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.