1.0 POLICY
1.1
Certifying
Authority
The TRICARE contractor is the certifying
authority for applications for status as a TRICARE-authorized institutional
provider for liver, heart, Combined Heart-Kidney (CHKT), Combination
Liver-Kidney (CLKT), lung, heart-lung, and Small Intestine (SI)
within its region. Medicare is the approving authority for kidney
transplant centers.
1.2
General
Certification Requirements
To obtain TRICARE
certification as an organ transplant center, the center must have:
1.2.1 An active solid
organ transplantation program.
1.2.2 Participation in a donor organ procurement
program and network.
1.2.3 An interdisciplinary body to determine
the suitability of candidates for transplantation on an equitable
basis.
1.2.4 An
anesthesia team that is available at all time.
1.2.5 A nursing service
team trained in the hemodynamic support of the patient and in managing
immunosuppressed patients.
1.2.6 Pathology and immunology resources that
are available for studying and reporting the pathological responses
to transplantation.
1.2.7 Evidence that the center safeguards the
rights and privacy of patients.
1.2.8 Continual compliance with state transplantation
laws and regulations, if any.
1.2.9 Legal counsel familiar with transplantation
laws and regulations.
1.3 The continued compliance of a certified
transplantation center must be verified by the contractor no less
than every 24 months.
1.4 Reporting Requirements
The
transplant center must report to the TRICARE certifying authority
any decrease in actuarial survival rates below the actuarial survival
rate established by TRICARE for initial facility certification.
1.5
Liver
Transplantation Centers
TRICARE
shall provide coverage for liver transplantation procedures performed
only by experienced transplant surgeons at centers complying with
the provisions outlined in
paragraph 1.2 and the following criteria or
status as a TRICARE-certified liver transplantation center may be
granted based upon Medicare certification as a liver transplant
center.
1.5.1 The
transplant center must:
1.5.1.1 Have staff board
eligible or board certified physicians and other experts in the
fields of hepatology, pediatrics, infectious disease, nephrology
with dialysis capability, pulmonary medicine with respiratory therapy
support, pathology, immunology, and anesthesiology to complement
a qualified transplantation team.
1.5.1.2 Have a transplant
surgeon who is specifically trained for liver grafting and who can assemble
and train a team to function successfully whenever a donor liver
is available.
1.5.1.3 Have at least
a 50% one year actuarial survival rate for 10 cases as calculated
using the Kaplan-Meier product limit method. A 50% one-year actuarial
survival rate for all subsequent liver transplantations must be
maintained for continued TRICARE approval.
1.6 Heart Transplantation
Centers
TRICARE shall provide coverage for
heart transplantation procedures performed only by experienced transplant
surgeons at centers complying with provisions outlined in
paragraph 1.2 and the
following criteria or status as a TRICARE-certified heart transplantation
center may be granted based upon Medicare certification as a heart
transplantation center.
1.6.1 The transplant center must:
1.6.1.1 Have experts
in the fields of cardiology, cardiovascular surgery, anesthesiology, immunology,
infectious disease, nursing, social services, and organ procurement
to complement the transplant team.
1.6.1.2 Have an active
cardiovascular medical and surgical program as evidenced by a minimum
of 500 cardiac catherterizations and coronary arteriograms and 250
open heart procedures per year.
1.6.1.3 Have an established
heart transplantation program with documented evidence of 12 or more
heart transplants in each of the three consecutive preceding 12-month
periods prior to the date of application (a total of 36 or more
heart transplantation procedures).
1.6.1.4 Demonstrate
actuarial survival rates of 73% for one year and 65% for two years
for patients who have had heart transplants since January 1, 1982
at that facility. The Kaplan-Meier product limit method shall be
used to calculate actuarial survival.
1.6.2 TRICARE
approval will lapse if either the number of heart transplants falls
below eight in 12 months or if the one-year actuarial survival rate
falls below 60% for a consecutive 24-month period.
1.7 Lung Transplantation
TRICARE shall provide coverage for
lung transplantation procedures performed only by experienced transplant
surgeons at centers complying with the provisions outlined in
paragraph 1.2 and
the following criteria or status as a TRICARE-certified lung transplantation
center may be granted based upon Medicare certification as a lung
transplantation center.
1.7.1 The center must have:
1.7.1.1 Experts in the
fields of cardiology, cardiovascular surgery, pulmonary disease, anesthesiology,
immunology, infectious disease, nursing, social services, and organ
procurement to complement the transplant team.
1.7.1.2 Performed lung
(single and/or double) transplantation in at least 10 patients within
the 12 months prior to application and in at least an additional
10 patients prior thereto.
1.7.1.3 Demonstrated
Kaplan-Meier actuarial survival rates of no less than 65% at one-year
post-transplantation for patients who have undergone lung transplantation
at the center since January 1, 1987.
1.8 Heart-Lung
and Lung Transplantation
TRICARE
shall provide coverage for heart-lung transplantation procedures
performed only by experienced transplant surgeons at centers complying
with the provisions outlined in
paragraph 1.2 and meeting either the heart
or lung transplantation criteria or performed in a Medicare-certified heart,
lung or heart-lung transplant center.
1.9 Small Intestine (SI), Combined Small
Intestine-Liver (SI/L), and Multivisceral Transplantation
1.9.1 TRICARE
shall provide coverage for SI, SI/L, and multivisceral transplantation
procedures performed only by experienced transplant surgeons at
centers complying with the provisions outlined in
paragraph 1.2 and meeting
the following criterion or status as a TRICARE-certified transplant
center may be granted based upon Medicare certification as a SI
transplant center:
1.9.2 Perform 10 SI, SI/L, or multivisceral transplants
with a documented Kaplan-Meier actuarial survival rate of no less
than 65% at one-year.
1.10 Simultaneous Pancreas-Kidney (SPK),
Pancreas-Transplant-Alone (PTA), Pancreas-After-Kidney (PAK) Transplantation
TRICARE shall provide coverage for
SPK, PTA, and PAK transplantation procedures performed only by experienced
transplant surgeons at Medicare-approved renal transplant centers.
1.11 Combined
Liver-Kidney Transplantation (CLKT)
If the facility
is certified as a TRICARE (or Medicare) certified liver transplant
center, the facility may be considered to be a certified center
to perform CLKTs.
1.12 Kidney Transplantation
Kidney
transplants must be performed at a Medicare-approved transplant
center.
1.13
Combined
Heart-Kidney Transplantation (CHKT)
CHKTs must be
performed at a center certified by TRICARE or Medicare for heart transplantation
and Medicare-approved for renal transplantation.
1.14 Organ Transplant
Consortia
TRICARE shall approve individual
pediatric organ transplant centers which meet the General Certification
Requirements outlined in
paragraph 1.2, and would otherwise qualify
as a TRICARE-certified transplantation center by using the combined
experience and survival date of a consortium of which a single transplant
team rotates among member hospitals for purposes of meeting the certification
requirements outlined in
paragraphs 1.5 through
1.13,
for heart, heart-lung, lung, liver, liver-kidney (CLKT), heart-kidney
(CHKT), SI, SI/L, and multivisceral when:
1.14.1 The consortium
hospitals are under common control or have a formal affiliation arrangement
with each other under the auspices of an organization such as a
university or a legally-constituted medical research institute;
1.14.2 The consortium
hospitals share resources by using the same personnel or services
in their transplant programs. The individual physician members of
the transplant team practice in all of the hospitals;
1.14.3 The same organ
procurement organization, immunology, and tissue typing services
are used by all the hospitals; and
1.14.4 The hospital
submits its individual and combined experience and survival data
to the TRICARE authorizing authority; and
1.14.5 If one of the
hospitals is a pediatric transplant program, in addition to the
requirements previously listed the following apply:
1.14.5.1 Although pediatric
surgeons and pathologists are not required to practice the adult hospital
and vice versa, it can be documented that they otherwise function
as members of the transplant team.
1.14.5.2 The facility
must have other solid organ transplant program(s) that meet TRICARE
criteria for certification based on actuarial survival rates and
experience.
1.14.5.3 The surgeon
responsible for the transplant is commonly involved in the type
of surgery (i.e., related to hepatology, cardiology and pulmonary
medicine) with children of the age and size in whom the transplant
is being performed; and
1.14.5.4 If the program
involves heart transplant, the facility must have an active pediatric cardiovascular
medical and surgical program with a minimum of 150 cardiac catheterizations performed
per year on patients in the pediatric range. A surgical case load
of 200 operations per year should be performed in combined adult
and pediatric programs: of these, at least 100 operations per year
(three of four should use extracorporeal circulation) should be
on pediatric patients. In programs serving only a pediatric population,
at least 100 cardiac procedures (three of four should use extracorporeal
circulation) should be performed per year.
1.15 Calculation
of Survival Rates for Transplantation
Each facility
seeking TRICARE certification as a transplantation center must calculate
survival rates using the Kaplan-Meier (product-limit) technique
utilizing the definitions and rules below. Each applicant facility
must identify its Kaplan-Meier actuarial survival percentage at
one year. Each applicant facility must also submit calculations
to support the reported survival percentage.
1.15.1 Each applicant
facility will report all transplantation experience from its inception
at the facility.
1.15.2 TRICARE recognizes
the team experience gained in retransplantation. Therefore, retransplantation
experience must be reported and calculated in the same manner as
first transplantation experience.
1.15.3 All experience
and survival rates must be reported as of a point in time that is
no more than 90 days prior to the submission of the application
for TRICARE certification. That date is referred to as the fiducial
date.
1.15.4 Calculations
assume survival only to (and censoring on) the date of last ascertained survival.
1.15.5 Patients who
are not thought to be dead are considered “lost to follow-up” if
they were:
1.15.5.1 Operated
more than 120 days before the fiducial date, but have no ascertained
survival within 60 days of the fiducial date; or
1.15.5.2 Operated from
61 to 120 days before the fiducial date, but ascertained survival
is less than 60 days from date of transplant; or
1.15.5.3 Operated within
60 days of the fiducial date, but not ascertained to have survived
as of the fiducial date.
1.15.6 Survival must
be calculated with the assumption that each patient in the “lost
to follow-up” category died on or one day after the date of last
ascertained survival.
1.15.7 Clearly
defined and well justified secondary or alternate treatment of “lost
to follow-up” may also be submitted, but primary attention will
be given to the results using definitions and procedures specified
above.
1.15.8 These
specified definitions and procedures use a simpler format but are
identical to those published by CMS (Federal Register,
Volume 52, Number 85; April 6, 1987; pages 10947-8).
1.15.9 Facilities seeking
certification for lung and/or heart-lung transplantation must report
all lung and heart-lung transplantation experience. When facility
experience is reported and the actuarial survival is calculated,
lung and heart-lung transplantation experience must be combined
to arrive at a single one-year survival percentage.
1.16 Revocation
of Provider Status
In the event a transplant center’s
certified provider status is revoked, the certifying authority shall
provide a copy of the initial determination terminating the provider
to:
1.16.1 The
transplant center affected.
1.16.2 The TRICARE
Regional Offices of the TRICARE region.
1.16.3 The Defense
Health Agency-Aurora (DHA-A), Program Integrity Branch.
1.17 Patient Selection
The
patient must meet the requirements criteria for the applicable transplant
as outlined in each individual transplant policy.