ASTS continuing to monitor surveyors use of CMS Interpretive Guidelines in certifying transplant centers.

The Conditions of Participation (CoPs) were published as a final rule by the Centers for Medicare and Medicaid Services (CMS) on March 30, 2007, and became effective on June 28, 2007.

The rule stated that all US transplant centers must be certified by CMS for each organ type, and recertified every three years thereafter.

Once the final rule was published, the CMS began implementing the process drafting interpretive guidelines (IGs) to be used by surveyors to interpret the final rule and determine whether transplant centers meet the regulatory requirements. The language contained in the IGs is considered crucial by transplant centers because they are used by surveyors to interpret the CMS final rule and determine if the centers are meeting the regulatory requirements.

The American Society of Transplant Surgeons (ASTS) had carefully monitored the development of both the final rule and the IGs and met with CMS on a regular basis and submitted comprehensive responses and recommendations during the public comment period.

In a Special Article entitled Transplant Center Regulations - A Mixed Blessing? An ASTS Council Viewpoint which appearing in the current issue of the American Journal of Transplantation, members of the council, addressed the CMS process of developing the IGs and their impact on the surveyor's process to date. The lead author of the article was Michael Abecassis, MD, MBA, Chief, Division of Transplantation, Professor of Surgery, Northwestern University in Chicago, and ASTS treasurer.

Here are portions of the AJT article on the impact of the IGs on the CMS surveyor teams actions to date and the ongoing dialogue with the CMS.

"When the first set of draft IGs was made available, the ASTS felt that they deviated from the final rule in several areas," the ASTS council members write. "Members of the ASTS Executive Committee met and corresponded with CMS in order to make the agency aware of areas of concern. CMS responded by amending the language in the IGs to better reflect the intent of the final rule. Specifically, the agency eliminated several requirements and modified others to provide transplant centers with increased flexibility in the areas of multidisciplinary care, verification of patient selection criteria, continuing education for clinical staff and availability of tissue typing services, among others. In addition, the agency clarified the roles of the transplant surgeon and transplant coordinator. A third and final version of the IGs was issued to surveyors in June 2008, which addressed a number of concerns that remained after the second draft, and these final IGs replaced all previous versions.

"The most recent changes made by CMS in response to ASTS comments include clarification that surveyors must limit their review to the effective date of the new CoPs, recognition that meetings are not required to document multidisciplinary care and that this can be documented through entries in the patient chart, clarification that the compliance survey does not encompass care provided in outpatient clinics, clarification that postdischarge care can be provided by the local physician and a provision for increased flexibility in documentation of the team involved in living donor assessments."

The authors noted that at one point CMS shared the results of the first set of surveys (without revealing the names of the transplant centers) and identified areas where transplant centers have frequently been found to be out of compliance with the requirements. They included:

*Organ receipt: verification of ABO and other data (42% of centers deficient)

*Written documentation of transplant multidisciplinary patient care planning (27%)

*Components of quality assessment and performance - QAPI (24%)

*Transplant teamidentified and responsibilities described (24%)

*Written documentation of discharge multidisciplinary patient care planning (22%)



*Written documentation (patients medical record) of selection criteria used to waitlist patient (20%).

"There are two levels used by CMS to determine how deviations from outcomes

Standard will affect certification. A condition' level citation is deemed grounds for termination of a center's certification; for instance, a transplant center may receive a termination letter (which may be publicly available) if its most recent outcomes fail to meet standards and if more than one outcomes report over the past 2 years fails to meet the standards. Although the rule provides for mitigating circumstances' in order to prevent such an unfavorable certification decision, the requirements for mitigating circumstances are undefined and it is unclear what type of correction action plan' can avert termination. The lag in data reporting by centers and analysis provided the SRTR makes it unrealistic that a transplant center can correct its outcomes within 210 days provided. The ASTS has registered these concerns with CMS."

Finally the authors expressed concern about costs being incurred by transplant centers to meet the requirements.

"The implementation and monitoring required to meet the requirements of the final rule, especially the documentation requirements, have resulted in added costs to transplant centers without additional funding, outside of allowable costs under the Organ Acquisition Cost Center provisions," they write. Several centers have noted the need to add at least two to three individuals to their program for the purposes of implementing and monitoring the regulations. Other centers have noted the need to incorporate the processes involved in the regulations into their electronic medical records requiring further information systems personnel. These costs can be estimated to be in the hundreds of thousands of dollars in additional annual expense. In the current environment of falling reimbursements and rising costs, particularly for higher acuity recipients and more marginal donors, it is difficult to support costs associated with these regulations. This issue has not been addressed to date and requires further discussion."

"We have raised important questions about the impact of the regulations on the safety and quality of care provided to transplant patients, questions that can only be answered through further study. In this, CMS, transplant caregivers and patients are all on the same page, desiring to advance the quality and outcomes of transplant services."

On December 4, 2008, Transplant News in conjunction with the ASTS produced a 90-minute webinar entitled The CMS Interpretive Guidelines for transplant centers CoPs: What centers waiting to be audited need to know; why centers that have already been audited must remain vigilant. The speakers included: Abecassis; Diane Millman and Rebecca Burke, from the law firm of Powers, Pyles, Sutter and Verville, ASTS legal counsel; and Jennifer Milton, BSN, CCTC, MBA, Administrative Director, Associate Faculty, University of Texas Health Center in San Antonio.

The entire 90-minute Webinar, including a 30 minute Q&A period is available for purchase from Transplant Communications, Inc. Materials include a WMV DVD, Audio CD, written transcript and all written materials including speaker's power points and supplemental materials. For information, contact Jim Warren at 800-689-4262 or e-mail: [e-mail]