes for all transplants of the 

appropriate organ type performed at the center.

and expertise as surgical transplantation 

of whole organs. 

D. Summary of Proposed Data 

Submission and Outcome Measure 

Requirements for Initial Approval, by 

Organ Type 

Since the requirements proposed in 

§ 482.80 vary by organ type, the 

following table summarizes the data 

submission and outcome measure 

requirements that each type of organ 

transplant center would have to meet 

under this proposed CoP.

Type of center Proposed data submission and outcome measure requirements for initial approval 

Heart, Kidney, Liver, or Lung ............... • Timely submission of at least 95 percent of required data on all transplants 1 performed to OPTN; 

and 

• As long as a center has 1-year post-transplant follow-up on at least 9 transplants that were performed during the 2.5-year period reported in the most recent SRTR center-specific report and the 

center’s observed 1-year patient and graft survival rate is higher than its expected 1-year patient and 

graft survival rate, the center’s outcomes would be acceptable. 

• If the center’s observed 1-year patient and graft survival rate is lower than its expected 1-year patient 

and graft survival rate, the center’s patient and graft survival could still be acceptable, unless all 3 of 

the following thresholds are crossed: 

(1) p-value < 0.05, 

(2) O¥E > 3, and 

(3) O/E > 1.5. 

Heart-lung ............................................. • Timely submission of at least 95 percent of required data on all heart-lung transplants performed to 

OPTN. 

Intestine ................................................ • Timely submission of at least 95 percent of required data on all intestinal, combined liver-intestinal, 

and multivisceral transplants performed to OPTN. 

Pancreas .............................................. • Timely submission to the OPTN of at least 95 percent of required data on all pancreas and kidneypancreas transplants performed. 

Condition of Participation: Data 

Submission, and Outcome Measure 

Requirements for Re-approval of 

Transplant Centers (Proposed § 482.82) 

A. Overview 

The current Medicare policies on 

organ transplants do not have criteria 

for re-approval of transplant centers. In 

2000, 37 percent of Medicare-approved 

heart transplant centers fell below the 

Medicare-required volume or survival 

rate criteria and yet still retained their 

Medicare-approved status. We believe 

there is a need to establish criteria for 

evaluating the ongoing performance of 

Medicare-approved transplant centers, 

including post-approval criteria for data 

submission and outcomes. Without 

these criteria, we are unable to be 

assured that once a transplant center 

becomes Medicare-approved it 

continues to provide transplantation 

services in a safe and efficient manner. 

Given that outcome measures are 

important indicators of transplantation 

quality, periodic re-assessment of these 

indicators, along with the requirement 

for complete and timely submission of 

data, would serve as a valuable 

oversight tool for ensuring that once a 

transplant center becomes Medicareapproved, it can continually 

demonstrate a minimum level of 

commitment to and expertise in 

transplantation. Therefore, we are 

proposing specific data submission and 

outcome requirements for re-approval.

B. Proposed Data Submission 

Requirements for Re-approval of 

Transplant Centers 

As we proposed for initial approval, 

we also propose that no later than 90 

days after the due date established by 

the OPTN, heart, heart-lung, intestine, 

kidney, liver, lung, and pancreas 

transplant centers must submit to the 

OPTN at least 95 percent of required 

data submissions on all transplants 

(deceased and living donor) performed 

at the center over the 3-year approval 

period. As in initial approval, we 

propose required data submissions 

include, but not be limited to, 

submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration, and transplant recipient 

follow-up for the type of organ(s) 

transplanted. 

C. Proposed Outcome Measure 

Requirements for Re-approval of 

Transplant Centers 

We propose using the same outcome 

measures for the re-approval of heart, 

kidney, liver, and lung centers that we 

propose for initial approval of these 

centers. However, while we proposed to 

give transplant centers the option of 

using 1-month post-transplant outcomes 

under certain conditions for initial 

approval, we are not proposing a similar 

option for re-approval. Each heart, 

kidney, liver, and lung center would 

have to use 1-year patient and graft 

survival data contained in the most 

recent SRTR center-specific report for 

re-approval. We would also review 

outcomes for all transplants performed 

at the center, including living donor 

transplants, if applicable.

Furthermore, each heart, kidney, 

liver, and lung center that has Medicare 

approval to perform adult transplants 

would need to have 1-year posttransplant follow-up on at least 9 adult 

transplants of the appropriate organ 

type performed during the 2.5-year 

period reported in the most recent SRTR 

center-specific report. Except for lung 

transplant centers, we would review 

outcomes for pediatric and adult 

patients separately if a center has 

Medicare approval to perform pediatric 

transplants. As with initial approval, 

transplant centers that have Medicare 

approval to perform pediatric 

transplants would not need to perform 

a minimum number of pediatric 

transplants. As we stated earlier, 

requiring centers to perform a minimum 

number of pediatric transplants would 

preclude many centers from obtaining 

Medicare approval to perform pediatric 

transplants. Again we request comments 

on our proposed approach to evaluating 

pediatric transplant centers’ outcomes. 

For the same reasons discussed for the 

proposed outcome measure 

requirements for initial approval, we 

also propose adopting the same 

methodology for evaluating a heart, 

kidney, liver, or lung transplant center’s 

outcomes that we propose for initial 

approval. As long as the center’s 

6158 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

2Each transplant center must submit data on all 

transplants performed at the center, including 

living donor transplants if applicable, because CMS will review outcomes for all transplants of the 

appropriate organ type performed at the center.

observed outcomes are higher than the 

center’s expected outcomes, the center’s 

outcomes would be acceptable. If a 

center’s observed outcomes are lower 

than its expected outcomes, the center’s 

patient and graft survival could still be 

acceptable, unless all of the following 

three thresholds are crossed: 

• The one-sided p-value is less than 

0.05; 

• The number of observed events 

minus the number of expected events 

(O¥E) is greater than 3; and 

• The number of observed events 

divided by the number of expected 

events (O/E) is greater than 1.5. 

Again, we propose that when a 

center’s observed patient and graft 

survival is lower than the expected 

patient and graft survival and the center 

crosses over all three thresholds for a 

particular outcome measure, we would 

not consider the center to be in 

compliance with the requirements for 

that particular measure. Centers still 

would have to meet the outcome 

requirements for each outcome measure 

separately. In other words, a heart, 

kidney, liver, or lung center in which 

both the observed 1-year patient 

survival rate and the observed 1-year 

graft survival rates are lower than the 

expected survival rates would have 

acceptable outcomes unless the center 

crosses the thresholds for all three tests 

(i.e., p-value, O¥E, and O/E) with 

respect to its observed and expected 1-

year patient survival rates and with 

respect to its observed and expected 1-

year graft survival rates. 

We welcome comments on the 

proposed thresholds for re-approval of 

heart, kidney, liver, and lung centers 

and on the methodology itself. Given 

that failure to meet the outcome 

measure requirements would not 

necessarily result in denial of reapproval, as it would for initial 

approval, we specifically request 

comments on whether we should 

consider a heart, kidney, liver, or lung 

center’s outcomes to be unacceptable if 

the center crosses the thresholds for all 

three tests as proposed or whether we 

should consider a heart, kidney, liver, or 

lung center’s outcomes to be 

unacceptable if the center crosses the 

thresholds for just one or two of the 

three tests, as discussed earlier. 

For re-approval of heart-lung, 

intestinal, and pancreas centers, we 

propose the same requirements as we do 

for initial approval of heart-lung, 

intestinal, and pancreas centers. For 

heart-lung, intestinal and pancreas 

transplant centers, we do not propose 

any outcome measure requirements 

since we feel that at this time skill and 

expertise in heart and lung 

transplantation, in liver transplantation, 

and in kidney transplantation, 

respectively, are sufficient. We request 

comments on our proposed approach to 

evaluating heart-lung, intestine, and 

pancreas transplant centers’ outcomes. 

D. Summary of Proposed Data 

Submission and Outcome Requirements 

for Re-Approval, by Organ Type 

Since the proposed data submission 

and outcome requirements for reapproval vary by organ type, the 

following table summarizes the data 

submission and outcome measure 

requirements that each type of organ 

transplant center would have to meet 

under this CoP.

Type of center Proposed data submission and outcome measure requirements for re-approval 

Heart, Kidney, Liver, or Lung • Timely submission of at least 95 percent of required data on all transplants 2 performed to OPTN; and 

• As long as a center has 1-year post-transplant follow-up on at least 9 transplants that were performed during 

the 2.5-year period reported in the most recent SRTR center-specific report and the center’s observed 1-year 

patient and graft survival rate is higher than its expected 1-year patient and graft survival rate, the center’s outcomes would be acceptable. 

• If the center’s observed 1-year patient and graft survival rate is lower than its expected 1-year patient and graft 

survival rate, the center’s patient and graft survival would still be acceptable, unless all 3 of the following 

thresholds were crossed: 

(1) p-value < 0.05, 

(2) O¥E > 3, and 

(3) O/E > 1.5. 

Heart-lung ............................. • Timely submission of at least 95 percent of required data on all heart-lung transplants performed to OPTN. 

Intestine ................................ • Timely submission of at least 95 percent of required data on all intestinal, combined liver-intestinal, and multivisceral transplants performed to OPTN. 

Pancreas .............................. • Timely submission to the OPTN of at least 95 percent of required data on all pancreas and kidney-pancreas 

transplants performed. 

Proposed Transplant Center Process 

Requirements 

A. Overview 

We believe sound policies and 

processes are keys to ensuring quality 

care for patients. State agency surveys of 

hospitals with transplant centers 

indicate that deficiencies are usually 

associated with inadequate or poor 

implementation of patient management 

policies and procedures, inadequate 

staffing, and poor or inadequate 

monitoring of QAPI programs. We 

believe it is critical to include processoriented requirements in the regulation 

in addition to data submission and 

outcome requirements. The combination 

of outcome-oriented and processoriented requirements will enhance 

efficient usage of donated organs and 

thereby decrease organ wastage. The 

process requirements that we are 

proposing promote efficiency in the 

Medicare program and are based heavily 

on accepted standards of practice in the 

transplantation field and on continuous 

quality improvement efforts that have 

been proven to improve outcomes. To 

reduce burden on providers, we are 

revising or eliminating specific 

requirements that currently apply to 

heart, kidney, liver, and lung centers 

and proposing only requirements that 

will ensure the overall quality of 

transplant centers for all transplant 

types. Proposing that transplant centers 

meet process requirements is intended 

to promote the quality of transplant 

services. 

The well-being of living donors is as 

important as the well-being of 

transplant recipients. Consequently, 

based on the Secretary’s authority under 

section 1861(e)(9) of the Act to require 

hospitals to meet requirements 

‘‘necessary in the interest of the health 

and safety of individuals who are 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6159

furnished services in the institution,’’

we have proposed several process 

requirements we believe are necessary 

to protect the health and safety of 

prospective living donors. 

B. Current Requirements 

Currently, kidney transplant centers 

are covered under applicable 

regulations in § 405.2135 through 

§ 405.2160 and specific kidney 

transplant regulations in § 405.2170 

through § 405.2171. The current 

regulations for kidney transplant centers 

require, among other things, a kidney 

transplant center to be under the general 

supervision of a qualified transplant 

surgeon or a qualified physiciandirector, serving as the director of renal 

transplantation and responsible for the 

following: (1) Participating in the 

selection of suitable treatment 

modalities for each patient; (2) ensuring 

adequate training of nurses in the care 

of transplant patients; (3) ensuring 

tissue typing and organ procurement are 

available either directly or under 

arrangement; and (4) ensuring 

transplantation surgery is performed 

under the direct supervision of a 

qualified transplantation 

surgeon(§ 405.2170). 

The regulations also require a kidney 

transplant center to meet specific 

minimal service requirements: (1) Be 

part of a Medicare certified and 

participating hospital; (2) participate in 

a patient registry program with an OPO 

certified or recertified under part 486, 

subpart G ; (3) be under the supervision 

of the hospital administrator and 

medical staff; (4) utilize a qualified 

social worker to evaluate transplant 

patients’ psychosocial needs, participate 

in care planning of the patients and 

identify community resources to assist 

the patient and family; (5) utilize a 

qualified dietitian who will, in 

consultation with the attending 

physician, assess the nutritional and 

dietetic needs of each patient, prescribe 

therapeutic diets, provide diet 

counseling to patients and their 

families, and monitor adherence and 

response to a prescribed diet; (6) utilize 

a laboratory that is approved under 42 

CFR Part 493 and that can perform 

histocompatibility testing on a 24-hour 

emergency basis, and (7) utilize the 

services of a designated organ 

procurement organization(§ 405.2171). 

The current Medicare transplant 

policies for heart, liver, and lung centers 

have specific process requirements for 

patient selection, patient management, 

commitment, facility plans, 

maintenance of data, organ 

procurement, laboratory services, and 

billing.

C. Proposed Process Requirements 

Our goals in developing the CoPs are 

to ensure the quality of care provided in 

transplant centers and to increase the 

number of successful transplants. We 

believe that the OPTN also shares these 

goals. We believe it will be beneficial for 

us to adopt certain aspects of the OPTN 

policies, as they are specific to current 

practice, in our proposed process 

requirements. We specifically invite 

comments on this proposal. 

To keep process-oriented 

requirements to a minimum and to 

reduce burden on providers, we are 

proposing only requirements that are 

directly related to patient outcomes or 

that are necessary for data collection 

purposes to ensure the efficient 

operation of the Medicare program. We 

propose that our process requirements 

address the following subjects: (1) 

Patient and living donor selection, (2) 

organ recovery and receipt, (3) patient 

and living donor management, (4) QAPI, 

(5) human resources, (6) organ 

procurement, and (7) patients’ and 

living donors’ rights, and (8)additional 

requirements for kidney transplant 

centers. We want to emphasize that our 

overall focus is on the continuous, 

integrated care process that a patient 

experiences across all aspects of 

transplantation. 

1. Condition of Participation: Patient 

and Living Donor Selection (Proposed 

Section 482.90) 

[If you choose to comment on this 

section, please include the caption 

‘‘PATIENT AND LIVING DONOR 

SELECTION’’ at the beginning of your 

comments.] 

We believe transplant centers should 

have an active role in the management 

of patients prior to transplantation. We 

propose to require centers to utilize 

written patient selection criteria in 

making determinations regarding a 

patient’s suitability for placement on the 

waitlist and a patient’s suitability for 

transplantation. When a patient is 

placed on the center’s waitlist or is 

selected to receive a transplant, we 

propose that the center must document 

in the patient’s medical record the 

patient selection criteria that were 

utilized. We are also asking for 

comments on whether transplant 

centers should be required to make the 

patient selection criteria available to 

patients, either routinely or upon 

request. 

We have not specifically defined 

patient selection criteria in the proposed 

rule because transplant technology is 

continually changing. We want to 

preserve centers’ flexibility in 

identifying organ transplants that are 

medically reasonable and necessary in 

light of the most recent transplantation 

research and the needs of transplant 

recipients. However, we propose that 

the patient selection criteria must 

ensure fair and non-discriminatory 

distribution of organs. 

In general, organ transplants, should 

be performed only on carefully selected 

patients whose medical needs cannot be 

met by other therapies (except for 

kidney transplants where the dialysis 

option may continue to exist). We 

propose that before a transplant center 

selects a patient for extra-renal 

transplant, the center would have to 

consider or employ all other appropriate 

medical and surgical therapies that 

might be expected to yield both short 

and long-term survival comparable to 

transplantation. 

We are proposing an exception to this 

patient selection requirement for kidney 

transplant candidates because while 

kidney transplantation is the preferred 

treatment for patients with kidney 

failure, ESRD patients, unlike patients 

with other types of end-stage organ 

failure, have an alternative dialysis 

treatment option available to them, 

when kidney transplant is not feasible 

or when the graft has failed. Renal 

replacement therapy, which is required 

when kidney functions fall below 10–15 

percent, includes either dialysis or 

kidney transplants. 

Studies have shown that dialysis does 

not seem to yield survival comparable to 

transplantation. Kidney transplantation 

has many advantages, such as a lifestyle 

free from dialysis, a better quality of life 

and a longer life expectancy. However, 

kidney transplants have risks, such as 

surgical complications, rejection, and 

life-long maintenance medications and 

associated side effects. Therefore, 

dialysis continues to be a viable 

treatment option for an ESRD patient 

whose kidney transplant was 

unsuccessful.

We propose that a prospective 

transplant candidate must receive a 

psychosocial evaluation prior to 

placement on the waitlist. Although a 

person may be medically suitable for 

transplantation, he or she may have 

inadequate social support or coping 

abilities, or may be unable to 

demonstrate adequate adherence to a 

therapeutic regimen, which could then 

put the graft, and ultimately the 

transplant recipient at risk. 

We also propose that before a 

transplant center places a patient on its 

waitlist, the candidate’s medical record 

would have to contain documentation 

that the candidate’s blood type has been 

determined. Requiring documentation 

6160 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

of the candidate’s blood type would 

ensure that transplant centers are 

verifying the accuracy of vital data 

necessary to match the transplant 

candidate to a potential donor. We are 

specifically requesting comments on 

this proposal. 

Like organ transplant candidates, we 

believe potential living donors should 

be carefully selected. Unlike deceased 

donor transplantation, living donor 

transplantation presents an ethical 

quandary in that living donation 

represents the only area of medicine in 

which an otherwise healthy individual 

is subject to surgical risk for somebody 

else’s benefit. Any benefits to the donor 

are primarily psychological. We propose 

that transplant centers performing living 

donor transplants would have to use 

written living donor selection criteria to 

determine the suitability of candidates 

for living donation. We propose that the 

center must document in the transplant 

candidate’s and living donor’s medical 

records the living donor’s suitability for 

donation. We have not proposed 

specific living donor selection criteria 

for transplant centers because there are 

no established guidelines concerning 

the selection of living donors at this 

time. Until living donor standards are 

established, we propose that the centers’

living donor selection criteria must be 

consistent with the general principles of 

medical ethics. We propose that prior to 

donation, a prospective living donor 

must receive a medical and 

psychosocial evaluation. We also 

propose that the transplant center must 

document that the living donor has 

given informed consent, as required 

under § 482.102. 

2. Condition of Participation: Organ 

Recovery and Receipt (Proposed Section 

482.92) 

As reported in The Charlotte 

Observer, a recent death of a transplant 

recipient was caused by transplantation 

of organs from a donor of an 

incompatible blood type. The incident 

was attributed to a combination of 

system errors that occurred during the 

organ procurement, organ receipt, and 

transplant processes. Another death was 

attributed to a miscommunication of 

blood types between the center’s 

laboratory and the transplant team 

(Grady, Denise and Lawrence K. 

Altman, ‘‘Suit Says Transplant Error 

Was Cause in Baby’s Death in August,’’

The New York Times, 12 March 2003, 

Section A, Page 23, Column 5). These 

two events might have been avoided if 

certain steps were actively taken to 

validate the ABO (i.e. blood type) 

compatibility and other key data 

elements. 

Under the current policies for heart, 

liver and lung transplants and the 

current regulations for renal transplant 

centers, there are no provisions 

addressing procedures for transplant 

centers to ensure that donor organ and 

transplant recipient data are compared, 

or to prevent the transplantation of 

mismatched organs. The OPTN rules 

specify that an OPO with an organ 

available for transplantation must obtain 

a ‘‘match run’’ for that organ type from 

UNOS. The match run lists potential 

recipients on the waitlist who are the 

correct size and blood type to receive 

the organ that is available. The OPTN 

also requires the OPO to provide the 

transplant center with written 

documentation of the potential donor’s 

age, sex, and race, appropriate 

laboratory values, blood type, ABO or 

HLA typing, vital signs, cause of brain 

death and diagnosis, and current 

medication and transfusion history. 

However, these OPTN policies are 

voluntary. To prevent transplant 

mishaps caused by blood type 

mismatch, we propose that transplant 

centers would need to have written 

protocols for organ recovery and organ 

receipt. We propose that the protocols 

would have to ensure that the transplant 

center validates the donor’s and the 

recipient’s blood type and other vital 

data. Examples of vital data about the 

donor and the recipient that a transplant 

center should validate include, but are 

not limited to, appropriate laboratory 

values, vital signs, current medication 

and transfusion history. We also 

propose assigning responsibility for 

ensuring the medical suitability of 

donor organs for transplantation into the 

intended recipient to the transplanting 

surgeon, or the surgeon in the transplant 

center receiving the organ offer for his 

or her patient. 

We propose that a center’s protocols 

for organ recovery specify that a 

transplant center’s organ recovery team 

would have to review and compare the 

recipient and donor data before recovery 

takes place. We also propose that when 

an organ arrives at the center, the 

transplanting surgeon and at least one 

other individual at the transplant center 

would have to verify that the donor’s 

blood type and other vital data are 

compatible with transplantation of the 

intended recipient prior to 

transplantation. These verifications 

would ensure that transplant centers are 

actively taking steps to avoid 

transplantation of mismatched organs 

throughout the organ distribution 

process and would also prevent wastage 

of organs in the event a mismatch was 

not discovered until the organ(s) arrived 

at the transplant hospital. 

We also propose that a center’s 

protocols for organ recovery and receipt 

would have to ensure that the 

transplanting surgeon and at least one 

other individual at the transplant center 

verifies that the living donor’s vital data 

(including blood type) are 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).

3. Condition of Participation: Patient 

and Living Donor Management 

(Proposed Section 482.94) 

Under the current policies for heart, 

liver and lung transplants, a center is 

required to have adequate patient 

management plans and protocols that 

include therapeutic and evaluative 

procedures during the waiting, inhospital, and discharge phases of 

transplantation. The current conditions 

for coverage for ESRD services require 

each ESRD facility, which includes 

renal transplant centers, to maintain for 

each patient a written long-term 

program and a written patient care plan 

to ensure that each patient receives the 

appropriate modality of care and the 

appropriate care within that modality. 

We believe that a patient’s care should 

be managed during every stage of 

transplantation, starting with the 

patient’s evaluation for placement on a 

center’s waitlist and through the 

patient’s discharge from the hospital 

following transplant, to ensure that the 

services provided meet the patient’s 

care needs and that the patient is 

involved in his or her care. We propose 

that centers must have written patient 

management policies and patient care 

planning for pre-transplant, and through 

the patient’s discharge from the hospital 

following transplant. It is equally 

important to ensure that living donors 

receive services that meet their care 

needs throughout the various stages of 

donation, starting with donor evaluation 

and continuing through the donor’s 

immediate discharge from the hospital 

post-donation. Therefore, we propose 

that centers performing living donor 

transplants must have written donor 

management policies for the donor 

evaluation, donation, and through the 

donor’s discharge from the hospital 

following donation. We propose that a 

transplant center must ensure that each 

patient or living donor is under the care 

of a multidisciplinary patient care team 

coordinated by a physician during all 

phases of transplantation or living 

donation. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6161

A center’s initial responsibility for a 

transplant patient begins when he or she 

is evaluated for placement on that 

center’s waitlist, regardless of whether 

or not the patient is on another center’s 

waitlist. Effective waitlist management, 

in our view, means installing and 

maintaining a reliable administrative 

system that tracks patient status and 

provides accurate updated patient data 

on demand. Inaccurate information on 

waitlist patients may create a situation 

where a center may initially agree to 

accept organs that are offered to them 

but later decline them at the last minute 

when they discover that the organs are 

not suitable for the intended recipients. 

In order to prevent organs from being 

wasted once they are recovered, we are 

proposing a standard specifically for 

waitlist management. 

In 2002, the Clinical Practice 

Committee of the American Society of 

Transplantation issued guidelines 

regarding waitlist maintenance based on 

a questionnaire sent out to 287 

transplant centers, of which 192 

responded. The guidelines specifically 

recommend annual follow-up or 

assessment of potential transplant 

recipients as deemed appropriate to 

ascertain transplant status. Although we 

do not specifically propose annual 

follow-up or assessment of transplant 

candidates, we believe transplant 

centers need to reassess patients placed 

on their waitlist to ensure that (1) the 

center’s information on the patient is 

accurate and (2) the transplant is still 

medically indicated. We are proposing 

that transplant centers keep their 

waitlists up to date, including updating 

waitlist patients’ clinical information on 

an ongoing basis. We also propose that 

the transplant center must remove a 

patient from its waitlist when the 

patient receives a transplant or dies, or 

if there is any other reason why the 

patient should no longer be placed on 

a center’s waitlist (for example, the 

patient’s health could deteriorate or 

improve to the point that a transplant 

would no longer be medically suitable 

or a patient could voluntarily ask to be 

removed from a center’s waitlist). We 

propose requiring transplant centers to 

notify the OPTN of the patient’s removal 

from the center’s waitlist no later than 

24 hours after such removal. This timely 

notification to the OPTN of a patient’s 

removal from a center’s waitlist is 

crucial. Not only would this notification 

provide patients with confirmation of 

their removal from a center’s waitlist, 

but the OPTN would also rely on this 

information to keep the national waitlist 

current. Prompt notification of a 

patient’s removal from the waitlist 

provides more accurate data to facilitate 

accurate patient placement on the 

waitlist. Prompt notification of patient’s 

removal from a center’s waitlist would 

also enhance the accuracy of the SRTR 

data analyses. Furthermore, OPOs have 

a very narrow window of opportunity 

for allocating recovered organs to the 

appropriate recipient. Some OPOs have 

complained that transplant centers 

sometimes agree to accept an organ for 

a particular individual only to discover 

later that the individual has already 

received a transplant or has died prior 

to receiving a transplant.

We are proposing a requirement at 

§ 482.94(c) that transplant centers 

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 transplant. 

We believe that accurate patient records 

are especially crucial in determining a 

patient’s readiness for transplants. 

Accurate information about a patient’s 

transplant status needs to be readily 

available to individuals involved in the 

care of the patient, and to the patients 

themselves. For example, we have 

found that in some cases, after a kidney 

dialysis patient is evaluated for 

placement on a center’s waitlist, the 

patient’s status is not communicated to 

the dialysis facility or to the patient. 

The patient, and the dialysis facility, 

may believe he or she has been placed 

on a waitlist, only to find months later 

that the transplant center is waiting for 

the patient to undergo further clinical 

testing. 

Given that time on the waitlist is often 

one of the factors that determine which 

patients ultimately are transplanted, we 

propose that for each patient who has 

received an evaluation for placement on 

a center’s waitlist, the transplant center 

must document in the patient’s record 

that it has notified each patient of his or 

her placement status. Specifically we 

propose that the center must notify the 

patient of: (1) The patient’s placement 

on the center’s waitlist; (2) the center’s 

decision not to place the patient on its 

waitlist; or (3) the center’s inability to 

make a determination regarding the 

patient’s placement on its waitlist 

because further clinical testing or 

documentation is needed. 

After a patient is placed on a center’s 

waitlist, we believe it is the transplant 

center’s responsibility to provide 

waitlisted patients with an annual 

update of their waitlist status. We 

propose that once a patient is placed on 

a center’s waitlist, the center must 

document in the patient’s record that 

the patient has been notified of his or 

her waitlist status at least once a year, 

even if there is no change in the 

patient’s placement status. In addition, 

we propose that no later than 10 days 

after a patient’s removal from a center’s 

waitlist for reasons other than death or 

transplantation (such as the patient’s 

voluntary withdrawal from the waitlist 

or a change in the patient’s medical 

status such that a transplant is no longer 

indicated), the center must document in 

the patient’s record that the patient has 

been notified of his or her removal from 

the waitlist. For dialysis patients, we 

propose that the transplant center also 

must document in each patient’s record 

that both the patient and the patient’s 

usual dialysis facility are informed of 

the patient’s transplant status or of 

changes in the patient’s transplant 

status. In the event there are changes in 

a dialyzed patient’s transplant status, 

we believe it is imperative for dialysis 

facilities to have up-to-date and accurate 

information about kidney transplant 

candidates to ensure adequate care and 

coordination between the dialysis 

facility and the transplant center prior 

to transplantation. In the case of 

patients admitted for organ transplants, 

we propose that the patient records 

contain written documentation of 

multidisciplinary care planning during 

the pre-transplant period and 

multidisciplinary discharge planning for 

the patient’s post-transplant care. 

In addition, we propose requiring 

transplant centers to make available 

social and nutritional services, 

furnished by qualified social workers 

and dietitians, to patients and living 

donors. The current kidney transplant 

center regulations at § 405.2171 require 

centers to provide a qualified social 

worker to evaluate transplant patients’

psychosocial needs, participate in care 

planning of patients, and identify 

community resources to assist the 

patient and family. Similarly, we 

believe social services, such as assisting 

and supporting patients and their 

families in maximizing the social 

functioning and adjustment of the 

patient, are important to all transplant 

patients and living donors. Therefore, 

we are proposing that social services, 

furnished by a qualified social worker, 

be made available to all transplant 

patients, living donors and their 

families. Based on the definition of 

‘‘qualified social worker’’ contained in 

§ 405.2102, we propose to define a 

qualified social worker as an individual 

who meets licensing requirements in the 

State in which practicing, and (1) has 

completed a course of study with 

specialization in clinical practice, and 

holds a masters degree from a graduate 

school of social work accredited by the 

6162 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

Council on Social Work Education; or 

(2) has served for at least 2 years as a 

social worker, one year of which was in 

a transplantation program, and has 

established a consultative relationship 

with a social worker who has obtained 

the education described above.

The current kidney transplant center 

regulations at § 405.2171 also require a 

qualified dietitian, in consultation with 

the attending physician, to assess the 

nutritional and dietetic needs of each 

patient, recommend therapeutic diets, 

counsel patients and their families on 

prescribed diets and monitor adherence 

and response to diets. All transplant 

patients and living donors may need 

dietary modifications, permanently or 

temporarily, to maintain balances in 

fluids, electrolytes, and macro or micronutrients. We are proposing that 

nutritional assessments and diet 

counseling, furnished by qualified 

dietitians be made available to all 

transplant patients and living donors. 

Based on the definition of ‘‘qualified 

dietitian’’ contained in § 405.2102, we 

propose to define a qualified dietitian as 

an individual who (1) is eligible for 

registration by the American Dietetic 

Association under its requirements in 

effect on June 3, 1976 and who 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. 

4. Condition of Participation: Quality 

Assessment and Performance 

Improvement (QAPI) (Proposed Section 

482.96) 

QAPI is the process of using objective 

data to study and continually make 

improvements to all aspects of an 

organization’s operations and services. 

QAPI rests on the assumption that an 

organization’s own quality management 

system is the key to improved 

performance. It seeks to increase the 

amount and quality of information on 

which to base decisions and improve 

quality. 

We believe that QAPI is regarded by 

the health care community as the most 

efficient and effective method for 

improving the quality and performance 

of health care providers. Most transplant 

centers, by virtue of being part of a 

hospital, already participate in QAPI 

programs because, in addition to being 

required by our regulations at § 482.21, 

QAPI is a process required by JCAHO 

through its hospital accreditation 

standards. Although the transplant 

hospital’s QAPI program may not 

contain elements that are specific to the 

transplant center, many transplant 

centers have voluntarily established 

strong QAPI programs and utilize them 

to effect change within the 

transplantation system. However, 

transplant centers’ QAPI programs vary 

in their sophistication and scope. 

Therefore, we are proposing a 

requirement that every transplant center 

develop, implement, and maintain a 

written, comprehensive, data-driven 

QAPI program designed to monitor and 

evaluate all transplantation services, 

including services provided under 

contract or arrangement. These 

requirements are based on our 

commitment to encouraging continuous 

quality improvement for all Medicare 

providers and suppliers. A requirement 

for transplant centers to have a QAPI 

program will encourage continuous 

quality improvement at the center level, 

as well as the use of best practices, as 

determined by the individual centers 

and the transplant community. 

We do not intend to stipulate specific 

activities a transplant center must 

include in its QAPI program. We 

propose requiring a transplant center’s 

QAPI program to use objective measures 

to evaluate improved performance with 

regard to transplant activities. Areas to 

be evaluated would include patient and 

donor selection criteria, accuracy of the 

waitlist in accordance with the OPTN 

waitlist, accuracy of donor and recipient 

matching, patient and donor 

management, techniques for organ 

recovery, consent practices, patient 

satisfaction and patient rights. We 

propose that the transplant center 

would be required to take actions that 

result in performance improvements 

and track performance to ensure that 

improvements are sustained. 

As part of the QAPI process, a 

transplant center would be required to 

establish and implement a written 

policy to address adverse events that 

occur during any phase of the organ 

transplant process. The policy must 

address at a minimum, the process for 

identification, reporting, analysis, and 

prevention of adverse events. An 

adverse event for a transplant center 

could be, for instance, living donor 

death due to mismanagement of a 

donor; transplantation of organs of 

mismatched blood types due to failure 

to validate donor and recipient’s vital 

information; or transplanting organs to 

unintended recipients. Examples of 

situations involving direct patient 

outcomes that might qualify as adverse 

events include: (1) Avoidable loss of a 

healthy living donor; and (2) 

unintended transmission of infectious 

disease to a recipient.

In addition, we are proposing that 

transplant centers would be required to 

conduct a thorough analysis of and 

document any adverse event and to 

utilize the analysis to effect changes in 

the transplant center’s policies and 

practices to prevent repeat incidents. 

We believe that the formal analysis is 

essential to examining a transplant 

center’s existing policies and practices, 

improving the organ transplantation 

process, and improving efficiency and 

outcomes. 

5. Condition of Participation: Human 

Resources (Proposed Section 482.98)

[If you choose to comment on this 

section, please include the caption 

‘‘HUMAN RESOURCES’’ at the 

beginning of your comments.] 

We propose that transplant centers 

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. Currently, the ESRD 

regulations require a renal transplant 

center to be under the general 

supervision of a qualified transplant 

surgeon or qualified physician-director, 

who is responsible for planning, 

organizing, and directing the renal 

transplant center and devotes sufficient 

time to carry out certain responsibilities. 

We believe that all transplant centers 

should be directed by a qualified 

transplant surgeon or physician. 

Therefore, we propose at § 482.98(a) that 

each transplant center would have to be 

under the general supervision of a 

qualified transplant surgeon or a 

qualified physician-director. 

The director of a transplant center 

would be responsible for planning, 

organizing, conducting, and directing 

the transplant center and would have to 

devote sufficient time to carry out these 

responsibilities. Specific responsibilities 

would include, but not be limited to, 

ensuring adequate training of nursing 

staff in the care of transplant patients; 

ensuring tissue typing and organ 

procurement services are available; and 

ensuring that transplantation surgery is 

performed under the direct supervision 

of a qualified transplant surgeon in 

accordance with § 482.98(b). The 

director of a transplant center would not 

need to serve in such capacity full-time 

and may also serve as the center’s 

primary surgeon or physician, as 

discussed below. Since this would be a 

new requirement for extra-renal 

transplant centers, we request 

comments regarding whether it is 

necessary to require each transplant 

center to have a director to oversee the 

center, in addition to other human 

resources requirements.

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6163

We propose at § 482.98(b) 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. For example, 

we would consider a transplant surgeon 

or transplant physician that meets the 

OPTN’s policies regarding the training 

and experience of transplant surgeons 

and transplant physicians to have the 

appropriate training and experience to 

provide transplantation services. The 

transplant surgeon would be responsible 

for providing surgical services related to 

transplantation while the transplant 

physician would be responsible for 

providing and coordinating 

transplantation care. 

In addition, we propose that 

transplant centers 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. Many transplant 

centers have clinical transplant 

coordinators on their teams to ensure 

coordination and continuity of care 

before patients are transplanted, while 

they are hospitalized for the transplant, 

and following the transplant. We 

propose that a qualified clinical 

transplant coordinator would have to be 

certified by the American Board of 

Transplant Coordinators (ABTC) which 

requires at least 12 months of work 

experience as a transplant professional 

in vascular organ transplantation and 

successful completion of the 

certification examination. We believe 

ABTC certification ensures that an 

individual serving in the capacity of a 

clinical transplant coordinator has met 

a standard of competency and possesses 

the necessary knowledge and skills 

needed to provide quality care for 

transplant recipients and donors. 

Clinical transplant coordinators are 

usually charged with the 

responsibilities of: (1) Educating 

patients, living donors, and families 

about treatment options, and postoperative care or therapies; (2) 

monitoring patients’ and living donors’

medical, surgical and psychosocial 

status; and (3) providing feedback to 

other team members. We request 

comments concerning whether an 

alternative set of training and 

experience standards should be used for 

qualified clinical transplant 

coordinators. 

In addition, we propose that a 

transplant center must identify a 

multidisciplinary transplant team and 

describe the responsibilities of each 

member of the team. We propose 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. For example, a 

transplant team in a liver center should 

be composed of individuals with 

training and experience to treat and care 

for patients with end-stage liver disease 

and not ESRD patients. We have 

proposed this requirement to ensure 

that transplant centers have the ability 

to provide the services necessary to 

meet all of a transplant patient and a 

living donor’s medical and psychosocial 

needs. We also believe that a transplant 

center must make a sufficient 

commitment of resources and planning 

to its transplantation program. We 

propose that a transplant center must 

demonstrate the availability of expertise 

in internal medicine, surgery, 

anesthesiology, immunology, infectious 

disease, pathology, radiology, and blood 

banking as related to the provision of 

transplantation services. 

6. Condition of Participation: Organ 

Procurement (Proposed Section 

482.100) 

In this proposed rule, we are also 

proposing to require that transplant 

centers ensure that the transplant 

hospital in which the center operates 

has a written agreement for the receipt 

of organs with an OPO designated by 

the Secretary. We propose at § 482.100 

that the transplant center would have to 

ensure that the transplant hospital-OPO 

agreement identifies specific 

responsibilities for the hospital and for 

the OPO with respect to organ recovery 

and organ allocation. In the event that 

a transplant hospital terminates any 

agreement with an OPO or an OPO 

terminates any agreement with the 

transplant hospital, we propose that the 

transplant center must notify us in 

writing no later than 30 days after the 

termination of the agreement.

7. Condition of Participation: Patients’

and Living Donors’ Rights (Proposed 

Section 482.102) 

[If you choose to comment on this 

section, please include the caption 

‘‘PATIENTS’ AND LIVING DONORS’

RIGHTS’’ at the beginning of your 

comments.] 

In addition to meeting the general 

hospital requirements for patients’

rights in 42 CFR 482.13, we propose that 

a transplant center must protect and 

promote each transplant patient’s and 

living donor’s rights. Prior to 

transplantation or living organ donation, 

transplant centers must inform patients 

(including living donors) of their rights. 

There are some unique aspects of 

transplantation and living donation that 

make patient rights, particularly 

informed consent, critical. Hence, we 

propose requiring transplant centers to 

have a written informed consent process 

that addresses these unique aspects of 

transplantation and living donation. For 

example, the critical shortage of donor 

organs nationwide has caused 

transplant centers, researchers, and 

OPOs to investigate the potential of 

‘‘extended criteria organs’’ to increase 

the supply of organs available for 

transplantation. Only a decade ago, 

these organs would not have been 

deemed usable due to the donor’s age or 

health, or the condition of the organ. 

Such extended criteria organs included 

livers with excess fat, kidneys with 

extended cold ischemia time, or organs 

from donors 70 years of age or older. 

Although surgeons once rejected such 

organs, they now may choose to 

transplant them. Advances in transplant 

technology and skills, 

immunosuppressive drugs, improved 

infection management, and careful 

donor and recipient selection in 

combination with our national donor 

shortage have helped relax the criteria 

for accepting donor organs. The use of 

organs from extended criteria donors is 

now viewed as a viable alternative for 

patients with medical urgency. 

Although we agree that extended 

criteria donors can help to expand the 

donor pool, we believe it is important 

that patients be informed that organs 

from extended criteria donors could 

affect the success of the graft or the 

health of the patient. 

We propose that the transplant 

center’s written informed consent 

process notify transplant patients of 

information about all aspects of and 

potential outcomes from 

transplantation, including, but not 

limited to: (1) The evaluation process; 

(2) the surgical procedure; (3) 

alternative treatments; (4) potential 

medical or psychosocial risks; (5) 

national and transplant center-specific 

outcomes, such as graft and patient 

survival; (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 possible 

risk of contracting the human 

6164 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

immunodeficiency virus and other 

infectious diseases if the disease cannot 

be detected in an infected donor; and (8) 

the right to refuse transplantation. 

OPOs make every effort to obtain a 

social/behavioral history for each 

potential donor from the next-of-kin or 

other knowledgeable individual. If a 

potential donor has engaged in a 

behavior that would have put him or her 

at high risk of contracting an infectious 

disease, such as HIV or hepatitis (for 

example, injecting illegal drugs), 

donation generally is ruled out, unless 

the risk to the recipient of not 

performing a transplant is greater than 

the risk of contracting an infectious 

disease. In such case, informed consent 

regarding the possibility of transmission 

of infectious disease must be obtained 

from the transplant recipient.

In 2002, there was a case in Oregon 

in which hepatitis C was transmitted to 

transplant recipients that received 

organs from an individual who tested 

‘‘negative’’ for hepatitis C at the time of 

donation. After further investigation, it 

was determined that the recipients 

became infected with hepatitis C 

because the donor had been infected 

with the disease but had not built up 

enough antibodies to test ‘‘positive’’ for 

the disease at the time of donation. If a 

donor’s social history (e.g., history of 

drug use, sexual history, etc.) indicates 

that the donor could potentially be in a 

‘‘window’’ period for transmitting HIV, 

hepatitis C, hepatitis B, or other 

infectious diseases, we believe that the 

patient’s informed consent should also 

include this information. In other 

words, transplant patients should be 

notified when they are receiving organs 

from high-risk donors and should be 

notified that they may be at risk of 

contracting these diseases by accepting 

the donated organs. Examples of highrisk donors include, but are not limited 

to, donors who have tested ‘‘negative’’

for an infectious disease but whose 

social history indicates that the donor is 

at high risk for contracting the disease. 

In notifying transplant patients about a 

donor’s history, we would expect the 

transplant center to do so in a manner 

that would keep the identity of the 

donor confidential. Given that it is 

difficult to predict whether a high-risk 

donor could be in a ‘‘window’’ period, 

and that there is no national standard 

guiding the use of organs from extended 

criteria donors, and that some patients 

can afford to wait for a healthier organ 

that may become available later, we are 

soliciting comments on our proposal of 

the requirements to inform patients of 

potential risks. 

Recently, the ACOT developed a set 

of recommendations for living donors at 

the Secretary’s request. ACOT has 

agreed upon a set of ‘‘Ethical Principles 

of Consent to Being a Live Organ 

Donor.’’ The principles state that the 

person who gives consent to becoming 

a live organ donor must be: 

• Competent (possessing decision 

making capacity), 

• Willing to donate, 

• Free from coercion, 

• Medically and psychosocially 

suitable, 

• Fully informed of the risks and 

benefits as a donor, and 

• Fully informed of the risks, 

benefits, and alternative treatment 

available to the recipient. 

ACOT also endorsed two other ethical 

principles: 

• Equipoise; that is, the benefits to 

both the donor and the recipient must 

outweigh the risks associated with the 

donation and transplantation of the live 

donor organ; and 

• A clear statement that the potential 

donor’s participation must be 

completely voluntary, and may be 

withdrawn at any time. 

ACOT further recommends that the 

following ‘‘Standards of Disclosure: 

Elements of Informed Consent’’ be 

incorporated into the informed consent 

document given to the potential live 

organ donor, with specific descriptions 

that would ensure the donor’s 

awareness of: 

• The purpose of the donation, 

• The evaluation process—including 

interviews, examinations, laboratory 

tests, and other procedures—and the 

possibility that the potential donor may 

be found ineligible to donate, 

• The donation surgical procedure, 

• The alternative procedures or 

courses of treatment for potential donor 

and recipient, 

• Any procedures which are or may 

be considered to be experimental, 

• The immediate recovery period and 

the anticipated post-operative course of 

care, 

• The foreseeable risks or discomforts 

to the potential donor, 

• The potential psychological effects 

resulting from the process of donation, 

• The reported national experience, 

transplant center and surgeon-specific 

statistics of donor outcomes, including 

the possibility that the donor may 

subsequently experience organ failure, 

disability and death, 

• The foreseeable risks, discomforts, 

and survival benefit to the potential 

recipient,

• The reported national experience 

and transplant center statistics for 

recipient outcomes, including failure of 

the donated organ and the frequency of 

recipient death, 

• The fact that the potential donor’s 

participation is voluntary, and may be 

withdrawn at any time, 

• The fact that the potential donor 

may derive a medical benefit by having 

a previously undetected health problem 

diagnosed as a result of the evaluation 

process, 

• The fact that the potential donor 

undertakes risk and derives no medical 

benefit from the operative procedure of 

donation, 

• The fact that unforeseen future risks 

or medical uncertainties may not be 

identifiable at the time of donation, 

• The fact that the potential donor 

may be reimbursed for the personal 

expenses of travel, housing, and lost 

wages related to donation, 

• The prohibition against the donor 

otherwise receiving any valuable 

consideration (including monetary or 

material gain) for agreeing to be a donor, 

• The fact that the donor’s existing 

health and disability insurance may not 

cover the potential long-term costs and 

medical and psychological 

consequences of donation, 

• The fact that the donor’s act of 

donation may adversely affect the 

donor’s future eligibility for health, 

disability, or life insurance, 

• Additional informational resources 

relating to live organ donation (possibly 

through the establishment of a separate 

resources center, as recommended 

below. 

• The fact that by donating, the donor 

authorizes Government approved 

agencies and contractors to obtain 

information regarding the donor’s health 

for life, and 

• The principles of confidentiality, 

clarifying that:

—Communication between the donor 

and the transplant center will remain 

confidential; 

—A decision by the potential donor not 

to proceed with the donation will 

only be disclosed with the consent of 

the potential donor; 

—A transplant center will only share 

the donor’s identity and other medical 

information with entities involved in 

the procurement and transplantation 

of organs, as well as registries that are 

legally charged to follow donor 

outcomes; and 

—Confidentiality of all patient 

information will be maintained in 

accordance with applicable laws and 

regulations.

We recommend that transplant 

centers that perform living donor 

transplants consider the ACOT’s 

recommendations in developing 

informed consent policies for living 

donors. Transplant centers may also 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6165

wish to review two specific informed 

consent documents developed by 

ACOT. The first relates to the potential 

donor’s initial consent for evaluation as 

a possible donor, ‘‘Living Liver Donor 

Initial Consent for Evaluation.’’ The 

second deals with the potential donor’s 

informed consent for surgery, ‘‘Living 

Liver Donor Informed Consent for 

Surgery.’’ These documents are 

available on the Department’s organ 

donation Web site at http://

www.organdonor.gov.

Although the proposed requirements 

for informed consent incorporate some 

of the ‘‘Standards of Disclosure’’

recommended by ACOT, we are not 

proposing to require that transplant 

centers include all of these standards in 

their informed consent process for 

living donors. To serve the best interest 

of living donors, we are proposing at 

§ 482.102(b) that transplant centers 

implement a written informed consent 

process for living donors that inform 

potential living donors about all aspects 

of and potential outcomes from living 

donation. Specific issues on which 

potential living donors would have to be 

informed of include, but are not limited 

to: (1) The fact that communication 

between the donor and the transplant 

center will remain confidential in 

accordance with the Department’s 

Health Information Privacy Rules (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 such as graft and patient 

survival 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 request 

comments regarding our proposed 

informed consent requirements for 

living donors, including those 

requirements we have adopted from the 

ACOT recommendations, and whether 

we need to establish additional criteria 

for transplant centers performing living 

donor transplants (such as, 

incorporating other ACOT 

recommendations). 

In addition to requesting assistance in 

improving the lives of recipients and 

protecting living organ donors, the 

Secretary also requested that ACOT 

consider the desirability of an 

independent donor advocate (or 

advocacy team) to represent and advise 

the donor so as to ensure that the 

previously described elements and 

ethical principles are applied to the 

practice of all living donor 

transplantation. ACOT has provided 

detailed recommendations as to how 

such an independent donor advocate 

should be established, as well as the 

role and qualifications of such an 

advocate. ACOT recommended that 

each transplant center identify and 

provide to each potential donor an 

independent and trained patient 

advocate whose primary obligation 

would be to help donors understand the 

process, the procedure and risks and 

benefits of living organ donation; and to 

protect and promote the interests and 

well-being of the donor. We believe that 

a living donor advocate (or advocacy 

team) would ensure that the informed 

consent standards meet ethical 

principles as they are applied to the 

practice of all living organ 

transplantation. We are requesting 

comments on whether we should 

include a requirement for transplant 

centers performing living donor 

transplants to provide the service of an 

independent donor advocate (or 

advocacy team) and what the individual 

or team’s credentials should be. 

Additionally, we believe that waitlist 

patients need to be informed of 

circumstances within a transplant 

center that may impact their ability to 

receive a transplant should an organ 

become available and what procedures 

are in place to ensure coverage. Thus, 

we are proposing that a transplant 

center served by a single transplant 

surgeon or physician must inform its 

patients of this fact and of the potential 

unavailability of the transplant surgeon 

or physician should an organ become 

available for the patient. If a transplant 

center is served by a single transplant 

surgeon or physician, we also propose 

that the center inform its patients 

whether or not the center has a 

mechanism for providing an alternate 

transplant surgeon or transplant 

physician that meets the hospital’s 

credentialing policies should the 

center’s transplant surgeon or physician 

be unavailable.

It is not our intent to disrupt the 

availability of covered organ transplants 

for Medicare beneficiaries. Therefore, in 

the event that termination becomes 

imminent during the 3-year approval 

period, we are proposing at least 30 

days before a center’s Medicare 

approval is terminated, whether 

voluntarily or involuntarily, that the 

center must inform the patients on the 

waitlist 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 waitlist. (The OPTN 

controls the nation’s organ transplant 

waitlist and has rules to ensure that a 

patient who transfers from one waitlist 

to another does not lose any accrued 

time.) Generally speaking, we do not 

believe transferring patients from the 

waitlist of a center that is facing loss of 

its Medicare approval to an open 

center’s waitlist would increase the 

length of wait for others already on the 

open center’s waitlist because time on 

the waitlist is just one of several factors 

that are used to match donor organs to 

a potential transplant recipient. 

We also propose that at least 30 days 

before a center’s Medicare approval is 

terminated, whether voluntarily or 

involuntarily, the center would have to 

inform all Medicare beneficiaries added 

to the waitlist that Medicare will not 

pay for transplants performed at the 

center after the effective date of the 

center’s loss of approval. We are 

proposing these requirements to ensure 

that patients on the center’s waitlist do 

not lose precious waiting time as a 

result of a center’s loss of approval. 

8. Condition of Participation: Additional 

Requirements for Kidney Transplant 

Centers (Proposed Section 482.104) 

In addition to meeting the special 

requirements for transplant centers 

(proposed § 482.68), we also propose 

additional requirements for kidney 

transplant centers. As stated previously, 

we propose to delete § 405.2120 through 

§ 405.2134, § 405.2170 through 

§ 405.2171, and the definitions for 

‘‘histocompatibility testing,’’ ‘‘ESRD 

Network,’’ ‘‘ESRD network 

organization,’’ ‘‘organ procurement,’’

‘‘renal transplantation center,’’

‘‘transplantation service,’’ and 

‘‘transplantation surgeon’’ contained in 

§ 405.2102. We propose to retain some 

of these requirements at § 482.104. 

Specifically, we propose that kidney 

transplant centers must furnish directly, 

transplantation and other medical and 

surgical specialty services required for 

the care of the ESRD patients, including 

inpatient dialysis, either directly or 

under arrangement. We propose that the 

dialysis services furnished by transplant 

centers would have to be furnished in 

accordance with part 405, subpart U of 

this chapter. We propose that kidney 

transplant centers must cooperate with 

the ESRD Network designated for its 

geographic area in fulfilling the terms of 

the network’s current statement of work. 

6166 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

Special Procedures for Approval and 

Re-Approval of Transplant Centers 

Currently, a facility’s application to 

become a Medicare-approved heart, 

liver, or lung transplant center is 

evaluated with the aid and advice of 

non-Federal expert consultants. 

Generally, the consultants are 

responsible for reviewing applications 

at our request, making 

recommendations to us concerning 

qualified centers and supporting each 

recommendation with written 

documentation. CMS reviews intestinal 

transplant center applications for 

Medicare approval. For kidney 

transplant centers, the CMS Regional 

Offices review and process requests for 

Medicare approval. 

This proposed rule introduces facility 

criteria for heart-lung and pancreas 

transplant centers and changes the 

process for reviewing applications for 

approval of heart, intestine, kidney, 

liver, and lung transplant centers. The 

current facility criteria for heart, 

intestine, kidney, liver, and lung centers 

and the process for reviewing 

applications for approval of heart, 

intestine, kidney, liver, and lung 

transplant centers contained in the 

Medicare coverage policies and the 

regulations at 42 CFR part 405, subpart 

U would continue to be in effect until 

we announce otherwise. We propose 

that once this proposed rule is finalized, 

we, or our designee (e.g., a State survey 

agency or an accreditation organization 

with deeming authority for hospitals, 

such as the JCAHO or AOA), would 

have responsibility for monitoring and 

coordinating the procedures for 

approval or re-approval of a transplant 

center. For the purpose of approving 

and re-approving transplant centers, we 

propose at § 488.61 that we utilize 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. 

Last year, Congress passed the MMA. 

Section 901(b) of the MMA, adding new 

paragraph 1861(d) to the Act, states that 

‘‘[t]he term ‘supplier’ means, unless the 

context otherwise requires, a physician 

or other practitioner, a facility, or other 

entity (other than a provider of services) 

that furnishes items or services under 

this title.’’ Section 936 of the MMA 

added new section 1866(j) to the Act, 

which, among other things, gives both 

providers (as defined at section 1861(u) 

of the Act) and suppliers (as defined 

above) the right to seek judicial review 

of certain adverse agency decisions 

regarding enrollment and re-enrollment.

We believe that transplant centers are 

unique entities that do not fit perfectly 

into either the provider or supplier 

category. There is no enrollment process 

involved. A transplant center is an 

optional status based on conditions that 

are applicable only to Medicare 

hospitals that choose to apply for 

Medicare approval as a transplant 

center. A Medicare-approved transplant 

center must first meet all of the hospital 

CoPs in 42 CFR part 482, which serves 

as the basis of survey activities for the 

purpose of determining whether a 

hospital qualifies for a Medicare 

provider agreement. Thus, a Medicareapproved transplant center must be 

operated within a provider as defined in 

section 1861(u) of the Act (i.e., a 

Medicare hospital). 

However, ‘‘transplant center’’ is not 

listed in the definition of ‘‘provider’’

under section 1861(u) of the Act. By 

virtue of the fact that a transplant center 

is an entity other than a provider (as 

defined in section 1861(u) of the Act), 

we could argue that ‘‘transplant center’’

falls under the definition of ‘‘supplier’’

created in section 901 of the MMA. 

Given the unique nature of transplant 

centers, we are requesting comments on 

the appropriate appeals mechanism for 

transplant centers. Specifically, we are 

interested in receiving comments 

regarding whether transplant centers 

should be regarded as ‘‘providers’’ or as 

‘‘suppliers’’ for the purpose of appealing 

adverse approval and re-approval 

decisions. We believe that regardless of 

whether we define a transplant center to 

be a ‘‘provider’’ or a ‘‘supplier,’’ it is 

necessary to have some type of appeal 

process in the event that CMS decides 

to not approve or re-approve a hospital’s 

transplant center.

[If you choose to comment on this issue, 

please include the caption ‘‘PROVIDER 

VS. SUPPLIER STATUS FOR 

APPEALS’’ at the beginning of your 

comments.] 

A. Initial Approval Procedures 

We propose at § 488.61(a) that a 

transplant center can submit a letter of 

request to CMS for Medicare approval at 

any time. We are not proposing any 

particular formal application. The letter, 

signed by a person authorized to 

represent the hospital (for example, a 

chief executive officer), would need to 

include the hospital’s Medicare 

provider I.D. number, 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. 

We propose to determine a heart, 

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

or pancreas transplant center’s 

compliance with the data submission 

and outcome requirements proposed at 

§ 482.80 by reviewing the center’s data. 

For compliance with the data 

submission requirements, we would 

expect the OPTN to review its statistics 

on data completeness for the previous 

calendar year and certify compliance 

with the data submission requirements. 

For compliance with the outcome 

measures requirements, we would 

review the 1-year patient and graft 

survival data contained in the most 

recent SRTR center-specific report 

unless the center is eligible for initial 

approval on the basis of its 1-month 

patient and graft survival. If 1-month 

patient and graft survival data are used, 

we would review the customized 

reports prepared by the SRTR for the 

previous 1-year period. The center 

would be responsible for requesting the 

SRTR to prepare these customized 

reports. 

The SRTR center-specific reports are 

updated every six months (currently, 

the reports are updated in January and 

July of each year). If, for example, we 

receive a letter from a transplant center 

requesting Medicare approval on 

October 1, 2006, we would review the 

center’s 1-year patient and graft survival 

statistics from the SRTR’s July 2006 

reports, which includes 1-year graft and 

patient survival statistics on transplants 

performed anywhere between 1 to 3.5 

years previously. As we have stated 

previously, we will be reviewing the 

post-transplant outcomes for all 

transplants, including living donor 

transplantation, performed at a center 

during the 2.5-year period in which the 

outcomes are reported.

However, a new transplant center may 

request initial Medicare approval using 

1-month patient and 1-month graft 

survival data if 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 and if the transplant center’s 

team meets the human resources 

requirements at § 482.98. We would 

review the 1-month patient and graft 

survival data on at least 9 transplants 

performed during the previous 1-year 

period captured in the customized 

reports prepared by the SRTR. 

If a center requires Medicare approval 

to perform pediatric transplants, the 

center would have to meet the outcome 

requirements for its pediatric and adult 

transplant centers separately. 

If we determine that a transplant 

center requesting initial approval is in 

compliance with the proposed data 

submission and outcome measure 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6167

requirements proposed at § 482.80 

(based on our review of the data), then 

we, or our designee, would conduct a 

site survey of the center to determine 

compliance with CoPs proposed at 

§ 482.68 through § 482.76 and § 482.90 

through § 482.104 using the procedures 

described at 42 CFR part 488, subpart A. 

To maximize efficient utilization of 

resources, the data and outcome 

requirements would serve as 

prerequisites that would need to be met 

based on a desk review of the data 

before a survey for compliance with the 

process requirements would be 

conducted. We propose that centers that 

failed to meet the data or outcome 

requirements, including the requirement 

to have post-transplant follow-up on at 

least 9 transplants during the reported 

cohorts, would be denied approval and 

no survey would be performed. 

B. Effective Dates for Initial Approval 

Under the current national coverage 

decisions for heart, liver, and lung 

transplant centers, Medicare approval of 

a facility to perform Medicare-covered 

transplants is effective as of the date of 

the letter notifying the center of its 

approval. Under this proposed rule, 

Medicare approval of all transplant 

centers to perform Medicare-covered 

transplants would be effective as of the 

date of the letter notifying the center of 

its approval. However, in order to 

ensure that Medicare-covered 

transplants are performed only in 

centers with continued demonstration 

of experience and skill in a particular 

type of transplant, we propose limiting 

a transplant center’s approval to 3 years. 

A time-limited approval would provide 

us with a mechanism to re-evaluate a 

transplant center’s ability to maintain 

the skill and experience necessary to 

perform transplants safely and 

efficiently. 

C. Re-approval Procedures 

We propose at § 488.61(b) that 

transplant centers would be required to 

comply with the data submission, 

outcome and process requirements at all 

times during the 3-year approval period. 

We may evaluate whether a transplant 

center is in compliance with the CoPs 

for transplant centers at any time during 

the 3-year approval period. For 

example, if the OPTN notified us that a 

center failed to meet the proposed data 

submission requirements, we would 

consider this significant information 

that would warrant conducting a 

complaint investigation. 

At least 180 days before the end of a 

transplant center’s 3-year approval 

period, we would evaluate each center’s 

data for compliance with the data 

submission and outcome requirements 

for re-approval proposed at § 482.82, 

including the requirement to have posttransplant follow-up on at least 9 

transplants during the 2.5-year period 

reported by the SRTR in the most recent 

center-specific report. For compliance 

with the data submission requirements, 

we would review the OPTN’s statistics 

on data completeness for the previous 3 

calendar years. For compliance with the 

outcome measures requirements, we 

would review the data contained in the 

most recent SRTR center-specific 

reports. As stated previously, the SRTR 

center-specific reports are updated 

every six months in January and July of 

each year. If, for example, a transplant 

center’s Medicare approval ends on 

October 1, 2006, we would review the 

center’s 1-year patient and graft survival 

statistics from the SRTR’s July 2006 

reports. As stated previously, the July 

2006 SRTR center-specific reports 

would include patient and graft survival 

statistics on transplants performed 

anywhere between 1 to 3.5 years 

previously.

We propose that if we determine that 

a transplant center has met the data 

submission and outcome requirements 

proposed at § 482.82, including the 

requirement to have post-transplant 

follow-up on at least 9 transplants 

during the 2.5-year period reported by 

the SRTR in the most recent centerspecific report, the transplant center 

would be re-approved for 3 years. The 

re-approval dates would vary from 

center to center based on their initial 

approval dates. We propose that if, 

however, we determine that a center has 

failed to meet the data submission and 

outcome measure requirements 

proposed at § 482.82, including the 

requirement to have post-transplant 

follow-up on at least 9 transplants 

during the 2.5-year period reported by 

the SRTR in the most recent centerspecific report, a survey for compliance 

with the CoPs proposed at § 482.68 

through § 482.76 and § 482.90 through 

§ 482.104 would be necessary for a 

transplant center to be re-approved. 

Under some circumstances, we 

believe that a transplant center’s 

inability to meet the data submission or 

outcome requirements can be 

influenced by factors that are not 

necessarily indicative of the quality of 

transplantation care. It is possible that a 

transplant center with a large number of 

transplant recipients that live outside 

the transplant center’s geographical area 

might have a difficult time tracking 

these patients to assess the patients’

outcomes or that the center-specific 

model might fail to take into 

consideration a significant variable 

unique to the transplant center. For 

example, a transplant center may be 

participating in an institutional review 

board (IRB) approved 

immunosuppression withdrawal 

research protocol that may have resulted 

in worse than expected graft survival. 

Therefore, when a center fails to meet 

the data submission or outcome 

requirements (including failure to 

perform at least 9 transplants during the 

2.5-year period reported by the SRTR in 

the most recent center-specific report) 

based on a desk review of the data, we 

would also incorporate an onsite survey 

for compliance with the process 

requirements. If, based on the survey 

results, we determine that a center is in 

compliance with the process 

requirements, then we would assume 

that particular center’s data submission 

or outcome data are not necessarily 

indicative of the quality of 

transplantation care provided at the 

center.

As a result, there could be some 

circumstances under which a center that 

failed to meet the data submission or 

outcome requirements would be reapproved. In other words, a successful 

survey may under certain circumstances 

make up for a center’s failure to meet 

one or more of the quantitative 

requirements. We propose that we or 

our designee would notify the 

transplant center in writing if it has 

been re-approved or not. If re-approved, 

we would also notify the transplant 

center of the effective date of the reapproval. 

D. Alternative Process To Re-Approve 

Transplant Centers 

[If you choose to comment on this issue, 

please include the caption 

‘‘ALTERNATIVE PROCESS TO REAPPROVE TRANSPLANT CENTERS’’ at 

the beginning of your comments.] 

We have proposed that transplant 

centers would be re-approved for 3 

years if they met the data submission 

and outcome requirements proposed at 

§ 482.82. We or our designee would 

conduct a survey for compliance with 

the process requirements only if we 

determined that a center failed to meet 

the data submission and outcome 

measures requirements. Nonetheless, we 

are concerned that adherence to the data 

submission and outcome measures 

requirements does not necessarily 

indicate that a transplant center also is 

in compliance with the process 

requirements. For example, a transplant 

center could have good outcomes but be 

in violation of our proposed 

requirements for protection of living 

donors. Therefore, we have developed 

an alternative approach for re-approval 

6168 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

of transplant centers that would more 

closely monitor transplant center 

compliance with the process 

requirements. We are requesting 

comments on this alternative process 

from the public. 

First, as put forth in this proposed 

rule, we would conduct complaint 

investigations of transplant centers as 

needed. In addition, we would conduct 

random surveys of a certain percentage 

of centers every year to determine their 

compliance with the process 

requirements. Finally, before reapproving centers based on their 

meeting the data submission and 

outcome measures requirements, we 

would determine for each center 

whether a survey for compliance with 

the process requirements should be 

conducted prior to re-approval. We 

would decide whether to conduct a 

survey based on information provided 

to us by the OPTN, such as desk and onsite audit findings and actions taken 

against a transplant center since the last 

Medicare approval or re-approval of the 

center. 

We are requesting comments on the 

feasibility and utility of this option, as 

well as specific comments regarding: (1) 

How a random sample should be 

selected (percentage and type of 

centers); (2) whether all centers should 

be surveyed every 3 years, regardless of 

their compliance with the data 

submission and outcome requirements; 

and (3) whether it would be appropriate 

for CMS to base decisions about the 

need to conduct individual transplant 

center surveys on information provided 

by the OPTN. 

E. Loss of Medicare Approval 

We propose that centers that have lost 

their Medicare approval may seek reentry into the program at any time. 

Although we are not proposing to 

restrict when a center can re-enter the 

Medicare program, we propose that the 

center must request initial Medicare 

approval as if it were a new center. In 

other words, the center would have to 

request approval using the initial 

approval procedure described in 

§ 488.61(a). Furthermore, the center 

would have to be in compliance with all 

requirements for transplant centers, 

except for the re-approval requirements 

at § 482.82, at the time of its request. 

Regardless of whether the loss of 

Medicare approval was voluntary or 

involuntary, we propose that a center 

seeking to re-enter the Medicare 

program would have to submit a report 

documenting any changes or corrective 

actions the center has taken as a result 

of the loss of its Medicare approval 

status.

F. Applications From Consortia 

A consortium is a group of hospitals 

with cooperative arrangements to 

perform organ transplants. The 

cooperative arrangements can be formed 

between a variety of hospitals, such as 

cooperative arrangements between a 

university hospital and a Veterans 

Administration hospital or between 

hospitals in a given city, state, or region. 

In most consortia, a single transplant 

surgeon performs transplants 

throughout all hospitals in the 

consortium. Currently, we do not 

approve consortia collectively as organ 

transplant centers. However, an 

individual center that is a member of a 

consortium may submit an individual 

application at any time. 

We are proposing to retain this policy 

under the revised requirements because 

we believe that the extent of a facility’s 

skills and experience can be accurately 

determined only by looking at each 

facility on an individual basis; 

attempting to determine a center’s 

experience level on a consortium basis 

will not provide the same assurances. 

G. Effect of New CoPs for Transplant 

Centers on Centers That Are Currently 

Medicare-approved 

Since this proposed rule introduces a 

survey component to the approval 

procedures for transplant centers, we 

propose that a hospital that is currently 

Medicare-approved for furnishing 

organ-specific transplants would need 

to request approval for each particular 

type of transplant center. We propose to 

treat centers that are currently 

Medicare-approved as new centers. In 

other words when this proposed rule is 

published as a final rule, all transplant 

centers that are currently Medicareapproved would have to submit a letter 

of request to CMS for initial Medicare 

approval if they would like to continue 

operating as Medicare-approved 

transplant centers. Transplant centers 

that are currently Medicare-approved 

would be expected to meet the data 

submission outcome, and process 

requirements contained at § 482.68 

through § 482.80 and § 482.90 through 

§ 482.104 when they request Medicare 

approval. 

In order to determine whether or not 

a center that is currently Medicareapproved is in compliance with the 

requirements in this proposed rule, we 

will need to conduct surveys of the 

transplant center. We propose that 

transplant centers that are currently 

Medicare-approved have 180 days from 

the date these regulations become 

effective to submit a letter requesting 

Medicare approval. We, or our designee, 

would review the center’s compliance 

with the data submission and outcome 

measure requirements proposed at 

§ 482.80. If we determine that the center 

that is currently Medicare-approved is 

in compliance with these quantitative 

requirements, then we would schedule 

a survey to determine compliance with 

the CoPs proposed at §§ 482.68 through 

482.76 and §§ 482.90 through 482.104. 

During the time that the data is 

reviewed, the survey is conducted and 

a determination is made, we propose 

that the transplant centers that are 

currently Medicare-approved would be 

able to continue to provide transplant 

services until we notify them whether or 

not we have approved them under the 

new CoPs for transplant centers. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

(PRA) of 1995, we are required to 

provide 60-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 comment 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. 

Therefore, we are soliciting public 

comments on each of these issues for 

the information collection requirements 

discussed below. 

The following information collection 

requirements and associated burdens 

are subject to the PRA. 

Condition of Participation: Notification 

to CMS (Section 482.74) 

Centers must notify CMS immediately 

of any significant changes related to the 

center’s transplant program or that 

would otherwise alter specific elements 

in their application or re-approval. 

Several examples are given. 

We estimate that the burden 

associated with this rule will be the 

time required to notify CMS of 

significant changes. We estimate that 

there will be 3 occasions annually per 

center requiring notification. For each 

occasion, we estimate that it will take 5 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6169

minutes to notify us. Therefore, we 

believe that it should take no more than 

15 minutes annually for each center to 

notify us of any significant changes such 

as personnel changes. Assuming that all 

centers may have significant changes 

each year, we estimate that there will be 

approximately 900 centers that will 

need to inform us of these significant 

changes for a national total of 225 hours. 

Condition of Participation: Pediatric 

Transplants (Section 482.76) 

In order to be reimbursed for pediatric 

transplants provided to Medicare 

beneficiaries, a hospital that furnishes 

transplantation services to pediatric 

patients must seek Medicare approval to 

provide pediatric transplantation 

services. The center must submit a 

written request for Medicare approval. 

We believe that the burden associated 

with this rule would be the time 

required to prepare and give us the 

information. In 2002, there were 75 

hospitals that reported performing 

pediatric heart, heart-lung, intestine, 

liver, lung, and/or pancreas transplants 

to the OPTN. Assuming that the number 

of transplant centers performing 

pediatric transplants does not fluctuate 

significantly from year to year and 

assuming that we can expect all eligible 

hospitals to apply, we anticipate that 

there will be 75 hospitals requesting 

approval under this provision and that 

it will take each hospital 1 hour per 

center (i.e. a pediatric hospital with a 

lung center and heart center would 

require 1 hour to request Medicareapproval for its lung center and 1 hour 

to request Medicare-approval for its 

heart center). Since the 75 hospitals 

performing pediatric transplants have 

an average of 2 centers, we anticipate 

the total amount of time required for 

each hospital to request Medicareapproval will be 2 hours for an one-time 

national total of 150 hours. 

Condition of Participation: Data 

Submission and Outcome Measure 

Requirements for Initial Approval of 

Transplant Centers (Section 482.80) 

Except as specified in paragraph (c) of 

this section, transplant centers must 

meet all of the data submission 

requirements in order to be granted 

approval by CMS. 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 it has 

performed.

We believe that these requirements 

reflect usual and customary business 

practice and would be followed even if 

there were no Medicare requirements. 

Therefore, the burden of these 

requirements is exempt under 5 CFR 

1320.3(b)(2). 

Under certain circumstances, a center 

may be eligible for initial approval on 

the basis of its 1-month patient and graft 

survival rates. In order for CMS to have 

1-month patient and graft survival data 

on all transplants performed during the 

previous 1-year period, the center may 

have to submit follow-up data to the 

SRTR, in addition to the data it 

normally would submit to the OPTN. 

The SRTR would need to prepare 

customized reports based on the 1-

month follow-up data. We anticipate 

that the burden associated with this 

requirement would be the time required 

by the transplant centers to submit the 

necessary data to the OPTN and the 

time required by the SRTR to prepare 

the customized reports and submit them 

to us. However, we do not believe that 

more than 9 entities will be eligible to 

be approved on the basis of its 1-month 

post-transplant outcomes, making this 

requirement not subject to the PRA, in 

accordance with 5 CFR 1320.3(c). 

Between 1998 and 2002, we received 

and approved applications from an 

average of approximately 10 heart, 

intestine, liver, and lung centers each 

year. We expect that fewer than 10 

centers will apply for and be eligible to 

apply on the basis of their 1-month posttransplant outcomes each year. 

Furthermore, out of the 239 heart, liver, 

lung and intestinal transplant centers 

that are Medicare-approved as of 

October 20, 2003, only 5 have 

voluntarily terminated their Medicare 

approval. We do not expect this 

requirement to significantly increase the 

number of centers that voluntarily 

terminate their Medicare approval. 

Condition of Participation: Data 

Submission and Outcome Measure 

Requirements for Re-Approval of 

Transplant Centers (Section 482.82) 

Except as specified in paragraph (c) of 

this section, transplant centers must 

meet all the data submission and 

outcome measure standards in order to 

be re-approved. No later than 90 days 

after the due dates established by the 

OPTN, a transplant center must submit 

to the OPTN 95 percent of the required 

data submissions on all transplants it 

has performed over the last 3 years. 

We believe that these requirements 

reflect usual and customary business 

practice and would be followed even if 

there were no Medicare requirements. 

Therefore, the burden of these 

requirements is exempt under 5 CFR 

1320.3(b)(2). 

Condition of Participation: Patient and 

Living Donor Selection (Section 482.90)

The transplant center must use 

written patient selection criteria in 

determining a patient’s suitability for 

placement on the waitlist 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. 

Before a transplant center places a 

transplant candidate on its waitlist, the 

candidate’s medical record must contain 

documentation that the candidate’s 

blood type has been determined on at 

least two separate occasions. When a 

patient is placed on a center’s waitlist 

or is selected to receive a transplant, the 

center must document in the patient’s 

medical record the patient selection 

criteria used. 

The facility must document in the 

transplant candidate’s and living 

donor’s medical record the living 

donor’s suitability for donation. 

We believe that these requirements 

reflect usual and customary business 

practice and would be followed even if 

there were no Medicare requirements. 

Therefore, the burden of these 

requirements is exempt under 5 CFR 

1320.3(b)(2). 

Condition of Participation: Organ 

Recovery and Receipt (Section 482.92) 

Transplant centers must have written 

protocols for deceased organ recovery, 

organ receipt, and living donor 

transplantation to validate donorrecipient matching of blood types and 

other vital data. 

We believe that these requirements 

reflect usual and customary business 

practice and would be followed even if 

there were no Medicare requirements. 

Therefore, the burden of these 

requirements is exempt under 5 CFR 

1320.3(b)(2). 

Condition of Participation: Patient and 

Living Donor Management (Section 

482.94) 

Transplant centers must have written 

patient management policies and 

patient care planning for the pretransplant, 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 set 

forth in writing the required policies 

and planning. We believe that it is usual 

6170 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

and customary business practice for 

these entities to write down their 

policies and planning procedures. Thus, 

any burden would not be subject to the 

PRA. 

In addition, transplant centers must 

keep their waitlists up to date, 

including:

(1) Updating waitlist patients’ clinical 

information, as needed to assess a 

patient’s status if an organ becomes 

available; 

(2) 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 placed on a center’s waitlist; 

and 

(3) Notifying the OPTN within 24 

hours of a patient’s removal from the 

center’s waitlist. 

Transplant centers must maintain upto-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. 

(1) For each patient who receives an 

evaluation for placement on a center’s 

waitlist, the center must document in 

the patient’s record that the patient has 

been informed of his or her transplant 

status, including notification of: 

(i) The patient’s placement on the 

center’s waitlist; 

(ii) The center’s decision not to place 

the patient on its waitlist; or 

(iii) The center’s inability to make a 

determination regarding the patient’s 

placement on its waitlist because further 

clinical testing or documentation is 

needed. 

Once a patient is placed on a center’s 

waitlist, the center must document in 

the patient’s record that the patient is 

notified of: 

(1) His or her placement status at least 

once a year, even if there is no change 

in the patient’s placement status; and 

(2) His or her removal from the 

waitlist for reasons other than 

transplantation or death within 10 days 

of the patient’s removal from the 

center’s waitlist. 

In the case of dialysis patients, 

transplant centers must document in the 

patient’s record that both the patient 

and the dialysis facility has been 

notified of the patient’s transplant status 

or of changes in the patient’s transplant 

status. 

In the case of patients admitted for 

organ transplants, transplant centers 

must maintain written records of 

multidisciplinary care planning during 

the pre-transplant period and 

multidisciplinary discharge planning for 

post-transplant care. 

The burden associated with this rule 

is the time required to document all the 

necessary information. We believe that 

it will take about 17,971 hours per year 

for all transplant centers to comply with 

these documentation requirements. 

Condition of Participation: Quality 

Assessment and Performance 

Improvement (QAPI) (Section 482.96) 

Under this section, a transplant center 

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. 

As part of this condition, a transplant 

center must establish a written policy to 

address and document adverse events 

that occur during any phase of an organ 

transplantation case and specifies what 

the policy must address at a minimum. 

The burden associated with this rule 

is the time required to write the 

improvement program, including the 

adverse action policy. We anticipate 

that this will take 8 hours on a one-time 

basis. Between 1998 and 2002, we 

received and approved applications 

from an average of approximately 10 

heart, intestine, liver, and lung centers 

each year. We do not expect that more 

than 10 centers will apply for and be 

accepted per year, so the burden 

subsequent to the implementation of the 

final rule will be approximately 80 

hours. 

Condition of Participation: Human 

Resources (Section 482.98)

The transplant center must identify to 

CMS and the OPTN a primary 

transplant surgeon and a transplant 

physician with appropriate training and 

experience to provide transplantation 

services. The burden associated with 

this requirement is the time it will take 

to notify CMS. It is information that will 

be included in the letter requesting 

initial approval and will not take any 

additional time. 

Condition of Participation: Organ 

Procurement (Section 482.100) 

Under this section, the transplant 

center must notify CMS in writing no 

later than 30 days after the termination 

of any agreement concerning organ 

procurement between the hospital and 

the OPO. 

The burden associated with this rule 

is the time required to notify CMS. We 

estimate that this will not take more 

than 15 minutes. However, we also do 

not believe that more than 9 entities will 

have to comply with this requirement, 

making it not subject to the PRA, in 

accordance with 5 CFR 1320.3(c). 

Condition of Participation: Patient and 

Living Donor Rights (Section 482.102) 

Transplant centers must have a 

written informed transplant patient 

consent process that informs each 

patient of: 

(1) The evaluation process. 

(2) The surgical procedures. 

(3) Alternative treatments. 

(4) Potential medical or 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 immediate or future success of 

the graft or the health of the patient, 

such as 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. 

(8) His or her right to refuse 

transplantation. 

Transplant centers must also have a 

written living donor informed consent 

process that informs 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 specified 

subjects. 

Transplant centers must notify 

patients placed on the center’s waitlist 

of information about the center that 

could impact the patient’s ability to 

receive a transplant should an organ 

become available: 

(1) A transplant center served by a 

single transplant surgeon or physician 

must inform patients placed on the 

center’s waitlist of 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. 

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

Medicare approval is terminated, either 

voluntarily or involuntarily, the center 

must: (a) Inform patients on the center’s 

waitlist of this fact and assist them in 

transferring to the waitlist of another 

Medicare-approved transplant center 

without loss of time on the waitlist; and 

(b) inform Medicare beneficiaries added 

to the center’s waitlist that Medicare 

will no longer pay for transplants 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6171

performed at the center after the 

effective date of the center’s loss of 

approval. 

The burden associated with this rule 

is the time required to give the patient/

living donor the required information. 

For each patient on a center’s waitlist, 

we estimate that there will be an average 

of no more than 2 instances that will 

require the center to comply with any 

one of these requirements. We expect an 

average of 88,211 (81,604 patients on 

the waitlist + 6,607 living donors) 

waitlist patients and living donors per 

year who will have to be notified. 

Assuming that each notification would 

take approximately 5 minutes, the total 

national annual burden would be 14,701 

hours.

Special Procedures for Approval and 

Re-Approval of Organ Transplant 

Centers (Section 488.61) 

Under this section, transplant centers 

must submit a letter of request to CMS 

for Medicare approval. The letter, 

signed by a person authorized to 

represent the center (for example, a 

chief executive officer), must include 

the hospital’s Medicare provider I.D. 

number; 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. 

Once this rule is finalized, all 

transplant centers that are currently 

Medicare-approved would be required 

to submit this letter if they wish to 

retain their Medicare approval. Since 

many transplant hospitals have more 

than one transplant center, we would 

assume that we would receive one letter 

from the hospital containing the 

required information for each of the 

hospital’s transplant centers rather than 

a letter from each transplant center. 

Currently, there are approximately 230 

hospitals with a Medicare-approved 

transplant center. We assume that all 

230 hospitals with centers that are 

currently Medicare-approved would 

request approval under the new CoPs 

for transplant centers. Assuming that 

each letter would take approximately 15 

minutes, the total national burden upon 

initial implementation of this rule 

would be approximately 58 hours (230 

hospitals × 15 minutes/hospital). 

In addition, we receive and approve 

applications from an average of 

approximately 10 heart, intestine, liver, 

and lung centers each year. Assuming 

that we continue to receive and approve 

10 new transplant centers each year 

subsequent to the implementation of the 

final rule and that each letter from a 

transplant center would take 

approximately 10 minutes, we expect 

the total annual burden subsequent to 

implementation of the final rule to be 

approximately 2 hours. 

Finally, we propose that any center 

that has lost its Medicare approval 

would have to submit a report 

documenting any changes or corrective 

actions taken as a result of the center 

losing its Medicare approval. This 

report would be submitted to us along 

with the letter to request Medicare 

approval. We do not believe that more 

than 9 entities will be affected by this 

requirement making this requirement 

not subject to the PRA, in accordance 

with 5 CFR 1320.3(c). Out of 239 heart, 

liver, lung, and intestine centers that are 

Medicare-approved currently or 

previously, only 5 centers have 

voluntarily terminated their Medicare 

approval. Transplant centers, like other 

Medicare providers, have rarely had 

their Medicare approval status revoked 

involuntarily. 

We have submitted a copy of this 

proposed rule to OMB for its review of 

the information collection requirements 

described above. These requirements are 

not effective until they have been 

approved by OMB. 

If you comment on any of 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, 

Regulations Development and 

Issuances Group, Attn: John Burke, 

CMS–3835–P Room C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850; and 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 

20503, Attn: Christopher Martin, CMS 

Desk Officer, CMS–3835– P, 

christopher_martin@omb.eop.gov Fax 

(202) 395–6974.

IV. Response to Comments 

Because of the large number of items 

of correspondence we normally receive 

on Federal Register documents 

published for comment, we are not able 

to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, if we proceed with 

a subsequent document, we will 

respond to the comments in that 

document. 

V. Regulatory Impact Statement 

A. Overall Impact 

We have examined the impacts of this 

proposed rule as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review), the 

Regulatory Flexibility Act (RFA) 

(September 16, 1980 Pub. L. 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 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 rule to be $300,148; therefore, we 

do not believe this would be a major 

rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

non-profit 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 would not have a significant 

impact on a substantial number of small 

businesses. 

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 603 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 and has 

fewer than 100 beds. We believe this 

proposed rule would 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 

6172 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

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. 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 

proposed rule (and subsequent 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 notice of proposed rulemaking 

would not significantly affect the rights, 

roles, and responsibilities of States.

This proposed rule would 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. Although we do 

not believe this rule will have a 

significant impact on small rural 

hospitals or a significant economic 

impact, to the extent the rule may have 

significant effects on beneficiaries, or be 

viewed as controversial, we believe it is 

desirable to inform the public of our 

projections of the likely effects of the 

proposed rule. Thus, we have prepared 

the following analysis, which, in 

combination with the other sections of 

this proposed rule, is intended to 

conform to the objectives of the RFA 

and section 1102(b) of the Act. 

B. Anticipated Effects 

1. Effects on Transplant Hospitals or 

Centers 

Our intent in developing and 

implementing the proposed conditions 

of participation for transplant centers is 

to ensure Medicare-covered transplants 

are performed in an efficient manner in 

keeping with the importance of this 

scarce resource for individuals on organ 

transplant waitlists. This proposed 

regulation also serves to keep Medicare 

requirements current with the state of 

the art in transplantation. We do not 

anticipate that changes in the 

performance standards for transplant 

centers would affect the number of 

transplants performed. 

This proposed rule would establish 

conditions of participation for 

transplant centers that perform organ 

transplants. The proposed rule would 

maintain many of the same 

requirements that are in the current 

Federal Register notices for heart, lung 

and liver transplants; National Coverage 

Policies for pancreas, intestinal and 

multivisceral transplants, and 

conditions for coverage for kidney 

transplant centers. Some of the 

proposed changes could result in 

additional costs for some centers. While 

we do not believe the requirements in 

this proposed rule would 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 the proposed rule. There are 

two reasons this proposed rule would 

have a minimal economic effect. 

First, nearly 900 transplant centers 

may potentially be affected by the 

requirements in this proposed rule to a 

greater or lesser degree. However, the 

majority of the transplant centers 

probably have already put into practice 

most of the process requirements we are 

proposing, because the proposed 

requirements, for the most part, merely 

reflect advances in transplantation 

technology, as well as standard care 

practices. 

Second, although the proposed rule 

requires a large amount of data to be 

submitted, transplant centers already 

submit these data to the OPTN. 

a. OPTN Membership 

We do not believe there would be any 

economic impact as a result of our 

proposal requiring transplant centers to 

be in a transplant hospital that is 

member of the OPTN and that abides by 

OPTN’s approved rules and 

requirements. By statute and under 

regulations at § 482.45(b)(1) of this 

chapter, Medicare-approved transplant 

centers are already required to be in 

hospitals that are members of the OPTN 

and that abide by the OPTN’s approved 

rules and requirements. 

b. Notice of Significant Changes to CMS 

Current Medicare transplant policies 

require centers to report immediately to 

CMS any events or changes that would 

affect their approved status. 

Specifically, a center is required to 

report, within a reasonable period of 

time, any significant decrease in its 

experience level or survival rates, the 

departure of key members of the 

transplant team or any other major 

changes that could affect the 

performance of transplants at the center. 

The proposed standard for notification 

of significant changes to CMS is almost 

identical to the current requirements. 

We do not anticipate any additional 

economic impact associated with this 

requirement.

c. Pediatric Transplants 

We have proposed to treat centers that 

perform pediatric transplants like any 

other transplant center seeking 

Medicare approval. In addition, we 

proposed to give heart centers the 

option of meeting the current 

requirements for Medicare approval to 

perform pediatric heart transplants. 

Hence, we believe the proposed 

requirements for pediatric transplant 

centers will result in the same economic 

impact that centers requesting Medicare 

approval to perform adult transplants 

would face when meeting the 

requirements of this proposed rule. The 

requirements for pediatric transplants 

alone would not be an economic 

burden. 

d. Data Submission 

The proposed data submission 

requirements for initial approval and reapproval require a transplant center to 

submit to the OPTN, no later than 90 

days after the due date established by 

the OPTN, at least 95 percent of 

required data submissions on all 

transplants it has performed. We believe 

there would be little or no economic 

impact since the proposed requirements 

essentially mirror the OPTN’s policies 

on data submission. We anticipate that 

most transplant centers are already 

submitting data to the OPTN as part of 

their membership responsibilities. 

e. Outcome Measures 

Currently, heart, liver and lung 

centers are required to calculate and 

report 1-year and 2-year actuarial 

survival analysis using the modified 

Kaplan-Meier technique. We propose 

shifting all the calculation and analysis 

responsibilities from the centers to the 

SRTR, which currently uses the OPTN 

data to prepare both center-specific and 

national statistical reports. We have 

proposed utilizing the SRTR centerspecific reports to evaluate transplant 

center outcomes. Therefore, we believe 

there would be no or little economic 

impact on transplant centers as a result 

of this proposed requirement, unless 

one of the conditions in which a center 

may request Medicare approval on the 

basis of its 1-month post-transplant 

outcomes applies. In this case, there 

would be minimal economic burden 

associated with submitting follow-up 

data to the SRTR. There will be a cost 

of approximately $1,000 to generate a 

customized report from the SRTR for 1-

month post-transplant data. However, 

transplant centers have the option of 

waiting until their 1-year posttransplant data is available as part of the 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6173

center-specific reports if they do not 

wish to incur this cost. 

f. Patient and Living Donor Selection 

Under current policies, centers must 

have adequate written patient selection 

criteria and medical criteria for heart, 

liver and lung transplants, and clinical 

indications for coverage for pancreas 

and intestinal transplants. We propose 

similar patient selection requirements 

under the proposed condition and we 

believe there would be little or no 

economic impact from this condition. 

In addition to the proposed patient 

selection criteria, we are also proposing 

to require written living donor selection 

criteria and a psychosocial and medical 

evaluation for living donors. Given the 

potential risks to living donors, we 

believe that every hospital that performs 

living donor transplants has protocols 

for the selection of living donors that 

include procedures for performing a 

medical and psychosocial evaluation of 

the donor. Therefore, the condition 

proposed here would only affect those 

few transplant centers performing living 

donor transplants that do not already 

have written donor selection criteria. 

g. Organ Recovery and Receipt

The proposed condition for organ 

recovery and receipt requires transplant 

centers to have protocols for organ 

recovery and receipt that include 

protocols for validating the donorrecipient match. We believe nearly all 

transplant centers already have these 

protocols. We also believe that most 

transplant centers follow these practices 

to some degree. The proposed condition 

for organ recovery and receipt also 

assigns responsibility for ensuring the 

medical suitability of donor organs for 

transplantation into the intended 

recipient to the transplanting surgeon. 

We believe that most transplant centers 

currently follow this practice. Therefore, 

we foresee only minimal economic 

impact from the proposed requirements. 

h. Patient and Living Donor 

Management 

Some of the requirements proposed in 

this condition require transplant centers 

to have patient and living donor 

management policies during all phases 

of transplantation or living donation 

and this would have some economic 

impact on centers. We are proposing a 

waitlist management requirement for 

transplant centers to keep their waitlist 

current with patients’ clinical data and 

information regarding patients’ removal 

from the waitlist. The requirement also 

stipulates timely notification of patients’

removal to the OPTN. Updating the 

OPTN of a patient’s removal from the 

center’s waitlist and updating the 

waitlist patients’ clinical information on 

an ongoing basis are best practices that 

transplant centers use to assess 

transplant suitability should an organ 

become available. We do not anticipate 

additional economic impact associated 

with this requirement. 

We propose a patient records 

requirement for transplant centers to 

maintain current and accurate 

management records for each patient 

who is evaluated for placement on the 

center’s waitlist and is admitted for 

organ transplantation. Specifically, we 

propose that once a patient has received 

an evaluation for transplant, a 

transplant center is required to 

document that it has notified the patient 

when: (1) The patient is placed on the 

center’s waitlist; (2) the center decides 

not to place the patient on its waitlist; 

or (3) the transplant center requires 

further clinical testing or documentation 

before determining whether the patient 

can be placed on the center’s waitlist. 

We also propose that once a patient is 

placed on a center’s waitlist, the center 

must notify the patient of his or her 

removal from the waitlist for reasons 

other than transplantation or death no 

later than 10 days after the patient’s 

removal from the center’s waitlist and 

document that the patient has been 

notified in the patient’s record. These 

proposed patient notification and 

documentation requirements are based 

on the OPTN requirements. 

The currently, the OPTN requires 

transplant centers to notify patients of 

their status in writing (1) within 10 

business days of the patient’s placement 

on the OPTN Patient Waitlist or if a 

determination has been made based on 

evaluation of the patient that the patient 

will not be placed on the OPTN waitlist 

at this time and (2) within 10 business 

days of removal from the OPTN Patient 

Waitlist for reasons other than 

transplant. We expect that most 

transplant centers are currently in 

compliance with this OPTN 

requirement. We also believe that our 

proposed requirements provide 

transplant centers with more flexibility 

to determine how to notify patients than 

the current OPTN requirements. 

Therefore, we do not believe that 

transplant centers would incur any 

additional economic impact as a result 

of this proposed rule.

We are also proposing to require that 

once a patient has been placed on a 

center’s waitlist, the center must 

document in the patient’s record that 

the center has informed the patient of 

his or her status at least once a year, 

even if there is no change in status. 

Furthermore, for patients on dialysis, 

the patient’s record must also include 

documentation that the patient’s usual 

dialysis facility is also notified of a 

patient’s transplant status and of 

changes in the patient’s transplant 

status. We anticipate this requirement 

would result in some economic impact 

on transplant centers. As of December 

31, 2003, there were 83,731 waitlist 

registrations on the OPTN waitlist for 

deceased organs, which was a 5.5 

percent increase from 79,387 

registrations at the end of 2002 (2003 

SRTR Annual Report). Assuming that, 

on average, the number of registrations 

on the OPTN waitlist for deceased 

organs increases by 6 percent each year, 

we can expect that by the end of 2006, 

there will be 99,725 registrations on the 

OPTN waitlist for deceased organs. 

Since transplant centers vary by size, it 

is not possible to determine a mean 

number of patients that each center lists 

on the OPTN waitlist. Thus, in 

quantifying the burden of notifying 

patients of their status annually, we are 

assuming that every transplant center 

that is a member of the OPTN either has 

Medicare approval or applies for 

Medicare approval as a transplant center 

as a result of this proposed rule. 

Consequently, assuming that it will take 

administrative support personnel, at an 

average salary of $12 per hour, no more 

than 10 minutes to provide each patient 

on the deceased organ waitlist written 

notification of their status then the total 

maximum annual labor hours to all 

transplant centers is expected to be 

16,621 hours (99,725 patient 

notifications × 10 minutes for 

notification) and the total maximum 

annual labor cost to all transplant 

centers in the U.S. is expected to be 

$199,452 (16,621 hours × $12/hour) in 

2006. In addition, we estimate the total 

cost of the paper, envelopes, toner, and 

postage required to produce and mail 

each letter would be $49,863 (99,725 

patient notifications × $0.50/

notification). Therefore, the total 

estimated cost of notifying patients 

annually of their waitlist status is 

$249,315 ($199,452 + $49,863), if we 

assume that transplant centers choose to 

notify patients in writing.

We assume that in order to notify a 

dialysis facility of a patient’s status, the 

transplant center would just send the 

dialysis facility a copy of the letter 

notifying the patient of his or her status. 

We estimate that the 99,725 OPTN 

waitlist registrations expected by the 

end of 2006 would include 64,203 

registrations on the OPTN kidney 

waitlist and 3,062 registrations on the 

OPTN kidney-pancreas waitlist if we 

assume that the 6 percent annual growth 

6174 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

rate for all transplants applies to kidney 

transplants and kidney-pancreas 

transplants. Therefore, transplant 

centers would need to notify dialysis 

facilities of the status of 67,265 patients. 

Since we are assuming that transplant 

centers would notify patients in writing 

and just send dialysis facilities a copy 

of the letter to the patient notifying the 

patient of his or her status, we estimate 

that it will take administrative support 

personnel, at an average salary of $12 

per hour, approximately 1 minute per 

letter to print a copy for the dialysis 

facility. Consequently, the total 

estimated annual labor burden for all 

transplant centers to notify dialysis 

facilities of patient status is 

approximately 1,121 hours (67,265 

dialysis facility notifications × 1 

minute/notification) and the total 

estimated labor costs for all transplant 

centers to notify dialysis facilities of 

patient status is approximately $13,452 

(1,121 hours × $12/hour). The total cost 

of the paper, toner, and postage required 

to produce and mail each letter is 

estimated to be $33,633 (67,265 dialysis 

facility notifications × $0.50/

notification). Therefore, we estimate the 

total cost of mailing notification letters 

to the dialysis facility to be $47,085 and 

the total cost of notifying both patients 

and dialysis facilities to be $296,400 

($47,085 for notifying dialysis facilities 

annually + $249,315 for notifying 

patients annually).

PROJECTED NUMBER OF WAITING LIST PATIENTS

Calendar year 

Number of patients on: 

OPTN waiting 

list (all transplants) 

Kidney waiting 

list 

Kidney-pancreas waiting 

list 

2003 ............................................................................................................................................. 83,731 53,906 2,571 

2004 ............................................................................................................................................. 88,755 57,141 2,725 

2005 ............................................................................................................................................. 94,080 60,569 2,888 

2006 ............................................................................................................................................. 99,725 64,203 3,062 

CALENDAR YEAR 2003 COST ESTIMATES

Requirement Calculations 

Annual

burden

hours 

Annual cost

estimate 

Annual notification of patient status to patients ... 99,725 patients on OPTN waiting list × 10 min./written notification.16,621 

1 admin. support staff × $12/h × 16,621 h ................................... .................... $199,452 

99,725 notifications × $0.50/notification ....................................... .................... $49,863 

Total for annual notification to patients ......... ....................................................................................................... 16,621 $249,315 

Annual notification of patient status to dialysis 

centers.

67,265 patients on OPTN waiting list for kidney or kidney-pancreas transplant × 1 min./written notification.1,121 

1 admin. support staff × $12/h × 1,121 ........................................ .................... $13,452 

67,265 dialysis facility notifications × 0.50/notification ................. .................... $33,633 

Total for annual notification to dialysis facilities........................................................................................................ 1,121 $47,085 

Annual Total For Both Requirements .... ....................................................................................................... 17,742 $296,400 

For patients admitted for organ 

transplants, we expect that 

documentation of pre-transplant 

multidisciplinary patient care planning 

and post-transplant discharge planning 

are common practices for most 

transplant centers. Therefore, there will 

be little resultant economic impact. 

We are proposing to require every 

center to make available a qualified 

social worker to provide psychosocial 

supportive services to transplant 

patients, living donors, and their 

families. We are also proposing to 

require every center to make available a 

qualified dietitian to provide nutritional 

assessments and diet counseling to all 

transplant patients and living donors. 

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 and a dietitian to 

provide psychosocial, supportive, and 

nutrition services. Thus, most centers 

would not need to hire any additional 

staff to meet this requirement. 

Therefore, there will be little resultant 

economic impact. 

i. QAPI 

The condition for QAPI will have 

some economic impact on the minority 

of centers that do not have a data-driven 

QAPI program. We estimate that a 

center that does not currently have a 

QAPI program probably would need one 

professional position to develop, 

implement, and coordinate a program 

that reflects the scope and complexity of 

the center’s transplant program. We 

imagine a center would likely utilize an 

experienced individual from its hospital 

QAPI staff. QAPI coordinators are 

usually registered nurses (RNs) and 

sometimes individuals with other 

backgrounds. In 2002, the mean annual 

income of an RN was $42,730. We 

request 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. 

j. Human Resources 

The condition for human resources 

would require every center to designate 

a qualified director to provide general 

supervision over the center and to 

designate a primary transplant surgeon 

and physician with the appropriate 

training and experience to provide 

transplantation services. The director of 

the transplant center would not need to 

serve full time and may also serve as the 

center’s primary transplant physician. 

Therefore, the primary transplant 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6175

surgeon and the physician could be the 

same individual, if necessary. The 

kidney transplant regulations require 

renal transplant centers to be supervised 

by a qualified transplantation surgeon or 

qualified physician-director. Current 

transplant center criteria require a 

transplant center to be a member of the 

OPTN and abide by its rules. The OPTN 

requires its members to have transplant 

surgeons and physicians with specific 

qualifications, training and experience. 

We believe all transplant centers already 

have designated primary transplant 

surgeons and transplant physicians. We 

also believe that in most transplant 

centers the primary transplant surgeon 

or transplant physician provides general 

supervision over the transplant center. 

Therefore, we do not believe this 

condition would have a significant 

economic impact. 

We are also proposing to require every 

center to have a clinical transplant 

coordinator. Because of the complex 

medical needs of post-transplant 

patients and living donors, we believe, 

it is crucial for every center to have a 

clinical transplant coordinator. We 

believe most centers have a clinical 

transplant coordinator on staff to 

coordinate all patient care and 

management activities. Clinical 

transplant coordinators are usually 

registered nurses (RNs). According to 

the Bureau of Labor Statistics, the 2002 

mean annual income of an RN was 

$42,730.

Like the current policies for heart, 

liver and lung transplants, the human 

resources condition also would require 

centers to have a stable transplant team 

with delineated responsibilities for its 

members. The team must be composed 

of individuals with appropriate 

qualifications, training, and experience 

in relevant areas of medicine, nursing, 

nutrition, social services, transplant 

coordination, and pharmacology. Since 

transplant centers and transplant 

hospitals are usually staffed with such 

individuals, we believe this requirement 

would not have a significant economic 

impact on transplant centers. Also, we 

propose that transplant centers must 

demonstrate availability of expertise in 

internal medicine, surgery, 

anesthesiology, immunology, infectious 

disease, pathology, radiology, and blood 

banking as related to the provision of 

transplantation services. We expect 

these are integral parts of 

transplantation services. Therefore, this 

requirement would not have resultant 

economic impact. 

k. Organ Procurement 

We propose requiring transplant 

hospitals to have a written agreement 

for the receipt of organs with an OPO 

designated by the Secretary. The 

transplant hospital-OPO agreement 

would have to identify specific 

responsibilities for the hospital and for 

the OPO with respect to organ recovery 

and organ allocation. Under § 482.45, all 

Medicare participating hospitals already 

have such written agreements with an 

OPO in their service areas. There is no 

additional economic impact associated 

with this condition. 

l. Patients’ and Living Donors’ Rights 

Current kidney transplant regulations 

require a center to inform patients 

regarding their suitability for 

transplantation. The OPTN states that 

patients must be informed of their rights 

in advance of transplantation. The 

proposed condition for patients and 

living donors’ rights would require 

every transplant center to inform 

patients and living donors of their rights 

in advance of transplantation or 

donation and to provide written 

informed consent to patients and living 

donors. The proposed condition 

requires centers to inform patients of 

donor history, the use of marginal 

organs or organs from donors who are at 

risk for HIV and other infectious 

diseases. We also propose requiring 

centers to inform patients of all aspects 

of and potential outcomes from 

transplantation, such as the evaluation 

process, the surgical procedure, 

alternative treatments for the transplant 

patient, potential medical and 

psychosocial risks to the patient, 

specific transplant outcomes for 

recipients, and their right to refuse 

transplantation. Furthermore, the 

proposed standard requires centers to 

provide information to prospective 

living donors regarding all aspects of 

and potential outcomes from living 

donation, such as the evaluation 

process, surgical procedure, alternative 

treatments for the transplant patient, 

potential medical and psychosocial 

risks to the donor, specific transplant 

outcomes for both donors and 

recipients, and potential future health 

and life insurance coverage problems 

related to living donation. The proposed 

standard also requires centers to give 

potential living donors the option to 

refuse donation at any time during the 

donation process. We believe all 

transplant centers have policies for an 

informed consent process for patients. 

Under the proposed condition, some 

centers may have to broaden their 

informed consent policies to include 

living donors. However, these 

provisions would have little resultant 

economic impact. 

Furthermore, the condition also 

requires centers with a single transplant 

team to inform patients of the potential 

unavailability of the transplant team 

should an organ become available for 

the patient and whether or not the 

transplant center has a mechanism to 

provide an alternate transplant surgeon 

or transplant physician that meets the 

hospital’s credentialing policies should 

the center’s transplant surgeon or 

physician be unavailable. We also 

propose that at least 30 days before a 

center’s Medicare approval is 

terminated, the center must inform 

patients on the center’s waitlist of this 

fact immediately and provide assistance 

to waitlist patients who choose to 

transfer to the waitlist of another 

Medicare-approved center and inform 

Medicare beneficiaries added to the 

center’s waitlist that Medicare will no 

longer pay for transplants performed at 

the center after the effective date of the 

center’s termination. We believe that 

any additional economic impact from 

this requirement would be minimal 

because current OPTN requirements 

require transplant centers that are 

inactive, either voluntarily or 

involuntarily, to notify patients and to 

assist them in transferring to a waitlist 

of an active center. The OPTN 

requirements also allow the patient to 

retain his or her waiting time. 

m. Additional Requirements for Kidney 

Transplant Centers 

Current kidney transplant regulations 

require ESRD facilities such as kidney 

transplant centers to participate in 

ESRD network activities for ESRD 

program administration. Therefore, we 

do not expect these requirements to 

have any resultant economic impact. 

2. Effects on the Rights of Patients and 

Living Donors 

The patients’ and living donors’ rights 

proposed in this rule are designed to 

increase the focus on patient and living 

donor transplantation choices. We 

believe we have strengthened a number 

of patient protections and have 

reinforced our mandate to protect the 

health, safety, and welfare of patients 

served.

3. Effects on the Medicare Program 

Although the number of organ 

transplants has grown rapidly, donor 

availability is a significant limitation on 

the number of transplants that are 

performed. Because of their age and the 

presence of other complicating 

conditions, only a relatively small 

number of Medicare beneficiaries are 

presently heart, heart-lung, liver, lung, 

intestinal, or pancreas transplant 

6176 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

candidates. For example, while 

Medicare covered 12,721 kidney 

transplants in 2002, only 515 heart 

transplants, 779 liver transplants, 209 

lung transplants, 6 heart-lung 

transplants, and 693 pancreas 

transplants were covered by Medicare. It 

is difficult to precisely estimate future 

Medicare costs, largely due to the 

difficulty of predicting the availability 

of donor organs over the next few years. 

All dollar estimates depend on 

assumptions and estimates related to the 

number of covered transplants. Based 

on the Office of the Actuary’s 5-year 

budget projections, we consider future 

changes in organ transplant cost 

estimates over time to be negligible, and 

therefore we believe that this regulation 

will have no significant dollar impact. If 

anything, the CoPs could save Medicare 

dollars by improving patient care 

(preventing morbidity that would result 

in re-hospitalization) and preventing 

some graft failure (which would obviate 

the need for re-transplantation) or a 

return to dialysis for kidney patients. In 

addition, we do not believe this rule 

will increase the number of Medicarecovered transplants performed since 

there is nothing in the rule that impacts 

donation or the allocation of organs. 

We propose procedures for approval 

and re-approval of transplant centers at 

§ 488.61. For initial approval, we 

propose that all the CoPs proposed at 

§ 482.68 through § 482.104, except for 

§ 482.82 (Re-approval requirements), 

would have to be met in order for a 

transplant center to become Medicareapproved. Determinations on whether or 

not a transplant center is in compliance 

with these requirements would be made 

based on a review of a transplant 

center’s data submission and outcome 

measures data required at § 482.80 and 

on the results of a survey for compliance 

with proposed § 482.68 through § 482.76 

and § 482.90 through § 482.104, using 

the survey, certification, and 

enforcement procedures described at 42 

CFR part 488, subpart A. 

We propose to re-approve transplant 

centers every 3 years, but transplant 

centers would need to be in compliance 

with CoPs at § 482.68 through § 482.76 

and § 482.82 through § 482.104 at all 

times. At least 180 days prior to the end 

of a transplant center’s 3-year approval 

period, we would review the transplant 

center’s data submission and outcome 

measures data. We propose that if we, 

or our designee, determine that a 

transplant center has met the data 

submission or outcome requirements 

proposed at § 482.82, the transplant 

center would be approved for 3 years. If 

we, or our designee, determine that the 

transplant center has failed to meet the 

data submission and outcome measure 

requirements 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 propose 

that transplant centers which have lost 

their Medicare approval would have to 

apply for initial approval as if they were 

a new center to re-enter the Medicare 

program and submit a report 

documenting any changes and/or 

corrective actions that have been made 

as a result of the loss of the center’s 

Medicare approval status. We believe 

that such documentation would be a 

customary business practice that would 

be part of the center and/or hospital’s 

QAPI program. 

We believe that the proposed 

procedures for approval and re-approval 

will have some economic impact on the 

Medicare program since transplant 

centers may need to be surveyed more 

frequently. We believe most of the 

economic impact on the Medicare 

program associated with the proposed 

approval and re-approval procedures 

would occur during initial 

implementation. We propose to treat 

centers that are currently Medicareapproved as new centers that would 

need to submit a letter of request to 

CMS for initial Medicare approval and 

meet the requirements for initial 

approval. Therefore, we, or our 

designee, would need to survey all the 

centers that are currently Medicareapproved that meet the data submission 

and outcome measure requirements 

proposed at § 482.80 when this 

proposed rule goes into effect. We 

propose that all transplant centers that 

are currently Medicare-approved and 

that wish to continue to be Medicareapproved under the new CoPs for 

transplant centers would have 180 days 

from the date these regulations become 

effective to submit a letter requesting 

Medicare approval. Based on the 

number of request letters we receive 

during these initial 180 days, we would 

schedule the survey of these transplant 

centers in a manner that would allow 

the surveyor(s) to survey all the 

transplant centers requesting approval 

within a particular hospital during the 

same visit. To further minimize burden 

on the Medicare program, we also 

propose that during the time the data 

are reviewed, the survey is conducted, 

and a determination made, transplant 

centers that are currently Medicareapproved would be able to continue to 

provide transplant services until we 

notify them whether or not we have 

approved them under the new CoPs for 

transplant centers.

Currently, there are approximately 

250 transplant hospitals that are 

members of the OPTN. About 93 percent 

of these transplant hospitals have at 

least one Medicare-approved transplant 

center. Assuming that all the transplant 

centers that are currently Medicareapproved request approval under the 

new CoPs and meet the data submission 

and outcome requirements proposed at 

§ 482.80, we would need to survey 

approximately 230 hospitals. Since the 

transplant centers would be able to 

continue to provide transplantation 

services until we notify them of their 

approval status under the new CoPs, we 

plan to stagger surveys of these 

hospitals over time. Therefore, we do 

not believe there would be a significant 

economic impact as a result of our 

proposal to treat all centers that are 

currently Medicare-approved as new 

centers. 

C. Conclusion 

We believe that the criteria we have 

developed are the most effective means 

available to ensure that organ 

transplants made available to patients 

are provided in a safe and effective 

manner. We estimate the net cost of this 

proposed rule to be approximately 

$300,000. We do not believe that any 

transplant hospitals are small rural 

hospitals within the definition of the 

Social Security Act. Although some 

transplant hospitals are small entities by 

virtue of their non-profit status, few if 

any of them will have any consequential 

cost. For these reasons, we are not 

preparing analyses for either the RFA or 

section 1102(b) of the Act because we 

have determined, and we certify, that 

this rule would not have a significant 

economic impact on the operations of a 

substantial number of small rural 

hospitals or on other small entities. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget (OMB).

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. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6177

42 CFR Part 488 

Administrative practice and 

procedure, Health facilities, Medicare, 

Reporting and recordkeeping 

requirements.

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services would amend 42 CFR 

chapter IV as set forth below:

PART 405—FEDERAL HEALTH 

INSURANCE FOR THE AGED AND 

DISABLED

Subpart U—Conditions for Coverage 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.

§§ 405.2120 through 405.2134 and 405.2170 

through 405.2171 [Removed] 

2. Sections 405.2120 through 

405.2134 and 405.2170 through 

405.2171 are removed.

§ 405.2102 [Amended] 

3. Section 405.2102 is amended by—

A. Removing the definitions for 

‘‘histocompatibility testing,’’ ‘‘Network, 

ESRD,’’ ‘‘Network organization,’’ and 

‘‘organ procurement’’. 

B. Amending the definition of ‘‘ESRD 

facility’’ by removing paragraph (a) and 

by redesignating paragraphs (b) through 

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

C. Amending the definition of ‘‘ESRD 

service’’ by removing paragraph (a) and 

by redesignating paragraphs (b) and (c) 

as paragraphs (a) and (b). 

D. Amending the definition of 

‘‘Qualified personnel’’ by removing 

paragraph (g).

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

1. 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.

2. 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 and 

Outcome Requirements 

482.80 Condition of participation: Data 

submission and outcome measure 

requirements for initial approval of 

transplant centers. 

482.82 Condition of participation: Data 

submission and outcome measure 

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 § 482.70 

through § 482.104 in order to be granted 

approval from CMS to provide 

transplant services. 

(a) Unless specified otherwise, the 

conditions of participation at § 482.70 

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 

§ 482.70 through § 482.104, a transplant 

center must also meet the conditions of 

participation specified in § 482.1 

through § 482.57.

§ 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 living donor death due to 

mismanagement of the donor; 

transplantation of organs of mismatched 

blood types due to failure to validate the 

donor and recipient’s vital information; 

transplantation of organs to unintended 

recipients; avoidable loss of a healthy 

living donor; 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. 

Intestinal transplant center means a 

Medicare-approved liver transplant 

center that performs intestinal 

transplants, combined liver-intestinal 

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 within a 

transplant hospital (i.e., 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 

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 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 

6178 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

rules and requirements approved by the 

Secretary pursuant to § 121.4 of this 

title. No transplant hospital 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 transplant center must notify CMS 

immediately of any significant changes 

related to the center’s transplant 

program or changes that would 

otherwise alter specific elements in 

their application for approval or reapproval. Instances in which CMS 

should be notified include, but are not 

limited to: 

(a) Change in key staff members of the 

transplant team, such as a change in the 

individual the transplant center 

designates to the OPTN as the center’s 

‘‘primary transplant surgeon’’ or 

‘‘primary transplant physician;’’ or 

(b) A decrease in the center’s volume 

or survival rates that could result in the 

center being out of compliance with 

§ 482.82.

§ 482.76 Condition of participation: 

Pediatric Transplants. 

A transplant center that wishes 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 in § 488.61. 

(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 contained in § 482.68 

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 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, will not 

impact the center’s Medicare approval 

to perform adult transplants. 

(c) 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. 

(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, will not 

impact the center’s Medicare approval 

to perform pediatric transplants. 

(3) No minimum number of 

transplants (adult or pediatric) is 

required prior to approval. 

(d) Instead of meeting all of the 

conditions of participation contained in 

§ 482.68 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 following criteria: 

(1) The center’s pediatric transplant 

program must be operated jointly by the 

center 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. 

Transplant Center Data Submission and 

Outcome Requirements

§ 482.80 Condition of participation: Data 

submission and outcome requirements for 

initial approval of transplant centers.

Except as specified in paragraph (c) of 

this section, transplant centers must 

meet all of the data submission and 

outcome measure standards in order to 

be granted initial approval by CMS. No 

waivers will be granted to centers that 

have failed to meet any one of the 

standards: 

(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 recipient follow-up. 

(b) Standard: Outcome measures.

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, as long as the center has 1-year 

post-transplant follow-up on at least 9 

transplants of the appropriate organ 

type. 

(2) The 9 transplants must have been 

performed during the timeframe 

reported in the most recent SRTR 

center-specific report. 

(3) CMS will not consider a center’s 

patient and graft survival rate to be 

acceptable if: 

(i) 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; 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. 

(4) A center may request that CMS 

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 the following 

conditions are met: 

(i) 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 and the 

transplant center’s team meets the 

human resources requirements at 

§ 482.98., and 

(ii) The most recent SRTR centerspecific report does not contain 1-year 

post-transplant follow-up on at least 9 

transplants of the appropriate organ 

type that were performed during the 

timeframe reported in the most recent 

SRTR center-specific report 

(5) A center that chooses to request 

initial Medicare approval using its 1-

month patient and graft survival 

outcomes must: 

(i) Request the SRTR to calculate the 

center’s observed and expected 1-month 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6179

patient and graft survival outcomes for 

transplants performed during the 

previous one-year period; and 

(ii) Have 1-month post-transplant 

follow-up on at least 9 transplants of the 

appropriate organ type that were 

performed during the previous one-year 

period.

(6) When assessing a center’s 1-month 

post-transplant outcomes, CMS will 

compare each transplant center’s 

observed number of patient deaths and 

graft failures 1-month post-transplant to 

the center’s expected number of patient 

deaths and graft failures 1-month posttransplant using the methodology 

described in § 482.80(b)(3). 

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

transplant center is not required to 

comply with the outcome measure 

requirements at § 482.80(b) for heartlung transplants performed at the 

center. 

(2) An intestinal transplant center is 

not required to comply with the 

outcome performance measure 

requirements at § 482.80(b) for 

intestinal, combined liver-intestinal or 

multivisceral transplants performed at 

the center. 

(3) A pancreas transplant center is not 

required to comply with the outcome 

measure requirements at § 482.80(b) for 

pancreas transplants performed at the 

center. 

(4) A center that is requesting initial 

Medicare approval to perform pediatric 

transplants is not required to perform a 

minimum number of pediatric 

transplants prior to its request for 

approval.

§ 482.82 Condition of participation: Data 

submission and outcome requirements for 

re-approval of transplant centers. 

Except as specified in paragraph (c) of 

this section, transplant centers must 

meet all data submission and outcome 

measure standards in order to be reapproved. 

(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. Required data 

submissions include, but are not limited 

to, submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration, and recipient follow-up. 

(b) Standard: Outcome measures.

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 SRTR 

center-specific report, as long as the 

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

appropriate organ type. 

(2) The 9 transplants must have been 

performed during the timeframe 

reported in the most recent SRTR 

center-specific report. 

(3) CMS will not consider a center’s 

patient and graft survival rate to be 

acceptable if: 

(i) A center’s observed patient 

survival rate and 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: 

(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. 

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

transplant center is not required to 

comply with the outcome measure 

requirements at § 482.82(b) for heartlung transplants performed at the 

center. 

(2) An intestinal transplant center is 

not required to comply with the 

outcome measure requirements at 

§ 482.82(b) for intestinal, combined 

liver-intestinal and multivisceral 

transplants performed at the center. 

(3) A pancreas transplant center is not 

required to comply with the outcome 

measure requirements at § 482.82(b) for 

pancreas and kidney-pancreas 

transplants performed at the center. 

(4) A center that is approved to 

perform pediatric transplants is not 

required to perform a minimum number 

of pediatric transplants to be reapproved.

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 waitlist 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) Before a patient is selected for 

transplant, except for kidney transplant 

patients, the 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. 

(2) Prior to placement on the center’s 

waitlist, a prospective transplant 

candidate must receive a psychosocial 

evaluation. 

(3) Before a transplant center places a 

transplant candidate on its waitlist, the 

candidate’s medical record must contain 

documentation that the candidate’s 

blood type has been determined. 

(4) When a patient is placed on a 

center’s waitlist or is selected to receive 

a transplant, the center must document 

in the patient’s medical record 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. Transplant centers 

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.

§ 482.92 Condition of participation: Organ 

recovery and receipt. 

Transplant centers must have written 

protocols for deceased organ recovery, 

organ receipt, and living donor 

transplantation to validate donorrecipient matching of blood types and 

other vital data. 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. A 

transplant center’s organ recovery team 

must review and compare the donordata with the recipient blood type and 

other vital data before organ recovery 

takes places. 

(b) Standard: Organ receipt. When an 

organ arrives at the center, the 

6180 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

transplanting surgeon and at least one 

other individual 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. 

(c) Standard: Living donor 

transplantation. If a center performs 

living donor transplants, the 

transplanting surgeon and at least one 

other individual 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 pretransplant, 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 pre-transplant, 

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: Waitlist management.

Transplant centers must keep their 

waitlists up to date, including: 

(1) Updating of waitlist patients’

clinical information on an ongoing 

basis; 

(2) 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; and

(3) Notifying the OPTN no later than 

24 hours after a patient’s removal from 

the center’s waitlist. 

(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 

waitlist and who is admitted for organ 

transplantation. 

(1) For each patient who receives an 

evaluation for placement on a center’s 

waitlist, the center must document in 

the patient’s record that the patient is 

informed of his or her transplant status, 

including notification of: 

(i) The patient’s placement on the 

center’s waitlist; 

(ii) The center’s decision not to place 

the patient on its waitlist; or 

(iii) The center’s inability to make a 

determination regarding the patient’s 

placement on its waitlist because further 

clinical testing or documentation is 

needed. 

(2) Once a patient is placed on a 

center’s waitlist, the center must 

document in the patient’s record that 

the patient is notified of: 

(i) His or her placement status at least 

once a year, even if there is no change 

in the patient’s placement status; and 

(ii) His or her removal from the 

waitlist for reasons other than 

transplantation or death no later than 10 

days after the patient’s removal from the 

center’s waitlist. 

(3) In the case of dialysis patients, 

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 any changes in the 

patient’s transplant status. 

(4) In the case of patients admitted for 

organ transplants, transplant centers 

must maintain written records of: 

(i) Multidisciplinary patient care 

planning during the pre-transplant 

period; and 

(ii) Multidisciplinary discharge 

planning for post-transplant care. 

(d) Standard: Social services. The 

transplant center must make available 

social services, furnished by qualified 

social workers, to transplant patients, 

living donors, and their families. A 

qualified social worker is an individual 

who meets licensing requirements in the 

State in which practicing, and 

(1) Has completed a course of study 

with specialization in clinical practice, 

and holds a masters degree from a 

graduate school of social work 

accredited by the Council on Social 

Work Education; or 

(2) Has served for at least 2 years as 

a social worker, one year of which was 

in a transplantation program, and has 

established a consultative relationship 

with a social worker who is qualified 

under § 482.94(d)(1). 

(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: 

(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.

§ 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. Activities and outcomes may 

include, but are not limited to, patient 

and donor selection criteria, accuracy of 

waitlist in accordance with the OPTN 

waitlist, accuracy of donor and recipient 

matching, patient and donor 

management, techniques for organ 

recovery, consent practices, 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 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 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6181

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). 

This 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) Ensuring adequate training of 

nursing staff in the care of transplant 

patients. 

(2) Ensuring tissue typing and organ 

procurement services are available. 

(3) Ensuring that transplantation 

surgery is performed 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. 

(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 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. A 

qualified clinical transplant coordinator 

is an individual who is certified by the 

American Board of Transplant 

Coordinators. 

(d) 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. 

(e) 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.

§ 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. 

(a) The transplant center must ensure 

that the hospital’s agreement with the 

OPO identifies specific responsibilities 

for the hospital and for the OPO with 

respect to organ recovery and organ 

allocation. 

(b) The transplant center must notify 

CMS in writing no later than 30 days 

after the termination of any agreement 

between the hospital and the OPO.

§ 482.102 Condition of participation: 

Patient and living donor rights. 

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. Transplant centers 

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 or 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. 

(8) His or her right to refuse 

transplantation. 

(b) Standard: Informed consent for 

living donors. Transplant centers must 

implement a written living donor 

informed consent process that informs 

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 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. 

(8) The donor’s right to opt out of 

donation at any time during the 

donation process.

(c) Standard: Notification to patients.

Transplant centers must notify patients 

placed on the center’s waitlist 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 waitlist of: 

(i) The potential unavailability of the 

transplant surgeon or physician; and 

(ii) Whether or not the center has a 

mechanism to provide an alternate 

transplant surgeon or transplant 

physician that meets the hospital’s 

credentialing policies. 

(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 

waitlist of this fact and provide 

assistance to waitlist patients who 

choose to transfer to the waitlist of 

another Medicare-approved transplant 

center without loss of time accrued on 

the waitlist; and 

(ii) Inform Medicare beneficiaries 

added to the center’s waitlist that 

Medicare will no longer pay for 

transplants performed at the center after 

the effective date of the center’s loss of 

approval.

§ 482.104 Condition of participation: 

Additional requirements for kidney 

transplant centers. 

(a) Standard: End stage renal disease 

(ESRD) services. Kidney transplant 

centers must furnish directly 

transplantation and other medical and 

surgical specialty services required for 

the care of ESRD patients. 

(b) Standard: Dialysis services.

Kidney transplant centers must furnish 

inpatient dialysis services directly or 

6182 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

under arrangement. Such kidney 

dialysis centers or units must meet the 

Conditions for Coverage of Suppliers of 

ESRD Services contained in part 405 

subpart U of this chapter. 

(c) Standard: Participation in network 

activities. Kidney transplant centers 

must cooperate with the ESRD Network, 

designated for its geographic area, in 

fulfilling the terms of the Network’s 

current statement of work.

PART 488—SURVEY, CERTIFICATION, 

AND ENFORCEMENT PROCEDURES 

1. 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).

Subpart B—Special Requirements 

3. 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 contained in 

§ 488.20. 

(a) Initial approval procedures. A 

transplant center can submit a letter of 

request to CMS for Medicare approval at 

any time. 

(1) The letter, 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; 

(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 

outcome measure requirements 

contained at § 482.80(c), CMS or its 

designee will review the 1-year patient 

and graft survival data contained in the 

Scientific Registry of Transplant 

Recipient’s (SRTR’s) most recent centerspecific reports. 

(3) If both of the conditions in 

§ 482.80(b)(4) apply, the center may 

request the SRTR to prepare a 

customized report of the center’s 1-

month patient and graft survival data for 

the previous 1-year period. CMS or its 

designee will determine compliance 

with the outcome measure requirements 

contained at § 482.80(b) using the data 

contained in these customized reports. 

(4) If CMS or its designee determines 

that a transplant center has met the data 

submission and outcome measure 

requirements of § 482.80, CMS or its 

designee will 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. 

(5) If a transplant center seeking 

Medicare approval is found to be in 

compliance with all the conditions of 

participation contained at § 482.68 

through § 482.104, except for § 482.82 

(Re-approval Requirements), CMS will 

notify the transplant center in writing of 

the effective date of its Medicareapproval.

(6) CMS or its designee will notify the 

transplant center in writing if it is not 

Medicare approved. 

(7) Initial approval of a transplant 

center will be for 3 years. 

(b) Re-approval procedures. Once 

Medicare-approved, a transplant center 

must be in compliance with all the 

conditions of participation for 

transplant centers contained at § 482.68 

through § 482.104, except for § 482.80 

(initial approval requirements) 

throughout the 3-year approval period. 

(1) At least 180 days before the end of 

the 3-year approval period, CMS, or its 

designee, will review the transplant 

center’s data in making re-approval 

determinations. 

(i) To determine compliance with the 

data submission requirements contained 

at § 482.82(a), CMS or its designee will 

request data submission data from the 

OPTN for the previous 3 calendar years. 

(ii) To determine compliance with the 

outcome measure requirements at 

§ 482.82(c), CMS or its designee will 

review the data contained in the most 

recent SRTR center-specific reports. 

(2) If CMS or its designee determines 

that a transplant center has met the data 

submission and outcome measure 

requirements contained at § 482.82, the 

transplant center will be re-approved for 

3 years. 

(3) If CMS or its designee determines 

that a transplant center has failed to 

meet the data submission or outcome 

measure requirements contained at 

§ 482.82, the transplant center will 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. 

(4) CMS or its designee will notify the 

transplant center in writing if it is reapproved or if its approval is being 

revoked. If re-approved, CMS or its 

designee will notify the transplant 

center of the effective date of the reapproval. 

(c) 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 §§ 482.68 

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 CMS 

documenting any changes or corrective 

actions taken by the center as a result of 

the loss of its Medicare approval status.

(Catalog of Federal Domestic Assistance 

Program No. 13.773 Medicare—Hospital 

Insurance Program; and No. 13.774, 

Medicare-Supplementary Medical Insurance 

Program)

Approved: July 30, 2004. 

Tommy G. Thompson, 

Secretary.

Editorial Note: This document was 

received at the Office of the Federal Register 

on January 26, 2005.

[FR Doc. 05–1696 Filed 1–28–05; 8:45 am] 

BILLING CODE 4120–01–P