MEDICARE PROPOSES CONDITIONS OF PARTICIPATION FOR TRANSPLANT CENTERS AND ORGAN PROCUREMENT ORGANIZATIONS
TO IMPROVE PERFORMANCE AND QUALITY OF CARE FOR MEDICARE BENEFICIARIES
The Centers for Medicare & Medicaid Services (CMS) today proposed new requirements that organ procurement organizations (OPOs) and organ transplant centers must meet to have their services covered by Medicare.
“These new requirements are a key element in our Gift of Life Donation Initiative, a multi-level approach to increasing organ, tissue, and bone marrow donation and assuring the highest quality care for Medicare beneficiaries who need transplants,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.
Proposals in a notice of proposed rulemaking for OPOs, placed on display today at the Office of the Federal Register, include conditions for coverage with both outcome and process performance measures and focus on OPOs’ performance improvement through sound operational policies.
Today there are more than 87,000 people in the United States waiting for a lifesaving organ transplant. While 25,448 organ transplants were performed in 2003, nearly 7,000 people died while waiting for a lifesaving transplant.
“We believe promulgation of the multiple outcome and process performance measures in this rule will improve OPO performance and, as a result, increase organ donation and transplantation in the United States,” McClellan said.
The proposed transplant center rule, which also went on display today at the Office of the Federal Register, contains transplant center approval and re-approval requirements as a subset of the CMS hospital conditions of participation (CoPs). The proposed requirements for transplant centers focus on a center’s ability to perform successful transplants and deliver quality patient care as evidenced by good outcomes as well as sound policies and procedures.
“This rule would ensure Medicare-covered transplants are performed in a safe and efficient manner,” McClellan said. “It also serves to keep Medicare requirements current with the state-of-the-art practice in transplantation and enhance the safety of transplant recipients and living donors.”
Remarkable strides in transplantation technology and pharmacology are turning organ transplantation into a mainstream treatment for patients in end stage renal failure. However, the United States is facing a severe shortage of organs.
CMS’s goal in developing the transplant CoPs is to keep Medicare transplant outcome requirements current with state-of-the-art practice; develop process requirements for use in oversight and enforcement activities; and decrease confusion by codifying requirements for all transplant center types in one source. Once approved, transplant centers are eligible for re-approval every three years. The CoPs give CMS the ability to revoke the approval of under-performing centers if attempts at corrective action are unsuccessful.
Current OPO regulations, published in 1996, include performance standards based on the population in each OPO’s service area. The organ donation community has raised concerns that population-based performance measures are not the best way to judge OPO performance. The Organ Procurement Organization Certification Act of 2000 required CMS to draft new standards.
The legislation requires CMS to increase the re-certification cycle for OPOs from 2 years to 4 years; provide new outcome and process performance standards based on empirical evidence obtained through reasonable efforts of organ donor potential and other related factors in each OPO’s service area; use multiple outcome measures as part of the certification process; and provide a process for a qualified OPO to appeal a de-certification on substantive and procedural grounds.
On December 31, 2001, CMS published an interim final rule with comment (IFC) that increased the OPO re-certification cycle from two years to four years, re-certified the 59 existing OPOs through December 31, 2005 and extended their agreements with CMS until July 31, 2006. The rule proposed today would satisfy the remaining requirements of the legislation.
Provisions of the proposed rule include:
- Multiple outcome measures for OPOs based on “organ donor potential,” as defined by CMS. Each OPO’s organ donor potential would be calculated based on hospital referral data.
- Multiple process performance standards that address all OPO functions, from screening hospital referral calls to packaging organs for transport.
- A process for OPOs to appeal a decertification to a CMS hearing officer on substantive or procedural grounds.
Both proposed rules will be published in the Federal Register on Feb. 4, 2005.