[Congressional Record Volume 146, Number 66 (Wednesday, May 24, 2000)]
[Senate]
[Pages S4389-S4390]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS (for herself, Mr. Dodd, Mr. Hutchinson, Mr. 
        Wellstone, Mr. Torricelli, Mr. Murkowski, Mr. Dorgan, Mr. 
        Lieberman, and Mr. Moynihan):
  S. 2625. A bill to amend the Public Health Service Act to revise the 
performance standards and certification process for organ procurement 
organizations; to the Committee on Health, Education, Labor, and 
Pensions.


      THE ORGAN PROCUREMENT ORGANIZATION CERTIFICATION ACT OF 2000

  Ms. COLLINS. Mr. President, I rise today on behalf of myself, Senator 
Dodd, Senator Hutchinson, Senator Wellstone, Senator Murkowski, Senator 
Torricelli, Senator Dorgan, Senator Lieberman and Senator Moynihan, to 
introduce the Organ Procurement Organization Certification Act of 2000 
to improve the performance evaluation and certification process that 
the Health Care Financing Administration currently uses for organ 
procurement organizations.
  Our nation's 60 organ procurement organizations (OPOs) play a 
critical role in procuring and placing organs and are therefore key to 
our efforts to increase the number and quality of organs available for 
transplant. They provide all of the services necessary in a particular 
geographic region for coordinating the identification of potential 
donors, requests for donation and recovery and transport of organs. The 
professionals in the OPOs evaluate potential donors, discuss donation 
with family members, and arrange for the surgical removal of donated 
organs. They are also responsible for preserving the organs and making 
arrangements for their distribution according to national organ sharing 
policies. Finally, the OPOs provide information and education to 
medical professionals and the general public to encourage organ and 
tissue donation to increase the availability of organs for 
transplantation.
  According to the Institute of Medicine's (IOM's) 1999 report on organ 
procurement and transplantation, a major impediment to greater 
accountability and improved performance on the part of OPOs is the 
current lack of a reliable and valid method for assessing donor 
potential and OPO performance.
  The current certification process for OPOs sets an arbitrary, 
population-based performance standard for certifying OPOs based on 
donors per million of population in their service areas. It sets a 
standard for acceptable performance based on five criteria: donors 
recovered per million, kidneys recovered per million, kidneys 
transplanted per million, extrarenal organs (heart, liver, pancreas and 
lungs) recovered per million, and extrarenal organs transplanted per 
million. The HCFA assesses the OPOs' adherence to these standards every 
two years. Each OPO must meet at least 75 percent of the national mean 
for four of these five categories to be recertified as the OPO for a 
particular area and to receive Medicare and Medicaid payments. Without 
HCFA certification, an OPO cannot continue to operate.
  The GAO, the IOM, the Harvard School of Public Health and others all 
have criticized HCFA's use of this population-based standard to measure 
OPO performance. According to the GAO, ``HCFA's current performance 
standard does not accurately assess OPOs' ability to meet the goal of 
acquiring all usable organs because it is based on the total 
population, not the number of potential donors, within the OPO's 
service areas.''
  OPO service areas vary widely in the distribution of deaths by cause, 
underlying health conditions, age, and race. These variations can pose 
significant advantages or disadvantages to an OPO's ability to procure 
organs, and a major problem with HCFA's current performance assessment 
is that it does not account for these variations. An extremely 
effective OPO that is getting a high yield of organs from the potential 
donors in its service area may appear to be performing poorly because 
it has a disproportionate share of elderly people or a high rate of 
people infected with HIV or AIDS, which eliminates them for 
consideration as an organ donor. At the same time, an ineffective OPO 
may appear to be performing well because it is operating in a service 
area

[[Page S4390]]

with a high proportion of potential donors.
  For example, organ donors typically die from head trauma and 
accidental injuries, and these rates can vary dramatically from region 
to region. According to the Centers for Disease Control and Prevention 
(CDC), in 1991, the number of drivers fatally injured in traffic 
accidents in Maine was 15.54 per 100,000 population. In Mississippi, 
however, it was 30.56, giving the OPO serving that state a tremendous 
advantage over the New England Organ Bank, which serves Maine.
  Use of this population-based method to evaluate OPO performance may 
well result in the decertification of OPOs that are actually excellent 
performers. Moreover, unlike other HCFA certification programs, the 
certification process for OPOs lacks a clearly defined due process 
component for resolving conflicts--an OPO that has been decertified has 
no opportunity for appeal to the Secretary of HHS on either substantive 
or procedural grounds. The current system therefore forces OPOs to 
compete on the basis of an imperfect grading system, with no guarantee 
of an opportunity for fair hearing based on their actual performance. 
This situation pressures many OPOs to focus on the certification 
process itself rather than on activities and methods to increase 
donation, undermining what should be the overriding goal of the 
program. Moreover, the current two-year cycle--which is shorter than 
other certification programs administered by HCFA--provides little 
opportunity to examine trends and even less incentive for OPOs to mount 
long-term interventions.
  The legislation we are introducing today has four major objectives. 
First, it imposes a moratorium on the current recertification process 
for OPOs and on the use of population-based performance measurements. 
Under our bill, the certification of qualified OPOs will remain in 
place through January 1, 2002, for those OPOs that have been certified 
as of January 1, 2000, and that meet other qualification requirements 
apart from the current performance standards. Second, the bill requires 
the Secretary of Health and Human Services to promulgate new rules 
governing OPO recertification by January 1, 2002. These new rules are 
to rely on outcome and process performance measures based on evidence 
of organ donor potential and other relevant factors, and 
recertification for OPOs shall not be required until they are 
promulgated. Third, the bill provides an opportunity for an OPO to 
appeal a decertification to the Secretary on substantive and procedural 
grounds, and fourth the bill extends the current two-year certification 
cycle to four years.
  Mr. PRESIDENT, the bill we are introducing today makes much needed 
improvements in the flawed process that HCFA currently uses to certify 
and assess OPO performance, and I urge all of our colleagues to join us 
in supporting it.
                                 ______