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 geographic area
of responsibility. 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
will 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
will 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 will 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
will 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 SI, Combined Small Intestine/Live
(SI/L), and Multivisceral (MV) Transplantation
1.9.1 TRICARE
will provide coverage for SI, SI/L, and MV 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 MV
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
will provide coverage for SPK, PTA, and PAK transplantation procedures
performed only by experienced transplant surgeons at Medicare-approved
renal transplant centers.
1.11 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
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 will 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, CLKT, CHKT, SI, SI/L, and MV
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 calendar 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 calendar
days before the fiducial date, but have no ascertained survival within
60 calendar days of the fiducial date; or
1.15.5.2 Operated from 61 to 120 calendar
days before the fiducial date, but ascertained survival is less
than 60 calendar days from date of transplant; or
1.15.5.3 Operated within 60 calendar
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 Government Designated Authority
(GDA).
1.17 Patient Selection
The patient must meet the requirements
criteria for the applicable transplant as outlined in each individual transplant
policy.