[Congressional Record Volume 146, Number 39 (Monday, April 3, 2000)]
[Extensions of Remarks]
[Pages E476-E477]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            ORGAN PROCUREMENT ORGANIZATION CERTIFICATION ACT

                                 ______
                                 

                             HON. DAVE CAMP

                              of michigan

                    in the house of representatives

                         Monday, April 3, 2000

  Mr. CAMP. Mr. Speaker, I rise today on behalf of myself and my 
colleagues, Representatives Johnson of Connecticut, Portman, Matsui, 
and Pallone to introduce the Organ Procurement Organization 
Certification Act. This important legislation will improve the process 
that the Health Care Financing Administration (HCFA) uses to certify 
organ procurement organizations (OPOs).
  Each day about 57 people receive an organ transplant, but another 13 
people on the waiting list die because not enough organs are available. 
According to the United Network for Organ Sharing, there are now 68,220 
patients in the United States on the waiting list for a transplant. 
April 16 through 22 is National Organ and Tissue Donor Awareness Week. 
Communities nationwide will be celebrating the critical importance of 
organ and tissue donation. First designated by Congress in 1983, this 
week is used to raise awareness of the critical need for organ and 
tissue donation and to encourage all Americans to share their decision 
to donate with their families so their wishes can be honored. This is 
especially important as the gap between the supply of organs and the 
growing number of transplant candidates continues to widen.
  Next week, it is expected that the House will consider legislation 
dealing with organ allocation--this issue has been very controversial 
and certainly deserves our attention. But one of the most critical 
aspects of the organ transplant system gets very little attention. 
Organ Procurement Organizations--or OPOs--play a

[[Page E477]]

critical role in procuring and placing organs and are therefore key to 
our efforts to increase the number and quality organs available for 
transplant. The OPOs' job is to provide all of the services, within a 
geographic region, for coordinating the identification of potential 
donors, requests for donation, and recovery and transplant 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 the people that are responsible for preserving 
the organs and making arrangements for distribution within the national 
organ sharing policies. Finally, the OPOs provide information and 
education to medical professionals and the
  I don't think that most people are aware of how significant these 
organizations are, or the impact they have on these recipients' lives. 
There are currently 60 organ procurement organizations in the United 
States. Unfortunately, OPOs are suffering from what many other health 
care providers deal with on a regular basis--excessive regulations from 
HCFA.
  Under current regulations, OPOs are subject to a recertification 
process every two years. Within that process, HCFA's current measures 
for certification are based on invalid assumptions. First, they assume 
that potential donors are equivalent per capita in each OPO service 
area. Harvard University and industry studies have demonstrated 
otherwise. Demographic and epidemiologic data have shown wide 
variations across the country in suicides, homicides, and gunshot 
wounds; in motor vehicle fatalities; and in HIV incidence and 
frequency. HCFA also assumes that potential donors die where they live. 
Recent data examining donors recovered with a home address outside of 
the OPO service area, however, show wide variations. None of these 
variations are adjusted by HCFA. HCFA also assumes that populations are 
accurately determined and assigned. We know, however, that there exist 
differential growth rates across the country with lags in reporting, 
and we know that census undercounts vary across the nation. HCFA 
frequently splits populations arbitrarily across counties as part of 
OPO service area assignments. None of these variations are adjusted for 
in the current measures. These are just a few of the problems. I'm not 
a statistician, but even I can see the inefficiencies in these 
measures.
  For example, while Michigan ranks below the national average in its 
rate of recovery of vital organs, it is the single largest supplier in 
the country of human bone for transplantation. The processes for 
identifying potential donors and obtaining consent is virtually 
identical for human organs and for bone. Therefore, it cannot be an 
organization performance issue that causes Michigan to appear to be a 
poor performer in recovering vital organs.
  To compound matters, every two years, these OPOs face 
decertification, and unlike other HCFA certification programs, there is 
no provision for corrective action plans to remedy a deficient 
performance and there is no appeals process for resolving conflicts. 
The current system forces OPOs to compete on the basis of an imperfect 
grading system, with no guarantee of an opportunity for a 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 
ultimate goal of the program. In addition, the two year cycle--which is 
shorter than any other certification program administered by HCFA--
provides little opportunity to examine trends and even less incentive 
for OPOs to mount long term interventions.
  The General Accounting Office, the Institute of Medicine, the Harvard 
School of Public Health and a host of others have criticized HCFA's use 
of the population based standard. HCFA has updated certification 
processes and increased the cycle of accreditation for Medicare 
Hospitals, Home Health Services, Ambulatory Surgery Centers, Long Term 
Care Organizations and Methadone Clinics--but they have done nothing to 
change the certification process for OPOs, despite Congressional urging 
these changes.
  We are introducing legislation that will accomplish three major 
objectives. First of all, it will impose a moratorium on the current 
recertification process for OPOs and the use of the population-based 
performance measurements. Under this bill, the certification of 
qualified OPOs will remain in place through January 1, 2000, for those 
OPOs that are certified as of January 1, 2000. 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. Finally, the bill provides for the 
filing and approval of a corrective action plan by an OPO that fails to 
meet the standards, a grace period to permit corrective action, an 
opportunity to appeal a decertification to the Secretary on substantive 
and procedural grounds and a four-year certification cycle.
  It is my hope that through enacting this legislation, we can improve 
a system that touches hundreds of thousands of lives every year. I urge 
all of my colleagues to join us as cosponsors.

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