I
106TH CONGRESS
2D SESSION
H. R. 4152
To amend title XI of the Social Security Act to revise the performance
standards and certification process for organ procurement organizations.
IN THE HOUSE OF REPRESENTATIVES
APRIL 3, 2000
Mr. CAMP (for himself, Mrs. JOHNSON of Connecticut, Mr. PORTMAN, Mr.
MATSUI, Mr. PALLONE, and Mr. MOORE) introduced the following bill;
which was referred to the Committee on Ways and Means, and in addi-
tion to the Committee on Commerce, for a period to be subsequently de-
termined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned
A BILL
To amend title XI of the Social Security Act to revise the
performance standards and certification process for
organ procurement organizations.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION. 1. SHORT TITLE.
This Act may be cited as the ‘‘Organ Procurement
Organization Certification Act of 2000’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Organ procurement organizations play an
important role in the effort to increase organ dona-
tion in the United States.
(2) The current process for certification and re-
certification of organ procurement organizations
conducted by the Department of Health and Human
Services has created a level of uncertainty that is
interfering with organ procurement organization ef-
fectiveness in raising the level of organ donation.
(3) The General Accounting Office, the Insti-
tute of Medicine, and the Harvard School of Public
Health have identified substantial limitations in the
organ procurement organization certification and re-
certification process and have recommended changes
in that process.
(4) The limitations in the recertification process
include—
(A) an exclusive reliance on population-
based measures of performance that do not ac-
count for the potential in the population for
organ donation and do not permit consideration
of other outcome and process standards that
would more accurately reflect the relative capa-
bility and performance of each organ procure-
ment organization;
(B) an immediate decertification of organ
procurement organizations solely on the basis of
the performance measures, without an appro-
priate opportunity to file and a grace period to
pursue a corrective action plan; and
(C) a lack of due process to appeal to the
Secretary of Health and Human Services for
recertification on either substantive or proce-
dural grounds.
(5) The Secretary of Health and Human Serv-
ices 
has 
the 
authority 
under 
section
1138(b)(1)(A)(ii) of the Social Security Act to ex-
tend the period for recertification of an organ pro-
curement organization from 2 to 4 years on the
basis of its past practices in order to avoid the inap-
propriate disruption of the Nation’s organ system.
(6) The Secretary of Health and Human Serv-
ices can use the extended period for recertification
of all organ procurement organizations to—
(A) develop improved performance meas-
ures that would reflect organ donor potential
and interim outcomes, and to test these meas-
ures to ensure that they accurately measure
performance differences among the organ pro-
curement organizations; and
(B) improve the overall certification proc-
ess by incorporating process as well as outcome
performance measures, and developing equitable
processes for corrective action plans and ap-
peals.
SEC. 3. CERTIFICATION AND RECERTIFICATION OF ORGAN
PROCUREMENT ORGANIZATIONS.
(a) IN GENERAL.—Section 1138(b) of the Social Se-
curity Act (42 U.S.C. 1320b–8(b)) is amended—
(1) in paragraph (1)(A)(ii) by striking ‘‘within
the previous 2 years (4 years if the Secretary deter-
mines appropriate for an organization on the basis
of its past practices) as meeting the standards to be
a qualified organ procurement organization (as so
described);’’ and inserting ‘‘under paragraph (2)
within the previous 4 years;’’;
(2) by redesignating paragraph (2) as para-
graph (3); and
(3) by inserting after paragraph (1) the fol-
lowing new paragraph:
‘‘(2) Not later than January 1, 2002, the Secretary
shall set forth in regulations the process and performance
standards by which an organization shall be certified or
recertified as a qualified organ procurement organization
consistent with the following:
‘‘(A) Certification or recertification of such an
organization shall be made not more frequently than
once every 4 years.
‘‘(B) Performance standards applicable for cer-
tification or recertification of an organization shall
use—
‘‘(i) outcome and process performance
measures that are based on empirical evidence
of organ donor potential and other related fac-
tors in each service area of qualified organ pro-
curement organizations, and
‘‘(ii) multiple outcome measures, which
may or may not be based on empirical evidence.
‘‘(C)(i) In the case of a certified qualified organ
procurement organization that the Secretary deter-
mines does not meet the performance standards for
recertification, the organization may submit to the
Secretary a corrective action plan.
‘‘(ii) If the Secretary approves the corrective ac-
tion plan submitted under clause (i), the Secretary
shall provide for an additional 3-year period during
which such organization shall implement the correc-
tive action plan. An organization implementing a
corrective action plan shall be treated as being cer-
tified by the Secretary during such 3-year period.
The Secretary shall develop and implement appropriate
procedures for an organization to appeal a decision of the
Secretary to deny certification or recertification of an or-
ganization under this paragraph.’’.
(b) TRANSITION RULE.—In the case of an organiza-
tion that on January 1, 2000, has in effect a certification
or recertification by the Secretary of Health and Human
Services as a qualified organ procurement organization
under section 1138(b)(1)(A)(ii) of the Social Security Act
(42 U.S.C. 1320b–8(b)(1)(A)(ii)), such certification or re-
certification shall remain in effect until the earlier of Jan-
uary 1, 2002, or the date on which the Secretary publishes
a final rule implementing the provisions of 1138(b)(2), as
added by subsection (a) of this Act.
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