[Federal Register Volume 61, Number 86 (Thursday, May 2, 1996)]
[Rules and Regulations]
[Pages 19722-19760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10901]
[[Page 19721]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Health Care Financing Administration
_______________________________________________________________________
42 CFR Parts 405 and 486
Medicare and Medicaid Programs; Conditions of Coverage for Organ
Procurement Organizations (OPOs); Final Rule
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Rules
and Regulations
[[Page 19722]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Parts 405 and 486
[BPD-646-FC]
RIN 0938-AE48
Medicare and Medicaid Programs; Conditions of Coverage for Organ
Procurement Organizations (OPOs)
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: This final rule with comment period sets forth changes to the
conditions of coverage for organ procurement organizations (OPOs). It
provides for exceptions to the OPO qualification and performance
standards under certain circumstances, revises the methodology for
counting organs, and extends the period for interim OPO designations
and notification of termination. It also adds new regulations relating
to hospitals that change OPO designations when there is a change in the
OPO service area.
This final rule with comment period modifies conditions of coverage
previously set forth in an interim final rule. These changes are being
made in response to public comments received on that interim rule. New
regulations contained in this final rule implement provisions of the
Social Security Act Amendments of 1994.
DATES: Effective date: This final rule is effective May 31, 1996.
Comment date: Written comments on the definition of ``donor''
(Section VI of the preamble) or the hospital waiver process (XI of the
preamble) will be considered if we receive them at the appropriate
address, as provided below, no later than 5 p.m. on July 1, 1996.
ADDRESSES: Mail written comments (One original and three copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: BPD-646-FC, P.O. Box 7518,
Baltimore, MD 21207-0518.
If you prefer, you may deliver your written comments (one original
and three copies) to one of the following addresses: Room 309-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD.
Due to staffing and resource limitations, we cannot accept comments
by facsimile (FAX) transmission. In commenting, please refer to file
code BPD-646-FC. Comments received timely will be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, in Room 309-G of the
Department's offices at 200 Independence Avenue SW., Washington, DC, on
Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone:
(202) 690-7890).
See section XV of this preamble for special instructions regarding
the submission of comments and recommendations regarding the
information collection requirements contained in these regulations.
FOR FURTHER INFORMATION CONTACT: Jackie Sheridan, (410) 786-4635.
SUPPLEMENTARY INFORMATION:
I. Background
A. Legislative History
Medicare coverage of services furnished to individuals with end-
stage renal disease who require dialysis or kidney transplantation is
authorized under section 1881 of the Social Security Act (the Act).
Medicare also covers certain other organ transplants that HCFA has
determined are ``reasonable and necessary'' under section 1862 of the
Act, and pays for those transplants and related organ procurement
services.
Under the Medicaid program, payment is made for ``medical
assistance'' as defined in section 1905(a) of the Act and in our
regulations at 42 CFR Part 440. Each State has a considerable degree of
flexibility to supplement Medicaid-required services with optional
services the State elects in its State plan. States must pay Medicare
coinsurance and deductible amounts for transplant services for
``qualified Medicare beneficiaries,'' and must pay for transplant
services to individuals under the age of 21 who receive early and
periodic screening, diagnostic, and treatment services. In addition,
States may pay for other transplant services based on written standards
which provide that similarly situated individuals are treated alike.
Payment may be made under the Medicare and Medicaid programs for
organ procurement costs attributable to payments to an organ
procurement organization (OPO) only if the organization has been
designated by the Secretary as meeting the conditions for coverage as
an OPO. OPOs are generally paid indirectly for organ procurement costs.
Usually, the transplanting hospital pays those costs to the OPO and
claims them on its cost report. An OPO, however, does have to file a
cost report with us at the end of its fiscal year. At that time, we
settle any overpayments or underpayments with the OPO.
Section 1138(b) of the Act sets forth the statutory qualifications
and requirements that an OPO must meet for coverage of the costs of its
services in procuring organs for hospitals under the Medicare and
Medicaid programs.
Title IV of the Health Omnibus Programs Extension Act of 1988
(Public Law 100-607) contained the Transplant Amendments Act of 1988.
This Act contained amendments to section 371 of the Public Health
Service Act (PHS Act) (42 U.S.C. 273), which defines OPOs.
Specifically, section 402(c)(1)(A) of Public Law 100-607 amended
section 371(b)(1)(E) of the PHS Act by revising the definition of
``service area'' that must be encompassed by an OPO. Public Law 101-
274, enacted on April 23, 1990, postponed until January 1, 1992, the
effective date of section 402(c)(1)(A) of Public Law 100-607.
Additional legislation regarding the definition of a service area was
included in the Transplant Amendments Act of 1990 (Public Law 101-616).
The details of these provisions are discussed under section II
``Service Area'' of this preamble.
Section 201(d)(1) of Public Law 101-616 redesignated section
371(b)(2) of the PHS Act as section 371(b)(3). That section sets forth
the functions of an OPO. However, the Congress did not amend two
textual references in section 371(b)(1) to the OPO functions formerly
specified in paragraph (2). Since that was clearly an oversight and
failure to read the section 371(b)(1) text as if those ``paragraph
(2)'' references had been changed to ``paragraph (3)'' would make part
of the statute meaningless, we are using the corrected references in
this document.
Additional legislation regarding OPOs was included in section 155
of the Social Security Amendments of 1994 (Public Law 103-432, enacted
on October 31, 1994). This legislation amended section 1138(a)(1) of
the Act to require a hospital to have an agreement for notification of
potential organ donation only with the OPO designated for the area in
which the hospital is located. Because this legislation was passed
after our issuance of proposed and interim final rules in 1991 and 1994
respectively to implement statutory provisions, we did not include any
revisions regarding this subject in those publications. We are,
however, including revisions to the regulations in this final rule to
reflect the provisions of Public Law 103-432. These
[[Page 19723]]
provisions are discussed under section XI. ``Waiver of Service Area
Designations'' of this preamble.
B. Regulations
Regulations regarding organ procurement are currently found at 42
CFR part 486 (``Conditions for Coverage of Specialized Services
Furnished by Suppliers'') under subpart G (``Conditions of Coverage:
Organ Procurement Organizations''). The existing regulations were
recently redesignated from subpart D of 42 CFR Part 485 in a final rule
with comment period published in the Federal Register on September 29,
1995 (60 FR 50446). For the benefit of the reader, we are including a
redesignation table. All succeeding regulations references will be to
the redesignated sections. Throughout this preamble, we generally use
the new section numbers in our discussion of specific sections. In some
cases, we use both the old and the new section numbers for ease of
reference.
------------------------------------------------------------------------
Old section (subpart D of part 485 New section (subpart G of part 486
------------------------------------------------------------------------
485.301............................ 486.301
485.302............................ 486.302
485.303............................ 486.304
485.304............................ 486.306
485.305............................ 486.308
485.306............................ 486.310
485.307............................ 486.314
485.308............................ 486.316
485.309............................ 486.318
485.311............................ 486.325
------------------------------------------------------------------------
On June 21, 1991, we published a Notice of Proposed Rulemaking in
the Federal Register (56 FR 28513). In it, we proposed to implement
section 402 of Public Law 100-607 and section 201 of Public Law 101-616
by amending certain sections of 42 CFR part 482, which set forth the
Medicare conditions of participation for hospitals, and subpart D of 42
CFR part 485, which, at that time, set forth the Medicare and Medicaid
conditions of coverage for OPOs.
In addition to the provisions necessary to implement these laws, we
proposed some other revisions to the existing regulations. These
additional regulations were derived from our experience in
administering the OPO program and not related to legislation. The most
noteworthy of these latter provisions dealt with change of ownership of
an OPO and with termination of participation in the Medicare and
Medicaid.
These proposed regulations were updated, revised, and adopted in an
interim final rule with comment period issued on September 8, 1994 (59
FR 46513). Provisions in the interim final rule which contained changes
based on public comments included:
Participation in the Organ Procurement and Transplantation
Network (OPTN) as one of the Medicare conditions of participation for
hospitals.
Certification requirements for an OPO.
Requirements for an OPO service area.
Requirements that an OPO obtain HCFA approval before
entering into any change of ownership, merger, consolidation, or change
in its service area.
Medicare payment provisions.
OPO performance standards.
We have included detailed information regarding the provisions of
the proposed and interim final rule with comment period as background
in the discussion of individual topics.
We received 33 timely items of correspondence in response to the
September 8, 1994, interim final rule with comment period. This final
rule with comment period responds to the comments we received on the
interim final rule with comment period. It also contains revisions to
the regulations to implement provisions of the Social Security Act
Amendments of 1994 (Public Law 103-432). These changes to the
conditions of coverage for OPOs (42 CFR Part 486) are discussed below.
II. Service Area (Sec. 486.307)
A. Background
Before enactment of Public Law 100-607, the PHS Act provided that,
unless an OPO service area comprised an entire State, it had to be of
sufficient size to include ``at least 50 potential organ donors'' each
year.
Section 402(c)(1)(A) of Public Law 100-607 amended section
371(b)(1)(E) of the PHS Act to require the service area to be large
enough that the OPO ``can reasonably expect to procure organs from not
less than 50 donors each year.''
We determined that this change would have resulted in a substantial
number of existing OPOs failing to qualify for redesignation, because
we interpreted the requirement that the OPO ``can reasonably expect to
procure organs from not less than 50 donors'' to be more stringent than
the requirement that the service area include ``at least 50 potential
organ donors.'' According to a Departmental study cited in the Report
of the Committee on Energy and Commerce on a precursor to the 1988
legislative amendments to the Transplant Amendments Act of 1987 (H.R.
Rep. No. 383, 100th Cong., 1st Sess. 5-6 (1987)), the average OPO was,
at the time of the report, procuring organs from only 44 donors per
year. (Because more than one organ may be obtained from a donor, the
average number of organs obtained per OPO per year was about 110.)
Currently, the average number of donors per OPO is 77, resulting in an
average of 279 organs per OPO.
Most of the designated OPOs were scheduled for redesignation
beginning in March 1990 and would have been required to meet the new
requirement imposed by Public Law 100-607. Information obtained from
many representatives of organ procurement organizations (OPOs) revealed
that almost one-half of the OPOs would not have been able to meet the
new requirement. Some organ procurement and transplantation experts
believed that many of the OPOs that did not have a realistic
expectation of procuring organs from at least 50 donors were
nonetheless effective and efficient entities. Consequently, the
Department and other interested parties sought statutory relief to
avoid disruption to the nation's organ procurement system.
On April 23, 1990, Public Law 101-274 was passed. It postponed
until January 1, 1992, the effective date of section 402(c)(1)(A) of
Public Law 100-607, which changed the definition of ``service area.''
Therefore, the ``at least 50 potential donors'' requirement would have
remained in full force and effect until that date. However, Public Law
101-616 further amended section 371(b)(1)(E) of the PHS Act to require
an OPO to have a defined service area that (1) is of sufficient size to
assure maximum effectiveness in the procurement and equitable
distribution of organs, and (2) either includes an entire Metropolitan
Statistical Area (MSA) or does not include any part of the area.
Section 201(d)(2) of Public Law 101-616 required the Secretary to
publish a proposed definition of ``service area'' by February 14, 1991,
and final regulations defining ``service area'' by November 16, 1991.
In the June, 1991 proposed rule, we specified in Sec. 485.304(d)
that an OPO cover a service area ``* * * of sufficient size to assure
maximum effectiveness in the procurement and equitable distribution of
organs and that either includes an entire metropolitan statistical area
as specified by the Office of Management and Budget or does not include
any part of such area * * * *''.
In the September 1994 interim final rule, we revised proposed
Sec. 485.304(d) (now Sec. 486.306(d)) to provide that, for designations
in 1996 and thereafter, an
[[Page 19724]]
OPO's service area must include an entire State or the OPO must procure
organs from an average of at least 24 donors per calendar year in the 2
years before the year of designation. We provided that an OPO operating
in a noncontiguous U.S. State, a U.S. Territory, or a U.S.
Commonwealth, such as Hawaii or Puerto Rico, was subject to a
specified, alternative standard beginning January 1, 1996. We also
provided that if an entity has not previously operated as a Medicare-
certified OPO, it must demonstrate that it can procure organs from at
least 50 potential donors per calendar year.
B. Public Comments and Our Responses
Comment: One commenter suggested that we require that every
transplant center have a working relationship with an OPO.
Response: Existing law and regulations already require this
relationship. Sections 1138(a)((1)(C) and 1138(a)(3) of the Act require
that a hospital have an agreement, as described in section 371(b)(3)(A)
of the PHS Act, with its designated OPO if it is to participate in the
organ procurement program. Medicare regulations at 42 CFR 405.2163
require that every renal transplant center ``* * * participates in a
patient registry program with an OPO designated or redesignated under
Part 485, Subpart D * * * ''. (We are changing this reference to Part
486, Subpart G in this final rule with comment period to reflect the
redesignation). In addition, we have published in the Federal Register
notices containing the Medicare coverage criteria for heart (52 FR
10935, April 6, 1987), liver (56 FR 15006, April 12, 1991), and lung
(60 FR 6537, February 2, 1995) transplantations. Each of these notices
requires that a hospital submit documentation demonstrating the
hospital's agreement with a Medicare-certified OPO as one of the
conditions necessary for Medicare approval as a facility for which
respective organ transplantation may be covered. We believe that these
requirements meet the commenter's suggestion.
Comment: One commenter suggested that more consideration be given
to regional MSAs than to State boundaries. The commenter believed the
current policy results in poor service to remote areas.
Response: It is not clear to us how the current policy would
inappropriately effect organ distribution to remote areas. We believe,
however, that the law is clear regarding the MSAs and provides little
latitude for alternative interpretation. Section 371(b)(1)(E) of the
PHS Act provides that an OPO ``* * * has a defined service area that is
of sufficient size to assure maximum effectiveness in the procurement
and equitable distribution of organs, and that either includes an
entire MSA (as specified by the Director of the Office of Management
and Budget) or does not include any part of the area.'' Thus, we have
no authority to split MSAs in designating OPO service areas. Other than
repeating this statutory language, our Medicare regulations do not
address MSAs.
As a matter of practice, we designate OPO service areas on a county
specific basis. An OPO's service area will include all of the counties
within the MSA and as many other counties as it desires and is awarded
based on the criteria in Sec. 485.308 (now redesignated as
Sec. 486.316). We note that all counties that contain a hospital are
assigned to one of the designated OPOs. In addition, in principle, we
believe that organ donation is most likely to be enhanced where there
is a willing and cooperative arrangement between the hospital and the
OPO. Therefore, we believe that it could be potentially deleterious
rather than helpful to force hospitals in counties that are not
officially part of an MSA to be served by the OPO servicing the MSA.
However, if the parties agree that designation of a regional MSA would
be helpful, we would not preclude such designations.
Comment: One commenter noted that current terminology used by the
Office of Management and Budget (OMB) refers to ``Metropolitan Area''
(MA) rather than MSA as the general term describing urban
classifications. Within MAs, there are several categories: MSA,
Consolidated MSAs (CMSAs), Primary MSAs (PMSAs), and New England County
Metropolitan Areas (NECMAs). The commenter requested clarification as
to which MA categories are applicable to the OPO regulations.
Response: For purposes of the OPO regulations, MSAs encompass the
current MA categories of MSA, PMSA, and NECMA. A CMSA is comprised of a
number of PMSAs that are considered separately for purposes of defining
OPO service areas. In New England, we use NECMAs rather than MSAs and
PMSAs which are based on townships rather than county areas. Since OPO
service areas are defined based on counties, we believe it is more
appropriate to use the county equivalent MA designations in New England
(that is, NECMAs). The law clearly states that we may not divide an MSA
into the service areas of multiple OPOs. If an OPO's service area
includes any part of an MSA, PMSA, or NECMA, it must include the entire
area.
Comment: One commenter noted that a newly established OPO could
qualify based on a determination that it has the potential to procure
organs from at least 50 potential donors. The commenter requested
clarification as to how the organization would demonstrate this fact.
The commenter also noted that currently OPOs convert fewer than 50
percent of the potential donors to actual donors. Therefore, it is
unlikely that an organization with only a 50-donor potential can meet
the 24-donor criterion.
Response: The current criterion for qualification as an OPO
servicing an area of fewer than 2.5 million people is that the
organization demonstrate that it has the potential to procure organs
from 50 donors. Thus, the criterion we have established for newly
functioning OPOs is identical to that currently applied to the existing
OPOs. We have historically not prescribed how an OPO must demonstrate
this standard is met. Rather, when making such a determination, we have
accepted the information submitted by the OPO, evaluated it, and
requested clarification if necessary. We believe it is appropriate to
hold newly established OPOs to the condition in place for existing
OPOs. Thus, we do not intend to specify how such a standard is to be
met. We will continue to allow flexibility for the OPO to come forward
with reasonable information to demonstrate its position.
We do, however, intend to take a more rigorous look at the
information than we have previously. Newly established OPOs need to
qualify at the end of a 2-year period based on one of the other
criteria. In most cases, this criterion will be an average 24 donors
per year over a 2-year period. We believe it would be disruptive to the
organ procurement industry to allow OPOs to enter the arena only to
exit 2 years later if they cannot meet the qualification criteria.
Consequently, we expect OPOs to act responsibly and to have a specific
plan for achieving the long-term qualification criteria.
Comment: Several commenters expressed concern about the 24-donor
rule. For the most part, these commenters believed that some very small
OPOs are performing efficiently as is evidenced by the fact that they
meet the performance criteria. The commenters believed that the 24-
donor criteria is not an appropriate measure of performance. They
recommended that no size limitations be part of the qualification
criteria for designation as a Medicare-approved OPO.
One commenter believed that we should continue to permit an OPO
that meets the performance criterion to
[[Page 19725]]
qualify if it has an alternative local unit (ALU) to address the
equitable distribution issue. An ALU is an area developed by the OPO
and approved by the OPTN contractor as an alternative area as an aid to
equitable distribution. An ALU may be treated as a substitute for the
OPO's service area in the allocation scheme. The commenter, from a very
small OPO that is one of three OPOs operating in a single medium-size
State, believed that HCFA should continue to permit an OPO that meets
the performance criterion to qualify if it has an ALU to address the
equitable distribution issue. In the commenter's State, the three OPOs
share certain matched organs on a broader scale than they would if the
ALU were not in place, but the majority of organs are allocated
locally. The commenter believed that the regulations should be modified
to provide for an exception criterion that would allow this small OPO
to continue to qualify.
Response: The qualification criteria are intended to implement
section 371 of the PHS Act. Section 371(b)(1)(E) of the PHS Act
provides that an OPO must have a defined service area that ``* * * is
of sufficient size to assure maximum effectiveness in the procurement
and equitable distribution of organs * * *.'' We believe the use of
the explicit words ``of sufficient size'' in the statutory language is
a clear expression that the Congress intended the Secretary to
establish some measures of size in response to this mandate in the law.
Further, when we look at the legislative history, we believe that
the Congress intended that the service area size criterion be rigorous.
Section 371 initially set the qualification criterion at 50 potential
donors. However, the Congress recognized that this criterion was too
lax. The Congress subsequently modified section 371(b)(1)(E) in section
402 of Public Law 100-607 to require the service area to be large
enough that the OPO ``* * * can reasonably expect to procure organs
from not less than 50 donors each year''.
When this legislation was enacted, we recognized that setting the
qualification standard at this level at that time would have resulted
in decertification of approximately one-half of the OPOs approved by
Medicare. Consequently, we sought legislative relief from the statutory
standard. The Congress responded to our request with Public Law 101-
616.
We acknowledge that the fact that an OPO procures 24 donors per
year is not in and of itself assurance of ``maximum effectiveness'' in
organ procurement. We believe, however, that this criterion certainly
contributes to the retention of OPOs that are more likely to be
effective in organ procurement. This is true particularly for OPOs with
service areas that have populations under 1.5 million. We do not
believe that it is productive and cost effective to continue to retain
several OPOs operating within a single, often small, State. In these
cases, often too much time and effort are spent in competition with the
neighboring OPO rather than in organ outreach. Generally, a merger of a
number of small competing OPOs is cost effective because it results in
shared overhead, shared optimal practices, and a higher ratio of organs
to fixed operating costs.
Our decision to proceed with the 24-donor rule, however, is not
solely based on the maximum effectiveness portion of the statutory
language. The law also specifically requires that service area
designations be sufficiently large to ensure equitable distribution of
organs. Organs available for transplant are a scarce resource. There
are many more people on the transplant waiting list than there are
available organs. Both the Congress and this Administration support
transplant policies that contribute to the equitable distribution of
organs. We believe a proliferation of a large number of very small OPOs
does not contribute to this goal. The organ allocation policies give
priority, in most cases, to distribution of organs within the service
area. Consequently, OPOs must give first priority to keeping organs
procured within their service areas for transplant rather than
dispersing them to a larger area. The existence of a substantial number
of small OPOs could be disruptive to an effective large organ
allocation system because each of these OPOs would be keeping organs
for transplant within its own small service area.
For example, a small hospital-based OPO may have only a single
transplant center (itself) within its service area. In most cases, all
the organs procured in the service area are then transplanted to
patients on the waiting list at the transplant center instead of being
allocated to patients on a regional or national basis. The OPO, in
accordance with the national allocation rules, is transplanting the
procured organs to the highest-ranking appropriate patients in the
local area. These patients may have been on the waiting list a very
short time. Equally appropriate patients in the region who have been
waiting a much longer period of time would not receive the organs
because they are outside the local area. Since the OPO is servicing
only itself, it has an incentive to be a high-performing OPO. The
patients at this center have a shorter wait time.
However, in a neighboring town that is part of a larger OPO service
area, there may be several hospitals that must share the organs
procured from an OPO that is as effective in procuring organs as the
small OPO. Because this OPO must share organs among several transplant
centers, patients in these centers must wait considerably longer for
the needed lifesaving organs. As a result, there is significant
disparity among the transplant center waiting times. In various
hearings on organ transplantation over the years the Congress has
expressed concern about the disparity in waiting times for organ
transplantation among various geographic areas. Many members of the
Congress have expressed a strong desire to move toward a national
allocation methodology to mitigate this condition. We believe that the
definition of service area in the statute that addresses the idea that
an OPO's service area be of sufficient size to assure equitable
distribution is direction to the Secretary to not only look at OPO
performance or effectiveness but to also consider the impact of service
area size on organ distribution since very small OPO service areas tend
to result in disproportionately short waits in some areas and
disproportionately long waits in other areas. We conclude that a
proliferation of very small OPOs may not be consistent with an
equitable distribution system as required in the statute.
While we acknowledge the existence of an ALU for the purpose of
organ distribution may potentially mitigate some of the concern
regarding equitable distribution, we believe that there are other
values associated with establishing OPO minimal service area size that
cause us to continue to support this position. There are many benefits
of the consolidation of OPOs, such as the sharing of best practices,
shared overhead, expediency in reacting to emergency situations,
consistent procurement and transplant practices, and promotion of
equitable treatment. We find no benefit to the program or the American
public in retaining very small OPOs under a system of exceptions when
there is no potential that these OPOs would ever meet the size
criterion.
On the other hand, we have not arbitrarily set up criteria that
restrict OPOs to a certain size or population base. We recognize that
small OPOs can be very effective in procuring and distributing organs
despite serving a small population area in certain circumstances. OPOs
may qualify if they service an entire State, regardless of the
population or the number of donors
[[Page 19726]]
available. Similarly, we have established special qualifying criteria
for OPOs servicing areas that are not contiguous to the rest of the
nation. OPOs servicing Hawaii, Alaska, and U.S. territories must meet
alternative criteria as discussed below.
We also point out that the criterion is applied based on a 2-year
average. Thus, if an OPO fails to meet the criterion in one year due to
uncontrollable or unforeseen circumstances, it will have an opportunity
to make up for lost donors in the following period. Since this is a
static number, OPOs will be able to continually monitor themselves
against this criterion and take corrective actions as necessary to
improve.
In evaluating the impact of this criterion on the existing OPOs
using historical data, we are comfortable that the criterion will not
have a major adverse impact on the existing OPOs.
Based on 1994/1995 data, three OPOs that would have met the
performance criterion if it had existed in that period would not have
met the 24-donors per year criterion. However, one of these OPOs would
have qualified under the statewide criterion. The remaining two OPOs
are small organizations located in States with alternative, OPOs. We
believe alternative, high-performing OPOs could service the respective
areas adequately, while providing for a broader allocation area that is
likely to promote more equity in organ distribution. Consequently, we
continue to believe that the 24-donor rule is appropriate as one of the
qualification criteria.
In response to the comment that the 24-donor rule is not an
appropriate measure of performance, we have reviewed this requirement.
We agree that the 24-donor rule is not a measure of performance but a
measure of service area size. Furthermore, it is redundant to maintain
this requirement as both a performance and a qualification criterion.
All OPOs must meet all of the qualification criteria to be recertified.
It serves no purpose to place the requirement in two separate sections.
Therefore, we are deleting Sec. 486.310(b)(2) (formerly
Sec. 485.306(b)(2)) from this final rule with comment period.
Comment: Some commenters noted that this same criterion was both a
qualification standard and a performance standard. The performance
standard is one that is subject to a corrective action plan. However,
it was not clear whether the qualification criterion is subject to
corrective action.
Response: As noted above, we are deleting the 24-donor rule as a
performance criterion. Nonetheless, we think the commenters' concern
that there is no provision for exception to the qualification criteria
is important.
The law specifically requires that an OPO be of sufficient size to
assure maximum effectiveness in the procurement and equitable
distribution of organs. As discussed above, we do not believe it is in
the best interests of the program or the public to establish an
exception system for very small OPOs that historically do not possess
the base to achieve 24 donors. Even though such a small OPO may be
performing adequately based on its population base, we are concerned
that the proliferation of extremely small service areas runs counter to
the objectives of an equitable national organ allocation system.
However, we recognize that an OPO may experience unforeseen
circumstances beyond its control that result in the OPO failing to meet
the qualification criterion during a single recertification period.
Consequently, we are adding a new Sec. 486.307(d)(3) to provide for an
exception process.
This exception process is explicitly limited to those OPOs that
have historically met the criteria and that have a specific plan to
achieve 24 donors per year in the future. We are also allowing a one-
time exception for the transitional period. This exception allows an
OPO that meets the performance standards in Sec. 486.310 to continue
Medicare and Medicaid participation for 2 years while it puts in place
a plan to achieve 24 donors per year in the future. (See Section X of
this preamble)
To receive the exception, an OPO must file its request with HCFA at
least 15 days before its recertification date. The request must be in
narrative form. If the exception is based on unusual circumstances the
narrative must explain in detail the unusual circumstances that
contributed to the OPOs failure to procure 24 donors per year. The
exception request must also include data regarding the number of donors
per year for the 5 years immediately preceding the present designation
period. For example, if an OPO fails to meet the qualification standard
for the 1996 designation period and it requests an exception, it must
submit data, by year, for donors procured from 1991 through 1995. The
exception request must also detail the specific actions the OPO intends
to take to increase organ donors to 24 per year. Detailed instructions
concerning the exception process and the corrective action will be
included in the manual instructions.
Comment: One commenter wrote encouraging us to view the
qualification criteria as bare minimum which should not be weakened for
any reason. The commenter was concerned with the discrepancy between
the qualification standards for new OPOs and currently existing OPOs.
Response: We appreciate support for the qualification standards
adopted. As noted above, we believe it is important to maintain high
standards to encourage OPOs to make every effort to procure all
available organs. However, we are not aware of any means to avoid a
discrepancy in standards between new and existing OPOs. That is, a new
OPO will not have actual data on any objective measure of organ
recovery or transplant rates. Consequently, we have no alternative than
to use a measure of potential procurement for the initial designation.
On the other hand, if an OPO is not recovering the potential
organs, despite the fact that the area is large enough to support
minimum recovery level, we believe it would be irresponsible to
continue to allow that OPO to service the area. Thus, while there may
be some discussion as to what exactly is the most appropriate
qualification standard for existing OPOs, we believe that there should
be no alternative to setting the standard using actual experience
measures as opposed to potential. Since it is impossible to use actual
data for new OPOs and we are wedded to using actual data for existing
OPOs, there appears to be no alternative but to use different standards
for new and existing OPOs.
However, from the context of the comment, it appears that the
commenter believes the standard for new OPOs, which uses potential
recoveries, is more difficult than the standard for existing OPOs. We
point out that while the number of potential donors for new OPOs is
higher than the number of actual donors for existing OPOs, we do not
believe the standard for new OPOs is more rigorous. We have been told
by some OPOs that the average conversion rate of potential organs is
approaching 3 to 1. This means that to achieve the standard for
existing OPOs of 24 donors, a new OPO should have an area big enough to
have close to 72 potential donors.
We did not use the 72-donor criterion for several reasons. First,
we believe it is inappropriate to hold new OPOs to a different initial
standard than that which had to be met by their competitors when they
first entered the program. Second, we believe that new OPOs deserve the
benefit of the doubt in achieving a conversion rate that is above the
national average. That is, a new OPO may have only 50 potential
[[Page 19727]]
donors, but because of effective practices is able to achieve a
conversion rate of 2 to 1, and thus would continue to meet the
qualification criterion at recertification time.
Comment: One commenter noted that not all OPO service areas are
contiguous territories. The commenter requested that HCFA prohibit OPOs
from developing noncontiguous areas, citing difficulty in organ
allocation when service areas are separated.
Response: The commenter did not present any data or examples
demonstrating that noncontiguous areas are problematic. Further, the
issue of noncontiguous service areas has not presented a significant
problem for organ allocation or procurement to the best of our
knowledge. Most OPOs that have noncontiguous service areas have
established field offices in each territory. Often, they have secured
approval for alternative allocation policies for each portion of the
service area. While there may be some administrative complexities
associated with noncontiguous areas, this concept has appeared to work
very well. We find no reason to prohibit the practice in the future.
C. Provisions of This Final Rule With Comment Period
We are making the following changes to the interim final rule.
We are revising Sec. 486.306(d). We are retaining the
general requirements for documentation of service area in paragraph (d)
and moving the specific detailed requirements in that paragraph to new
Sec. 486.307 OPO service area requirements and documentation and
including a cross-reference to Sec. 486.307 in Sec. 486.306(d). We are
making this change as a technical change to allow for a better
organization and readability of the regulations.
We are adding Sec. 486.307(d)(3) to provide for an
exception process when an OPO experiences unforeseen circumstances
beyond its control that result in the OPO failing to meet the
qualification criterion during a single certification period. To
qualify for an exception, the OPO must demonstrate that (1) it failed
to meet the 24-donor criterion due to unusual circumstances beyond its
control, (2) it has historically maintained a service area sufficient
to assure effective procurement and equitable distribution (that is, it
has historically achieved 24 donors per year), and (3) it has a
specific plan to achieve 24 donors per year in the future.
We are deleting Sec. 486.310(b)(2) (formerly
Sec. 485.306(b)(2)). This paragraph contains the 24-donor rule as a
measure of performance. As noted above, we are keeping this measure as
a qualification criterion.
Although we did not receive a comment to this effect, we
are redesignating Sec. 486.310(a)(3) (formerly Sec. 485.306(a)(3)),
that requires OPOs to enter into a working relationship with any
hospital or transplant center in the OPO's service area that requests a
working relationship, as Sec. 486.304(b)(8). We believe that this
requirement is more appropriately considered as a qualification
standard for OPOs rather than as a performance standard.
III. Composition of the Board of Directors of an OPO
(Sec. 486.306(f))
A. Background
Section 485.304(f) (redesignated as Sec. 486.306(f)) requires that
as one of the conditions for qualification as an OPO under the Medicare
and Medicaid programs, an OPO must have a board of directors or an
advisory board that has the authority to recommend policies relating to
the donation, procurement, and distribution of organs. That section
also specifies that the board must include members with various
backgrounds and areas of interest. In the proposed rule, we included a
revision to Sec. 485.304(f)(3) (now Sec. 486.306(f)(3)) to allow either
a physician or an individual with a doctorate degree in a biological
science with knowledge, experience, or skill in the field of
histocompatibility to serve on an OPO board of directors or advisory
board. In the interim final rule, we changed the requirement from ``a
physician with knowledge, experience, or skills in the field of human
histocompatibility'' to ``a physician with knowledge, experience or
skill in human histocompatibility, or an individual with a doctorate
degree in a biological science and with knowledge, experience, or
skills in the field of human histocompatibility.''
In addition to this requirement, Sec. 486.306(f) specifies that the
board must also consist of:
Members who represent hospital administrators, tissue
banks, voluntary health associations in its service area, or emergency
room personnel.
Members who represent the public residing in that area.
A neurosurgeon or another physician with knowledge or
skills in the field of neurology; and
A transplant surgeon from each transplant center in its
service area with which the OPO has an arrangement to coordinate its
activities.
While an OPO may have more than one board, the membership
composition specified in Sec. 486.306(f) must exist on a single board.
B. Public Comments and Our Responses
Comment: Several commenters questioned the composition of the
policy board. Some commenters expressed concern with the involvement of
a transplant surgeon from each transplant center. They interpreted the
regulation as requiring that each transplant surgeon from each center
be placed on the board. They commented that this provision would
produce very large and costly boards and would give transplant surgeons
control.
Response: The commenters misinterpreted the regulation. We are not
requiring that each transplant surgeon be included on the OPO policy
board. Rather, we are including in the regulations the statutory
requirement contained in section 371(b)(1)(G)(i)(V) of the PHS Act.
This section requires that there be one transplant surgeon from each
transplant center within the OPO service area included on the policy
board.
We agree with the commenter that to include all transplant surgeons
would be inappropriate. Such a situation would give transplant surgeons
a disproportionate influence over OPO policies. We did not intend to
require the inclusion of every transplant surgeon. In fact, we read the
statute as prohibiting this composition. That is, we believe the
statute does not provide the OPO an opportunity to alter the
composition of the board from that provided in the law. Section
371(b)(1)(G)(i) of the PHS Act states clearly that the board ``is
composed of * * * from each transplant center * * * a member who is a
surgeon * * *.'' We believe the use of the article ``a'' to modify
transplant surgeon members, expresses the will of the Congress that the
board be composed using only a single transplant surgeon from each
transplant center within the service area. The statute does not say
that the board must include at least the following members. Rather it
clearly states that the board is composed as directed. Thus, OPOs may
not add additional members to the policy board other than those
specified in Sec. 486.306(f). We are modifying this section to specify
that the board must ``be composed of'', rather than say ``include'' to
clarify this provision.
Comment: Another commenter recommended that Sec. 486.306(f) be
modified to include only a single representative from one of the
disciplines from each transplant center on the policy board. The
commenter was concerned that the current regulation gives surgeons a
disproportionate influence on the board
[[Page 19728]]
or requires very large boards to balance their influence.
Response: As noted above, the statute is very clear in describing
the composition of the policy board. To alter the composition would
require a change in the law. However, we are not convinced that the
composition mandated in the law is problematic in most cases.
The law requires both a neurologist and a histocompatibility expert
on the board. In addition, it requires an unspecified number of other
people that may be included; for example, representatives of hospital
administrators, intensive care and emergency room personnel, tissue
banks, voluntary health associations, and members of the public.
Although the law does not specify the number of these representatives,
it is clear that there must be multiple representatives through the use
of the plural of the word ``members'' in sections 371(b)(1)(G)(i) (I)
and (II) of the PHS Act. In all but a few extremely large urban OPO
service areas, using only the minimum representation from these other
categories will result in a fairly small and balanced policy board.
We acknowledge that there will be isolated cases where the
requirement for a surgeon from each transplant center may be
problematic. For example, we are aware of one OPO that services 17
transplant centers. The inclusion of 17 transplant surgeons will result
in a very large and potentially difficult policy board. Therefore, we
are considering recommending a statutory change to the Congress
regarding the law governing OPO board composition. In the meantime, the
boards must be composed as directed in the law.
Comment: Other commenters recommended that OPOs be allowed to
establish committees, such as a quality of organs recovered committee
or a medical committee, in lieu of full representation on the policy
board by all surgeons. Still other commenters expressed support for
inclusion of one transplant physician from each transplant center on
the policy board.
Response: As noted above, the composition of the board is explicit
in the statute. We do not have the authority to condone alternative
governing strategies. We will consider developing a recommendation for
statutory change in this regard. However, we believe that the statute
would not prohibit OPOs from establishing the committees that have been
suggested. Such committees could advise the board and may be very
helpful in developing the OPO's policies and influencing its practices.
We strongly encourage OPOs to seek opinions from their customers and
others affected by their decisions. The only problem we find with the
commenter's recommendation is that such committees cannot be used in
lieu of full representation.
Comment: One commenter suggested that Sec. 485.304(f)(3) (now
Sec. 486.306(f)(3)) relating to histocompatibility representation on
the board be broadened further to include a doctorate level individual
in bioethics or a nursing specialty.
Response: We are not certain if the commenter intended that the
histocompatibility requirement be met by someone with bioethic or
nursing doctorate level education or that such individuals be added in
addition to the histocompatibility person. We believe that the
histocompatibility requirement is extremely important to the policy
board composition. Histocompatibility testing is paramount in
discussing policies related to equitable distribution of organs. We
believe that the histocompatibility representative on the policy board
must be someone with a medical degree or a biological science degree
with experience in human histocompatibility.
The requirement included in Sec. 486.306(f)(3) is a reiteration of
the requirement in the statute. The current law does not authorize
alternative education for this requirement. However, the current
regulations do not prohibit an OPO from including someone with a
doctorate level education in nursing or bioethics on the board. The
statute does not provide specific direction as to the education or
number of representatives from hospitals and the public. An OPO could
certainly choose to include a person with advanced nursing and
bioethics training, or both, as one of these board representatives.
Comment: One commenter recommended that the OPO boards be comprised
of not more than 50-percent representation from transplant centers.
Response: As noted above, we have described the composition of the
OPO boards in this regulation in accordance with section 371 of the PHS
Act. We note that the law does not prescribe the number or skills mix
of representatives from hospitals or the public. We expect that, given
that the boards must include a transplant surgeon from each transplant
center, in most cases the transplant centers will be heavily
represented on the boards.
We believe, however, that it is unnecessary and inappropriate to
dictate the percentage of transplant center representatives on the
board. We believe that each OPO is best equipped to determine the needs
of its operation and the community. Given the number of transplant
centers in the OPO's service area, such a requirement could result in
extremely large boards which could be costly to the OPO and,
consequently, the Medicare and Medicaid programs. Further, we do not
believe that the statute supports such a requirement because the law
was deliberately vague in its use of the term ``representatives'' as
opposed to use of limiting article ``a'' in the requirements regarding
members of the board.
However, given the rigorous performance standards that OPOs must
meet, we expect that each OPO will ensure as broad a representation as
practicable in setting up its policy board. We expect that it would
want to seek out increased involvement with donor hospitals and public
representatives to achieve innovative strategies to increase donation
rates. OPOs that fail to modify their boards to achieve a balance in
representation from the donor community and the transplant community
are likely to feel the consequences in failure to meet performance
standards. Thus, although we are not specifying the percentage of
representatives, we are holding OPOs accountable for appropriate
decisions.
C. Provisions of this Final Rule With Comment Period
We are clarifying Sec. 486.306(f) by revising the language
describing the OPO board. The revised language, ``the advisory board
must be composed of the following,'' more clearly indicates that there
is no discretion to add or remove skills to the mix on the board.
IV. Equitable Distribution of Organs (Sec. 486.306(i))
A. Background
In a proposed revision to Sec. 485.304(i) (now Sec. 486.306(i)), we
specified that an OPO must have a system to allocate donated organs
equitably among transplant centers and patients according to
established medical criteria. This revision was made to include the
word ``equitably'' in the previously existing requirement. In the
interim final rule with comment period, we changed the requirement to
eliminate the allocation of organs among ``centers'' and to specify the
medical criteria that the system must operate under; that is, they must
be consistent with Centers for Disease Control and Prevention (CDC)
standards and with OPTN rules. We made the former change to be
consistent with section 371(b)(3)(E) of the PHS Act.
[[Page 19729]]
B. Public Comments and Our Responses
Comment: One commenter believed there was now an absence of a
requirement for OPOs to equitably distribute organs. Another commenter
recommended that there be a follow-up mechanism to ensure that OPOs use
a system to allocate organs according to established medical criteria.
Response: The regulations at Sec. 486.306(i) require OPOs to have a
system to equitably allocate donated organs among transplant patients
that is consistent with the CDC and the OPTN rules. We made the change
in the interim final rule to specifically add the word ``equitably'' to
the distribution requirement. Currently, the OPTN develops a national
organ allocation system. The system is developed by the membership and
is medically based.
Although we are aware of isolated instances of OPOs using
allocation systems that do not comport with the national OPTN rules, we
do not believe that this situation is widespread. Consequently, we
believe it is unnecessary to establish a formal mechanism to evaluate
OPO allocation methodologies at this time. However, we invite the
public to advise the Department of incidents of organ allocation that
fall outside the established system. Incidents should be reported to
Judith B. Braslow, Director, Division of Organ Transplantation, Room 7-
18, 5600 Fishers Lane, Rockville, MD 20857.
Comment: Two commenters requested clarification regarding the
reference to the CDC standards. They noted that the CDC guidelines were
published as guidelines, not rules. They inquired if inclusion in
Sec. 485.304(i) (now Sec. 486.306(i)) sets these guidelines as
standards of practice for the entire transplant community.
Response: Section 486.306(i) requires that an OPO's system of
distribution of organs among patients be consistent with the CDC
standards. For the most part, these CDC standards relate to screening
potential organ donors and organs recovered for Human Immunodeficiency
Virus (HIV) infection. We believe that the monitoring for HIV infection
is critical and is an essential element for Medicare certification of
OPOs. In fact, in section 371(b)(3)(C) of the PHS Act, the Congress has
specifically required that OPOs evaluate an organ for HIV infection.
Exclusion of prospective blood donors based on their acknowledged
risk factors for HIV infection began in 1983. In 1985, when the test
for the HIV antibody became available, screening of prospective donors
of blood, tissue and organs began. Both measures have reduced
remarkably the transmission of HIV via these routes. A 1991
investigation, however, determined that several recipients had been
infected with HIV by an organ/tissue donor who had negative HIV
antibodies at the time of the donation. This occurrence raised
questions about the need for additional Federal oversight of
transplantation of organs and tissues.
A work-group was formed by the Public Health Service (PHS) to
address transmission of HIV through transplantation of human tissue.
This group produced a set of recommendations that were included in the
CDC Guidelines that we have included as an appendix to subpart G of
part 486 and referenced in the OPO regulations. OPOs must abide by the
CDC guidelines to qualify for Medicare and Medicaid certification.
In developing the recommendations, the PHS sought assistance from
public and private health professionals and representatives of the
transplant community, public health and other organizations. A total of
37 external consultants and 18 government staff formulated the
recommendations. These recommendations address issues such as donor
screening; quarantine of tissue from a living donor; inactivation or
elimination of infectious organisms in organs and tissues before
transplantation; timely detection, reporting, and tracking of
potentially infected tissues, organs and recipients; and recall of
stored tissues from donors found after donation to have been infected.
Factors considered in the development of these guidelines included
differences between the screening of living and cadaveric donors; time
constraints due to organ/tissue viability that may preclude performing
certain screening procedures; differences in the risk of HIV
transmission from various organs and tissues; differences between
systems for procuring and distributing organs and tissues; the effect
of screening practices on the limited availability of organs and some
tissues; and the benefit of the transplant recipients.
The CDC guidelines are intended to promote public health and
safety. They were not arrived at without appropriate assessment of the
risks and benefits for the public health of Americans. We fully support
the CDC guidelines and have attempted to assure compliance with them
through inclusion in the Medicare conditions of coverage. Thus, the
inclusion of the CDC guidelines as a requirement for OPOs does give the
CDC guidelines regarding organ allocation the force of regulation. That
is, any OPO found to be failing to conduct appropriate screening or
distributing organs that are not in compliance with the CDC guidelines
for organ allocation can be found out of compliance with the
qualifications for becoming a Medicare- or Medicaid-certified OPO and
have its certification terminated.
However, we acknowledge that the reference to the CDC guidelines
contained in the interim final rule with comment period is not
sufficiently clear on this point. Consequently, we are revising
Sec. 486.306(i) to specifically incorporate by reference the CDC
guidelines. The guidelines were issued as one of the CDC Morbidity and
Mortality Weekly Reports, ``Guidelines on Preventing Transmission of
Human Immunodeficiency Virus Through Transplantation of Human Tissue
and Organs,'' Vol. 43, No. RR-8, May 20, 1994.
We did not receive a formal comment on the application of the CDC
guidelines during the public comment period for the interim final rule.
We understand, however, that OPOs have taken the position that
acceptance of recovered organs is a matter of patient choice. Some
patients are so dangerously close to death while on the waiting list
that they are willing to risk receiving an organ potentially infected
with a fatal virus rather than risk the chance of not finding in a
timely manner an appropriate healthy organ. Some OPOs support the
patient having the opportunity to make this choice for themselves and
believe the CDC guidelines prohibit this practice.
The law at section 371(b)(3)(C) of the PHS Act is clear regarding
testing for infection with the etiologic agents (HIV-1 and HIV-2) for
acquired immune deficiency syndrome and taking steps to prevent
exposure to HIV through transplantation of these organs. Regardless of
the personal preference of a potential recipient or the opinion of the
OPO staff, the law requires that potential donors be tested for viral
markers for HIV-1 and HIV-2, and if found to be infected, organs from
that donor are not to be transplanted.
The CDC guidelines, however, do permit some measure of judgment for
organs tested negative for HIV etiological agents, but procured from
donors who have demonstrated high-risk behaviors. The recommendation in
the CDC guidelines on donor screening state that ``* * * Regardless of
the HIV antibody test results, persons who meet any of the high-risk
criteria should be excluded from donation of organs or
[[Page 19730]]
tissues unless the risk to the recipient of not performing the
transplant is deemed to be greater than the risk of HIV transmission
and disease. In such a case, informed consent regarding the possibility
of HIV transmission should be obtained from the recipient. * * *''
Thus, while compliance with the CDC guidelines requires OPOs to
conduct screening of donors through asking questions about the
potential donor's behavior relative to HIV-risk factors, the guidelines
do not unilaterally prohibit transplantation of the organs from donors
found to have high-risk behavioral criteria who have negative HIV-1 and
HIV-2 serologic tests. The OPO may procure the organs from such donors
and make the information concerning HIV-risk factors available to the
transplant surgeon. The transplant surgeon will then assess the risk
factors for HIV against the risk associated with delaying
transplantation and together with the potential recipient (and his or
her family if appropriate) make a decision to accept or reject the
organ. It is imperative, however, that full information regarding the
risk factors be disclosed by the appropriate transplant surgeon to the
potential recipient.
C. Provisions of this Final Rule With Comment Period
We are including the specific CDC guidelines cited in the interim
final rule as appendix A of part 436 subpart G. We are also clarifying
the reference to the CDC guidelines in Sec. 486.306(i). As a result of
these revisions, we are making the guidelines required standards for
OPOs.
V. Testing of Organs (Sec. 486.306 (q) and (s))
A. Background
In the proposed rule, we added a new Sec. 485.304(r) (now
Sec. 486.306(q)) to require OPOs to assure appropriate tests consistent
with OPTN standards and CDC guidelines are performed to prevent the
acquisition of organs that are infected with the HIV-1 and HIV-2
etiologic agents for acquired immune deficiency syndrome. In the
interim final rule, we redesignated the contents of paragraph (r) as
paragraph (q) and the contents of paragraph (q) as paragraph (r) and
added a new paragraph (s). Revised paragraph (r) required OPOs to
assist hospitals in establishing and implementing protocols for making
routine inquiries about organ donations by potential donors. New
paragraph (s) required OPOs to ensure that serologic testing for HIV-1
and HIV-2 viral markers is performed on potential donors consistent
with OPTN rules and CDC guidelines for solid organ donation.
B. Public Comments and Our Responses
Comment: One commenter recommended that we include standard
provisions that are required for all hospital donation protocols. The
two provisions the commenter specifically suggested were that (1)
hospitals refer all potential donors to the OPO before donation has
been mentioned, and (2) a trained professional be involved in all
donation requests.
Response: We believe that the suggested protocols are good and are
likely to work quite effectively for many OPOs and hospitals. However,
it is inappropriate to regulate specific donation protocols at this
time. There are many different protocols that can be highly effective
in organ donation. We do not wish to stifle the development of
innovative means of increasing the procurement rate by regulating
specific methodologies or protocols.
Comment: One commenter expressed concern with the requirement in
Sec. 485.304(s) (now Sec. 486.306(s)) regarding CDC guidelines for
preventing transmission of HIV through transplantation of human tissue
and organs. The commenter noted that an OPO has no knowledge of what
information the transplant center provided to the potential recipients
regarding their informed consent to the risks of transmission of
infections. The commenter suggested alternative language describing an
OPO's responsibility to make information available to the transplant
center. This language would state that an OPO is not responsible for
the decision to transplant high-risk organs in life-threatening
situations.
Response: Section 485.304(s) (now Sec. 486.306(s)) requires that
OPOs ``Ensure that donors are tested for human deficiency viral markers
consistent with OPTN rules and CDC guidelines for solid organ
donation.'' Similarly, Sec. 485.304(i) (now Sec. 486.306(i)) requires
that the OPO allocate organs in accordance with these guidelines. OPOs
are responsible for testing and allocating organs in accordance with
these guidelines.
If an OPO only allocates organs that comply with the guidelines to
a transplant hospital, a transplant center would receive a high-risk
organ to transplant to the recipient only on a very rare and carefully
selected basis. The OPO is required to ensure that informed consent of
the recipient is obtained. Thus, while the commenter is accurate in the
statement that an OPO does not formally have direct contact with the
recipient, we do not agree that such a situation in any way alters the
responsibility of an OPO to follow the CDC guidelines regarding testing
and allocation of organs. We expect that in these rare cases the OPO
will work closely with the transplant center to impress upon the center
the importance of getting informed consent documentation to the OPO
timely. We expect hospitals will cooperate with the OPOs in meeting
this requirement.
An OPO's responsibility does not stop with testing the donor and
making information available to the transplant center. The regulations
go beyond this to require the OPOs to allocate organs in accordance
with CDC guidelines. We believe it is appropriate to continue to hold
OPOs responsible for compliance with the CDC guidelines for allocation
as well as testing. Therefore, we are not modifying the regulations as
recommended by this commenter. However, as we stated above in
discussing Sec. 486.306(i), we believe that the nonspecific reference
to the CDC guidelines could be confusing. Thus, we are clarifying the
regulations to include a reference to the CDC guidelines in
Sec. 486.306(s). The guidelines are also included as an appendix to
part 486 subpart G.
Comment: One commenter suggested we also require OPOs to use the
guidelines and recommendations of the PHS workgroup on the testing of
organ donors for the presence of hepatitis.
Response: Unlike the requirement for testing for HIV viral markers,
which is contained in section 371(b)(3)(C) of the PHS Act, there is no
express legislative authority to mandate a requirement for hepatitis
testing. Although we believe that hepatitis testing is not precluded by
the law, there is no clear indication in either the statutory language
or the legislative history indicating the Congress intended that the
direction provided for HIV testing be expanded to other infectious
diseases.
We believe that it would be permissible to issue a regulation
requiring hepatitis testing for potential organ donors. However, we
believe that it would be imprudent to proceed with such a requirement
without the benefit of a prior public comment period to solicit the
input of the industry and other interested parties. We recognize that
there are significant OPO concerns that must be considered before we
proceed with any proposal to require testing for hepatitis. We
especially want to consider any cost impact and potential for decline
in organ donations before we develop a regulatory change of this
nature. Consequently, we are inviting public comment on this issue at
[[Page 19731]]
this time. If, after considering any comments we receive, we believe
that change in the regulations is appropriate, we will issue a new
regulation.
C. Provisions of the Final Rule With Comment Period
We have revised Sec. 486.306 (q) and (s) to include a reference the
CDC guidelines as standards in this final rule with comment period. We
have also included the CDC guidelines as an appendix to part 486
subpart G.
VI. Qualification Data (Sec. 486.306(t))
A. Background
In the interim final rule with comment period, we added
Sec. 485.304(t) (now Sec. 486.306(t)) to enable us to verify an OPO's
compliance with the performance standards. Section 486.306(t) requires
an OPO to submit accurate data to us within 15 days following the end
of a calendar year (unless otherwise notified), giving information on
the--
Population of designated service areas based on the most
recent U.S. Bureau of the Census data;
Number of actual organ donors;
Number of kidneys procured;
Number of kidneys transplanted;
Number of extrarenal organs by type procured; and
Number of extrarenal organs transplanted.
B. Public Comments and Our Responses
Comment: One commenter believed that there are multiple
interpretations for the terms for ``actual donor'' and ``procured''
that are used in the performance standards. The commenter recommended
that HCFA adopt the definitions that have been developed by the OPTN
contractor.
Response: Because, in the case of the OPO performance criteria, we
are using criteria that are based on the performance of peers, it is
important that all OPOs use the same data definitions to report data
uniformly. We surveyed the use of various terms within the industry,
including the OPTN contractor, and developed the following definitions:
Kidneys recovered--The number of kidneys recovered is the
actual number of kidneys the OPO recovers with the intent to
transplant. Kidneys recovered that are intended for research are not to
be included in the count. However, if a kidney was recovered with the
intent to transplant but was not actually transplanted due to
unforeseen circumstances, it may be counted. Kidneys recovered en bloc
are counted as two kidneys.
Kidneys transplanted--The number of kidneys transplanted
is the actual number of kidneys that were transplanted into recipients.
Kidneys transplanted en bloc are counted as two kidneys. Kidneys
transplanted as part of multiple organ transplants, for example,
kidney-pancreas transplants, are counted as both a kidney transplant
and an extrarenal transplant.
Extrarenal organs recovered--The number of extrarenal
organs recovered is the actual number of hearts, livers, lungs, and
pancreas the OPO recovers with the intent to transplant. Each organ is
counted individually regardless of the number of organs transplanted
into the same recipient.
Extrarenal organs transplanted--The number of extrarenal
organs transplanted into recipients. Each organ is counted individually
regardless of the number of organs transplanted into a single
recipient.
We had initially collected data from the OPOs using alternative
definitions that may have disadvantaged some OPOs serving hospitals
that frequently engaged in multiple organ transplants, such as heart-
lung transplants, bilateral lung transplants, and kidney-pancreas
transplants. We believe these revised definitions treat OPOs fairly. We
note that the OPTN contractor has agreed to use these common
definitions in its data gathering activities. Consequently, the
feedback that the OPTN contractor provides to an OPO throughout the
performance period to monitor an OPO's performance against its peers
should be consistent with the HCFA performance standards. Moreover,
based upon our impact analysis, we believe that changing the
definitions from those contained in the interim final rule with comment
period will not adversely impact any OPO's ability to meet the
performance standards.
We defined ``donors'' in our previous collections as ``the number
of cadavers from which the OPO actually recovers at least one viable
organ.'' Some OPOs advised us that differences in OPO protocols may
result in unintended differences among the OPOs through the use of this
definition. They recommended that we alter the definition to count only
those cadavers from which at least one organ was ultimately
transplanted.
Unlike the changes in other definitions that increase the number of
organs counted for nearly all OPOs, this recommendation for the change
in the definition of ``donors'' would decrease the count of donors for
many OPOs. Further, in conducting an impact analysis, we found at least
one OPO that would have met the performance standard under the
previously announced definition would not meet the standard under the
recommended revision.
We do not want to change the standard without benefit of comment
from the full industry, particularly in light of the fact that OPO
representatives differ in their views of the most appropriate
definition. Similarly, we are concerned that making a change in the
definitions that would adversely impact some OPOs at this late time in
the performance period without providing those entities an opportunity
for comment is not equitable. Consequently, we are retaining the
definition of ``donors'' that we used when we initially collected data
to calculate performance standards for the 1996 designations. We are,
however, open to altering the definitions for the 1998 recertification
process. Therefore, we specifically invite the public to comment on
this provision. If, after analysis of the comments, we believe that
changes are appropriate, we will advise the public, including all OPOs,
of these changes on a timely basis.
We advised OPOs of these definitions in our letters to them
regarding the collection of data throughout the performance period.
Similarly, we intend to include these definitions in the manual
instructions being prepared on the OPO conditions of coverage. We
believe that this way of proceeding will give us more flexibility in
adopting more appropriate definitions that become evident through
continued work with the data. We are also soliciting comments on
whether changes in the definitions should be made through rulemaking.
Comment: Several commenters objected to our requirement that organs
procured and transplanted en bloc, such as a pair of kidneys or lungs,
be counted as a single organ. The commenters believed that each organ
should be counted separately.
Response: We had intended that the organs be counted in accordance
with industry standards. Mistakenly, we utilized the HCFA standard for
counting organs that is applied during the cost reporting process. We
have now changed our definitions to be consistent with industry usage.
Each organ will be counted separately. OPOs are not able to influence
the transplantation of multiple organs and therefore should not be
penalized for serving centers that engage in this practice at a greater
frequency than the national average.
We note that we have already clarified this in our operational
instructions to the OPOs in verifying the performance data. Thus, the
performance standards
[[Page 19732]]
applied for the 1996 recertification process have been calculated based
on these revised definitions. Moreover, we are deleting any regulatory
reference to how organs are to be counted. We believe that this type of
detailed operational instruction is more appropriately placed in a
manual where it can be revised more easily as appropriate.
Comment: A few commenters recommended that HCFA use only verified
data from the OPTN contractor to monitor performance.
Response: We have analyzed portions of the OPTN data relative to
organ recovery and transplantation. We found the donor data reasonably
consistent with that reported to HCFA directly. Thus, the idea of using
the OPTN data for calculating performance standards is very appealing.
This method would reduce the reporting burden on the OPOs and is
consistent with the Administration's goal of reducing the Federal
regulatory burden. If we make such a change, we will, of course, first
notify all OPOs timely.
However, we have two concerns before we can implement such a
strategy. First, to make the performance standards as current as
possible while still meeting the recertification schedule, we require
that the calendar year data be reported as close to the end of the year
as possible. Currently, we require the OPOs to report this data to us
by January 15 annually. Because of the lag time of hospitals notifying
the OPTN of recipient registrations, the OPTN contractor questions if
the data reported by the 15th of the following month through routine
channels are comprehensive.
Second, we are concerned that OPOs have an avenue to request
adjustment of the data or to provide any necessary explanatory
material. For example, all of the performance criteria are population
based. Due to hospitals dealing with OPOs other than the one designated
for the service area or census changes, changes in the actual
population data for an area may be necessary. The OPTN data on
population is not, to the best of our knowledge, specific to the actual
hospitals served by OPOs. Thus, to use the OPTN data without the
benefit of adjustment could unfairly penalize some OPOs.
We established a process for collecting data from the OPOs. Each
OPO has been asked to submit its data in accordance with our directions
defining the variables. OPOs have the opportunity to identify necessary
adjustments to the population for its designated service area to take
into account hospitals that deal with multiple OPOs or an OPO other
than the one designated for the area. When an OPO requests a population
adjustment, we will work with the alternative OPO and our regional
offices using appropriate census data to accurately apportion the
population in question.
National averages and performance criteria are calculated and
forwarded to the OPOs, along with our recorded data from that OPO, to
provide an opportunity to review the data recorded. The OPO has an
opportunity to assure that data entry errors or other mistakes have not
been made and provide any necessary corrections to the data base. We
believe it is essential to provide OPOs this form of opportunity for
input before we use the data for purposes that could potentially result
in termination of the OPO from Medicare and Medicaid participation.
Initially, we were concerned that this opportunity for input would
not be available if we were to use the OPTN data. However, we
anticipate that once the initial population for the OPO service areas
has been calculated, future changes or adjustments, or both, will be
minor and infrequent. Thus, we may be able to develop a process that is
based on calculation of the standards using OPTN data, yet incorporates
a process for individual OPO adjustment requests.
Despite these concerns, we are supportive of the concept of using
the OPTN data to calculate the performance standards. We, together with
the OPTN contractor, will work with the OPOs and the transplant centers
throughout the year to obtain the necessary data as timely as possible
and develop a process for appropriate adjustments to achieve this goal.
We intend to test the 1995 and 1996 OPTN contractor data submissions
and analyze differences between the OPTN data and the OPO data. If the
OPTN data prove satisfactory, we will begin using them to set the 1998
standards rather than collecting the data individually from the OPOs.
We would, however, continue to allow OPOs to review the data and
request changes as appropriate. We note that adopting the OPTN data may
require revisions to the regulation or paperwork requirements or both.
We invite OPOs to participate with us in this process during the
ongoing evaluation.
Comment: One commenter believed that the requirement that the data
be submitted within 15 days of the end of an calendar year is
unreasonable. The commenter recommended that OPOs be given 60 days in
which to submit data.
Response: We acknowledge that a 15-day period for submission of
data after the end of the year may appear unnecessarily onerous. But,
upon closer examination, we believe that the request is quite
reasonable. The data are for items routinely collected by nearly all
OPOs, there are only six data elements, and the data for the first 11
months may be gathered in advance of the due date with the final
month's data added at the end of the year.
In addition, we believe that it is impractical to extend this
timeframe because of the work that must be done to determine the
performance standards before the recertification process which, for
most OPOs, begins in April. Prior to the beginning of April in the
years in which the recertification process takes place, we must review
the data submitted by the OPOs, make any necessary adjustments, enter
the data into a database, and calculate the performance standards. This
work must be completed as early in the year as possible so that the
OPOs can be notified of the standards, be afforded an opportunity to
verify the accuracy of their data, and make any changes to the data
prior to the recertification process. Because, the performance
standards are based on averages, a change in a single OPO's data can
result in a change in the standard that could impact upon other OPOs.
We believe that it would be inequitable to OPOs to delay having the
performance standards available to them until immediately preceding the
recertification.
Additionally, we must also have estimates available as early as
possible of those service areas currently served by OPOs that do not
appear to meet the standards so that any OPO interested in moving into
a service area of a poorly performing OPO has an opportunity to prepare
a plan for operating in the service area.
The only alternative we have to collecting data within 15 days of
the end of the performance period is to change the base years from
which we calculate the standards. That is, we could calculate the
performance standards for the 1996 redesignation using data from 1993
and 1994 rather than 1994 and 1995. We find this alternative
unsatisfactory. We believe that it is important that the data used to
evaluate an OPO's suitability for redesignation reflect the most recent
performance of an OPO. The use of old data could result in our
terminating the agreement of an OPO that has just completed an
outstanding performance year because the OPO did not meet the criteria
2 or 3 years ago.
We note that very few OPOs appear to have difficulty with the data
collection process and due date once they have gotten used to the
process. For example, only six OPOs did not file their data
[[Page 19733]]
timely in response to our 1995 collection effort. Further, none of the
OPOs called us to complain that the timeframe was unworkable or
unreasonably difficult.
C. Provisions of the Final Rule With Comment Period
We have not made any revisions to Sec. 486.306(t) in this final
regulation with comment period. We have, however, removed the
introductory paragraph of Sec. 486.310 containing operational
instructions regarding the counting of organs. We are removing these
instructions from the OPO regulations because they will be more
appropriately placed and more easily updated in an operational manual.
VII. Performance Standards (Sec. 486.310)
A. Background
Section 485.306 (now Sec. 486.310) lists the performance standards
for OPOs. In the proposed rule, we proposed revisions to this section
to state that we would not ``redesignate'' any OPO that fails to meet
the performance standards contained in this section. We also revised
Sec. 485.306(b) (now Sec. 486.310(b)) to distinguish between an OPO
which has not previously been designated by us for a particular service
area and a redesignated OPO with respect to the exemption from meeting
the performance standards in Sec. 485.306(a) (1) and (2) (now
Sec. 486.310(a) (1) and (2)) for 2 years.
In the interim final rule with comment period, we revised the
proposal to add the performance standards that OPOs must meet beginning
January 1, 1996. An OPO must meet the primary performance standard by
achieving at least 75 percent of the national mean for four of the five
performance categories over 2 calendars years before the year of
redesignation. The performance categories are:
Actual donors per million population.
Kidneys recovered per million population.
Extrarenal organs recovered per million population.
Kidneys transplanted per million population.
Extrarenal organs transplanted per million population.
In addition to the primary performance standard, the interim final
rule provided for three additional performance standards. An OPO must:
Procure organs from an average of at least 24 donors per
calendar year in the 2 calendar years before redesignation.
Maintain an average procurement ratio of three organs per
donor.
Enter into a working relationship with any hospital or
transplant center in the OPO's service area that requests a working
relationship.
For the purpose of measuring adherence to the performance
standards, organs removed en bloc and transplanted en bloc are counted
as a single organ.
In addition, Sec. 485.306 (now Sec. 486.310) permits an OPO to
submit corrected information if it believes the data used to apply the
performance standards were inaccurate. It also allows us to grant an
exception from some of the performance standards to OPOs operating
outside the contiguous United States.
B. Public Comments and Our Responses
Comment: One commenter suggested that performance measures be
reevaluated annually to ensure that the system can incorporate a
superior model for assessing underlying donor potential that is under
development.
Response: We intend to continually reevaluate the performance
standards as new data become available. We believe it is unnecessary to
commit to an annual reevaluation because it is unlikely that new
measures will surface at a rate that would indicate that the existing
standards are antiquated that quickly. Nonetheless, readers can be
assured that we will continue to monitor research and experience to
further refine and perfect performance standards. Any proposed changes
in the standards will be published for public comment before being
effectuated.
Comment: One commenter noted that performance standards based on
potential would be more accurate and effective than the ones specified
in the regulation.
Response: We do not agree with the commenter that standards based
on potential performance are superior to standards based on actual
performance. We believe it would be inappropriate for us to certify any
except a new OPO based on its potential to perform at a certain level,
if the OPO is not achieving a certain level of that potential. For
example, an OPO could service an area with the potential to produce 100
organ donors and significantly higher than average organs per million
population. However, if that OPO does not actually achieve 24 donors
and 75 percent of the national average organs per million population,
we believe strongly that it would be inappropriate for us to ignore the
actual performance and continue to certify the OPO based on its
potential performance.
Comment: One commenter expressed concern that the performance
criteria disproportionately accentuated recovery over transplantation.
That is, the commenter noted that three of the primary performance
standards related to recovery (that is, donors per million, kidneys
recovered, and extrarenal organs recovered), while only two related to
transplantation (that is, kidneys and extrarenal organs transplanted).
The commenter believed this emphasis on recovery over transplantation
does little to accomplish the primary goal of OPOs--providing
transplantable organs for thousands of waiting recipients. The
commenter was concerned that such an emphasis may result in increased
discard rates.
Response: We believe that both organ recovery and transplantation
are critical areas of OPO performance that need to be monitored. We
acknowledge that the commenter is accurate in noting that the primary
performance criteria do slightly emphasize recovery over
transplantation. One of the primary reasons for this is that an OPO can
more directly influence the recovery rate than the transplant rate.
While we acknowledge that a small portion of the organs discarded
are within the control of the OPO through tasks such as thorough
medical history taking, we believe the majority of organ discards occur
for reasons that are beyond the OPO's control. For example, surgical
nicks, damage to the organ during removal, and diseases that were
unknown to the family or not reported in medical records account for
many discards.
While we believe it is important to hold OPOs accountable for
making every effort to avoid unnecessary discards, we believe it is
unnecessary and inappropriate to accentuate the transplantation over
recovery. After all, an organ must first be recovered before it can be
transplanted. Given that there are but five criteria in the primary
performance standard, we continue to believe that it is appropriate to
have three recovery-related criteria and two transplant-related
criteria. We note that, for the most part, the OPO industry widely
supports this division.
Comment: Another commenter expressed concern that the primary
performance criteria were antiquated in that they emphasize kidney
transplants almost to the exclusion of other tissues and organs.
Response: We do not agree with the commenter that the primary
performance standard disproportionately emphasizes kidney transplants
``almost to the exclusion of'' other tissues and organs. Three of the
five primary standards are not related to kidney transplants. However,
since the
[[Page 19734]]
number of kidney transplants significantly outweighs other organ
transplants, we believe it is appropriate to establish separate
standards that look solely at the kidney recoveries and transplants as
part of overall OPO performance. Of the 19017 transplants in 1994,
11,391 or 59 percent were for kidneys. We believe this high incidence
of kidney organ transplants justify standards that concentrate
exclusively on that organ. We welcome comments on whether this emphasis
on kidney transplants is the best course for the future, given the
science of transplantation.
Comment: One commenter stated that some OPOs may not meet the
extrarenal organ standards for reasons beyond their control, such as
geography or availability of transplant surgeons. The commenter stated
that there are no pancreas, lung, or heart/lung programs in the
commenter's State so the OPO often did not recover these organs due to
unavailability of transplant surgeons. The commenter suggested that if
an OPO is able to demonstrate that it cannot meet the standard due to
such reasons, it be given credit for unrecovered organs.
Response: Although we can sympathize with this OPO's concerns, many
OPOs are faced with this situation. Some have developed mechanisms to
facilitate procurement of extrarenal organs for transplantation in
patients listed at transplant centers outside their States. Many OPOs
are meeting these goals by utilizing local surgeons to perform
excisions. Other OPOs are developing relationships with extrarenal
programs to facilitate placements without impediment from geographic
boundaries.
It is an OPO's responsibility to recover all viable organs from all
acceptable donors and facilitate their placement in suitable
recipients. The performance standards are designed specifically to
encourage more effective organ retrieval and transplantation. We
believe it would be irresponsible, given the number of persons awaiting
organs, to modify the performance standards in any way that would
validate the failure to retrieve transplantable organs. Therefore, we
are not altering the regulations as suggested by the commenter. We note
that in areas where geographical boundaries present real obstacles to
placement, such as noncontiguous States and territories, the
regulations now located at Sec. 486.310(c)(1) already adequately
address this issue through an exception process.
If it is true that viable organs are going unrecovered because
there is no transplant program for a specific type of organ in a State,
we find a severe problem exists that should certainly be corrected. We
do not want to encourage the continuance of the problem by altering the
performance standards.
All organs can be transported at least 500 miles without
significant chance of damage. With few exceptions, this 500-mile radius
goes significantly beyond State and, generally, OPO service area
boundaries. Consequently, an organ should be recovered even when the
organ cannot be transplanted in the State or within the OPO's service
area. We strongly encourage any OPO that has adopted the practice of
not recovering organs that it cannot transplant locally to alter that
practice immediately.
Comment: One commenter suggested that HCFA include data from all
OPOs, including new OPOs, in the calculation of the national mean.
Response: We intend to include all OPOs in the calculation of the
national mean, including new OPOs and those in noncontiguous States and
territories. However, we believe it is unnecessary to amend the
regulations to specify this intention. Since the regulatory language
does not restrict the calculation, we believe it already supports our
position to include all OPOs in the calculation.
Comment: Several commenters suggested that we substitute deaths per
year as the denominator in the primary performance criteria is lieu of
population. They believe that logically this denominator is more
directly correlated to the potential donor pool and would produce
better performance standards.
Response: The objective of the performance standards is to
establish an appropriate measure that would enable us to assess how
well OPOs are maximizing organ resources and therefore warrant
certification by the Medicare/Medicaid program. As such, it is
important that the data we use to develop these standards provide an
accurate measure of OPO performance. Clearly, the use of hospital
deaths versus area population in the denominator from which these
standards are derived warrants further investigation. We agree that
since OPOs deal with cadaveric donors, deaths per year (particularly
hospital deaths per year) is a more targeted measure of an OPO's actual
potential donor pool. Therefore, we surveyed the OPOs in an attempt to
collect death data from them for 1994 so that we could study the
feasibility of using deaths per year as the denominator. In nearly
every State, OPOs reported problems obtaining timely data. In at least
one State, the data are not available at all. We were able to
determine, however, that national death statistics are available from
the National Center for Health Statistics (NCHS) and the Social
Security Administration (SSA).
Although we have decided to proceed with the use of population as
the denominator for a number of reasons discussed below, we are
soliciting public comments on which approach--population or death
statistics--would best achieve our objectives with respect to measuring
OPO performance.
Population Data:
For purposes of developing the performance standards, we use the
latest census data. In addition, adjustments are made in the population
data to account for hospitals that deal with OPOs outside the
designated OPO service area.
These data are relatively easy to obtain at minimal, if any, cost
to the OPOs. We are soliciting comment on the timeliness, cost, and
quality of these data and adjustments to these data.
NCHS Death Data:
NCHS produces a public use data tape that contains deaths by county
for all U.S. counties. This tape contains approximately 2.2 million
records per year. Although death data are available universally, there
are some data elements that may be missing for certain areas. The OPO
industry has suggested the use of in-hospital deaths rather than
general death data, and while this could be obtained from the NCHS
tape, certain areas, such as Oklahoma, do not make fine distinctions in
the hospital site. Also, we are not certain about the availability of
death data for the United States territories. The NCHS tape may allow
some finer analysis based on demographic characteristics that may
better reflect the viable organ pool.
In the United States, the collection of these vital statistics data
is a State responsibility. Data are gathered by the States, and each
State establishes its own definitions for terms and coding rules.
Although NCHS conducts a quality review of the data, it uses the
individual State guidelines to verify the data were coded
appropriately. This approach, especially in terms of the definition of
``hospital'', could affect the OPO performance standards. In addition,
there is approximately a two-year delay in the availability of death
data from NCHS.
The NCHS public use tape can be purchased for $590 per year. Since
performance standards utilize a two-year average to avoid penalizing
OPOs for short fluctuations in organ donation, it would cost an OPO
approximately $1200 per redesignation cycle to obtain
[[Page 19735]]
the tapes. At this time, the data file is only available in mainframe
medium. We expect that most OPOs do not employ the staff that would be
required to abstract data from the NCHS tapes, although we would
welcome comment on this point.
The NCHS data does not identify individual hospitals for any State,
and there may be confidentiality issues that preclude States from
collecting hospital-specific information. Lack of hospital-specific
data would create a problem in adjusting the performance data for those
hospitals that deal with OPOs outside of the designated OPO service
area. While for most OPOs the impact of hospitals dealing with
alternative OPOs is minimal, there are several OPOs where the impact of
such hospital choices is very significant.
SSA Death Data:
Although we may be able to obtain timely death data through the
Social Security Administration, we know through experience that there
are a small number of deaths that are not reported accurately. Our
experience with using these data in our intramural research indicates
it is approximately 98 percent accurate. However, we are very concerned
with use of data that the OPOs cannot verify. We are further
investigating the timeliness, cost and quality of the SSA mortality
data. We are interested in receiving public comment on this data
source.
Other Policy Implications:
We are concerned about the impact of using death as the denominator
for those OPOs servicing large urban areas. Urban areas may have a
higher death rate among apparently suitable donors, however, there is a
lower donor consent rate among the minority population and a higher
likelihood that a potential donor will be an HIV risk or present a
history of substance abuse. Therefore, in these cases, the death rate
may not accurately define the potential donor pool and may
disproportionately affect OPOs serving large urban areas. We may not
want to establish a performance standard that may systematically bias a
particular group of OPOs.
We conducted an impact analysis comparing the use of 1991 death
data (the most recent data available at the time of our analysis) and
population data as denominators in calculating performance standards.
We determined that the use of death data would not significantly alter
performance outcomes compared to using population data. However, three
OPOs servicing major urban areas would not meet the performance
standards if death data were substituted for population data, provided
that the performance standards is not also changed. We acknowledge that
if the denominator used to measure performance were changed, the
performance standard itself could in principle be changed, and solicit
comments on this issue.
While research is being conducted on determining adjustment factors
that would allow for normalization of death or population data to
account for demographic factors, we are not aware of a generally
accepted adjustment methodology at this time.
In summary, we are soliciting comments on the approaches discussed
above with respect to use of population versus death statistics (from
either NCHS, SSA or some other national source) as a denominator for
measuring performance. Specifically, we are interested in comments
concerning the timeliness, cost, and validity of the various data
sources. We would also appreciate suggestions concerning possible
adjustments to account for varying demographic factors across areas, as
well as any other potential changes in the performance measures that
could be used in conjunction with death data.
Comment: One commenter suggested that any adopted performance
standards include adjustment for demographic risk factors related to
the population of the service areas. The commenter suggested historical
consent rates and medical suitability rates of potential donors.
Response: We acknowledge that intuitively it would seem to be more
difficult to achieve performance standards in some service areas than
in others. However, the impact analysis we conducted based on 1994 AOPO
data does not support the assumption that the unadjusted population-
based performance standards would disproportionately impact on those
population bases that have higher demographic risk factors. Rather, it
appears that the selected performance standards appropriately identify
those OPOs that have not achieved designated performance standards
based on factors that are within the OPO's control. For the most part,
those OPOs with high demographic risk factors do not appear to have
difficulty meeting the standards. For example, the California
Transplant Donor Network exceeds the mean of all five of the
performance standards while servicing San Francisco, which has one of
the largest HIV populations in the country. Similarly, most OPOs
servicing populations that have historically had low consent rates also
appear to meet the standards.
Finally, the commenter did not propose an empirical value to be
used to adjust for these risk factors. Although we are aware of ongoing
research in this area, we have not found literature that unequivocally
supports a method to calculate exact demographic risk factors that
would appropriately adjust the planned performance standards. We are
interested in any empirical research in this area. We intend to
continue to monitor the research and will consider any significant
findings for future refinement of the standards.
We are very interested in the development of alternative
performance criteria that would be consistent with our goals of
increasing organ donation, setting achievable threshold levels of
acceptable performance that are realistic and fair to all the OPOs.
Unfortunately, we have not been able to ascertain empirical evidence
regarding the correlation between adjustment factors and donation. That
is, to the best of our knowledge organ donation is influenced by a
myriad of factors. An area that has a high incidence of some factor
that would seem to decrease donation may also have a high incidence of
another factor that would seem to increase donation. We are not aware
of any regression analysis or other statistical studies that would
allow us to appropriately adjust performance indicators for
idiosyncracies of a geographic area.
Nonetheless, we are very interested in further refining the
performance standards. We specifically invite the public to comment on
any alternative performance measures that are supportable by empirical
evidence.
We should point out, however, that it appears that the rigorous
performance standards we have selected are providing the appropriate
incentives to increase organ donation. Based on the unverified 1995
performance data reported, there has been an increase of 262 donors in
1995 over 1994, resulting in over 1100 additional organs being
procured. We find these statistics very gratifying and may demonstrate
that the use of rigorous performance standards significantly benefits
the public awaiting transplantation.
Comment: Two commenters noted that many OPOs deal with hospitals
outside of the designated service area. They asked if we would
calculate the appropriate, actual population served by an OPO in
applying the performance standards.
Response: As noted above, we believe that approximately 200
hospitals deal with OPOs outside their service areas. We recognize that
this arrangement can contribute to an OPO's failure to meet the
performance standards based on servicing a designated area. The
[[Page 19736]]
regulations at Sec. 486.310(c)(3) specify an OPO may provide
documentation to us to support an adjustment in its population rate if
one or more hospitals in its designated service area have agreements
with alternative OPOs.
Operationally, we have implemented this provision by soliciting
actual population data from each OPO. We asked the OPOs to advise us
when a population adjustment is appropriate. We then ascertained
appropriate population adjustments through discussions with the
alternative OPOs, the hospitals in question, and the HCFA regional
offices. We note that effective January 1, 1996, a hospital may deal
with only one OPO. We believe this requirement will make it easier to
allocate population as the entire hospital service area will be
designated to the one OPO with which it has an agreement. As noted
above, we calculated the performance standards based on the reported
data, asked OPOs to verify the accuracy of their submitted data, and
provided OPOs an opportunity to request further adjustments.
We believe that the process we developed provides an opportunity
for equitable adjustments to the population data and holds an OPO
accountable for all of the hospitals it serves--including hospitals
outside of its designated service areas.
Comment: One commenter noted that research currently underway at
the Harvard School of Public Health could potentially lead to a more
accurate methodology for measuring OPO performance. The commenter
requested that the current performance measures be reevaluated annually
to ensure that more current research does not produce a superior
mechanism for evaluating performance.
Response: We are pleased to see that there is research ongoing in
this area. We will be very interested in the results and will consider
them fully when the research is complete. While we are always open to
improving the mechanism for evaluating OPO performance from any
interested source, we believe it is unnecessary and inappropriate to
commit to an annual reevaluation in the regulations. OPOs must know in
advance to what standards they will be held, so that they can make
appropriate plans and changes in their procurement strategies. If the
research proves to be superior as the commenter believes, we will issue
a proposed notice in the Federal Register for public comment. Changes
in the performance standards will only be made after the public has had
an opportunity to review and comment on the proposal.
Comment: Two commenters suggested that we develop more appropriate
criteria for the noncontiguous States and territories. They noted that
Puerto Rico has historically had extremely poor success with organ
procurement and would fail to meet the planned standards of 50 percent
of the national mean.
Response: We acknowledge the historically small number of organ
donations in Puerto Rico. We note, however, that other noncontiguous
areas such as Hawaii have had higher donation rates. We feel challenged
to develop a standard that would provide an incentive for improvement
for Puerto Rico without being so lax as to fail to present any
challenge to Hawaii at all. We note that the performance standards for
the noncontiguous States and territories are limited exclusively to
kidneys procured and transplanted. For this single organ, the standard
is 50 percent of the national average.
During 1994, a new OPO assumed responsibility for Puerto Rico.
Under the guidance of this new OPO, we are optimistic that Puerto Rico
will eventually meet this performance standard. In the meantime, we do
not intend to allow a service area that contains a hospital to go
unserved. Thus, we have revised the regulations to specify that an OPO
that does not meet the performance standards will not be terminated as
long as another OPO does not compete for the territory
(Sec. 486.310(c)). Given this change in the regulations, we believe it
is acceptable to retain the standards for the noncontiguous States and
territories. An OPO may continue to be designated for Puerto Rico even
if it does not meet the performance standards as long as no other OPO
competes for the service area. If another OPO demonstrates that it can
achieve better performance in the area, we believe that it is
appropriate to terminate the low performing OPO and give the
alternative OPO an opportunity to achieve higher organ donation.
Comment: Several commenters were concerned that the primary
performance standard of achieving at least 75 percent of the national
mean for four out of the five performance categories is absolutely
mandatory. They believed that OPOs should have an opportunity to
provide a corrective action plan for the primary performance standards
rather than be terminated. Another OPO suggested that OPOs not meeting
the primary performance standard be placed on probation for one year.
Response: We, together with staff in the Health Resources and
Services Administration, have long believed that there are many more
potential organ donors available than are currently being identified by
the OPOs. For example, there are nearly 5,000 hospitals in this country
that have not identified a single organ donor over a 3-year period.
Based on recent research from the Johns Hopkins University, we believe
that approximately 850 of these hospitals have donor potential. While
there are a myriad of reasons for failure to identify all potential
organ donors and to convert all potential donors to actual donors, a
major influence on organ donation is unquestionably the OPO.
We believe that the establishment of primary performance standards
at 75 percent of the national average is a reasonable standard. We hold
no OPO accountable to an arbitrary number but rather look only to its
peers. We are not aware of geographical factors that by themselves make
it impossible for an OPO to meet the standards in certain service
areas. Rather with a 25-percent margin of error off the mean, we
believe that the most influential factor to performance is the OPO
itself.
We intend these performance standards to serve the people on the
transplant waiting lists in all areas of the country by fostering the
most efficient OPO service for them. We believe that all Americans,
regardless of whether they are Medicare or Medicaid beneficiaries,
deserve to be serviced by OPOs that make every effort and use every
skill available to procure transplantable organs so that lives may be
saved or improved through timely organ transplants.
Consequently, we believe it is important to hold each OPO
accountable for meeting the primary performance standard. If the OPO
that is assigned to a service area is not achieving appropriate organ
donation rates, we would be acting irresponsibly to the Americans on
the waiting list to allow that OPO to continue to serve that area
rather than replace it with another better-performing OPO.
However, we equally believe we would be acting irresponsibly to
allow an area to go unserved rather than to permit an OPO an
opportunity for improvement. Therefore, we are altering the regulations
to permit an OPO that does not meet the performance standards to retain
its certification and submit a corrective action plan, if no other OPO
that is performing acceptably is willing to assume the service area.
When an OPO does not meet the primary performance standard, we will
solicit interest in assuming the territory from other OPOs. When
another higher-
[[Page 19737]]
performing OPO wants to assume the service area, we believe that we
should make the potentially superior service available in that area. In
those cases where no other OPO expresses an interest in assuming the
service area, we will allow the poor-performing OPO to submit a
corrective action plan and retain its certification for an additional
2-year period.
Comment: Several commenters thought that the performance standard
requiring OPOs to maintain an average procurement ratio of three organs
per donor should be eliminated. Many of them thought that the standard
would discourage innovative practices by OPOs, particularly those
related to procuring organs from older donors.
Response: We had originally intended the use of a static number
standard, such as the 3 organs per donor and 24 donors per year
standards, as part the performance standards to ensure that the
standards remained rigorous over time. We wished to safeguard against
the industry as a whole becoming lax in performance and driving the
national average to artificially low numbers.
Upon further reflection, we believe that the use of static number
performance standards is unnecessary and could result in a burden on
the OPOs if we required the submission of justification or corrective
action plans when these standards are not met. In conducting an impact
analysis of these performance standards, we found that all OPOs that
did not meet the three organ per donor standard also failed to meet the
primary performance standard. Consequently, we anticipate that this
standard in and of itself would have no immediate impact.
We also recognize that industry changes that could result in these
static number standards not being met may not necessarily be
detrimental. For example, innovative practices, such as procuring
organs from older donors, can result in a net increase in organs
available even though the standard may not be met. We do not wish to
discourage aggressive organ procurement practices as long as they
promote safe organ acquisition and show respect for the families of
potential donors. Our principle goal in the development of performance
standards is to increase the total number of organs transplanted.
Standards that could potentially deter an OPO from obtaining every
viable organ available are contrary to our goal. Consequently, we
believe that our goal is best served if we eliminate the static number
standards and proceed with the primary performance standards alone.
Comment: One commenter requested that newly merged OPOs and OPOs
acquiring significant new territory be granted a grace period for
compliance with the performance standards, similar to what we permit
for newly formed OPOs. The commenter believed that failure to provide a
grace period would deter an OPO from expanding its territory.
Response: The concept of granting a grace period for merging OPOs
and OPOs acquiring significant new territory is a difficult one. We
recognize that significant changes in OPO management, administration,
or new service areas could potentially result in a temporary decline in
performance as the organization adjusts to the change.
On the other hand, we are extremely concerned that permitting a
grace period could instill a perverse incentive into the program. That
is, allowing a grace period could provide an incentive for two poorly
performing OPOs to merge merely to avoid termination or for OPOs to
enter into bidding wars over service areas to avoid application of
performance standards. Policies that promote frequent major changes in
the OPO structure could be counter to our goals by resulting in
decreased rather than increased organ donations.
After considerable thought, we have decided to retain our current
policy of not permitting a grace period for newly merged OPOs or OPOs
with significant changes in territory. We believe that this will
encourage OPOs to undertake such changes judiciously using careful
thought and extensive planning. It is far less likely that big OPOs
will overstep their capacity for expansion if they must maintain high
performance standards.
We note, however, that the above change in policy, related to the
failure to terminate an OPO's provider agreement when there is an
absence of interest by another OPO in assuming the service area, would
apply in the case of newly merged OPOs. That is, a newly merged OPO
will be allowed to continue in the program even if it does not meet the
performance standards when no OPO with acceptable performance levels is
interested in servicing the area.
We expect that, in most cases, there would be a reluctance on the
part of competing OPOs to move into the service area of a newly merged
OPO before that OPO has had an extended opportunity to demonstrate its
ability to perform. We base our expectation on the realization that
repeated changes in OPO personnel and organization practices are
disruptive to organ donation and are likely to make it more difficult
for the second OPO to meet its performance standards as well.
C. Provisions of this Final Rule With Comment Period
We have added new Sec. 486.310(c)(2) to provide that an
OPO that is performing below standards may be redesignated for a
service area if no acceptably performing OPO is willing to accept
responsibility for the service area and if the designated OPO submits a
corrective action plan.
We have reorganized Sec. 486.310(c) for clarity.
We have moved the requirement at Sec. 486.310(b)(4)
(formerly Sec. 485.306(b)(4)) that each OPO enter into a working
relationship with any hospital or transplant center in the OPO's
service area that requests a working relationship to
Sec. 486.304(b)(8).
We have deleted Sec. 486.310(b) (2) through (4) (formerly
Sec. 485.306(b) (2) through (4)) relating to the non-primary
performance standards for redesignation after January 1, 1996. We are
making conforming changes to various other sections to delete
references to these sections.
VIII. Definition of an Open Area (Sec. 486.302)
A. Background
In the proposed rule, we added the definition of ``open area'' to
Sec. 485.302 (now Sec. 486.302). We defined ``open area'' as a service
area for which we are accepting applications for designation. A service
area becomes open for competition once the normal 2-year designation
period or brief interim redesignation period has expired, when the
designated status of the existing OPO is terminated, or when no OPO
previously has been designated for the area. In the interim final rule
with comment period, we modified Sec. 485.308(a) (now Sec. 486.316(a))
to clarify that, based upon the language in Sec. 485.302 (now
Sec. 486.302), it is the OPO's provider agreement with HCFA (not the
OPO itself) that can be terminated.
B. Public Comments and Our Responses
Comment: A few commenters requested clarification of the concept of
an open area. The commenters believed that, if an OPO meets the
performance criteria, no other OPO should be allowed to compete for its
service area.
Response: It is the intent of the law to encourage the most
effective organ procurement and allocation system. During various
Congressional hearings on transplant issues, the Congress has made it
clear that it supports as
[[Page 19738]]
equitable a system as possible. We believe it is the Congress'
expectation that we establish conditions in the Medicare and Medicaid
program that provide incentives for OPOs to operate as efficiently and
effectively as possible in procuring lifesaving organs.
Consequently, we believe that the law does not in any way intend to
assure OPOs a monopoly simply because they barely meet the Medicare
performance criteria. The structure of the statute, which allows only a
single OPO to be designated in any given area, sets up an inherently
competitive system. Thus, it is appropriate and in keeping with the
principles of our national economy to permit competition regardless of
the fact that an OPO is meeting the performance criteria.
We intend to designate the best performing OPO for each service
area. We believe it is inappropriate to designate a marginally
performing OPO for a service area simply because it has operated in
that area previously if a peak-performing OPO is also competing for the
area and has the support of the hospital community. However, we
recognize that organ donation is a voluntary action. Therefore, to
perform well in an area, any OPO must have the support and cooperation
of the community. The ``tie-breaking'' criteria we will use to
adjudicate the competition are specified at Sec. 485.308(a) (1) through
(6) (now Sec. 486.316(a) (1) through (6)). These criteria emphasize the
relationship between the OPO and the hospitals in the service area, the
proximity of the OPO to the area, and past performance.
With regard to the explicit request for clarification of the open
area designations, every county in the country is open for competition
at redesignation time. Currently, most OPOs are in two-year designation
periods that end April through June 1996 and every two years
thereafter. Thus, an OPO may compete for any county, or all counties in
an MSA, that it believes it can serve better than the existing,
designated OPO at that time. To bid on an open area, the OPO must
notify the HCFA regional office of its intention. The regional office
will advise the existing, designated OPO of the competition and request
the necessary information to evaluate the proposals.
In addition to the open area competition that may occur at
redesignation time, an area will be declared open if the provider
agreement with the OPO serving the area is terminated or if no OPO has
been designated for the area. There are a number of counties that do
not contain hospitals. Consequently, no OPO had been designated for
these counties in prior designation periods. We believe that every
county should have a designated OPO to work within the community.
Therefore, we instructed our regional offices to designate these
counties based on the affiliation of the hospital from which the
majority of the residents seek care. That is, we asked the Regional
Offices to designate these counties to the OPO servicing the hospital
that is used routinely by the majority of the residents.
We had considered designating the county to the hospital furnishing
trauma care to the locality. However, we decided to designate the OPO
of the local hospital because the nearest trauma facility may be
located very far away. We believe that designating the area to an OPO
that is a great distance away is likely to be a deterrent to the OPO's
ability to serve the community.
Finally, we point out that the final regulation states explicitly a
policy HCFA has applied administratively in implementing the OPO
redesignation process. We have historically allowed competition for OPO
service areas designations at time of redesignation. Further, we would
accept a bid for a service area for undesignated counties or the
service area of a terminated OPO at any time should an entity apply.
Such competition has been minimal. We do not expect this to change with
the inclusion of this policy in the regulations. It is generally
accepted that OPO-hospital relationships may make procurement more
difficult during the transition. Since OPOs acquiring new service areas
will continue to be held to rigorous performance standards, we do not
believe OPOs will seek expansion without considerable thought and
planning.
Comment: Another commenter noted that the interim final rule did
not list the factors that would be used to adjudicate the designation
of a service area that is being contested. The commenter suggested the
following factors: procurement rate, satisfaction of transplant centers
with service provided by the OPO, organ procurement costs, response
time to donor referrals, extent and effectiveness of professional and
public education, established patterns of organ donor referrals, organ
discard rate, and donor hospital satisfaction.
Response: We did not reprint the factors that would be considered
in adjudicating contested service area designation because we did not
intend to change the regulations. As noted above, the factors are
listed at Sec. 486.316(a) (1) through (6). Many of the factors noted by
the commenter are included in these regulations. These factors follow.
(1) Prior performance, including the previous year's experience in
terms of the number of organs retrieved and wasted and the average cost
per organ;
(2) Actual number of donors compared to the number of potential
donors;
(3) The nature of relationships and degree of involvement with
hospitals in the organization's service area;
(4) Bed capacity associated with the hospitals with which the
organization has working relationships;
(5) Willingness and ability to place organs within the service
area; and
(6) Proximity of the organization to the donor hospitals.
As noted above, we have not heretofore experienced a significant
amount of competition among the OPOs. Thus, we have only limited
experience with these criteria. If competition increases among the OPOs
as a result of this final rule with comment period, we will consider
revising the factors in the future. In that regard, we will give
consideration to the factors noted by the commenter. We will also
publish a proposed notice of these changes in the Federal Register and
invite public comment on the proposal.
C. Provisions of This Final Rule With Comment Period
As we stated above, we are making no revisions in the definition of
``open area'' at this time.
IX. Termination of an OPO's Provider Agreement (Sec. 486.325(b))
A. Background
In the interim final rule, we added Sec. 485.311 (now
Sec. 486.325(b)) to specify the conditions for both voluntary and
involuntary termination of an OPO's provider agreement. For a voluntary
termination, we required that the OPO provide us with a written notice
of its intention with a proposed termination date. We will take action
to approve the request as submitted or take other action to ensure that
there is no disruption in services in the affected service area.
For an involuntary termination, we may terminate an agreement if we
find that an OPO no longer meets the conditions of coverage. Under
Sec. 485.311(b) (now Sec. 486.325(b)), we indicated we would give 15
days notice of termination. We also set forth an OPO's appeal rights,
the requirement that an OPO give prompt public notice regarding the
voluntary termination, and reinstatement provisions.
We made editorial changes to this section as part of the interim
final rule
[[Page 19739]]
with comment period but we did not make any significant changes in the
substance.
B. Public Comments and Our Responses
Comment: One commenter believed that a 15-day notice of
termination, if used, could lead to serious disruption of organ
procurement efforts. The commenter urged a minimum notice requirement
of 90 days.
Response: The added the 15-day termination notice is included in
the OPO regulations to be consistent with the treatment of providers
under the Medicare program. It is common practice in the Medicare
program to give providers a 15-day notice of termination of their
agreement to participate in the Medicare program for failure to comply
with the conditions of coverage.
However, upon further reflection, we can see some significant
differences between certification of Medicare participating providers
and certification/designation of an OPO that may warrant an alternative
policy for OPO termination. Most notably, providers are generally
terminated for serious and imminent health and safety reasons, while
OPOs are most likely to be terminated for failure to meet performance
standards. While it is possible for an OPO to be terminated for a
health and safety reason, such as procuring organs from HIV-infected
donors, such a termination has not occurred to date. Consequently, we
expect that such an occurrence would occur very rarely, if at all.
Thus, in the case of serious health and safety issues, it is important
to protect the health and safety of our beneficiaries by proceeding
with termination expeditiously. However, we believe that because no
serious harm is likely to befall anyone if we move more cautiously with
termination of an OPO's provider agreement, we can consider an extended
termination notification period.
In addition, Medicare beneficiaries generally have easier access to
alternative health care when a provider of health care services is
terminated. That is, while a Medicare beneficiary is no doubt
inconvenienced somewhat when the provider of choice is terminated from
the program, 15 days is generally enough notice for the beneficiary to
locate an alternative source of care within the area. In the case of an
OPO, however, the situation is significantly different. That is, an OPO
does not furnish health care services directly to the beneficiary, and
there are no generally available alternative OPOs within easy access.
Thus, in the case of OPOs, expeditious termination of the entity could
present a significant problem to the providers who have an agreement
with the OPO.
We note that we are changing the process for termination somewhat
from that in the interim final rule with comment period. That is, we
have concluded that we will not necessarily terminate an OPO that does
not meet the primary performance standard if no other OPO is willing to
assume the territory. Rather, we will solicit interest from other OPOs
in assuming the service area. Thus, it seems only practical to allow
for a period in which to solicit such interest from competing OPOs
before terminating the OPO that does not meet the performance standard.
To do otherwise would place an OPO in the anomalous position of being
terminated 15 days after notification of failure to meet the
performance standards only to be reinstated within a month or two when
we discover no alternative OPO is willing to assume the territory.
Consequently, we have modified Sec. 485.311 (now Sec. 486.325) to
provide that termination of OPOs will occur 90 days after the
notification by the Secretary that the OPO does not meet the standards.
C. Provisions of this Final Rule With Comment Period
We have revised Sec. 486.325(b) (formerly Sec. 485.311(b)) to
provide for a 90-day advance notification before a termination of an
OPO's provider agreement becomes effective. Similarly, we have revised
Sec. 486.304(e)(3)(ii) (formerly Sec. 485.303(e)(3)), relating to
interim designation periods, to extend the length of such designations
to 180 days to take into account the longer advance notification period
to effectuate terminations.
X. Effective Dates
A. Background
In the September 1994 interim final rule, we noted that, although
the regulations were effective 30 days after publication, we would
apply the new qualification and performance standards for the first
time with the recertification of OPOs that takes place in the spring of
1996 (for most OPOs, June 1, 1996). For purposes of the
recertification, we would use data from calendar years 1994 and 1995.
B. Public Comments and Our Responses
Comment: Several commenters suggested that we delay the effective
date of the regulations to provide for 2 full years of advance notice
before we apply the standards.
Response: Although the actual regulations were not issued until 9
months into the 24-month performance period (1994 and 1995), we believe
that OPOs have had adequate advance notice of the intent to improve
performance through both the law and the notice of proposed rulemaking
that was issued in June 1991. That is, since 1991, revisions in the
statute relating to OPOs that were discussed in the interim final rule
have expressed the intent of the Congress that OPOs be held to rigorous
performance standards. Moreover, while the 1991 notice of proposed
rulemaking did not specify detailed qualification and performance
standards, it included a discussion of the exact standards we included
in the September 1994 interim final rule.
We believe that OPOs have had adequate advance notice that
performance would be monitored and should have taken appropriate steps
to ensure that they are performing to the best of their ability. In
addition, the interim final rule was issued only 9 months into the
performance period. Thus, even if an OPO had not been planning for the
rigorous performance standards, it still has approximately 63 percent
of the performance period remaining to make up for any past performance
problems.
Finally, we note that the primary performance criteria are based on
national averages. All of the data that are used to set the actual
performance standards numbers come from actual performance of OPOs.
Since the content of the interim final rule was not released until
publication, all of the OPOs are treated equally with regard to
knowledge of the standards. Thus, it is reasonable to assume that no
OPO is unfairly treated by reliance on standards that are based on the
performance of its peers. We collected the 1994 performance data from
the OPOs. National averages were calculated and distributed to the OPOs
in 1995. Thus, each OPO had an indication of what the performance
standards would be and if it needed to significantly alter its
performance to achieve performance equivalent to its peers. In
addition, the AOPO has published peer performance data for OPOs to
review and monitor their own performances throughout the performance
period.
We are anxious to implement meaningful performance standards for
OPOs. We believe that implementation of these standards will promote
organ availability and result in additional lifesaving transplants for
not only Medicare and Medicaid beneficiaries, but for all Americans in
need of organ transplants. The 1996 recertifications are for a 2 year
period. Thus, if we delay implementation of the standards beyond
[[Page 19740]]
the 1996 recertification, the standards will not be fully effective
until June 1998.
Nonetheless, we recognize that the move to a system of performance
and qualification standards that are objectively measured and strictly
enforced is a major transition for the OPO community. Consequently, we
are providing for a transition mechanism for OPOs that do not meet the
standards for the 1996 redesignation period but are making progress
towards meeting them. Therefore, we are providing transitional
standards for both the service area size designation qualification
standard and the performance standards for the 1996 redesignation
period.
We will grant an exception to the 24-donor service area size
criterion during the 1996 redesignation process for those qualified
OPOs that meet the performance standards in Sec. 486.310. To qualify
for the exception, an OPO must submit a written request to HCFA that
includes a narrative description of its plans for meeting the standard
by the 1998 redesignation period. We emphasize that this is a one-time
exception opportunity that will not be repeated for any OPO after the
1996 redesignation process.
We are also providing a one-time exception process for OPOs that do
not meet four of the five performance standards at the time of
redesignation. This exception is limited to those qualified OPOs that
meet three out of the five performance criteria in Sec. 486.310(b) (1)
through (5). Similar to the exception process for the qualification
standard, an OPO must submit a written request to HCFA accompanied by a
detailed, narrative description of the OPO's plans for ensuring that it
will meet the performance standards by the 1998 redesignation.
C. Provisions of This Final Rule With Comment Period
We are not making any changes in the effective dates of the
provisions of the interim final rule with comment period. We are,
however, as explained above, adding two one-time exceptions for the
1996 redesignation process only.
We are adding Sec. 486.307(d)(4) stating that HCFA may
grant an exception to the 24-donor criterion in paragraph
Sec. 486.307(d)(2)(ii) to an OPO that can demonstrate that (1) it meets
the performance criteria in Sec. 486.310(b), and (2) it has a specific
plan to meet the service area size criterion in paragraph
Sec. 486.307(d)(2)(ii) by the 1998 redesignation period.
We are adding Sec. 486.310(c)(3) to provide that for the
1996 designation period only, HCFA may continue to designate for a
service area an OPO that does not meet the standards under paragraph
(b) of this section if the OPO (1) meets three of the five criteria in
Sec. 486.310(b)(1) through (b)(5); and (2) submits an acceptable
corrective action plan in accordance with Sec. 486.310(d).
XI. Waiver of Service Area Designations
A. Background
Section 1138(a)(1)(A)(iii) of the Act had required hospitals
participating in the Medicare program to notify an OPO of potential
organ donors. The use of the article ``an'' indicated that a hospital
need not have an agreement with the OPO whose designated service area
includes the county in which the hospital is located. Thus, a
significant number of hospitals, for various reasons, have chosen to
have agreements with a Medicare/Medicaid-certified OPO other than the
OPO designated for their areas. In fact, several hospitals have
agreements with multiple OPOs.
Sections 155 (a)(1)(A) and (a)(1)(B) of Public Law 103-432 amended
sections 1138 (a)(1)(A)(iii) and (a)(1)(C) of the Act to add
requirements that a hospital have an agreement for notification of
potential organ donation only with the OPO designated for the area in
which the hospital is located. Public Law 103-432 also provided for
waiver of the requirements under certain circumstances. Section
155(a)(1)(C) added new section 1138(a)(2)(A) to the Act. Specifically,
the Secretary must approve waiver requests if (1) the waiver is
expected to increase organ donations and (2) the waiver will assure
equitable treatment of both those patients within the service area
served by the hospital's designated OPO and those patients within the
service area served by the OPO with which the hospital seeks to enter
into an agreement under the waiver.
The law is quite specific in identifying the factors that HCFA may
consider in adjudicating waiver requests. That is, section
1138(a)(2)(B) provides that in making a determination on a waiver
request the Secretary may consider the factors that would include, but
not be limited to (1) cost effectiveness; (2) improvements in quality;
(3) any change in a hospital's designated organ procurement agency due
to a change made on or after December 28, 1992, in the definitions for
MSAs (as established by the Office of Management and Budget); and (4)
the length and continuity of a hospital's relationship with an organ
procurement agency.
Sections 1138 (a)(2)(C) and (a)(2)(D) of the Act are quite specific
in detailing the process for the waiver requests. Effective January 1,
1996, any hospital seeking a waiver must submit an application to the
Secretary. Within 30 days of receipt of a waiver request, the Secretary
will publish a public notice of the request offering interested parties
a 60-day period to comment on the request. Allowing HCFA only 30 days
to evaluate the comments and render a decision would result in a
minimum time period of 120 days for processing a waiver request.
Section 155(a)(2) of Public Law 103-432 contains a grandfathering
provision for hospitals which on October 31, 1994, the date of
enactment of Public Law 103-432, have existing agreements with OPOs
other than the OPO designated for their service areas. Any hospital
that has an agreement with an OPO other than the OPO designated for its
area on October 31, 1994, may continue the agreement until HCFA has
adjudicated its waiver request, provided the hospital has filed a
waiver request by January 1, 1996. This provision was included because
it would be disruptive to a hospital to force it into an agreement with
the OPO designated for its area while a waiver request is being
processed.
We believe the provisions of section 155 are self-implementing.
Thus, we proceeded with implementation prior to modification of the
regulations or prior public comment. In October 1995, we issued Program
Memorandum A-95-11 to our intermediaries outlining the process for
making a waiver request. We instructed each intermediary to notify
every hospital that it serviced of the opportunity to request a waiver
to deal with an OPO other than the OPO designated for the area. We
advised the hospitals that we intended to adjudicate the requests using
the criteria set forth in the law. We advised the hospitals that, to
retain their existing out-of-area OPO agreements that were in effect as
of October 31, 1994, their waiver requests must be received by January
1, 1996.
The law did not address the impact of changes in OPO service areas
on future waiver requests. That is, we note that changes in OPO service
areas are ongoing events. We anticipate that, with the implementation
of the provisions contained in the September 8, 1994, final rule with
comment period, such changes may become somewhat more frequent. Often
these changes occur through mergers or cooperative means. Some changes,
however, are the result of competitive actions among the OPOs with HCFA
awarding the service areas
[[Page 19741]]
based on the criteria in Sec. 485.308 (now Sec. 486.316). When these
changes in service areas occur, the hospitals in the affected counties
must enter into agreements with the newly designated OPO or request a
waiver to deal with an alternative designated OPO.
As noted above, the minimum period of time necessary to process a
waiver request is 120 days. We believe it is unproductive and contrary
to the goal of increasing national organ donation to force the
hospitals in affected areas into new working relationships with a OPO
and then to approve a waiver request and allow an alternative agreement
a few months later. Such a system would be disruptive to the hospital
and to effective organ procurement nationally.
Consequently, we are adding a new provision to the regulations at
Sec. 486.316 to permit the grandfathering of existing agreements
between an OPO and a hospital when changes in a service area occur
pending resolution of the hospital's waiver request.
To be eligible for the grandfathering, a hospital must have had an
agreement with the OPO prior to the changes in service area and the
hospital must have requested waiver from the provisions of section 1138
(a)(1)(A)(iii) and (c) of the Act within 30 days of the effective date
of the change in service area. Of course, if HCFA denies the waiver
request on its merits (the request does not demonstrate that it is
expected to increase organ donation and assure equitable treatment of
patients), the hospital must enter into an agreement with the new OPO
for the area. The regulations provide that such new agreements must be
executed within 30 days of notification of the determination on the
waiver request.
We recognize that this grandfathering provision is not explicitly
stated in the law. Nonetheless, we believe the provision is authorized
under section 1138(a)(2)(A) of the Act which vests broad authority to
HCFA to waive the new requirements of sections 1138(a)(1)(A)(iii) and
1138(a)(1)(C) of the Act. The provision is also complementary to the
grandfathering provision specified in section 155 of the Social
Security Act Amendments of 1994. We believe that allowing such a
grandfathering policy during the processing of the waiver request is
the only means to ensure a smooth transition and promote organ
donation. Nonetheless, we are providing an opportunity for public
comment in this final rule with comment period.
B. Provisions of This Final Rule With Comment Period
We have revised Sec. 486.316 (formerly Sec. 485.308) by adding new
paragraphs (c) through (f) to implement section 1138 (a)(2) of the Act
and the grandfathering provisions of section 155(a)(2) of Public Law
103-432. These revisions permit grandfathering of a hospital to the OPO
with which it has an historical working relationship while the
hospital's request for waiver is being considered when changes in the
OPO designated for the service area in which the hospital is located
occur beginning January 1, 1996. We are soliciting comments on this
provision of the final rule with comment period.
XII. Technical Revisions
We have made the following technical revisions to the regulations
for the purposes of clarifying and reorganizing the OPO regulations.
We amended Sec. 405.2163 by removing the reference to part
485, subpart D and replacing it with a reference to part 486, subpart G
to reflect the earlier published redesignation of the OPO regulations.
We revised Sec. 486.301 to add section 1138(a) and (b) of
the Act and section 371(b) of the PHS Act as the statutory bases of the
OPO regulations.
We reorganized Sec. 486.310 to include the exceptions and
exemptions to the OPO standard requirements under paragraph (c).
We deleted Sec. 486.310(e) (previously designated as
Sec. 485.306(e)) as it is unnecessary and has created confusion among
the OPO industry. This provision provides that an OPO that has not
previously been designated by HCFA for a particular service area is
exempt from meeting the performance standards for its first 2 years of
designation as the OPO for that area. However, the performance
standards are used to measure the OPO's qualifications to be
redesignated beginning 2 years after the OPO has been first designated
for any portion of a service area.
Since there is no data on the OPO's performance in the area when it
is newly designated, it would be impossible to apply the performance
standards at the time of initial designation. Thus, we believe it is
unnecessary to maintain an exemption of this nature. The remaining
portion of the provision merely states that we will apply the normal
performance standards at the time of redesignation. Therefore, this
portion of the regulation is also unnecessary since, without it, we
would have no alternative but to apply the normal performance
standards.
We revised the cross-reference in Sec. 486.314 (formerly
Sec. 485.307) to reflect the reorganization of the material.
XIII. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment before issuing a final
document. Most of the provisions of this rule were open for public
comment through both the June 21, 1991, proposed rule and the September
8, 1994, interim final rule. We are now publishing these provisions as
final rules. Because they have previously been open for comment, we are
not inviting further public comment on these provisions.
The Social Security Act Amendments of 1994 were enacted subsequent
to the September 8, 1994, interim final rule with comment period.
Section 155 of these amendments, relating to OPO hospital
relationships, are inextricably linked to this final rule. The
provisions of section 155 are self-implementing and do not require
rulemaking.
XIV. Regulatory Impact Statement
We generally prepare a regulatory impact statement that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612) unless we certify that a rule will not have a significant
economic impact on a substantial number of small entities.
For purposes of the RFA, we consider all providers and suppliers of
health care as small entities. Individuals and States are not included
in the definition of a small entity. Also, section 1102(b) of the Act
requires us to prepare a regulatory impact analysis if a rule may have
a significant impact on the operations of a substantial number of small
rural hospitals. Such an analysis must conform to the provisions of
section 604 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a MSA and has fewer than 50 beds.
This final rule with comment period sets forth changes required by
Public Law 100-607, Public Law 101-616, and Public Law 103-432. In the
September 1994 interim final rule with comment period, we provided an
impact analysis on the provisions of Public Law 100-607 and Public Law
101-616. In that analysis, we stated that we expected that, while OPOs
may incur some additional costs, those costs would be minimal. We
invited public comment on the impact statement in the interim final
rule with comment period. We did not receive any public comments.
The provisions of section 155 of Public Law 103-432 included in
this final rule with comment period conform to section 1138(a)(2) of
the Act to provide for a waiver of section
[[Page 19742]]
1138(a)(1)(A)(iii) and (c) of the Act under certain circumstances.
Section 1138(a)(1) requires that a hospital have an agreement for
potential organ donations only with the OPO designated for the area in
which the hospital is located. We expect any additional costs related
to this provision to be minimal. Any hospital wishing a waiver must
file a request with us. We believe, however, that any additional costs
are minimal compared to the improvement these provisions will have on
the quality of health care for organ recipients.
We have determined and we certify that this final rule with comment
period will not have a significant economic effect on a substantial
number of providers and suppliers. Also, OPOs (independent and
hospital-based) are not considered small rural hospitals since OPOs
generally service large geographical areas. Therefore, a regulatory
flexibility analysis under the RFA and a rural impact analysis under
section 1102(b) of the Act are not required.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
XV. Information Collection Requirements
Under the Paperwork Reduction Act of 1995, agencies are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. This
final rule with comment period contains information collections that
are subject to review by OMB under the Paperwork Reduction Act of 1995.
The title, description, and respondent description of the information
collections are shown below with an estimate of the annual reporting
and recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and collecting and reviewing the
collection of information.
We are, however, requesting an emergency review of these
regulations. In compliance with the requirement of section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted
to the Office of Management and Budget (OMB) the following requirement
for emergency review. We are requesting an emergency review because the
collection of this information is needed prior to the expiration of the
normal time limits under OMB's regulations at 5 CFR. Part 1320 to
permit recertification of OPO's as required by statute. Failure to
issue these rules in time for the 1996 redesignation process may result
in the termination of OPO agreements. As a consequence, persons in need
of organ transplants may not receive them. The agency cannot reasonably
comply with the normal clearance procedures because public harm is
likely to result if normal clearance procedures are followed. Without
this information, we could not ensure compliance with this
Congressional mandate.
We are requesting that OMB provide a 21-day public comment period
with a 7-day OMB review period and a 90-day approval. We will publish a
separate Federal Register notice for an emergency request for the OPO
manual requirements.
Type of Information Collection Request: New Collection.
Type of Information Collection: Conditions of Coverage for Organ
Procurement Organizations.
Form No.: HCFA-R-13.
USE: Organ Procurement Organizations are required to submit
accurate data to HCFA concerning population and information on donors
and organs on an annual basis in order to ensure maximum effectiveness
in the procurement and distribution of organs.
Frequency: Annually.
Affected public: Not-for-profit institutions.
Number of Respondents: 66.
Total Annual Responses: 66.
Total Annual Hours Requested: 4,096.
To request copies of the proposed paperwork collections referenced
above, call the Reports Clearance Office on (410) 786-1326.
The sections in these final regulations with comment period that
contain information collection requirements are:
Sections 486.304 (c)(2), (c)(4), (c)(7), and (c)(8)
require that an OPO submit documentation to HCFA as part of the
conditions for payment. These requirements include cost reporting, cost
projection, and data to show the number of organs procured and
transplanted. The OPO must maintain data in a format that can readily
be continued by a successor OPO.
Section 486.306(d) requires that an OPO document that it
meets the service area requirements at Sec. 486.307.
Section 486.306(t) requires that an OPO submit to HCFA
within 15 days following the end of the calendar year information on
the service area population, number of donors, number of organs
procured, and the number of organs transplanted.
Section 486.307(a) requires that an OPO make documentation
available to HCFA to verify that it meets the requirements for boundary
designation, service area location, and service area size.
Section 486.307(d) requires that, for the 1996
transitional redesignation period only, an OPO that does not meet the
qualification standards in Sec. 486.307(d)(2)(ii) may submit a request
to HCFA for a one-time exception to the standard if it can demonstrate
that it meets the performance criteria in Sec. 486.310(b) and has a
specific plan to meet the 24-donor standard by the 1998 redesignation
period.
Section 486.310(c)(3) requires that, for the 1996
transitional redesignation period only, HCFA may continue to designate
for a service area an OPO that does not meet the standards of
Sec. 486.310(b) if the OPO can demonstrate that it meets three of the
criteria in Sec. 486.310(b)(1) through Sec. 486.310(b)(5) and if the
OPO submits an acceptable correction plan in accordance with
Sec. 486.310(d).
Section 486.310(d) requires that an OPO that does not meet
the performance standards may continue to be designated for a service
area if no acceptably performing OPO is willing to accept
responsibility for the service area and if the OPO submits a corrective
action plan that is acceptable to HCFA.
Section 486.316 requires that an OPO submit an application
to HCFA if it wishes to be designated as the OPO for a service area.
Applications are only accepted if the area is an open area.
Section 486.318 requires that a designated OPO notify HCFA
if it is considering a change in ownership or service area. It must
submit the same information that it supplied at the time of
designation.
Section 486.325(a)(1) requires that an OPO that wishes to
terminate its agreement with HCFA send written notice of its intention
with the proposed termination date to HCFA.
The information collection requirements concern quantifiable data
for submission to us that document an OPO's performance. The
respondents for the information collection requirements are the 66 OPOs
participating in the Medicare program. The OPOs are required to keep
performance data on an ongoing basis and submit a yearly report. The
reporting burden for the collection of all of this information is
estimated to be 1,000 hours per submission.
Other reporting requirements for special circumstances such as
termination of agreements and requests for exceptions and exemptions
rely on the same information that an OPO must submit in its annual
report. Consequently, no extra collection of
[[Page 19743]]
information is required. Since these submissions depend on special
circumstances, we cannot give the exact number of submissions. However,
since there are only 66 OPOs participating in the Medicare program, we
expect the number of these submissions will be extremely small.
These information collection and recordkeeping requirements are not
effective until they have been approved by OMB. The agency has
submitted a copy of this final rule with comment period to OMB for its
review of these information collections. A notice will be published in
the Federal Register when approval is obtained. Interested persons are
invited to send comments regarding this burden or any other aspect of
these collections of information, including any of the following
subjects: (1) The necessity and utility of the information collection
for the proper performance of the agency's functions; (2) the accuracy
of the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden. Comments
should be sent to HCFA, OFHR, MPAS, C2-26-17, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
XVI. Response to Comments
Because of the large number of items of correspondence we normally
receive on a final rule with comment period, we are not able to
acknowledge or respond to them individually. However, we will consider
all comments that we receive related to the waiver process discussed in
section XI of this preamble, Sec. 486.316, and the definition of
``donor'' by the date and time specified in the DATES section of this
preamble, and, if we proceed with a final rule, we will respond to the
comments in the preamble of that rule.
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, Reporting and recordkeeping
requirements, Rural areas, X-rays.
42 CFR Part 486
Health facilities, Medicare, Reporting and recordkeeping
requirements.
42 CFR Chapter IV is amended as set forth below:
A. Part 405, subpart U is amended as follows:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart U--Conditions of Coverage of Suppliers of End-Stage Renal
Disease (ESRD) Services
1. The authority citation for part 405, subpart U continues to read
as follows:
Authority: Secs. 1102, 1138, 1861, 1862(a), 1871, 1874, and 1881
of the Social Security Act (42 U.S.C. 1302, 1320b-8, 1395x,
1395y(a), 1395hh, 1395kk, and 1395rr), unless otherwise noted.
2. Section 405.2163(f) is amended by removing the reference to
``part 485, subpart D'' and replacing it with a reference to ``part
486, subpart G.''
B. Part 486 is amended as follows:
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY PROVIDERS AND SUPPLIERS
Subpart G--Conditions for Coverage: Organ Procurement Organizations
1. The authority citation for part 486 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
2. Section 486.301 is revised to read as follows:
Sec. 486.301 Basis and scope.
(a) Statutory Basis. (1) Section 1138(b) of the Act sets forth the
requirements that an organ procurement organization must meet to have
its organ procurement services to hospitals covered under Medicare and
Medicaid. These include certification as a ``qualified'' organ
procurement organization (OPO) and designation as the OPO for a
particular service area.
(2) Section 371(b) of the PHS Act sets forth the requirements for
certification and the functions that a qualified OPO is expected to
perform.
(b) Scope. This subpart sets forth--
(1) The conditions and requirements that an OPO must meet;
(2) The procedures for certification and designation of OPOs; and
(3) The terms of the agreement with HCFA, and the basis for, and
the effect of, termination of the agreement.
3. In Sec. 486.304, the introductory text of paragraph (b) is
republished, new paragraph (b)(8) is added, and paragraph (e)(3)(ii) is
revised to read as follows:
Sec. 486.304 General requirements.
* * * * *
(b) Requirements for designated status. To be the designated OPO
for a service area, an entity must do the following:
* * * * *
(8) Enter into a working relationship with any hospitals, including
transplant centers, in the OPO's service area that request a working
relationship.
* * * * *
(e) Designation periods
* * * * *
(3) Interim designation. * * *
(ii) The interim designation period does not exceed 180 days after
the normal designation period has expired.
* * * * *
4. In Sec. 486.306, the introductory text and paragraphs (d), (f)
introductory text, (i), (q), and (s) are revised to read as follows:
Sec. 486.306 Qualifications for designation as an OPO.
To be designated as the OPO for a service area, an organization
must, at the time of application and throughout the period of its
designation, meet the following requirements:
* * * * *
(d) Document that it has a defined service area that meets the
requirements of Sec. 486.307.
* * * * *
(f) Have a board of directors or an advisory board that has the
authority to recommend policies relating to the donation, procurement,
and distribution of organs. While an OPO may have more than one board,
the members specified in paragraphs (f)(1) through (f)(5) of this
section must be members of a single board. The board of directors or
advisory board must be composed of the following:
* * * * *
(i) Have a system to equitably allocate donated organs among
transplant patients that is consistent with--
(1) ``Guidelines for Preventing Transmission of Human
Immunodeficiency Virus Through Transplantation of Human Tissue and
Organs'' issued by the Centers for Disease Control and Prevention (CDC)
that are appended to this subpart; and
(2) Rules of the Organ Procurement and Transplantation Network
(OPTN), see Sec. 486.308.
* * * * *
(q) Ensure that appropriate donor screening and infection tests,
consistent with OPTN standards and the CDC guidelines that are appended
to this subpart, are performed by a laboratory that is certified in the
appropriate specialty or subspecialty of service in accordance with
part 493 of this chapter, including tests to prevent the
[[Page 19744]]
acquisition of organs that are infected with the etiologic agent for
acquired immune deficiency syndrome.
* * * * *
(s) Ensure that donors are tested for human immunodeficiency viral
markers consistent with OPTN rules and the CDC guidelines appended to
this subpart for solid organ donation.
* * * * *
5. A new Sec. 486.307 is added to read as follows:
Sec. 486.307 OPO service area size designation and documentation
requirements
(a) General documentation requirement. An OPO must make available
to HCFA documentation verifying that the OPO meets the requirements of
paragraphs (b) through (d) of this section at the time of application
and throughout the period of its designation.
(b) Boundary designation. The defined service area either includes
an entire Metropolitan Statistical Area or a New England County
Metropolitan Area as specified by the Director of the Office of
Management and Budget or does not include any part of such an area.
(c) Service area location and characteristics. An OPO must
precisely define and document a proposed service area's location
through the following information:
(1) The names of counties (or parishes in Louisiana) served or, if
the service area includes an entire State, the name of the State.
(2) Geographic boundaries of the service area for which U.S.
population statistics are available.
(3) Total population in service area.
(4) The number of and the names of acute care hospitals in the
service area with an operating room and the equipment and personnel to
retrieve organs.
(d) Sufficient size requirements. (1) Before January 1, 1996, an
OPO must demonstrate that it can procure organs from at least 50
potential donors per calendar year or that its service area comprises
an entire State.
(2) Beginning January 1, 1996, an OPO must meet at least one of the
following requirements:
(i) Its service area must include an entire State or official U.S.
territory.
(ii) It must either procure organs from an average of at least 24
donors per calendar year in the 2 years before the year of
redesignation or request and be granted an exception to this
requirement under paragraph (d)(3) or (d)(4) of this section.
(iii) In the case of an OPO operating exclusively in a
noncontiguous U.S. State, a U.S. territory, or a U.S. commonwealth,
such as Hawaii or Puerto Rico, it must procure organs at the rate of 50
percent of the national average of all OPOs for kidney procurement per
million population and for kidney transplantation per million
population.
(iv) If it is an entity that has not been previously designated as
an OPO, it must demonstrate that it can procure organs from at least 50
potential donors per calendar year.
(3) HCFA may grant an OPO an exception to paragraph (d)(2)(ii) of
this section if the OPO can demonstrate that--
(i) It failed to meet the requirement because of unusual
circumstances beyond its control;
(ii) It has historically maintained a service area of sufficient
size to meet the criterion in paragraph (d)(2)(ii) of this section; and
(iii) It has a specific plan to meet the size criterion in
paragraph (d)(2)(ii) of this section in the future.
(4) During the 1996 redesignation process only, HCFA may grant an
exception to paragraph (d)(2)(ii) of this section to an OPO that can
demonstrate that--
(i) It meets the performance criteria in Sec. 486.310(b); and
(ii) It has a specific plan to meet the service area size criterion
in paragraph (d)(2)(ii) of this section by the 1998 redesignation
period.
6. Section 486.310 is amended by removing the introductory text,
adding a heading for paragraph (a); removing paragraphs (a)(3) and (e);
and revising paragraphs (b), (c), and (d) to read as follows:
Sec. 486.310 Condition: Adherence to performance standards.
(a) Standards before January 1, 1996.
* * * * *
(b) Standards beginning on January 1, 1996. Except as specified in
paragraph (c) of this section, each OPO must achieve at least 75
percent of the national mean for four of the following five performance
categories, averaged over the 2 calendar years before the year of
redesignation:
(1) Number of actual donors per million population.
(2) Number of kidneys recovered per million population.
(3) Number of extrarenal organs recovered per million population.
(4) Number of kidneys transplanted per million population.
(5) Number of extrarenal organs transplanted per million
population.
(c) Exceptions and exemptions.
(1) Exception based on location. OPOs operating exclusively in a
noncontiguous U.S. State, a U.S. territory, or a U.S. commonwealth,
such as Hawaii or Puerto Rico, may be granted an exception from the
performance standards of paragraph (b) of this section because of
special geographically related characteristics, such as difficulty in
transporting organs to the mainland, that impede satisfaction of the
national rate of organ procurement. They must meet a standard of 50
percent of the national average of all OPOs for kidneys recovered and
transplanted per million population.
(2) Exception because of lack of competition for a service area.
HCFA may continue to designate an OPO that does not meet the standards
under paragraph (b) of this section for a service area if no OPO that
meets the performance and qualification requirements is willing to
accept responsibility for the service area and if the designated OPO
submits an acceptable corrective action plan in accordance with
paragraph (d) of this section.
(3) Exception for 1996 transition period. During the 1996
designation period only, HCFA may continue to designate for a service
area an OPO that does not meet the standards under paragraph (b) of
this section if the OPO:
(i) Meets three of the criteria in paragraphs (b)(1) through (b)(5)
of this section; and
(ii) Submits an acceptable corrective action plan in accordance
with paragraph (d) of this section.
(d) Corrective action plans and corrected information.
(1) Corrective action plans. (i) If a designated OPO does not meet
the standards of paragraph (a) of this section, it may submit to the
appropriate HCFA regional office a corrective action plan explaining
why it failed to meet them and specifying the actions it will take to
ensure it meets those standards in the future.
(ii) HCFA will not accept corrective action plans from an OPO for
failure to meet the standards specified in paragraph (b) of this
section unless the OPO continues to be designated under paragraph
(c)(2) or (c)(3) of this section.
(2) Corrected information. An OPO may request correction of the
information required by Sec. 486.306(e) from HCFA throughout the two-
year designation period. HCFA will evaluate the OPO's request and may
seek input from other sources, such as hospital personnel, neighboring
OPOs, the OPTN contractor, and the Census Bureau as necessary to verify
the OPO's information before making the changes requested by the OPO.
In addition,
[[Page 19745]]
HCFA will notify an OPO if it does not meet the performance standards
based on the information reported. Any OPO so notified may provide
corrected information for consideration within 30 days of receipt of a
notice of failure to meet the standards.
(e) [Removed]
Sec. 486.314 [Amended]
7. Section 486.314 is amended by removing the reference to
``Sec. 485.310 (a) and (b)'' and replacing it with a reference to
``Sec. 486.310''.
8. Section 486.316 is amended by adding new paragraphs (c), (d),
(e), (f), and (g) to read as follows:
Sec. 486.316 Designation of one OPO for each service area.
* * * * *
(c) After January 1, 1996, a hospital must enter into an agreement
only with the OPO designated to serve the area in which the hospital is
located unless HCFA has granted the hospital a waiver under paragraphs
(d) through (g) of this section to be serviced by another OPO.
(d) If HCFA changes the OPO designated for an area, hospitals
located in that area must enter into agreements with the newly
designated OPO or submit a request for a waiver in accordance with
paragraph (e) of this section within 30 days of notice of the change in
designation.
(e) A hospital may request and HCFA may grant a waiver permitting
the hospital to have an agreement with a designated OPO other than the
OPO designated for the service area in which the hospital is located.
To qualify for a waiver, the hospital must submit data to HCFA
establishing that--
(1) The waiver is expected to increase organ donations; and
(2) The waiver will ensure equitable treatment of patients referred
for transplants within the service area served by the hospital's
designated OPO and within the service area served by the OPO with which
the hospital seeks to enter into an agreement.
(f) In making a determination on waiver requests, HCFA considers:
(1) Cost effectiveness;
(2) Improvements in quality;
(3) Changes in a hospital's designated OPO due to changes in the
metropolitan service area designations, if applicable; and
(4) The length and continuity of a hospital's relationship with an
OPO other than the hospital's designated OPO.
(g) A hospital may continue to operate under its existing agreement
with an out-of-area OPO while HCFA is processing the waiver request. If
a waiver request is denied, a hospital must enter into an agreement
with the designated OPO within 30 days of notification of the final
determination.
Sec. 486.325 [Amended]
9. In Sec. 486.325, in paragraph (b), ``15 days'' is removed and
``90 days'' is added in its place.
10. Appendix A is added to subpart G to read as follows:
Appendix A to Subpart G of Part 486--Guidelines for Preventing
Transmission of Human Immunodeficiency Virus Through Transplantation of
Human Tissue and Organs
BILLING CODE 4120-01-P
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(Catalog of Federal Domestic Assistance Programs No 93.774,
Medicare-- Supplementary Medical Insurance, and No. 13.714, Medical
Assistance Program)
Dated: April 15, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: April 25, 1996.
Donna E. Shalala,
Secretary.
[FR Doc. 95-10901 Filed 4-30-96; 8:45 am]
BILLING CODE 4120-01-C
