# Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A07-1435 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** March 30, 2007 - **Citation:** 72 FR 15198 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 482, 488, and 498 [CMS-3835-F] RIN 0938-AH17 Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule establishes, for the first time, Medicare conditions of participation for heart, heart-lung, intestine, kidney, liver, lung, and pancreas transplant centers. This rule sets forth clear expectations for safe, high quality transplant service delivery in Medicare-participating facilities. In addition, in this rule we respond to public comments on the proposed rule. EFFECTIVE DATES: These regulations are effective on June 28, 2007. FOR FURTHER INFORMATION CONTACT: Eva Fung, (410) 786-7539. Marcia Newton, (410) 786-5265. Diane Corning, (410) 786-8486. Jeannie Miller, (410) 786-3164. Rachael Weinstein, (410) 786-6775. SUPPLEMENTARY INFORMATION: I. Background A. Key Statutory Provisions Section 1102 of the Social Security Act (the Act) authorizes the Secretary to publish rules and regulations “necessary for the efficient administration of the functions” with which the Secretary is charged under the Act. Section 1871(a) of the Act authorizes the Secretary to “prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title.” Section 1864 of the Act authorizes the use of State agencies to determine providers' compliance with Medicare conditions of participation (CoPs). Responsibilities of the States in ensuring compliance with the CoPs are set forth in regulations at 42 CFR part 488, Survey, Certification, and Enforcement Procedures. Under section 1865 of the Act and § 488.5 of the regulations, hospitals that are accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or the American Osteopathic Association (AOA) are not routinely surveyed by State agency surveyors for compliance with the conditions, but are deemed to meet most of the requirements in the hospital CoPs based on their accreditation. JCAHO, AOA, and other national accreditation programs with deeming authority under § 488.6 of the regulations must meet requirements that are at least as stringent as the Medicare CoPs. (See Part 488, Survey and Certification Procedures.) An accreditation organization must apply for and receive approval of deeming authority from CMS. Section 1865(b)(1) of the Act states that providers of certain services listed in section 1881(b) of the Act cannot be deemed by a national accreditation body to meet the Medicare conditions of participation. Kidney transplant centers are entities listed in 1881(b); thus, they cannot be deemed to be accredited. Section 1881(b)(1) of the Act contains specific authority for prescribing the health and safety requirements for facilities, including renal transplant centers, that furnish end stage renal disease (ESRD) care to beneficiaries. B. Past Medicare Policy Regarding Transplantation Until now, kidney transplant centers have participated in Medicare by meeting requirements set forth at 42 CFR Part 405, subpart U, “Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services.” These requirements address issues such as compliance with applicable Federal, State, and local laws and regulations; governing body; patient care plans; patients' rights; medical records; and the physical environment. In addition, the ESRD conditions for coverage (CfCs) delineate minimum utilization rates, requirements for the director of transplantation, and minimum service requirements. (See 405.2170 and 405.2171.) Likewise, we have regulated extra-renal transplant centers under various national coverage decisions (NCDs) published beginning in 1987. The NCDs have been based on the “reasonable and necessary” provision of the Medicare statute (section 1862(a)(1)(A) of the Act). Generally, under section 1862(a)(1)(A), Medicare does not pay for any item or service unless it is medically reasonable and necessary. The NCDs provide that transplantation of extra-renal organs will be considered reasonable and necessary if performed in a center that meets the criteria specified in the applicable NCD. C. Our Efforts To Improve Oversight of Transplant Centers In the preamble of the proposed transplant center rule published February 4, 2005 (70 FR 6140), we discussed our efforts that are underway to improve organ donation and transplantation services, including the Secretary's Gift of Life Initiative. Publication of the proposed rule for new CoPs for transplant centers was the first step in moving toward a stronger oversight process. In February 2004, the Office of the Inspector General (OIG) published a report titled “Medicare-approved Heart Transplant Centers” (OEI-01-02-00520), and outlined three recommendations for CMS oversight of heart transplant centers: (1) CMS should expedite the development of continuing criteria for volume and survival rate performance and for periodic re-certification; (2) CMS should develop guidelines and procedures for taking actions against centers that do not meet Medicare criteria for volume and survival rate; and (3) CMS should take immediate steps to improve its ability to maintain accurate and timely data on center performance. All of the OIG's recommendations were incorporated into the rule. Through this final rule, we are codifying requirements for approval and re-approval of transplant centers as CoPs and placing Medicare-approved transplant centers under the survey and certification enforcement process used for all other providers and suppliers of Medicare services. Since publication of the proposed rule, we have identified quality and service issues that some transplant centers are experiencing. For example, in 2005, we investigated and cited a hospital whose liver transplant center was accused of turning down a large number of organs offered for the patients on its waiting list. As a result, the hospital closed its liver transplant center. In addition, the Government Accountability Office (GAO) is currently reviewing the Department's oversight of the transplantation system in the United States. Our current oversight of transplant centers relies on self-reporting of significant changes within a transplant center, as well as beneficiary complaints that may lead to a review or survey of a transplant center. The transplant center NCDs do not delineate explicit criteria for de-certifying of organ transplant programs. In this final rule, we are responding to public comments on the proposed rule and recommendations for improvement to this system by setting forth explicit expectations for outcomes, and high quality transplantation services. We are codifying the requirements for the approval and re-approval of transplant centers as an option under part 482, subpart E, for hospitals that choose to perform transplants. This final rule applies to hospitals with heart, heart-lung, intestine, kidney, liver, lung, and pancreas transplant centers. For purposes of this final rule, heart-lung transplant centers are those centers that are located in a hospital with an existing Medicare-approved heart transplant center and an existing Medicare-approved lung center that performs combined heart-lung transplants. Intestine centers are those Medicare-approved liver transplant centers that perform intestine transplants, combined liver-intestine transplants, and multivisceral transplants. Pancreas centers are those Medicare-approved kidney transplant centers that perform pancreas transplants, alone or subsequent to a kidney transplant, and that also perform kidney-pancreas transplants. II. Provisions of the Proposed Rule and Response to Comments on the February 4, 2005 Proposed Rule In the February 4, 2005 Federal Register (70 FR 6140), we published the proposed rule entitled, “Hospital Conditions of Participation: Requirements for Approval and Re-approval of Transplant Centers to Perform Organ Transplants” and provided for a 60-day comment period. On March 25, 2005, we published a notice in the Federal Register (70 FR 15264) extending the comment period for an additional 60 days, until June 6, 2005, to allow sufficient time for the public to provide comments on the large number of proposed new requirements. The proposed rule set forth new hospital CoPs for the approval and re-approval of transplant centers at 42 CFR part 482, subpart E. Additionally, following publication of the proposed rule, we conducted an external, independent peer review of several of the technical aspects associated with the proposed outcome measures and options. We contacted five scientists, of which three sent us detailed comments to address the technical questions that we raised. One scientist declined to provide detailed comments but said his views were reflected by the comments provided by the American Society of Transplant Surgeons/American Transplantation Society (ASTS/ATS). Comments provided by the ASTS/ATS partially addressed these technical issues, as well as more general issues of concern to the society. These peer reviews were received during the public comment period. Below we respond to the comments of the peer reviewers, in addition to the public comments received during the comment period. We received a total of 91 comments: 48 from individual transplant centers; 10 from professional associations representing those who work in the field of transplantation (including physicians, surgeons, dietitians, nurses, social workers, transplant coordinators, hospitals), 2 from organizations that support transplantation, (that is, the National Kidney Foundation and National Liver Foundation); 9 from individual social workers; 6 from individual transplant coordinators; 5 from individual organ procurement organizations; and 11 from various sources (including the Scientific Registry of Transplant Recipients, United Network for Organ Sharing, the Secretary's Advisory Committee on Organ Transplantation, the New York State Department of Health, the Joint Commission on Accreditation of Healthcare Organizations, individual physicians, a histocompatability laboratory, a living donor, and a dialysis facility). The comments ranged from general support or opposition to the proposed conditions of participation to very specific questions or comments regarding the proposed criteria. Note that comments made by peer reviewers are identified specifically as peer review comments. All other comments were made by the public. Brief summaries of each proposed provision, a summary of the public comments we received (with the exception of specific comments on the paperwork burden or the economic impact analysis), and our responses to the comments are set forth below. Comments related to the paperwork burden and the impact analysis are addressed in the Collection of Information and Impact Analysis Sections in this preamble. General Comments Comment: Many commenters supported and commended our efforts to update Medicare approval and re-approval requirements for transplant centers. Some commenters indicated they were impressed by our recognition of the highly complex issues faced by transplant recipients and living donors. Other commenters stated that the rationales provided in the February 4, 2005 proposed rule were based on sound medical and transplant practices. Some commenters stated that this rule may help to decrease organ wastage and graft failure, which would reduce the need for kidney dialysis services and re-transplantation of failed organs. Some of the professional associations and three peer reviewers supported our efforts to update transplantation standards for Medicare-approved centers, codify standards for extra-renal organ transplants, and improve care for Medicare beneficiaries and living donors. One peer reviewer was pleased with the comprehensiveness of the proposed rule, which the peer reviewer said builds upon the work of the Organ Procurement and Transplantation Network (OPTN), the Scientific Registry of Transplant Recipients (SRTR), and the Health Resources and Services Administration (HRSA). Another peer reviewer supported the re-approval process and stated that a mechanism to re-approve transplant centers is essential. Response: We thank the commenters and peer reviewers for their assistance in developing this final rule. We are committed to ensuring that Medicare-approved transplant centers consistently maintain the expertise and resources necessary to provide high quality transplantation services to patients. Comment: A few commenters stated that the proposed rule was too prescriptive and expressed concerns that implementation of the rule would bring extra burden to transplant centers, especially kidney transplant centers, in terms of cost and nursing hours. One commenter suggested a more general approach as opposed to using prescriptive language. One commenter inquired about the source of funding for the extra expenses generated by this rule. Response: One of our goals in publishing new CoPs for transplant centers is to provide flexibility for transplant centers within the framework of our regulatory authority. As stated in the proposed rule, we have set forth requirements that we believe are absolutely necessary to ensure quality care and protect the health and safety of patients. All of the CoPs are specifically transplant-oriented, and we believe that nearly all requirements in this final rule clarify or strengthen normal business practices for most transplant centers. Centers that have not incorporated the requirements in this final rule into their normal business practices will need to assess their transplantation practices and improve their performance. We believe this rule will strengthen accountability of transplant centers, and we expect centers to maintain compliance with the requirements in this final rule and continuously strive to improve quality of care and patient and living donor safety in their pursuit of optimal outcomes. We believe this rule will neither increase nursing workloads nor create significant burdens for centers, including kidney centers. We estimate that on average, the cost for each currently-approved Medicare transplant center to comply will be less than $56,000 in the first full year following the effective date of the final rule and less than $21,000 in subsequent years. Comment: A peer reviewer expressed concern that the level of detail in the proposed rule may hamper the Agency's ability to make needed modifications in the future. Response: We have included only those requirements that we believe are absolutely essential for ensuring quality care and protecting the health and safety of Medicare beneficiaries and living donors. From an oversight perspective, we must be specific in our expectations so that providers clearly understand the requirements for Medicare participation. We will continue to stay abreast of the latest advances in transplantation. If hospitals significantly change how they provide transplant patient care or the SRTR changes its outcome measure methodology, we will review and revise the final rule as necessary. Comment: One commenter stated that the OPTN oversight process and the CoPs would create inconsistent parallels for review of transplant center performance. Another commenter was concerned that the OPTN and the proposed CMS review processes were duplicative or inconsistent in some areas. The commenter believed that the OPTN oversight and compliance with the Medicare CoPs should be consistent and work in tandem. Response: Our intent is that OPTN policies and the requirements in this final rule will complement but not duplicate each other. Nevertheless, in some instances, we have incorporated OPTN policies into our requirements so that they are enforceable under Medicare. Below is a crosswalk chart that shows overlap and differences between OPTN policies and CMS regulations: Crosswalk of Transplant Center Final Rule, Part 121, & OPTN Policies and Bylaws CMS requirements 42 CFR Part 121, OPTN policies, and bylaws for transplant centers Comments Main focuses of CMS requirements. • Regulatory oversight of transplant centers. • Patient care & transplant services furnished to beneficiaries. • Relationship with transplant centers based on Provider Agreement & Medicare reimbursement. • Medicare approval & re-approval based on compliance with Conditions of participation (CoPs). • Provider responsibilities. Part 121 sets forth the governing structure of the OPTN and sets standards for availability of organ transplantation data. Part 121 lays out requirements for transplant program in hospitals at §§ 121.9 and 121.11(b)(1)(C) (defined as OMB-approved OPTN forms) Main focuses of Part 121. • Govern the operation of the OPTN which is under contract with HRSA • Require OPTN to develop policies for its members. However, as of today, with the exception of “data submission requirements”, none of the OPTN polices have been enforceable because they have not been approved and published by the Secretary Main focuses of OPTN policies/Bylaws. • Organ allocation. • Credential of transplant surgeons/physicians. • Relationship with transplant hospital members is collegial with the goal to help them to improve performance. • OPTN Membership application reviewed by peer reviewers. • Member obligations. *Additional requirements for non-Medicare approved transplant programs. § 482.68 Special Requirements for transplant centers In order to be granted approval from CMS to provide transplant services, a transplant center must: • Be located within a hospital that has a Medicare provider agreement. • Meet the CoPs of this final rule. • Meet all hospital CoPs. Compliance with Part 121 OPTN membership requirements. • This rule now makes the data submission requirements of OPTN a Condition of Participation. • Transplant centers must comply with CoPs to be reimbursed. § 482.70 Definitions. CMS has specific definitions for certain types of centers Generic definitions in part 121 No comparable OPTN definitions. § 482.72 Condition of participation: OPTN membership § 121.9 Designated transplant program requirements A transplant center must be located in a transplant hospital that is a member of and abides by the approved rules and requirements of the OPTN established and operated in accordance with § 372 of the Public Health Service (PHS) Act (42 U.S.C. section 274) • (a) To receive organs for transplantation, a transplant program must be in a hospital that is a member of the OPTN § 482.74 Condition of participation: Notification to CMS OPTN Bylaw Appendix B-3 CMS adopts the OPTN bylaw and adds more requirements. A transplant center must notify CMS immediately of any significant changes related to the center's transplant program or changes that would alter elements in the approval/re-approval application: OPTN member programs must notify OPTN immediately when a key person plans to leave • A change in key staff members of the transplant team. • A decrease in the center's volume or survival rates. • Termination of an agreement between the hospital in which the transplant center is located and an OPO for the recovery and receipt of organs. • Inactivation of the transplant center. § 482.76 Condition of participation: Pediatric Hospitals No specific OPTN policy/bylaw for pediatric transplant programs. • With the exceptions of heart centers, pediatric centers that wish to provide transplantation services to both adult and pediatric transplants must meet all requirements (except for clinical experience) in this rule and request separate Medical approval. • A center that mostly performs adult transplants cannot be approved to perform pediatric transplants if they lose their approval to perform adult transplants. • A center that mostly performs pediatric transplants cannot be approved to perform adult transplants if they lose their approval to perform pediatric transplants. • Heart centers that want to obtain Medicare approval for pediatric transplants have the option to be approved under the criteria listed under OBRA 1987. § 482.80 Condition of participation: Data submission, clinical experience, and outcome requirements for INITIAL APPROVAL of transplant centers (a) Standard: Data submission. No later than 90 days after the due date established by the OPTN, a transplant center must submit to the OPTN at least 95 percent of required data on all transplants (deceased and living donor) it has performed. § 121.11(b)(2) Reporting requirements. Member transplant hospitals must submit to the Secretary information as the Secretary prescribes (OPTN forms) § 121.11(b)(1)(C) • The OPTN & the SRTR shall provide to the Secretary any data that the Secretary requests • Make available to the public timely & accurate program-specific information on the performance of transplant programs OPTN Policy 7.8 Data Submission Requirements • Each transplant center must collect & submit 95% of expected forms complete within 3 months of the due date and 100% of expected forms complete within 6 months of the due date By using the publicly available SRTR data for outcome measures, CMS's outcome complements Part 121. CMS adopts the OPTN policy for the most part. (b) Standard: Clinical experience. We require an annual volume for the following types of transplant centers: • Heart, intestine, liver & lung transplant centers—10 transplants. • Kidney transplant centers—at least 3 transplants. • No annual volume requirement for heart-lung, and pancreas centers, and centers that primarily perform pediatric transplants. No annual volume required by the OPTN. However, it has definitions for “functionally inactive” centers: • No transplants performed in 3 months in the case of kidney, liver, & heart transplant programs • No transplants performed in 6 months in the case of pancreas & lung programs CMS requirements are straighter than OPTN policy for the purpose of monitoring inactivity of centers. (c) Standard: Outcome measures • We will review outcomes for all transplants performed at a center, including outcomes for living donor transplants, if applicable. Except for lung transplants, CMS will review adult and pediatric outcomes separately when a center requests Medicare approval to perform pediatric transplants • A center's (risk-adjusted) expected 1-year patient survival and 1-year graft survival will be compared to its observed 1-year patient survival and 1-year graft survival, based on the following non-compliance thresholds: • O − E >3. • O/E >1.5. • 1-sided p <0.05. OPTN Bylaw Appendix B Attachment Survival Rates • While the precise numerical criteria may be selected by the Membership & Professional service Committee, the initial criteria employed to identify programs with low patient/graft survival rates will include the following findings: • O − E >3. • O/E >1.5. • 1-sided p <0.05. CMS adopts the OPTN bylaws to the extent that the outcome measure standards and the OPTN policies for survival rate criteria & outcome methodology are essentially the same in the assessment of a center's outcomes. However, OPTN uses the survival outcomes as flags for further investigation while CMS uses them as criteria to make approval & re-approval determinations. Compliance with the OPTN's survival rate criteria is not required for initial approval of a new transplant program as an OPTN member. The OPTN grants conditional approval to new transplant programs, which gives the new transplant program 3 years to comply with the OPTN requirements. (d) Exceptions. No outcome requirements for: • Heart-lung transplant centers. • Intestinal transplant centers. • Pancreas transplant centers. § 482.82 Condition of participation: Data submission, clinical experience, and outcome requirements for RE-APPROVAL of transplant centers (a) Standard: Data submission. No later than 90 days after the due date established by the OPTN, a transplant center must submit to the OPTN 95 percent of the required data submissions on all transplants (deceased and living donor) it has performed over the 3-year approval period See Initial Approval See Initial Approval. (b) Standard: Clinical experience. We require an annual volume for the following types of transplant centers: See Initial Approval See Initial Approval. • Heart, intestine, kidney, liver & lung transplant centers—10 transplants • No annual volume requirement for heart- lung, and pancreas centers, and centers that primarily perform pediatric transplants (c) Standard: Outcome measures See Initial Approval See Initial Approval. • We will review outcomes for all transplants performed at a center, including outcomes for living donor transplants, if applicable. Except for lung transplants, CMS will review adult and pediatric outcomes separately when a center requests Medicare approval to perform pediatric transplants. • A center's (risk-adjusted) expected 1-year patient survival and 1-year graft survival will be compared to its observed 1-year patient survival and 1-year graft survival, based on the following non-compliance thresholds: • O − E >3. • O/E >1.5. • 1-sided p <0.05. (d) Exceptions. No outcome requirements for: • Heart-lung transplant centers. • Intestinal transplant centers. • Pancreas transplant centers. § 482.90 Condition of participation: Patient and living donor selection § 121.8 Allocation of Organs CMS requirements complement OPTN policies. (a) Standard: Patient selection. Patient selection criteria must: The OPTN has wait list policies for the purpose of organ allocation • Assure fair and non-discriminatory distribution of organs. • Include a psychosocial evaluation. • Include documentation in the patient's medical record that the candidate's blood type has been determined on at least two separate occasions. • Include documentation in the patient's medical record of the patient selection criteria used. (b) Standard: Living donor selection. The living donor selection criteria must be consistent with the general principles of medical ethics. No comparable OPTN policy/bylaw. Transplant centers must: • Ensure that a prospective living donor receives a medical & Psychosocial evaluation prior to donation. • Document in the living donor's medical records the living donor's suitability for donation. • Document that the living donor has given informed consent, as required. § 482.92 Condition of participation: Organ recovery and receipt • Written protocols for—deceased organ recovery, organ receipt, and living donor transplantation to validate donor-recipient matching of blood types and other vital information. • The transplanting surgeon at the transplant center responsible for ensuring medical suitability of donor organs for transplantation into the intended recipient. (a) Standard: Organ recovery. When an intended transplant recipient is known, the transplant center's organ recovery team must review and compare donor-data with the recipient blood type and other vital information before organ recovery takes place Policy 3.1 Organ Distribution: Definitions. 3.1.2 Transplant Center—The transplanting surgeon is responsible for ensuring medical suitability of donor organ for transplantation into the potential recipient, including compatibility of donor and candidate by ABO blood type CMS requirements complement OPTN policies. (b) Standard: Organ receipt. Policy 3.1 Organ Distribution: Definitions. CMS requirements complement OPTN policies. • When an organ arrives at the center, the transplanting surgeon and at least one licensed health care professional must verify that the donor's blood type and other vital information is compatible with transplantation of the intended recipient prior to transplantation 3.1.2 Transplant Center—Upon receipt of an organ, prior to implantation, the transplant center is responsible for verifying the recorded donor ABO with the recorded ABO of the intended recipient (c) Standard: Living donor transplantation. No comparable OPTN policy/bylaw. • If a center performs living donor transplants, the transplanting surgeon and at least one licensed health care professional at the transplant center must verify that the donor's blood type and other vital information is compatible with transplantation of the intended recipient immediately before the removal of the donor organ(s) and, if applicable, prior to the removal of the recipient's organ(s). § 482.94 Condition of participation: Patient and living donor management No comparable OPTN policy/bylaw. • Transplant center must have written patient management policies and patient care planning for the pre-transplant, transplant, and discharge phases of transplantation. • Center must have written donor management policies for the donor evaluation, donation, and discharge phases of living organ donation if it performs living donor transplants. (a) Standard: Patient and living donor care. No comparable OPTN policy/bylaw. Each transplant patient and/or living donor is under the care of a multidisciplinary patient care team coordinated by a physician throughout transplantation or donation. (b) Standard: Waitlist management. Transplant centers must keep their waitlists up to date, including: • Updating waitlist patients' clinical information on an ongoing basis. • Removing patients from the center's waitlist if a patient receives a transplant or dies, or if there is any other reason why the patient should no longer be on a center's waitlist. • Notifying the OPTN no later than 24 hours after a patient's removal from the center's waitlist. OPTN Policies 3.2.3.1, 3.6.6 • Require transplant centers to immediately remove transplant candidates that have received a transplant from a deceased donor, or have died while awaiting a transplant, from the center's waitlist and from the UNOS Patient Waiting List and to notify UNOS within 24 hours of such removal CMS Requirements complement OPTN policies. (c) Standard: Patient records. Transplant centers must maintain up-to-date and accurate patient management records for each patient who receives an evaluation for placement on a center's waitlist and who is admitted for organ transplantation. This includes notification to patient (and patient's usual dialysis facility if patient is a kidney patient) of: • Patient's placement on the center's waitlist; the center's decision not to place the patient on its waitlist; or the center's inability to make a determination regarding the patient's placement on its waitlist because further clinical testing or documentation is needed. • Removal from waitlist for reasons other than transplantation or death within 10 days. • Patient records must contain documentation of: • Multidisciplinary patient care planning during the pre-transplant period. • Multidisciplinary discharge planning for post-transplant care. OPTN Bylaw Appendix B II.C.10 Transplant Programs: Patient Notification Transplant programs must notify patients in writing: (i) within ten business days (a) of the patient's being placed on the UNOS Patient Waiting List including the date the patient was listed, or (b) of completion of the patient's evaluation as a candidate for transplantation, that the evaluation has been completed and that the patient will not be placed on the UNOS Patient Waiting List at this time, whichever is applicable; and (ii) within ten business days of removal from the UNOS Patient Waiting List as a transplant candidate for reasons other than transplantation or death that the patient has been removed from the Waiting List. The transplant program must maintain. CMS adopts OPTN bylaw for the most part. (d) Standard: Social services. The transplant center must make available social services, furnished by qualified social workers, to transplant patients, living donors, and their families. Definitions for a qualified social worker included. § 121.9(a) Designated Transplant Program Requirements OPTN Bylaw Appendix B, Attachment I, III.C.15 Transplant Programs: Social Support—Psychiatric and social support services must be available in transplant programs approved under 121.9(a)(2). The OPTN bylaw does not define qualification of a qualified social worker. CMS requirement complement OPTN bylaw. (e) Standard: Nutritional services. Nutritional assessments and diet counseling services furnished by a qualified dietitian must be available to all transplant patients and living donors. Definitions for a qualified dietitian included. No comparable OPTN policy/bylaw. § 482.96 Condition of participation: Quality assessment and performance improvement (QAPI) No comparable OPTN policy/bylaw. A transplant center must have a data-driven QAPI programs to monitor & evaluate performance of all transplantation services. § 482.98 Condition of participation: Human resources. (a) Standard: Director of a transplant center. Transplant center must be under the general supervision of a qualified transplant surgeon or a qualified physician-director. (b) Standard: Transplant surgeon and physician • Transplant center must identify to the OPTN a primary transplant surgeon and a transplant physician with the appropriate training and experience to provide transplantation services, who are immediately available to provide transplantation services when an organ is offered for transplantation. OPTN Bylaw Appendix B defines the credential of a qualified transplant surgeon and physician in 15 pages Each transplant center designated under 42 CFR 121.9(a)(2) must have on-site a qualified transplant surgeon The OPTN bylaw for credentials is too detailed for adoption in regulation. CMS requirement for “immediate availability of the primary transplant surgeon & physician” complement OPTN's “on-site” bylaw. • Transplant surgeon is responsible for providing surgical services related to transplantation. • Transplant physician is responsible for providing and coordinating transplantation care. (c) Standard: Clinical transplant coordinator. The transplant center must have a qualified clinical transplant coordinator to ensure the continuity of care of patients and living donors throughout transplantation and donation OPTN Bylaw Appendix B: Requirement for a Clinical Transplant Coordinator with defined responsibilities CMS requirement complement the OPTN bylaw. (d) Standard: Independent living donor advocate of living donor advocate team. The transplant center that performs living donor transplants must identify either an independent living donor advocate or an independent living donor advocate team to ensure protection of the rights of living donors and prospective living donors. (e) Standard: Transplant team. The transplant center must identify a multidisciplinary transplant team (composed of individuals from medicine, nursing, nutrition, social services, transplant coordination, and pharmacology) and describe the responsibilities of each member of the team § 121.9(a) Designated Transplant Program Requirements OPTN Bylaw Appendix B Attachment I. Collaborative Support—Transplant programs approved under 121.9(a)(2) must show evidence of collaborative involvement with experts in the field of hepatology, radiology, pediatrics, infectious disease, nephrology with dialysis capability, pulmonary medicine with respiratory therapy support, pathology, immunology, anesthesiology, physical therapy and rehabilitation medicine CMS requirements complement Part 121 requirements and OPTN bylaw. (f) Standard: Resource commitment. The transplant center must demonstrate availability of expertise in internal medicine, surgery, anesthesiology, immunology, infectious disease control, pathology, radiology, and blood banking as related to the provision of transplantation services § 121.9(a) Designated Transplant Program Requirements Bylaws Appendix B Attachment I. Transplant Programs—Ancillary services—Transplant programs approved under 121.9(a)(2) must have immediate access to sophisticated microbiology, clinical chemistry, tissue typing, bloodbank support, radiology services, as well as the facilities required for monitoring immunosuppressive drugs CMS adopts the Part 121 requirements and OPTN bylaw. § 482.100 Condition of participation: Organ procurement • Transplant center must ensure that transplant hospital has written agreement (with delineated responsibilities for both parties) with an OPO designated by the Secretary § 121.9(a) Designated Transplant Program Requirements Bylaws Appendix B Attachment I A transplant program approved under 121.9(a)(2) must have letters of agreement or contracts with an OPO CMS requirement complement the OPTN bylaw because the OPTN bylaw does not require transplant centers to notify the OPTN or CMS when an agreement with an OPO is terminated. § 482.102 Condition of participation: Patient and living donor rights No comparable OPTN policy/bylaw. • In addition to meeting the requirements at § 482.13, the transplant center must protect and promote each transplant patient's and living donor's rights. (a) Standard: Informed consent for transplant patients No comparable OPTN policy/bylaw. • Transplant centers must have written policies for the informed consent process. • Each patient will be informed about: —The evaluation process; —The surgical procedure; —Alternative treatments; —Potential medical or psychosocial risks; —National & center-specific outcomes from the most recent SRTR center-specific report, including (but not limited to) the transplant center's observed and expected 1-year patient and graft survival, national 1-year patient and graft survival, and notification about all Medicare outcome requirements not being met by the transplant center; —Organ donor risk factors that could affect the success of the graft or health of the patient; —His or her right to refuse transplantation; —The fact that if his or her transplant is not provided in a Medicare-approved transplant center it could affect the transplant recipient's ability to have his or her immunosuppressive drugs paid under Medicare Part B. (b) Standard: Informed consent for living donors • Transplant centers must have written policies for the informed consent process. • Each living donor will be informed about: No comparable OPTN policy/bylaw. CMS adopts many of the informed consent elements contained in the Secretary's Advisory Committee on Transplantation (ACOT) Recommendations. —The fact that communication between the donor & the transplant center will remain confidential, in accordance with the requirements at 45 CFR parts 160 & 164. —The evaluation process. —The surgical procedure, including post-op treatment. —The availability of alternative treatments for the transplant recipient. —The potential medical or psychosocial risks to the donor. —The national & center-specific outcomes for recipients & living donors as data are available. —The possibility that future health problems related to the donation may not be covered by the donor's insurance, and that the donor's ability to obtain health, disability, or life insurance may be affected. —The donor's right to opt out of donation at any time during the donation process. —The fact that if his or her transplant is not provided in a Medicare-approved transplant center it could affect the transplant recipient's ability to have his or her immunosuppressive drugs paid under Medicare Part B. (c) Standard: Notification to patients Transplant centers must notify patients placed on the center's waiting list of information about the center that could impact the patient's ability to receive a transplant should an organ become available, and what procedures are in place to ensure the availability of a transplant team: —The fact the center is served by a single transplant surgeon or physician, the potential unavailability of the transplant surgeon or physician, and whether or not the center has a mechanism to provide an alternative transplant surgeon or transplant physician that meets the hospital's credentialing policies. • At least 30 days before a center's Medicare approval is terminated, whether voluntarily or involuntarily, the center must inform: —Patients on the waiting list & provide assistance to waiting list patients who choose to transfer to the waiting list of another Medicare-approved center without loss of time accrued on the waiting list; and § 121.9 Designated Transplant Program Requirements (a) To receive organs for transplantation, a transplant program approved under 121.9(a)(2) agrees to promptly notify OPTN & patients awaiting transplantation if it becomes inactive OPTN Bylaws Appendix B Attachment I—Criteria for Institutional Membership III.C Transplant programs—A transplant program served by a single surgeon or physician shall inform patients of this fact and potential unavailability of 1 or both of these individuals during the year OPTN Bylaws, Appendix B. VI. Change in Program Status. When a transplant program is voluntarily or involuntarily inactivated, waitlist patients may retain existing waiting time and continue to accrue waiting time. Accrued waiting time may be transferred to the patient's credit when s(he) is listed with a new program CMS adopts Part 121 and OPTN bylaws. —Medicare beneficiaries on the center's waiting list that Medicare will no longer pay for transplants performed at the center after the effective date of the center's termination of approval. • As soon as possible prior to a transplant center's inactivation, the center must inform patients on the center's waiting list and, as directed by the Secretary, provide assistance to waiting list patients who choose to transfer to the waiting list of another Medicare-approved transplant center without loss of time accrued on the waiting list. § 482.104 Condition of participation: Additional requirements for kidney transplant centers No comparable Part 121 requirements or OPTN policy/bylaw for kidney transplant centers. (a) Standard: End stage renal disease (ESRD). • Kidney transplant centers must furnish directly transplantation & other medical & surgical specialty services required for the care of ESRD patients. (b) Standard: Dialysis services. • Kidney transplant centers must furnish inpatient dialysis services directly or under arrangement. (c) Standard: Participation in network activities. • Kidney transplant centers must cooperate with the ESRD Network designated for its geographical area, in fulfilling the terms of the Network's current statement of work. No comparable CMS requirements Bylaws Appendix B—Criteria for Institutional Membership Relocation and transfer of established programs is not addressed in CMS requirements. III.E Relocation and Transfer of Established Programs No comparable CMS requirements Part 121.8 Allocation requirements of Organs OPTN Policy 3.0 Organ Distribution. The OPTN policies are all organ allocation/acceptance policies. 3.3 Acceptance Criteria 3.4 Organ Procurement, distribution, and alternative systems for organ distribution or allocation 3.9 Allocation System for Organs Not Specifically Addressed 3.10 Back-up for Inactive Transplant Programs 3.11 Intestinal Organ Allocation Appendix to Policy 3.0 A. HLA Antigen Values and Split Equivalences C. Resolving Discrepant Donor and Recipient HLA Typing Results in the OPTN Database Policy 4.0 Acquired Immune Deficiency Syndrome (AIDS) and Human Pituitary Deceived Growth Hormone (HPDGH) and Human T-Lymphotropic Virus Type I (HTLV-I) Policy 6.0 Transplantation of Non-Resident Aliens § 488.61 Special procedures for approval and re-approval of organ transplant centers • Survey, certification, and enforcement procedures at 42 CFR part 488, subpart A, including the periodic review of compliance and approval contained in § 488.20. • Transplant centers that meet all data submission, clinical experience, outcome, and process requirements will be approved for 3 years. • Current Medicare-approved centers will continue to be Medicare approved after submitting applications and awaiting CMS's decision for approval. • At the end of 3-year approval period, CMS will review transplant center's data to determine compliance with data submission, clinical experience and outcome requirements at § 482.82. • If a center is in compliance with § 482.82, CMS may choose to review its compliance with the rest of the CoPs. • A transplant center may remain inactive and retain its Medicare approval for a period not to exceed 12 months during the 3-year approval cycle. • Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any time, and the center must: § 121.10(c)(1)(2) Enforcement of OPTN rules. Sanctions for violations of non-mandatory policies or mandatory policies (w/o approval from the Secretary of DHHS) include: • Warning, letter of admonition, or letter of reprimand • Probation. • Member Not in Good Standing. Additional Sanctions (only for violation of mandatory policies): • Suspension of member privileges. • Termination of OPTN membership. • Termination of Status as Designated Transplant Program, Termination of Participation in Medicare/Medicaid, Termination of Reimbursement under Medicare/Medicaid The 3 additional sanctions can only be imposed by the Secretary § 121.10(c) Sanctions can also be imposed for violations of Part 121, including its data submission requirements, and when the Secretary determines that the public health or patient safety is at risk OPTN policies and bylaws are voluntary, until approved (i.e., codified) by the Secretary. At this time, the Secretary has not approved or published any OPTN policies and bylaws, except for data submission requirements. For the first time, transplant centers have the same appeal rights as other Medicare providers. (1) Request initial approval; (2) Comply with the initial approval requirements; and (3) Submit a report to CMS documenting any changes or corrective actions taken by the center as a result of the loss of its Medicare approval status. Part 498 Appeals procedures for determinations that affect participation in the Medicare program and for determinations that affect the participation of ICFs/MR and certain NFs in the Medicaid program. • The definition of “provider” is amended by adding “transplant center” after “hospital” the first time it appears. CMS Oversight and OPTN Policies Some commenters voiced their opinions about our oversight of transplant centers in comparison to OPTN oversight of its transplant hospital members. Comment: Some commenters stated their appreciation that the proposed rule is congruent with OPTN policies and bylaws, because OPTN policies and bylaws were developed through a consensus process with broad participation by the transplant community. Commenters pointed out that the rule sets consistent and unified standards and provides an established infrastructure for performance monitoring and review of transplant centers. Response: The OPTN's primary responsibilities are to ensure the effectiveness, efficiency, and equity of organ allocation; increase the supply of transplantable organs; collect and disburse data; and designate transplant programs. We are responsible for establishing minimum standards to protect patient health and safety, and for implementing oversight mechanisms to ensure that transplant centers provide quality transplant and living donor care to Medicare beneficiaries through the development of health and safety requirements. In developing this rule, we worked closely with HRSA, which oversees the OPTN and SRTR, to ensure consistency and minimize the burden on transplant centers where possible. Comment: A commenter requested that we limit our role to reimbursement of clinical services. Response: As a health care regulatory agency and a prudent health care purchaser, our responsibility cannot be limited to reimbursement. The Secretary has the statutory authority and responsibility to protect patient health and safety and to ensure that high quality care is provided to patients. Comment: Many commenters stated that the OPTN oversight process and our approval and re-approval process would create an inconsistent and duplicative mechanism in the oversight of transplant centers. The commenters stated that we should collaborate with the OPTN to streamline the two processes into one unified consistent process, but with more reliance on OPTN oversight. One public commenter stated that CMS should consider termination of a center only if the OPTN Board reports to the Secretary that it has made a final decision to take adverse action against the center. A peer reviewer was concerned that the collegial relationship between OPTN and the transplant centers might be jeopardized by codification of some of the OPTN requirements. Response: We understand the commenters' concerns. However, for the most part, we and the OPTN have different roles vis-á-vis transplant centers. For example, when surveying transplant centers for compliance with the CoPs in this final rule, we will focus on protections for patient health and safety. When the OPTN surveys (or performs desk audits of) transplant centers, it focuses on compliance with candidate listing and delisting, data submission, and its patient notification policies and verifies that the designated physician and surgeon are the same individuals approved by the OPTN. The degree of authority to act in the event of non-compliance also differs. The OPTN generally takes a collegial approach and assists centers in improving their performance, while we generally take a regulatory approach which sometimes may lead to termination of the Medicare agreement with providers. However, compliance with the OPTN's policies will facilitate transplant centers' compliance with the requirements in this final rule. Therefore, the OPTN will continue to play a consultative role with transplant centers to assist them in complying with Medicare requirements. We believe the collegial relationship between the OPTN and the transplant centers may be enhanced and strengthened rather than compromised. Comment: Many commenters stated that the OPTN oversight process is vigorous and effective and that the OPTN should have full oversight of transplant centers to avoid duplicative efforts. The commenters cited 42 CFR part 121 as the regulation governing the operation of the OPTN and stated that the OPTN has legally binding rules enforceable on transplant centers. Other commenters noted that the OPTN already surveys heart and liver programs once every 3 years. The commenters recommended that the OPTN be recognized as the accrediting body to audit and survey centers periodically based on its expertise in dealing with the complexity of transplantation. A commenter recommended that we review a center for potential termination from the Medicare program only if the Secretary has been notified of a final decision of the OPTN Board to take an adverse action against the center. The commenters stated that reviews or surveys conducted by an inexperienced CMS designee would burden centers and lead to misinterpretation of OPTN policies and CMS regulations, which could cause confusion and loss of Medicare approval. Response: The commenters are correct that 42 CFR part 121 governs the operation of the OPTN, which establishes policies for transplant hospital members. OPTN policies are enforceable only when they have been incorporated into regulations by the Department. However, with the exception of the OPTN data submission requirements, OPTN policies have not been incorporated by the Department. Therefore, if the OPTN determines that removal of a member's designation as a transplant hospital is warranted for reasons of non-compliance with other OPTN policies, with the final rule governing the operation of the OPTN (42 CFR part 121), or because of a threat to public health and safety, the OPTN will recommend to the Secretary that the member's designation be revoked. The OPTN has made this recommendation on only two occasions. We have an obligation to oversee transplant centers serving Medicare beneficiaries, and we do not have the statutory authority to delegate oversight responsibilities to the OPTN. In our view, the OPTN oversight approach is a complement to the Medicare regulatory authority. Once the final rule becomes effective, and before conducting surveys, our surveyors will be trained in applicable OPTN policies for transplant centers. Comment: A commenter recommended that the Secretary take action to expand the role of the OPTN relative to oversight of living donors. Response: The commenter's recommendation falls outside the scope of this final rule. We will forward this recommendation to the Secretary for consideration. Comment: A commenter stated that despite the fact that the OPTN requires transplant programs to abide by OPTN policies and bylaws, we should not codify the OPTN policies and bylaws as regulatory language. One commenter stated that the relatively fluid OPTN policies and bylaws would allow the incorporation of future changes in transplant practice more quickly. Response: The requirements in this final rule are intended to be broadly applicable to transplant centers over a long period of time. OPTN policies or elements of OPTN policies that we have included in this final rule conform to this intent. We understand that many OPTN policies, particularly organ allocation, transplant surgeon and transplant physician credentials, and criteria for listing and de-listing transplant candidates are subject to rapid changes as transplant medicine advances. Therefore, we did not include such policies in this final rule. Comment: Some commenters raised confidentiality concerns regarding the sharing of data between the OPTN and CMS under applicable laws and regulations protecting the peer review process. One commenter suggested adding language to state that the regulation is not intended to affect the confidentiality of the process in any manner. Response: We understand the commenters' concerns about the confidentiality of data shared between the OPTN and CMS. However, under reporting requirements set forth in 42 CFR 121.11(b)(1)(iii), the OPTN and the SRTR are required to provide to CMS any data that we request, as appropriate. Nonetheless, it is not our intention to disrupt the OPTN confidential peer review process. We will obtain only the OPTN data that is necessary for our oversight of transplant centers. Comment: One commenter suggested that section 1865 of the Act and regulations at 42 CFR part 488 mean that only CMS's designated national accrediting organizations are eligible for deeming authority for transplant centers. The commenter further stated that organizations that accredit both hospitals and transplant centers are in the best position to ensure consistent quality oversight and avoid fragmented survey arrangements. Response: We will consider applications from any national accrediting organization for deeming authority for initial approval and re-approval for any of the extra-renal transplant centers. We believe that we have the statutory authority to permit national accrediting organizations to accredit most transplant centers as “facilities,” pursuant to paragraph 1865(b)(4) of the Act, with the exception of kidney transplant centers. As discussed previously, section 1864 of the Act authorizes the use of State agencies to determine providers' compliance with the CoPs. A national accreditation program may apply for deeming authority for the providers that are specifically listed in § 488.6. Since “transplant centers” are not specifically identified in § 488.6, this final rule inserts the language “transplant centers, except for kidney transplant centers” in § 488.6(a) with the list of providers eligible for deeming authority. Kidney transplant centers are specifically excluded because they are not eligible for deeming authority by statute. (See sections 1864 and 1865(b)(4) of the Act.) Special Requirements for Transplant Centers (Proposed § 482.68) We proposed that a transplant center located within a hospital that has a Medicare provider agreement must meet the CoPs specified in § 482.72 through § 482.104 in order to be granted our approval to provide transplant services. We proposed that the CoPs specified in § 482.72 through § 482.104 would apply to all heart, heart-lung, intestine, kidney, liver, lung, and pancreas transplant centers, unless specified otherwise. We also proposed that transplant centers seeking Medicare approval must meet the hospital CoPs specified in § 482.1 through § 482.57. We received no comments on this section of the proposed regulation and are finalizing it as proposed. Definitions (Proposed § 482.70) We proposed definitions for “transplant hospital,” “transplant program,” and “transplant center” to clarify the usage of these terms throughout the regulation. We proposed deleting the definitions for “histocompatibility testing,” “ESRD Network,” “network organization,” “organ procurement,” “renal transplantation center,” “transplantation service,” and “transplantation surgeon” contained in § 405.2102, as these terms are no longer used in the section. We proposed including the definitions for “ESRD,” “ESRD network,” and “network organization” from § 405.2102 in this final rule to emphasize the distinct statutory authority and requirements that kidney transplant centers have to meet and to clarify the use of the terms in the proposed CoPs for transplant centers. We proposed adding definitions for “adverse event,” “heart-lung transplant center,” “pancreas transplant center,” and “intestinal transplant center.” This final rule includes all definitions related to ESRD Network programs from 42 CFR part 405, subpart U, § 405.2102, as well as §§ 405.2110 through 2114. We note that in the proposed rule we incorrectly stated that our proposed definition for “adverse event” was derived from the JCAHO's definition of “adverse event.” In fact, JCAHO has a definition for “sentinel event” but not “adverse event.” Additionally, we have made a change to the definition of “adverse event” for clarification purposes. The proposed definition listed two examples of adverse events related to living donors: “living donor death due to mismanagement of the donor” and “avoidable loss of a healthy living donor.” We have replaced these two examples with “serious medical complications or death caused by living donation” to clarify that the death of any living donor or a living donor's serious medical complications caused by living donation should be investigated as an adverse event. Following are summaries of the comments we received and our responses. Comment: One commenter applauded our efforts to standardize definitions for transplant hospitals for the purpose of improving communication. The commenter noted that JCAHO developed a Patient Safety Event Taxonomy in response to the lack of agreement on definitions regarding medical errors. The commenter suggested that the adoption of the Patient Safety Event Taxonomy developed by the JCAHO in the quality assessment and performance improvement (QAPI) CoP would decrease confusion, improve patient safety, and promote quality. Response: A Patient Safety Event Taxonomy is a system of classifying adverse events at hospitals or other providers of health care. Thus, the Taxonomy is a “language” in which providers can report adverse events. One of the JCAHO's current initiatives is to “promote using health information technology to improve patient safety reporting, data analysis and learning from errors, and to promote a national reporting system for adverse events through the use of standardized patient safety taxonomy and ontology.” Although the final rule provides a general definition for an “adverse event” in transplantation, it does not attempt to classify all possible adverse events in health care or transplantation. The Patient Safety Event Taxonomy classifies all health care events, not just those related to transplantation. Incorporation of the Taxonomy into the QAPI CoP would be inappropriate because it falls outside the scope of this rule. Therefore, we have not adopted the commenter's suggestion. Comment: One commenter noted that the term “transplant center” is commonly used interchangeably with the term “transplant hospital.” For this reason, the commenter stated that our proposal to use the term “transplant center” interchangeably with “transplant program” is confusing and the commenter suggested the removal of the term “transplant center” in the final rule. Response: Although we agree that these terms often are used interchangeably, we believe the transplant community understands our use of the term “transplant center” in this final rule. We do not believe it is necessary to make a change based on this comment. Proposed General Requirements for Transplant Centers Condition of Participation: OPTN Membership (Proposed § 482.72) We proposed that a transplant center must be located in a transplant hospital that is a member of, and abides by the rules and requirements of, the OPTN, as set forth at § 482.45(b)(1), and that are enforceable under 42 CFR 121.10. We proposed that no transplant hospital would be considered to be out of compliance with section 1138(a)(1)(B) of the Act (which requires participation in the OPTN) unless the Secretary gave the OPTN formal notice that he or she approved the decision to exclude the transplant hospital from the OPTN and notified the center in writing. We received no comments on this section of the proposed rule. Therefore, we are finalizing it as proposed. Condition of Participation: Notification to CMS (Proposed § 482.74) We proposed requiring each transplant center to notify us immediately of any significant changes related to the center's transplant program or any change that would otherwise alter specific elements in its application for approval or re-approval. We proposed that instances in which we should be notified would include, but not be limited to, changes in key staff members of the transplant team (such as the individual who has been designated to the OPTN as the center's primary transplant surgeon or physician) or a decrease in the center's volume or survival rate that could result in the center being out of compliance with § 482.82. Note that in this final rule, we have added to this section two specific instances that must be reported to us immediately. First, a transplant center must notify us if the hospital in which it is located terminates its agreement with an OPO for recovery and receipt of organs. Further information about this requirement can be found in this preamble in our discussion of the CoP for organ procurement. Second, a transplant center must notify us if it becomes inactive. Further information about our requirements in regard to transplant center inactivity can be found in this preamble in our discussion of clinical experience requirements and special procedures for approval and re-approval of organ transplant centers. For clarity, we have replaced the language stating that a transplant center must notify us of any change that would otherwise alter specific elements in its application for approval. Section 482.100 of this final rule states that, “a transplant center must notify CMS immediately of any significant changes related to the center's transplant program or changes that could affect its compliance with the conditions of participation.” Following are summaries of the comments we received and our responses. Comment: A number of commenters supported the requirement for transplant centers to notify us of significant changes that may affect their approved status. However, some commenters stated that the requirement would be redundant and burdensome because the OPTN already requires such notification. Response: The OPTN bylaws require transplant hospital members to notify the OPTN immediately if the hospital learns that its primary surgeon or primary physician plans to leave. The transplant hospital is required to submit to the OPTN the name of the replacement surgeon or physician, curriculum vitae, and documentation of credentials and qualification at least 30 days (if possible) prior to the departure of the individual being replaced. Although we have avoided duplicating OPTN policies in this final rule (unless we have done so deliberately so that we can enforce a requirement), in this instance, we believe a transplant center should inform us in addition to the OPTN so that we can actively monitor the situation to confirm that the departing surgeon or physician is replaced. We note that the current NCDs require Medicare-approved heart, liver, and lung centers to report such information to us. Comment: One commenter suggested that transplant centers should not be required to notify us of a significant decrease in volume or survival rates. The commenter stated that an unusually large number of early deaths may not significantly affect 1-year outcomes if the transplant center subsequently has increased volume with successful results. Furthermore, these outcomes will be reflected in the subsequent SRTR 1-year survival reports. Response: As one component of the active monitoring and oversight of transplant centers, we need to be made aware of any significant changes at transplant centers. However, the outcome requirements in this final rule are based on 1-year patient and graft survival as calculated and reported by the SRTR, meaning that there may be a considerable lapse of time before we have access to data from the SRTR indicating that a transplant center's outcomes have dropped significantly. Although we understand that a decrease in clinical experience (that is, volume) and survival rates within a short period of time does not necessarily signify a problem, we need to be aware of these changes so that we can determine whether they are meaningful, for example, whether a decrease in the number of transplants signals ongoing inactivity and whether a decrease in outcomes signals a significant problem. When notified by a transplant center of a significant change, we will assess the information to determine how to proceed. We may note the information (such as a change in staff) and take no further action, contact the center for more information, analyze the information in conjunction with HRSA and the OPTN, and/or conduct an on-site review of the center. We recognize that it may be challenging for centers to determine whether decreases in the volume and unadjusted survival rates would be significant enough to warrant reporting to CMS. Centers will not be required to independently decide what constitutes a significant change. Centers will receive guidance from CMS through interpretive guidelines and provider notifications as to what constitutes a significant enough decrease in clinical experience or survival rates to necessitate reporting. This guidance is under development. Interpretive guidelines provide guidance to Medicare surveyors and clarify the intent of regulations. Each provider type is surveyed in accordance with the appropriate protocols based on the substantive requirements in the statute and regulations to determine whether a citation of non-compliance is appropriate. A center will be deemed deficient if it fails to meet the requirements of the statute or regulations, which, in turn, are based on the surveyor's observations of the providers' performance or practices. The specific process that surveyors use for each type of provider or supplier is outlined in the CMS State Operations Manual. The State Operations Manual is publicly available under the “Manuals” section of the CMS Web site. Included in the appendices of the State Operations Manual are the Interpretive Guidelines (also known as “Guidance to Surveyors”) for each type of provider or supplier. The Interpretive Guidelines interpret and clarify the Conditions and Standards that are outlined in statute and regulations. The Interpretive Guidelines merely define or explain the relevant statute and regulations and describe the specific elements that a surveyor will be reviewing and/or observing. The Interpretive guidelines do not impose any requirements that are not otherwise sets forth in statute or regulation. Implementation of the survey and certification process for transplant programs will follow this same process. CMS is developing revisions to the State Operations Manual and a separate appendix that will include the Interpretive Guidelines that will be used for surveyors of organ transplant programs. CMS will also be posting informational material on its Web site for providers that would like to request approval for their transplant program. We made no changes based on this comment. Comment: One commenter noted that there was no definition provided for the term “immediately” for purposes of describing the time frame within which a transplant center must notify us of changes. Other commenters questioned the term “significant changes” and recommended that the definition should be limited to staff changes and adverse events. Response: We disagree that the scope of significant changes should be limited to staff changes and adverse events. As we said in our previous response, decreases in the number of transplants performed and in the number of positive outcomes are also significant changes. We will address the time frame within which a transplant center must notify us of any significant changes and the meaning of “significant changes” in our interpretive guidelines for Medicare surveyors, as that medium permits a more thorough explanation of our expectations. Interpretive guidelines provide guidance to surveyors and serve to clarify and explain the intent of regulations. No changes were made based on this comment. Comment: One commenter inquired about the consequence of failure to comply with this requirement. The commenter stated that a good faith failure to comply should not constitute grounds for termination. Response: Notification to us is one of the conditions of participation required for Medicare-approved transplant centers. A center that fails to notify us of any significant changes as delineated in § 482.74 would be considered non-compliant with the transplant conditions of participation and 42 CFR part 488, may be subject to investigation, and could ultimately have its transplant center approval revoked. Comment: One commenter asked for a CMS contact for notification of changes. A commenter suggested linking transplant centers' notification of changes to the appropriate accrediting organization so that further assessment of the situation can be conducted promptly. Response: At this time, we do not know whether we or a designee will survey transplant centers. Therefore, under this final rule, a transplant center must report a significant change to us. (See § 482.74.) Comment: A commenter asked how we will communicate the changes in primary surgeons and physicians to the OPTN, once notified by transplant centers of the change. Response: The OPTN policies that transplant centers must meet as OPTN members already require transplant centers to inform the OPTN of changes in primary surgeons and physicians immediately; therefore, there is no need for us to communicate such changes to the OPTN. Condition of Participation: Pediatric Transplants (Proposed § 482.76) Children are eligible for Medicare on the basis of ESRD as follows: under section 226A of the Act, an insured worker's dependent child (as defined in regulations) who is medically determined to have ESRD is eligible for Medicare Part A and Part B. According to 42 CFR 408.13, a child is considered “dependent” if he or she is unmarried and is under the age of 22 or is between ages 22 and 26 and has been receiving at least one half of his or her support from the insured worker continuously since before attainment of age 22. Children are eligible for Medicare on the basis of disability as follows: (1) Under section 223(b) of the Act, individuals who have been entitled to Childhood Disability Benefits (CDB) under section 202(d) of the Act by reason of a disability (as defined in section 223(d) of the Act) for 24 months are entitled to Medicare Part A and Part B the 25th month of disability benefit entitlement. Section 202(d) restricts the first month of CDB entitlement to the month the child attains age 18. Therefore, the earliest month a CDB beneficiary can qualify for Medicare is the month he or she attains age 20; or (2) section 223 of the Act provides that any individual who is under age 65 and has the necessary Social Security work credits, as defined in section 223(c) of the Act, and is under a disability as defined in section 223(d) of the Act, is entitled to Medicare Parts A and B on the 25th month of disability benefit entitlement. In 2005, Medicare paid for 404 pediatric transplants of different organ types. We proposed that in order to be reimbursed for transplants performed on pediatric Medicare beneficiaries, a hospital that furnishes transplantation services to both adult and pediatric patients must seek separate Medicare approval to provide pediatric transplantation services. We also proposed retaining the statutory criteria found at section 4009(b) of the Omnibus Budget Reconciliation Act (OBRA) 1987 (Pub. L. 100-203) as an extra option for heart transplant centers that wish to become Medicare-approved to perform pediatric heart transplants. We did not reference this citation in the proposed rule as an oversight. We proposed that a center that wishes to become Medicare-approved to perform pediatric heart transplants may also be approved by meeting data submission, outcome, and process requirements in the final rule. We proposed that a center that performs 50 percent or more of its transplants on adult patients must be approved to perform adult transplants in order to be approved to perform pediatric transplants. For these centers, we proposed that a loss of Medicare approval to perform adult transplants, whether voluntary or involuntary, would result in a loss of the center's approval to perform pediatric transplants. We also proposed that a loss of Medicare approval to perform pediatric transplants, whether voluntary or involuntary, would not impact the center's Medicare approval to perform adult transplants. We proposed that a center that performs 50 percent or more of its transplants on pediatric patients must be approved to perform pediatric transplants in order to be approved to perform adult transplants. For these centers, we proposed that loss of Medicare approval to perform pediatric transplants, whether voluntary or involuntary, would result in a loss of the center's approval to perform adult transplants. We proposed that loss of Medicare approval to perform adult transplants would not impact the center's Medicare approval to perform pediatric transplants. For a center that performs 50 percent or more of its transplants on pediatric patients, we proposed that there would be no minimum number of adult or pediatric transplants required prior to its request for Medicare approval. Following are summaries of the comments we received and our responses. Comment: A commenter noted that it is important for pediatric transplant centers to continue to transplant adolescent and young adults beyond the pediatric age range (18-25) to maintain continuity of care of established patients. Response: We agree. In some situations, a young adult for whom an organ becomes available has received treatment for end stage organ failure from the same pediatric transplant surgeon and pediatric transplant physician for many years and understandably wishes to have the transplant performed at the pediatric center where these physicians practice. Under the proposed rule and this final rule, which require separate Medicare approvals for performing adult and pediatric transplants, a transplant center performing predominately pediatric transplants will be able to transplant adolescents and young adults age 18 and older. We recognize that pediatric programs may need to continue transplanting young adults beyond the pediatric age range in order to maintain continuity of care for established patients. The health care needs of these patients are best addressed in a pediatric setting until appropriate transition to adult care can occur. Pediatric centers are required to become certified as both a pediatric and adult transplant center if they intend to provide transplantation services to both populations. Comment: A few commenters agreed that pediatric centers should meet the transplant center conditions of participation, but they did not agree that adult and pediatric centers should be approved separately. The commenters noted that the low volume of adult transplants performed at pediatric centers does not justify the cost and labor for the centers to seek separate approval to perform adult transplants. Likewise commenters said it would be burdensome to require an adult center to seek separate Medicare approval just to perform a few pediatric transplants. Response: We understand the commenters' concerns. In our view, a center that performs 50 percent or more of its transplants on adult patients in a 12-month period is considered to be an adult transplant center whereas a center that performs 50 percent or more of its transplants on pediatric patients in a 12-month period is considered to be a pediatric transplant center. There are distinct differences between adult centers performing occasional pediatric transplant and pediatric centers performing occasional adult transplants in terms of patient selection criteria, patient management, and the number of transplants performed. Because of these differences, we believe that approving adult and pediatric centers as one unified program is problematic. For example, it would be difficult, if not impossible, for pediatric centers to meet clinical experience requirements that are appropriate for adult transplant centers, which could impair access to pediatric transplants. However, we will permit a transplant center to submit its request for approval as a pediatric transplant center and its request for approval as an adult transplant center using the same application, which should minimize the paperwork burden. We made no changes based on this comment. Comment: Some commenters stated that in most pediatric centers, the core transplant team performs both adult and pediatric transplants. The commenters said that to be consistent with OPTN requirements for pediatric centers, we should allow the sharing of personnel in transplant hospitals that have both adult and pediatric transplant programs. Some commenters recommended treating adult and pediatric transplant centers as one unified program or adopting the statutorily-based approval criteria as used in pediatric heart transplant centers. Response: We recognize that many centers that perform pediatric transplants are operated by, or affiliated with, a Medicare-approved adult transplant center. In some transplant centers, the core transplant team performs both adult and pediatric transplants. We have no objection to such arrangements, provided that a transplant center has committed sufficient resources to both its pediatric and its adult transplant programs. There is nothing in the final rule that precludes a pediatric center and an adult center from operating as one unified program. Nevertheless, we would emphasize that an adult transplant center may not attempt to meet the clinical experience requirement by combining the number of adult transplants it has performed with pediatric transplants that were performed at its pediatric center. The outcomes of pediatric and adult transplant centers are reviewed separately. Comment: A commenter recommended adopting the OPTN pediatric transplant standards. Response: OPTN pediatric transplant policies relate primarily to pediatric organ allocation, and transplant surgeon and physician training and experience, and they differ significantly from our proposed CoPs for pediatric centers. We did not make any changes based on the comment. We received no comments on our proposal to allow a heart transplant center to provide transplantation services to pediatric heart patients to be approved to perform pediatric heart transplants by meeting the OBRA 1987 criteria in section 4009(b) (Pub. L. 100-203). Therefore, the proposal was finalized without change except for the addition of the OBRA 1987 citation. Condition of Participation: Data Submission, Clinical Experience, and Outcome Requirements for Initial Approval of Transplant Centers (Proposed § 482.80) We proposed that transplant centers must meet all of the data submission and outcome requirements in order to be granted our initial approval. If a center failed to meet any of the requirements, no waiver would be granted. However, we did propose certain exceptions, which are discussed below. Proposed Data Submission Requirements We proposed at § 482.80(a) that no later than 90 days after the due date established by the OPTN, a transplant center must submit to the OPTN at least 95 percent of required data submissions on all transplants (deceased and living donor) that the center has performed at the center. We proposed that required data submissions would include, but not be limited to, the submission of the appropriate organ-specific OPTN forms for transplant candidate registration, transplant recipient registration, and transplant recipient follow up. We proposed using the same data submission requirements for both initial approval and re-approval. Proposed Outcome Requirements We proposed using the same outcome requirements for both initial approval and re-approval. We proposed using the SRTR's center-specific reports as the foundation of our outcome evaluation system. We proposed reviewing outcomes for all transplants performed at a center, including outcomes for living donor transplants, if applicable. With the exception of lung transplants, we will review adult and pediatric outcomes separately when a center requests Medicare approval to perform both adult and pediatric transplants. The OPTN policies for the cutoff for pediatric lung allocation and outcome assessment is under 12 years old, and the number of pediatric (under 12 years old) lung transplants is very small. Therefore, the outcomes of pediatric lung transplants and adult lung transplants are reviewed together. We proposed that we would compare each transplant center's observed number of patient deaths and graft failures 1-year post-transplant to the center's expected number of patient deaths and graft failures 1-year post-transplant (or under certain circumstances, 1-month post-transplant patient and graft survival in lieu of 1-year post-transplant patient and graft survival.) We proposed that under most circumstances, an adult transplant center requesting Medicare approval would need to have 1-year patient and 1-year graft survival follow-up data on at least 9 transplants of the appropriate organ type during the 2.5 year period reported in the most recent SRTR center-specific report. We proposed that we would compare each transplant center's observed 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 had 1-year post-transplant follow up on at least 9 transplants of the appropriate organ type. We also proposed that if a center's observed patient survival or graft survival rate was lower than the expected patient or graft survival rate and the center crossed over all 3 of the non-compliance thresholds for all 3 tests (p-value less than 0.05, observed—expected greater than 3, and observed/expected greater than 1.5) for either graft or patient survival, we would not consider the center to be in compliance with the outcome requirements. We proposed that a heart-lung transplant center, an intestine transplant center, and a pancreas transplant center, as defined in the final rule, would not be required to comply with the outcome requirements for re-approval. We proposed that a center requesting Medicare re-approval to perform pediatric transplants would not be required to perform a minimum number of pediatric transplants prior to its request for Medicare re-approval. Comment: Some commenters supported the proposed data submission requirements. The commenters were pleased that the provisions would not require additional data beyond the OPTN requirements. The commenters asked us to emphasize that follow-up data are essential for evaluating and reporting of outcomes and the refinement of organ allocation policies. Response: We appreciate the commenters' understanding of the importance of data submission in the accurate assessment of transplant center performance. We did not propose and are not requiring under this final rule that transplant centers report additional data beyond what they already report to the OPTN. The OPTN's comprehensive data reporting policies provide sufficient data for us to determine whether transplant centers meet the outcome measures in this final rule. Comment: A commenter stated that we should coordinate our data submission requirements with the OPTN's, so that centers do not have to submit data both to us and to the OPTN. Response: Under this final rule, we require transplant centers to continue to submit the required data to the OPTN UNet SM system (or any successor system under the OPTN Contract) in accordance with the specified time frame. UNet SM is a secure system for transplant hospitals to communicate transplant information and data to UNOS. We are not requiring transplant centers to submit data to us separately on a routine basis. Comment: A commenter stated that compliance with the data submission requirements should not be used as the basis for denial of Medicare approval and re-approval. The commenter said that there is no evidence linking failure to submit OPTN-required data with poor outcomes. Response: Given that the national and center-specific outcome measures calculated by the OPTN are based largely on data submitted by the transplant centers, it is imperative for centers to report data to the OPTN completely, accurately, and in a timely manner. We cannot provide meaningful oversight of center activities without complete and timely data submission. To ensure that the data used by the SRTR for analysis and compilation of the national and center-specific reports are comprehensive and accurate, we must have data submission requirements. We made no changes based on this comment. Comment: Some commenters expressed concern that the expanding scope and complexity of OPTN data submission have significant personnel and financial implications for transplant centers. The commenters urged us to confer with the OPTN to limit the Federal data submission requirements to data needed only to calculate 1-year post-transplant outcomes. Response: We understand the administrative workload required to achieve compliance with OPTN data submission policies. In 2006, the OPTN engaged in an extensive effort to review all data elements currently submitted by transplant centers to determine whether the number of elements could be reduced to lessen the burden on centers. Based on collaboration with the American Society of Transplant Surgeons and the American Society of Transplantation and input from the public, the OPTN succeeded in reducing the data entry burden on its transplant hospital members. For example, 268 data fields will no longer be required for validation of UNet SM forms, such as the transplant candidate registration form and the transplant recipient registration and follow up forms. Additionally, the requirement to follow transplant recipients for 2 years after graft failure has been eliminated. With significant reduction in data submission elements such as these, the OPTN anticipates that data quality will improve significantly. We continue to support the OPTN's commitment to review its data collection process annually for opportunities to reduce burden. However, we believe that the data submitted by transplant centers cannot be limited only to those data needed to calculate 1-year post-transplant outcomes. The more extensive data submitted by transplant centers form the backbone for the research and analyses produced by the SRTR, and the data are necessary for the OPTN, CMS, and transplant centers to develop sound policies. No changes were made based on this comment. Comment: Some commenters requested that we quantify whether “95 percent compliance” means 95 percent of forms, patients, or data fields. A commenter suggested a data compliance threshold of less than 95 percent. Response: By 95 percent compliance, we mean that 95 percent of the OPTN-required forms on all transplants (deceased and living donors) must be completed and submitted within 90 days following the OPTN-required time frame. This requirement provides transplant centers with an additional 90 days beyond the OPTN due date to comply. In our view, lowering the threshold to less than 95 percent is unacceptable and inconsistent with OPTN requirements. Therefore, we did not make any changes based on this comment. Comment: A commenter recommended that if a center produces independent evidence that it has submitted the required data timely or if a center's failure to produce the required data is attributable to unique circumstances that are unlikely to recur, we should consider the center to be compliant with data submission requirements. One commenter stated that the imposition of the “no later than 90 days after the OPTN due date” deadline is unnecessarily harsh and recommended that, as long as a transplant center submits 95 percent of the required 1-year data in time to be included in the SRTR report, we should consider the transplant center to be compliant. Another commenter expressed concern that tying Medicare approval to compliance with the 95 percent data submission requirement would result in centers submitting poor quality data. The commenter suggested that in an effort to comply, centers may resort to marking data elements as “unknown” or “lost to follow up” more often than is currently done. Response: Data submission policies that differ from those of the OPTN are likely to confuse transplant centers and result in decreased compliance with OPTN policies. When reviewing a center's compliance with the data submission requirements, we will take into consideration whether circumstances beyond the control of the center prevented it from fully complying with the data submission policies. Nevertheless, any willful falsification of data by a transplant center will be considered a violation of the data submission requirements in this final rule, as well as that of 42 CFR 121.11(b)(2). Comment: Some commenters asked that we exempt kidney transplant centers from data submission and outcome requirements because kidney transplants are covered under the Act. Response: The Act provides the authority for Medicare to pay for kidney transplantation. However, it does not preclude us from establishing requirements that kidney transplant centers must meet to participate in the Medicare program. In fact, the statute specifies that payment will be made for kidney transplantation to providers of services that “meet such requirements as the Secretary shall by regulation prescribe * * *” (See section 1881(b)(1)(A) of the Act.) Further, as noted in the preamble to the proposed rule, we are committed to bringing both the kidney and extra-renal transplant requirements up to date. For consistency across all types of transplant centers, we are requiring Medicare-approved transplant centers, including kidney transplant centers, to submit transplant data per OPTN data submission requirements. No changes were made based on this comment. Comment: Another commenter recommended that we amend the regulation text to require the submission of 95 percent of a program's data within 3 months of the due date and 100 percent of the program's data within 6 months of the due date. Response: We expect transplant centers to comply with the OPTN policy to submit 100 percent of the required data within 6 months of the due date. However, we are not including the requirement in this final rule because a requirement for 100 percent compliance would be problematic within our framework for Medicare oversight and enforcement. For example, if the OPTN notified us that a transplant center had submitted only 99.9 percent of its data within the required time frame, under such a requirement we would consider the transplant center to be out of compliance, which could subject the transplant center to review and adverse action. Clinical Experience We requested comments on: (1) Whether requiring a minimum number of 9 transplants during a 2.5 year period would be acceptable for the application of the SRTR methodology; and (2) whether our proposal to focus more heavily on a center's outcomes by eliminating volume as a separate standard and integrating volume into our outcome measures would provide us with the necessary data. In addition, three peer reviewers provided comments on the following specific issues related to volume: (1) Other alternative minimum volume criteria that would ensure that the 3 test criteria can be applied properly; and (2) appropriateness of volume standards for pediatric transplants. Comment: Only one commenter said that eliminating volume as a separate standard would be a positive change. Overall, commenters said that the proposed methodology-based volume of 9 transplants in a 2.5 year cohort would be unacceptable as a basis for approval or re-approval of transplant centers. Commenters noted that a threshold of 9 transplants in 2.5 years would be much lower than the current Medicare annual thresholds (10 for lungs and intestines, 12 for hearts and livers, and 15 for kidneys). One commenter said that the proposed volume should not be used to assess a center's performance because it neither serves the best interests of patients nor supports our stated goal to raise transplant standards. Another commenter said that no center performing only 9 transplants in 2.5 years can be considered a legitimate transplant program. Still another commenter said that the proposed volume is so low that it essentially would eliminate a requirement for volume. One commenter suggested that with the exception of isolated geographic locations, we should require 15 transplants as the absolute minimum annual volume, with a higher annual requirement for kidney and liver transplants, such as 30 transplants of each organ per year. Two peer reviewers voiced concern that the methodology-based volume requirement we proposed may allow Medicare-approved centers to become inactive but retain their Medicare approval. Response: We proposed requiring only 9 transplants in the 2.5 year cohort used for SRTR center-specific reports because 9 transplants is the minimum number necessary for the SRTR-based methodology to flag a poorly-performing center. In the preamble to the proposed rule, we acknowledged the possibility that a center could perform 9 transplants in a short period of time and remain inactive for a much longer period, while still retaining its Medicare approval. Nevertheless, we posited that the OPTN's oversight of transplant center “functional inactivity” would guard against this circumstance. Additionally, in our move toward an outcome-focused system that reflects the clinical experience, resources, and commitment of a transplant program, we have revised the preamble and the regulations text by removing references to “volume requirements” and instead refer to “clinical experience requirements.” We believe this change reflects our intent to approve transplant centers using an outcome-based methodology under which the number of transplants performed is one of several factors we consider. However, the comments we received from the public and from peer reviewers, as well as recent findings of prolonged inactivity or sub-optimal clinical experience at some transplant centers, have caused us to re-evaluate our position. In analyzing this issue, we considered several factors, including the possible impact of clinical experience on quality of outcomes and the ability of a patient on a transplant center's waiting list to obtain a transplant. Few research studies have been conducted on the link between volume and quality of outcomes in transplantation. A 1994 study found a significantly higher 1-year post-transplant mortality rate among patients transplanted at centers that performed fewer than 9 heart transplants per year when compared to patients transplanted at centers that performed 9 or more heart transplants per year. (Hosenpud JD, Breen TJ, et al. The effect of transplant center volume on cardiac transplant outcomes: a report of the United Network for Organ Sharing Registry. Journal of the American Medical Association , 1994; 271: 1844-1849.) A 1999 study using 1994 through 1997 data showed a similar correlation between liver transplant volumes and outcomes. Specifically, patients transplanted at liver centers that performed 20 or fewer transplants per year had significantly higher 1-year post-transplant mortality than patients transplanted at liver centers that performed more than 20 transplants per year. (Edwards, EB, Roberts JP, et al. The effect of the volume of procedures at transplantation centers on mortality after liver transplantation. New England Journal of Medicine , 1999; 341: 2049-2053.) However, we believe it would be problematic to base clinical experience requirements on research conducted on transplants performed when survival rates, particularly liver transplant survival rates, were significantly lower than they are today. That is, 1-year risk-adjusted survival after heart transplantation was 83.4 percent in 1994 but had increased to 87.96 percent during the most recent SRTR cohort for which data are available, July 1, 2002 through December 31, 2004. Further, 1-year risk-adjusted survival after liver transplantation was 76.3 percent in 1994 but had increased to 86.59 percent during the most recent time period for which data are available, January 1, 2003 through June 30, 2005. In contrast, 1-year survival from 1994 through 1997 at the high-volume liver centers in the 1999 study was only 80 percent. A study published in 2004 looked at data for adult patients who received kidney or liver transplants between January 1, 1996 and December 31, 2000. (Axelrod DA, Guidinger MK, et al. Association of center volume with outcome after liver and kidney transplantation. American Journal of Transplantation , 2004; 4: 920-927.) The study found a significantly lower rate of 1-year post-transplant kidney graft failure at high volume centers when compared to medium, low, or very low volume centers. The study also found a significantly different rate of 1-year post-transplant patient mortality at high, medium, and low volume liver centers; low volume centers were associated with a significantly higher risk of death. Despite these findings, the study's authors concluded that there is no clear minimal threshold volume. Additionally, the study's authors identified several potential implications from the results of the study, noting that efforts are underway in other (non-transplant) surgical fields to concentrate procedures at high volume centers when there is a relationship between volumes and outcomes. The study suggested that even with a clear association between volume and outcomes in transplantation, “The adoption of such a policy for liver and kidney transplantation would not be straightforward even if it were desirable, particularly in the case of deceased donor transplantation [because] the benefit of high-volume center performance must be carefully weighed against the increased risk of graft loss associated with the increased cold ischemia time [that] would likely accompany increased regionalization of transplant services.” The authors also pointed out that “the frequent follow-up visits necessary after transplantation might prove to be an added hardship if patients were forced to travel great distances. Because patients may be more compliant with follow-up visits if appointments are convenient, compliance may also be an important determinant of outcome.” Because research on the effect of volume on outcomes in transplantation provides little guidance in establishing the appropriate amount of clinical experience for Medicare approval, we looked at the waiting lists at heart, liver, and kidney centers that have volumes below current Medicare requirements, (12 transplants per year for heart centers and liver centers and 15 transplants per year for kidney centers), and compared them to the waiting lists at higher volume heart, liver, and kidney centers. We found indications that there may be a link between clinical experience and how well patients fare while they are still on the waiting list. For example, in 2005, there were approximately 117 adult heart transplant centers in the United States. According to the SRTR, 69 centers performed 12 or more transplants, and 48 performed fewer than 12 transplants. Out of the 69 centers that performed 12 or more transplants, 1 had a higher than expected mortality on the waiting list. Of the 48 centers that performed fewer than 12 transplants, 5 had higher than expected mortality on the waiting list. Nationwide in 2005, there were approximately 106 adult liver transplant centers in the United States. There were 6,122 patients on the liver transplant waiting list. Slightly more than 28 percent (1,745) of these patients died without receiving a transplant. Of the 96 adult liver transplant centers that performed 12 or more transplants in 2005, only one center had more deaths on the waiting list than the number of transplants it performed. However, among the 10 liver centers that performed fewer than 12 transplants in 2005, 5 centers had more deaths on the waiting list than the number of transplants it performed. Of those 5 centers, 2 centers had approximately 3 times the number of deaths on the waiting list as the number of transplants they performed. For example, one liver center performed 7 transplants in 2005 and had 20 waiting list deaths during the same time period. We also considered whether center clinical experience affects the ability of waiting list patients to obtain a transplant by reviewing transplant rates for kidney centers in 2004/2005. The SRTR calculates whether a center's transplant rate for deceased donor transplants is statistically higher, statistically lower, or not significantly different from other transplant centers. Although we found no definitive link between a kidney center's clinical experience and the transplant rate calculated by the SRTR, we note that the transplant rate of a small center generally would not be considered statistically lower than expected even if the center performed no transplants during a given year due to the small number of patients on its waiting list. However, in reviewing the data, we found that 7 out of the approximately 231 adult kidney transplant centers in the United States in 2004 and 2005 performed no transplants at all during those 2 years. The number of patients on the waiting lists of the 7 centers numbered between 9 and 47. Although the number of patients affected was small, we are concerned that patients continued to be listed on the waiting lists of centers that performed no transplants in 2 years. We note that, at present, all 7 centers are listed as inactive on the SRTR's Web site. In summary, public commenters and some peer reviewers recommended a volume standard higher than the proposed 9 transplants in 2.5 years. None of the peer reviewers recommended a specific volume. Studies of the effect of volume on outcomes in transplantation suggest that higher volume centers have better outcomes, although there is no evidence that indicates what the minimum threshold should be. Also, our review of waiting list data raises the concern that waiting list patients at small centers may not fare as well as waiting list patients at larger centers, both in terms of waiting list mortality and the ability to obtain a transplant. Further, as discussed earlier in this preamble, in the fall of 2005, we found that some centers, although not considered “functionally inactive” by the OPTN, performed few transplants and refused a high percentage of organs that were offered to them for transplantation into their waiting list patients, leading to longer than average waiting times and, possibly, an increased number of deaths among their waiting list patients. These factors must be weighed against the necessity to maintain Medicare beneficiaries' access to transplantation. Also, we must keep in mind the concerns raised by the 2004 study of volume and outcomes in kidney and liver transplantation that centralizing transplants in too few centers could be detrimental to transplant outcomes. Based on these considerations, we believe transplant centers should be required to perform more than 9 transplants in 2.5 years to become Medicare approved and, once approved, retain their Medicare approval. Without strong statistical evidence supporting a particular threshold for any of the organ types, we believe the most appropriate solution is to establish a clinical experience requirement that is close to the current volume requirements in our NCDs for heart, intestine, liver, and lung transplant centers and in our CfCs for kidney transplant centers. We believe establishing a clinical experience requirement of 10 transplants per year for all organ types for both approval and re-approval of transplant centers is both sensible and the least disruptive for transplant centers that have current Medicare approval and for the beneficiaries on the waiting lists of these centers. We are revising § 482.80(b) to state that to be Medicare approved under this final rule, adult transplant centers (with the exception of heart-lung centers, kidney transplant centers, and pancreas centers) generally must perform 10 transplants over a 12 month period. We are revising § 482.82(b) to state that to be re-approved under this final rule, a transplant center must perform an average of 10 transplants per year during the re-approval period. There are no minimum clinical experience requirements for initial approval or re-approval for heart-lung, pancreas, or pediatric centers. (Kidney transplant centers generally must perform 3 transplants over a 12-month period for initial approval and 10 transplants annually for re-approval.) (See §§ 482.80(d)(4) and 482.82(d)(4).) Note that an adult transplant center may not attempt to meet the clinical experience requirement by combining adult transplants with pediatric transplants performed at an affiliated pediatric center. As stated previously, the main intent of the clinical experience requirement for re-approval is to ensure that Medicare-approved centers stay active. We recognize that a center's transplant numbers may fluctuate at times. Nonetheless, we believe that a transplant center must perform an average of 10 or more transplants per year to demonstrate commitment to its transplant program and gain adequate clinical experience. To determine a center's compliance with the clinical experience requirement, we will review the data contained in the most recent OPTN Data Report and SRTR center-specific reports. (See § 488.61(a)(2) and § 488.61(c)(1)(ii).) Comment: Some commenters said that all kidney transplant centers should be exempt from initial approval requirements (such as the requirement to perform 9 transplants) because a lengthy initial approval process would delay access to the new kidney center's transplantation services for Medicare beneficiaries. That is, until a new kidney transplant center receives Medicare approval, Medicare will not pay for beneficiaries to receive transplants at the facility. Response: We share the commenters' concern that a lengthy approval process for kidney centers, particularly a requirement to perform 10 transplants prior to approval, may prevent kidney transplant centers from opening in areas of the country where access to kidney transplant services is already limited. 1 Meeting a clinical experience requirement of 10 transplants would be particularly difficult for new kidney transplant centers, because Medicare is either primary payer or secondary payer for 69 percent of kidney transplants performed in the United States, while the other 31 percent of kidney transplants are paid for by private insurance, Medicaid, and the Department of Veterans Affairs (unlike extra-renal transplants for which Medicare pays between approximately 20 percent and 40 percent, depending upon organ type). Thus, a new kidney transplant center would have considerable difficulty finding 10 non-Medicare patients to transplant. 1 Although nearly half of all transplant centers in the United States are kidney transplant centers, there are barriers to access to kidney transplantation services in some areas of the country where there are large dialysis populations but few kidney transplant centers, and in some largely rural States that have no in-State kidney transplant centers and few centers in neighboring States. Under the current ESRD CfCs for kidney transplant centers, a new center may be approved without performing any transplants if it has a written plan detailing how it will achieve conditional status (7-14 transplants) within 2 years and unconditional status (15 or more transplants) within 4 years. Currently, there are no outcome requirements for kidney transplant centers. However, this final rule contains outcome requirements for initial approval of kidney transplant centers, and in order for us to assess a new kidney transplant center's performance, the center must perform some transplants. Taking this information into consideration, we have determined that requiring new kidney transplant programs to complete 10 transplants before applying for approval could prevent new centers from entering the Medicare program. We believe that completing 3 consecutive, successful transplants, as determined by 1-year post-transplant graft and patient survival outcomes, is necessary for a new kidney center to demonstrate sufficient experience in transplantation and enhances the new transplant center's ability to recruit transplant candidates from the limited pool of the non Medicare-eligible kidney transplant candidate population. We are sensitive to the difficulty a new kidney transplant center will have in finding non-Medicare patients to transplant. We are committed to maintaining and improving access to kidney transplantation services for Medicare beneficiaries, but we also believe it is essential to assess a kidney transplant center's performance prior to approving it for the Medicare program. Therefore, this final rule establishes a clinical experience requirement of 3 transplants for initial Medicare approval for kidney transplant centers that had not been approved by Medicare under § 405.2122 as of this rule's effective date at § 482.80(d)(5). We believe this requirement will allow new kidney transplant centers to obtain Medicare approval expeditiously, while ensuring that some data are available to demonstrate whether the center's outcomes are acceptable. Like extra-renal transplant centers, kidney transplant centers will be approved for 3 years and will be required to perform an average of 10 transplants per year for re-approval. However, because a kidney center will be required to perform only 3 transplants before obtaining initial approval, we will scrutinize the center's clinical experiences and outcomes closely, particularly in the year following its initial approval. CMS will monitor the clinical experience and outcomes statistics of the center in the year following its initial approval. We are requesting center-specific data already collected through the OPTN, and expect to review the data at least quarterly. If the center's clinical experience and outcomes highlight a need for additional investigation, CMS will follow up through its survey and certification process. We note that in the past, new transplant centers interested in applying for Medicare approval have offered to perform transplants for Medicare beneficiaries free of charge so that the center could meet the clinical experience requirement for initial Medicare approval quickly. This practice has serious implications for a Medicare beneficiary who accepts a transplant center's offer of a free transplant. Medicare pays for prescription drugs used in immunosuppressive therapy under Medicare Part B only if the transplant was performed in a Medicare approved facility. Although an individual may be eligible for payment for his or her immunosuppressive drugs under Medicare Part D, the beneficiary may pay several thousand dollars more out of pocket every year. Therefore, we have added a requirement under the CoP for Patients' and Living Donor Rights at § 482.102(a)(8) and (b)(9) that a transplant center must inform Medicare beneficiaries who are prospective transplant recipients and their prospective living donors that receiving a transplant that is not provided in a Medicare-approved transplant center could affect the transplant recipient's ability to have his or her immunosuppressive drugs paid under Medicare Part B. See further discussion of this requirement in this preamble under “Patients and Living Donor Rights” and “Centers With Current Medicare Approval.” Comment: A commenter stated that OPTN policies do not specify that transplant centers must perform a minimum number of transplants per year and said that our requirements and those of the OPTN should be consistent. A commenter also asked us to clarify in more detail what the OPTN means when it terms a transplant center “functionally inactive,” as well as how this status may impact a center's eligibility to receive organs. Response: As discussed in the proposed rule, although the OPTN does not require a transplant center to perform a minimum number of transplants, programs (centers) are reviewed and may be classified as “functionally inactive” if they have not performed a single transplant within a specified period of time. The specific time frame that the OPTN Membership and Professional Standards Committee (MPSC) uses to determine “functional inactivity” is 3 months for kidney, liver, and heart programs, 6 months for pancreas and lung programs, and 1 year for stand-alone pediatric programs. Under OPTN Bylaws, Appendix B(II), an OPTN member transplant hospital that fails to remain functionally active with respect to any designated transplant program may be encouraged to voluntarily deactivate its transplant program until such time as the circumstances affecting the status of the program have been resolved (up to 12 months) or relinquish designated transplant status for the program. If the member fails to take either action voluntarily, the MPSC may recommend that the Board of Directors notify the Secretary of this inactivity (if the transplant program is Medicare approved or located within a Federal hospital) and take appropriate action in accordance with the OPTN bylaws. The OPTN's determination that a transplant program is “functionally inactive” does not, by itself, prohibit a center from receiving organs. However, hospitals with transplant centers usually follow the recommendation of the MPSC by voluntarily inactivating the transplant center in question. Although we want to ensure that transplant centers remain active, we do not want a transplant center that is experiencing problems to continue to perform transplants just to avoid losing its Medicare approval. Therefore, we have added a provision to this final rule that a transplant center may inactivate its program for a period not to exceed 12 months during the 3-year approval cycle without losing its Medicare approval (see § 488.61(e)), but the center must notify us immediately of significant changes in the number of transplants performed, as required at § 482.74(a)(4). The transplant center also must notify the patients on its waiting list and, as requested by the Secretary, assist patients in transferring to the waiting list at another transplant center, without loss of time accrued on the waiting list. (See § 482.102(c)(3).) We will confer with HRSA and the OPTN on a case-by-case basis to determine whether to instruct an inactive center to notify its waiting list patients and assist them in transferring to another transplant center's waiting list. We proposed that a center that was requesting initial Medicare approval to perform pediatric transplants would not be required to perform a minimum number of pediatric transplants prior to its request for Medicare approval. Comment: Most commenters agreed that volume requirements are not relevant for pediatric centers and they strongly supported having no volume requirements for centers performing pediatric transplants. Two peer reviewers said that a volume requirement would be inappropriate for pediatric centers. One peer reviewer agreed that volume standards are not appropriate for pediatric transplant programs, but also expressed concerns about the ability of pediatric centers to maintain their expertise because many centers perform so few pediatric transplants. Another peer reviewer stated that since setting a volume requirement for small pediatric centers is challenging, Medicare approval for pediatric centers that are affiliated with Medicare-approved adult transplant programs is recommended. Like the other peer reviewer, this peer reviewer also had concerns about small, stand-alone pediatric transplant programs' ability to maintain resources and expertise in transplantation. However, two commenters stated that a minimum volume requirement is necessary to ascertain the commitment and investment a hospital has made in its pediatric transplant center. One commenter recommended ten pediatric transplants a year for liver and kidney programs and a lower volume for heart programs. The commenter suggested counting open and closed congenital heart surgeries toward the volume requirement for pediatric heart transplants. One commenter expressed a strong belief that having no volume requirement for pediatric transplant centers would allow small programs with limited resources to perform transplants, with potential poor outcomes. Response: Given the nature of the pediatric transplants performed and the low numbers of pediatric transplants in general, it would be impossible for most pediatric transplant centers to obtain Medicare approval if we required them to meet clinical experience requirements, limiting access for pediatric Medicare beneficiaries who need transplants. As stated earlier, we will monitor pediatric centers' outcomes to ensure they provide high quality transplantation services to Medicare pediatric patients. We made no changes based on this comment. Comment: Som [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A07-1435. Public record. Not legal advice.