[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Proposed Rules]
[Pages 6140-6182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1696]



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Part III





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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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

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

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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 Re-Approval of Transplant Centers To 
Perform Organ Transplants

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would set forth the requirements that 
heart, heart-lung, 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 Sec.  488.5 of the 
regulations,

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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 Sec.  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 time-limited exception status. A 
center that does not meet the requirements for conditional or 
unconditional status and is not granted an exception status under Sec.  
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)

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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 Sec.  405.2120 
through Sec.  405.2134, Sec.  405.2170 through Sec.  405.2171, and the 
definitions for ``histocompatibility testing,'' ``ESRD Network,'' 
``Network organization,'' ``organ procurement,'' ``renal 
transplantation center,'' ``transplantation service,'' and 
``transplantation surgeon'' contained in Sec.  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 Sec.  482.90(a)(1));
     Condition of participation: Patient and living donor 
management (proposed Sec.  482.94(c)(3)); and
     Condition of participation: Additional requirements for 
kidney transplant centers (proposed Sec.  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

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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 
liver-intestinal 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 kidney-pancreas 
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

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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 re-approval 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 Medicare-approved 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 Medicare-approved 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

[[Page 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 re-approval 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 Sec.  
482.70 through Sec.  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 Sec.  
482.70 through Sec.  482.104 apply to all transplant centers addressed 
in this proposed rule (i.e., heart, heart-lung, 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 Sec.  482.1 
through Sec.  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 Sec.  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 Sec.  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 Sec.  
482.70 the definitions for ``ESRD,'' ``ESRD network,'' and ``network 
organization'' from Sec.  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 multi-organ 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 Sec.  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 
Sec.  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 Sec.  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 Sec.  121.4. The Secretary enforces the 
OPTN policies, or rules, pursuant to the procedure laid out at Sec.  
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

[[Page 6146]]

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 Sec.  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 Sec.  482.45(b)(1), which are enforceable under Sec.  
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 Medicare-approved; 
(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 Sec.  488.61. A center that wishes to be approved to perform 
pediatric transplants would have to meet the conditions of 
participation contained in Sec.  482.68 through Sec.  482.74 and Sec.  
482.80 through Sec.  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

[[Page 6147]]

transplants (adult or pediatric) for pediatric centers. We are 
requesting comments on our proposed methodology for approving and re-
approving 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 organ-specific 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 organ-specific 
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: kidney-pancreas, 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 post-transplant (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: Kidney-pancreas, 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.

[[Page 6148]]

     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 
Center-Specific 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 center-specific 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 center-specific 
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 
center-specific 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 follow-up 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 non-statistically 
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.

[[Page 6149]]

    Historically, there have been more than 100 models fit for each 
center-specific 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 
center-specific report post-transplant models. The table will include 
the index of concordance, the coefficients, and p-values 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 
center-specific reports to calculate expected 1-year patient survival 
rates for deceased donor adult transplants contained the following 
factors. (Analytic Conventions--Guide to the Center-Specific Reports, 
http://www.ustransplant.org/programs-report.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 
center-specific 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 Sec.  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

[[Page 6150]]

(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 long-term 
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

[[Page 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 long-term 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 
three-pronged 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 p-values 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 three-pronged approach of the SRTR 
methodology is the value of the finding for allocating resources to 
perform on-site 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

[[Page 6152]]

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 
under-performing transplant centers. We have carefully reviewed and 
evaluated the SRTR's methodology for flagging under-performing 
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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
                                                                                     programs        Flagged/
                           Center size                               Number of        flagged      program (2)/
                                                                   programs (1)   (patient/graft/       (1)
                                                                                     both) (2)
----------------------------------------------------------------------------------------------------------------
<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

[[Page 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 non-trivial 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 follow-up 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

[[Page 6154]]

SRTR's methodology to flag poor-performing 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 center-specific 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 re-approval. 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 
center-specific 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.

[[Page 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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Number (n) and percent (%) of centers identified using:
                                                         -----------------------------------------------------------------------------------------------
                                                                         Adult transplants                             Pediatric transplants
                       Organ type                        -----------------------------------------------------------------------------------------------
                                                             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 post-transplant data in lieu 
of 1-year post-transplant 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 post-transplant 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 
Sec.  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 Medicare-approval 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 
center-specific 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

[[Page 6156]]

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 heart-lung, 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 risk-adjustment 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 heart-lung 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 Sec.  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

[[Page 6157]]

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 Sec.  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.

------------------------------------------------------------------------
                                  Proposed data submission and outcome
        Type of center         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 kidney-pancreas
                                transplants performed.
------------------------------------------------------------------------

Condition of Participation: Data Submission, and Outcome Measure 
Requirements for Re-approval of Transplant Centers (Proposed Sec.  
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 Medicare-approved, 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.
---------------------------------------------------------------------------

    \1\ Each 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.
---------------------------------------------------------------------------

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 post-transplant 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

[[Page 6158]]

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 re-approval, 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 re-
approval 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.
---------------------------------------------------------------------------

    \2\ Each 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.

------------------------------------------------------------------------
                                  Proposed data submission and outcome
        Type of center            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 process-oriented 
requirements in the regulation in addition to data submission and 
outcome requirements. The combination of outcome-oriented and process-
oriented 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

[[Page 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 Sec.  405.2135 through Sec.  405.2160 and specific 
kidney transplant regulations in Sec.  405.2170 through Sec.  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 physician-
director, 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(Sec.  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(Sec.  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

[[Page 6160]]

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 Sec.  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, in-hospital, 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.

[[Page 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 Sec.  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 Sec.  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 Sec.  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

[[Page 6162]]

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 Sec.  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 micro-nutrients. 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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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.

[[Page 6163]]

    We propose at Sec.  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 post-operative 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 Sec.  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

[[Page 6164]]

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 high-risk 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

[[Page 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 Sec.  
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 Sec.  482.68), we also propose additional 
requirements for kidney transplant centers. As stated previously, we 
propose to delete Sec.  405.2120 through Sec.  405.2134, Sec.  405.2170 
through Sec.  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 Sec.  405.2102. 
We propose to retain some of these requirements at Sec.  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.

[[Page 6166]]

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 Sec.  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 Sec.  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 Medicare-approved 
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 Sec.  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 Sec.  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 Sec.  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

[[Page 6167]]

requirements proposed at Sec.  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 Sec.  482.68 
through Sec.  482.76 and Sec.  482.90 through Sec.  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 Sec.  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 Sec.  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 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 Sec.  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 center-specific 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 Sec.  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 center-specific report, a survey for compliance with the 
CoPs proposed at Sec.  482.68 through Sec.  482.76 and Sec.  482.90 
through Sec.  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 re-approved. 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 re-approval.

D. Alternative Process To Re-Approve Transplant Centers

[If you choose to comment on this issue, please include the caption 
``ALTERNATIVE PROCESS TO RE-APPROVE 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 Sec.  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

[[Page 6168]]

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 re-approving 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 on-site 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 re-entry 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 Sec.  
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 Sec.  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 Medicare-approved 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 Sec.  482.68 
through Sec.  482.80 and Sec.  482.90 through Sec.  482.104 when they 
request Medicare approval.
    In order to determine whether or not a center that is currently 
Medicare-approved 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 Sec.  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 Sec. Sec.  482.68 
through 482.76 and Sec. Sec.  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

[[Page 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 Medicare-approval 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 Medicare-approval 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 post-transplant 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 
donor-recipient 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 pre-transplant, 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

[[Page 6170]]

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 up-to-date and accurate patient 
management records for each patient who receives an evaluation for 
placement on a center's waitlist and who is admitted for organ 
transplantation.
    (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 center-specific 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

[[Page 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 x 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, 
[email protected] 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

[[Page 6172]]

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 Sec.  
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 
re-approval 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 
center-specific 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 post-transplant data is available as part of the

[[Page 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 donor-recipient 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 x 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 x $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 x $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

[[Page 6174]]

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 x 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 x $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 x $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
----------------------------------------------------------------------------------------------------------------
                                                                              Number of patients on:
                                                                 -----------------------------------------------
                          Calendar year                            OPTN waiting                       Kidney-
                                                                     list (all    Kidney waiting     pancreas
                                                                   transplants)        list        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
----------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                  Requirement                                Calculations                  burden    Annual cost
                                                                                           hours       estimate
----------------------------------------------------------------------------------------------------------------
Annual notification of patient status to        99,725 patients on OPTN waiting list x       16,621
 patients.                                       10 min./written notification.
                                                1 admin. support staff x $12/h x        ...........     $199,452
                                                 16,621 h.
                                                99,725 notifications x $0.50/           ...........      $49,863
                                                 notification.
    Total for annual notification to patients.  ......................................       16,621     $249,315
Annual notification of patient status to        67,265 patients on OPTN waiting list          1,121
 dialysis centers.                               for kidney or kidney-pancreas
                                                 transplant x 1 min./written
                                                 notification.
                                                1 admin. support staff x $12/h x 1,121  ...........      $13,452
                                                67,265 dialysis facility notifications  ...........      $33,633
                                                 x 0.50/notification.
    Total for annual notification to dialysis   ......................................        1,121      $47,085
     facilities.
        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

[[Page 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 Sec.  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

[[Page 6176]]

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 
Medicare-covered 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 Sec.  488.61. For initial approval, we propose that all the 
CoPs proposed at Sec.  482.68 through Sec.  482.104, except for Sec.  
482.82 (Re-approval requirements), would have to be met in order for a 
transplant center to become Medicare-approved. 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 Sec.  482.80 and 
on the results of a survey for compliance with proposed Sec.  482.68 
through Sec.  482.76 and Sec.  482.90 through Sec.  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 Sec.  
482.68 through Sec.  482.76 and Sec.  482.82 through Sec.  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 Sec.  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 Sec.  482.82, the 
transplant center would be surveyed for compliance with Sec.  482.68 
through Sec.  482.76 and Sec.  482.90 through Sec.  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 
Medicare-approved 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 Medicare-approved that meet 
the data submission and outcome measure requirements proposed at Sec.  
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 Medicare-approved 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 
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.
    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 Medicare-approved request 
approval under the new CoPs and meet the data submission and outcome 
requirements proposed at Sec.  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.

[[Page 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.


Sec. Sec.  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.


Sec.  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


Sec.  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 Sec.  482.70 through Sec.  482.104 in order to be granted approval 
from CMS to provide transplant services.
    (a) Unless specified otherwise, the conditions of participation at 
Sec.  482.70 through Sec.  482.104 apply to heart, heart-lung, 
intestine, kidney, liver, lung, and pancreas centers.
    (b) In addition to meeting the conditions of participation 
specified in Sec.  482.70 through Sec.  482.104, a transplant center 
must also meet the conditions of participation specified in Sec.  482.1 
through Sec.  482.57.


Sec.  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 Medicare-approved 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 Medicare-approved 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 kidney-pancreas 
transplants.
    Transplant center means an organ-specific 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


Sec.  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

[[Page 6178]]

rules and requirements approved by the Secretary pursuant to Sec.  
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.


Sec.  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 re-approval. 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 Sec.  482.82.


Sec.  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 Sec.  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 Sec.  482.68 through 
Sec.  482.74 and Sec.  482.80 through Sec.  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 Sec.  482.68 through Sec.  482.74 and Sec.  482.80 through 
Sec.  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


Sec.  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 post-transplant to the 
center's expected number of patient deaths and graft failures 1-year 
post-transplant using the data contained in the most recent 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 Sec.  482.98., and
    (ii) The most recent SRTR center-specific 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

[[Page 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 post-transplant 
using the methodology described in Sec.  482.80(b)(3).
    (c) Exceptions. (1) A heart-lung transplant center is not required 
to comply with the outcome measure requirements at Sec.  482.80(b) for 
heart-lung transplants performed at the center.
    (2) An intestinal transplant center is not required to comply with 
the outcome performance measure requirements at Sec.  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 Sec.  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.


Sec.  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 re-approved.
    (a) Standard: Data submission. No later than 90 days after the due 
date established by the OPTN, a transplant center must submit to the 
OPTN 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 post-transplant to the 
center's expected number of patient deaths and graft failures 1-year 
post-transplant using the data contained in the most recent SRTR 
center-specific 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 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 Sec.  482.82(b) for 
heart-lung transplants performed at the center.
    (2) An intestinal transplant center is not required to comply with 
the outcome measure requirements at Sec.  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 Sec.  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 
re-approved.

Transplant Center Process Requirements


Sec.  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 Sec.  482.102.


Sec.  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 
donor-recipient 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 donor-data 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

[[Page 6180]]

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).


Sec.  482.94  Condition of participation: Patient and living donor 
management.

    Transplant centers must have written patient management policies 
for the pre-transplant, 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-
to-date and accurate patient management records for each patient who 
receives an evaluation for placement on a center's waitlist and who is 
admitted for organ transplantation.
    (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 
Sec.  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.


Sec.  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.


Sec.  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

[[Page 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 Sec.  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 
Sec.  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.


Sec.  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.


Sec.  482.102  Condition of participation: Patient and living donor 
rights.

    In addition to meeting the requirements at Sec.  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 center-specific 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.


Sec.  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

[[Page 6182]]

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:


Sec.  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 Sec.  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 Sec.  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 center-specific 
reports.
    (3) If both of the conditions in Sec.  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 Sec.  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 Sec.  
482.80, CMS or its designee will conduct a survey and review the 
center's compliance with the conditions of participation contained at 
Sec.  482.68 through Sec.  482.76 and Sec.  482.90 through Sec.  
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 
Sec.  482.68 through Sec.  482.104, except for Sec.  482.82 (Re-
approval Requirements), CMS will notify the transplant center in 
writing of the effective date of its Medicare-approval.
    (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 Sec.  482.68 through Sec.  482.104, 
except for Sec.  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 Sec.  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 Sec.  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 
Sec.  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 Sec.  482.82, the transplant center will be surveyed for 
compliance with Sec.  482.68 through Sec.  482.76 and Sec.  482.90 
through Sec.  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 re-approved 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 re-approval.
    (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 
Sec.  488.61(a);
    (2) Be in compliance with Sec. Sec.  482.68 through 482.104, except 
for Sec.  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