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Congress passes transplant legislation affecting OPOs, children; NOTA action on hold till next year.

Despite the failure of Congress once again to reauthorize the National Organ Transplant Act (NOTA), last minute maneuvering did result in the passage of two bills of importance to organ procurement organizations (OPOs) and to children waiting for transplants.

The Organ Procurement Certification Act of 2000 imposes a moratorium on the Health Care Financing Administration's (HCFA) current recertification process and the use of population-based performance measures. The immediate beneficiaries of the bill, which was passed on October 27 as part of the Public Health Improvement Act of 2000, were 3 OPOs due to be decertified by HCFA-the Arkansas Regional Organ Recovery Agency (ARORA) in Little Rock; the Northeast OPO and Tissue Bank in Hartford, CT; and Lifelink of Puerto Rico.

The Pediatric Organ Transplantation Improvement Act of 2000 increases children's access to organs for transplantation. The act was contained in the Pediatric Organ Transplantation Improvement Act of 2000 spearheaded by Representative Diana DeGette (D-CO).

In addition, legislation providing unlimited Medicare coverage for immunosuppressive drugs awaits passage when congress reconvenes in an unusual special session scheduled to convene in on November 14. Eliminating the time restriction-Medicare now covers immunosuppressive drugs for transplant patients for 44 months-has broad bi-partisan support is not expected to be in trouble when congress and the President Clinton finally agree on a Medicare funding bill.

A last-minute effort to reach a compromise between the House version of NOTA and Senate version failed in mid-October when the House refused to accept a counter-offer to its proposal.

The House bill-championed by Representative Thomas Bliley, Jr. (R-VA)-was heavily tilted towards the United Network for Organ Sharing (UNOS) and would have given UNOS significant new authority over setting US transplant policy.

The Senate compromise-authored by Senators Bill Frist (R-TN) and Edward Kennedy (R-MA)-retained the authority of the Department of Health and Human Services (HHS) to set policy but created a Scientific Advisory Committee on Transplantation to oversee disputes.

Commenting on the failure to compromise, Cybele Bjorklund, a Kennedy health aide who participated in the negotiations, observed ''They asked us to undo virtually every compromise agreement we had come to. We didn't have a lot of room to move. This had been a heroic effort to get everyone on the same page.''

Another, less politic Democratic staffer was more blunt. ''I think they've decided to take their chances with the election and their lawsuits,'' he said.

Congress has not passed NOTA legislation since 1990, despite the fact the program is supposed to be reauthorized every 3 years. The failure to pass the legislation became less important to HHS with the announcement in early October that UNOS had signed a new contract to administer the Organ Procurement and Transplantation Network (OPTN). That contract which contained a provisions requiring organs to be shared on the basis of medical urgency, not geographical location.

By signing the contract UNOS, legislation or lawsuits to aimed at overturning the HHS regulation, implemented on March 16, are considered much less likely. "We would have liked to have had a bill, but the contract goes a long way to ensure a fairer transplant system in the future," an HHS spokesperson said.

Organ Procurement Certification Act of 2000

The legislation assures that the 3 OPOs, facing decertification by HCFA, will stay in business until at least December 31, 2001. (ARORA had received a decertification reprieve in July from a federal court in Little Rock (Transplant News, July 14, 2000); however, HCFA had indicated in recent days that it planned to file an appeal.

Conversely, HHS was the beneficiary of a favorable US District Court in San Juan ruling in early October, which said the agency had the authority to decertify Lifelink of Puerto Rico and certify a new OPO to serve the island and the Virgin Islands.)

The legislation was co-sponsored by Senators Susan Collins (R-ME), Christopher Dodd (D-CT) and others contains the following provisions in addition to the moratorium:

*requires that the certification of qualified OPOs remain in place through January 1, 2002, for those OPOs that were certified as of January 1, 2000, and that meet other qualification requirements apart from the current performance standards;

*requires the Secretary of HHS to promulgate new rules governing OPO recertification by January 1, 2002. The rules are to rely on the outcome and process performance measures based on evidence of organ donor potential and other relevant factors, and recertification for OPOs will be required until they are promulgated;

*provides for the filing and approve of a corrective action plan by an OPO that fails to meet the standards, a grace period to permit a corrective plan, and opportunity to appeal a decertification, and a four-year certification cycle. ''We are very happy the bill passed and plan to work very closely with HCFA to collaborate on new certification performance standards using death record reviews,'' Paul Schwab, executive director of the Association of Organ Procurement Organizations (AOPO) told Transplant News.

''We have had a positive response from them and have a briefing schedule set up at this time for November 15.''

Pediatric Organ Transplantation Improvement Act of 2000

The bill was part of the Beneficiary Improvements and Protection Act (BIPA). The bill (HR 4008) requires the OPTN to: ''(1) recognize the differences in health and organ transplantation issues between children (individuals under the age of 18) and adults and adopt criteria, policies, and procedures that address children's unique health care needs; and (2) carry out studies and demonstration projects to improve procedures for organ donation procurement and allocation.''

The bill also requires the Secretary of HHS to study and report to congress on the costs of immunosuppressive drugs provided to children prior to transplantation and the extent to which health plans and health insurance cover the costs, including recommendations on ''issues particular to the special health and transplantation needs of children.''

The Secretary is also required to study the following:

*The extend of denial of organs to be released for transplant by coroners and medical examiners;

*The special growth and developmental issues that children have pre- and post-organ transplantation; and

*Other issued that are particular to the special health and transplantation needs of children.
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Title Annotation:organ procurement organizations, National Organ Transplant Act
Comment:Congress passes transplant legislation affecting OPOs, children; NOTA action on hold till next year.(organ procurement organizations, National Organ Transplant Act)
Author:Publisher, Jim Warren Editor &
Publication:Transplant News
Geographic Code:1USA
Date:Nov 14, 2000
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