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Home > AORN News > CMS Issues Rule

CMS has issued a final rule that establishes, for the first time, Medicare Conditions of Participation (CoPs) for heart, heart-lung, intestine, kidney, liver, lung and pancreas transplant centers. The rule sets forth clear expectations for safe, high-quality transplant service delivery in Medicare-participating facilities. Until now, kidney transplant facilities operated under conditions for coverage for suppliers of end-stage renal disease (ESRD) services; extra-renal organ transplants were regulated by various national coverage decisions for extra-renal organ transplantation. This final rule, 42 CFR Parts 405, 482, 488 and 498, is effective June 28, 2007.

Under the new rule, existing Medicare-approved transplant centers have 180 days from the effective date of the final rule to submit a request for approval under the new conditions of participation (CoPs §482.72 through 482.104). Once a facility is approved under the new CoPs they will no longer have to comply with the requirements outlined by the national coverage decisions for renal or extra-renal transplant centers. Currently, approved facilities that do not apply within 180 days will no longer be reimbursed for services provided to Medicare beneficiaries related to organ transplants.

A transplant center that wishes to continue to be Medicare approved, or a transplant center seeking initial Medicare approval must be in compliance with the new CoPs and must submit a request signed by the person authorized to represent the facility (e.g. the chief executive officer) that includes:

• The facility’s Medicare provider ID number
• The names of the designated primary transplant surgeons and primary transplant physicians
• A statement from the Organ Procurement and Transplant Network (OPTN) that the center has complied with all data submission requirements

Some of the other new CoPs include:

• A transplant center must be located in a hospital that is a member of and abides by the approved rules and requirements of the OPTN and has an existing written agreement with an organ procurement organization (OPO).
• 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, including:
• 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
• Annual volume requirements for transplant center are:
• Heart, intestine, liver & ling transplant centers – 10 transplants during a 12-month period 
• Kidney transplant centers – three (3) transplants during a 12-month period
• Heart-lung, pancreas and pediatric transplant facilities have no annual volume requirements

The Final Rule also addresses patient management in Organ Transplant Centers. According to CMS, transplant centers need to have written patient management policies for the entire transplantation process, i.e., Pre-transplant Phase, Transplant Phase and the Discharge Phase of Transplantation.
 
A multidisciplinary team must oversee the care of each transplant patient or living donor. Each transplant patient and living donor needs to be provided with informed consent that includes, but is not limited to:

• The evaluation process
• The surgical procedure, including post-op treatment
• Medical and/or psychosocial risks
• Transplant center specific as well as national outcomes
• The possibility that future health problems related to the donation may not be covered by the donor’s insurance, and the donor’s ability to obtain health, disability, or life insurance may be affected
• The fact that immunosuppressive drugs will not be paid under Medicare Part B if the transplant is performed at a facility that is not Medicare-approved
• The right to refuse transplantation

According to CMS, transplant centers also need to keep their wait lists up-to-date including:

• Updating wait list patients’ clinical information on an ongoing basis
• Removing a patient from the wait list if a patient receives a transplant or dies, or if there is any other reason why the patient should no longer be on the wait list
• Notifying the Organ Procurement and Transplantation Network (OPTN) no later than 24 hours after a patient’s removal from the center’s wait list

Additionally, a patient must be notified when he/she is placed on the wait list, not placed on the wait list, or if a determination for wait list placement cannot occur until additional information is received. A patient must also be notified within 10 days if he/she is removed from the wait list for any reason aside from death or transplantation.

Facilities intending to seek approval or re-approval from Medicare under this final rule should review, in detail, the specifications of the regulation as published in the final rule:

• 42, CFR Parts 405, 482, 488, and 498 Medicare Program; Hospital conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants; Final Rule. Federal Register, March 30, 2007, http://www.cms.hhs.gov/CertificationandComplianc/downloads/Transplantfinal.pdf

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References:

42, CFR Parts 405, 482, 488, and 498 Medicare Program; Hospital conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants; Final Rule. Federal Register, March 30, 2007