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Surprise! CMS releases OPO final rules and they like them, they really like them.

When the proposed rules for regulating the nation's organ procurement organizations (OPOs) was published last February they were not exactly greeted with high-fives and hurrahs by the transplant community.

There were charges the proposed regulations would be harmful to the relationship between an OPO and the transplant centers it served, lead to harmful competition for donation service areas and mandate harmful outcome measures.

However, when the Centers for Medicare and Medicaid's Final Rules were published on May 31 the organ procurement community responded with something akin to a standing ovation.

"I feel a lot better about the process now than I did before going in. I was pleasantly surprised," Paul Schwab, executive director of the Association of Organ Procurement Organizations (AOPO) told Transplant News. "We met with CMS Administrator Mark McClellan before the contract closed and he assured us the agency would give serious attention to our concerns and he came through. Overall this is both a significant improvement of the proposed rule and reflective of the many comments they got."

AOPO President Tom Beyersdorf, executive director of Gift of Life Michigan, praised the final rule and the government's willingness to listen. "It is clear that CMS provided serious attention to the many comments it received regarding its proposed rule published early last year," Beyersdorf said. "We had been concerned that donation successes of recent years might have been in jeopardy by the impending rules. However, the focus of the new, final rules on quality and reducing uncertainly in the donation process are right on target."

"It took a long time for these rules to be developed and that may have been a good thing," Schwab observed. "Due to the breakthrough collaborative relationships between the transplant community and government have never been better and that parallels with the Joint Commission's relationship with transplant centers now. It is important to have a good alignment between oversight and incentives of donor hospitals, OPOs and transplant programs. I think much has been accomplished with the new regulations."

The Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations: Final Rule goes into effect on July 31, 2006.

The new rule "establishes new conditions for OPOs that include multiple new outcome and process performance measures based on organ donor potential [not donors per million] and other related factors in each service area of qualified OPOs." CMS said in a summary of the rule in the May 31 Federal Register. "Our goal is to improve OPO performance and increase organ donation. In addition, this final rule re-certifies these 58 OPOs from August 1, 2006 through July 31, 2010 and provides an opportunity for them to sign agreements with the Secretary that will begin on August 1, 2006 and end on January 31, 2011. New agreements are needed so that Medicare and Medicaid Programs can continue to pay them for the organ procurement activities after July 31, 2006."

"The rule establishes a competitive framework for OPO certification based on rigorous performance-based quality measures for OPOs," said McClellan in a press release. "This rule will support and enhance the Department's unprecedented success in saving lives by increasing organ donation and transplantation."

Here are some of the requirements contained in the 150-page Final Rule that OPOs will have to follow in order to have their services covered under Medicare and Medicaid.

Outcome and performance measures

New conditions for coverage for OPOs have been established by CMS based on comments received. None of the five outcome measures contained in the proposed rule were retained. The three new outcome measures for OPOs to be judged are: (1) donation rate; (2) observed donation rate as compared to the expected donation rate, as calculated by the Scientific Registry of Transplant Recipients (SRTR); and (3) a yield measure for both organs transplanted per donor and organs used for research per donor.

The donation rate will allow CMS to assess an OPO's conversion rate of potential donors to actual donors, which allows it to determine how an OPO has performed in regard to the donor potential (the number of eligible deaths) in its own donation service area (DSA). It also allows CMS to see how the OPO has performed when compared to other OPOs.

The second outcome measure uses the SRTR statistical methodology for determining an expected donation rate for each OPO which allows CMS to have a reasonable idea of how an OPO performed in view of its expected performance.

The third outcome measure allows CMS to assess how well an OPO fulfills its ultimate mission of recovering viable organs and placing them with transplant centers, and placing them for research.

Donation after Cardiac Death (DCD)

The proposed rule contained no requirements for donation after cardiac death (DCD). However, many commenters pointed out that recovering organs from DCDs has increased in recent years and will help address the shortage of donors. The final rule requires that an OPO's agreement with its hospital must describe the responsibilities of both the OPO and the hospital or critical access hospital in regard to DCD, if the OPO has a protocol for DCD. An OPO's policies must state whether it recovers organs from DCDs. Finally, OPOs that recover organs from DCD must have a protocol that establishes the following: (1) Criteria for evaluating patients for DCD; (2) withdrawal of support, including the relationship between the time of consent to donation and the withdrawal of support; (3) the use of medications and interventions not related to withdrawal of support; (4) the involvement of family members prior to organ recovery; and (5) criteria for declaration of death and the time period that must elapse prior to organ recovery.

Certification and recertification of OPOs

OPOs will have to be re-certified every fours years instead of the 2 years as originally proposed. OPOs can only compete to be a designated service area provider in DSAs where the previous OPO has been de-certified. The proposed rule would have allowed every OPO to compete to be the OPO in a DSA when an OPO was recertified.

In the final rule CMS will base its selection of an OPO for an open DSA on the following criteria: (1) performance on the outcome measures; (2) relative success in meeting the process performance measures; (3) success in identifying and overcoming barriers to donation in its own DSA and the relevance of those barriers to barriers in the open DSA; and contiguity to the DSA.

OPOs also must have (1) a written agreement with 95% of hospitals in its DSA that have both a ventilator, and an operating room, and have not been granted a waiver to work with another OPO; (2) offer training at least once a year to hospital employees on how to solicit organ donation; and (3) must have arrangements to cooperate with tissue banks that have arrangements with hospitals.

There are many other requirements tucked away in the 150-page Final Rule that will require further study. The rule can be found online at:
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Title Annotation:Centers for Medicare and Medicaid; organ procurement organizations
Comment:Surprise! CMS releases OPO final rules and they like them, they really like them.(Centers for Medicare and Medicaid)(organ procurement organizations)
Author:Warren, Jim
Publication:Transplant News
Geographic Code:1USA
Date:Jun 16, 2006
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