MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 1
Original Issue Date (Created): July 1, 2002
Most Recent Review Date (Revised): November 26, 2013
Effective Date: February 1, 2014
I. POLICY
Kidney
Kidney transplants with either a living or cadaver donor may be considered medically necessary
for carefully selected candidates with end-stage renal disease.
Kidney retransplant after a failed primary kidney transplant may be considered medically
necessary.
POLICY GUIDELINES
Potential contraindications to solid organ transplant (subject to the judgment of the transplant
center):
1. Known current malignancy, including metastatic cancer
2. Recent malignancy with high risk of recurrence
3. History of cancer with a moderate risk of recurrence
4. Systemic disease that could be exacerbated by immunosuppression
5. Untreated systemic infection making immunosuppression unsafe, including chronic
infection
6. Other irreversible end-stage disease not attributed to kidney disease
7. Psychosocial conditions or chemical dependency affecting ability to adhere to therapy
POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND
RATIONALE DEFINITIONS BENEFIT VARIATIONS
DISCLAIMER CODING INFORMATION REFERENCES
POLICY HISTORY
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 2
HIV (human immunodeficiency virus) -positive patients, who meet the following criteria, as
stated in the 2001 guidelines of the American Society of Transplantation, could be considered
candidates for kidney transplantation:
CD4 count >200 cells per cubic millimeter for >6 months
HIV-1 RNA undetectable
On stable antiretroviral therapy >3 months
No other complications from AIDS (acquired immune deficiency syndrome) (e.g.,
opportunistic infection, including aspergillus, tuberculosis, coccidiosis mycosis, resistant
fungal infections, Kaposi’s sarcoma, or other neoplasm), and
Meeting all other criteria for transplantation.
Indications for renal transplant include a creatinine level of greater than 8 mg/dL, or greater than
6 mg/dL in symptomatic diabetic patients. However, consideration for listing for renal transplant
may start well before the creatinine level reaches this point, based on the anticipated time that a
patient may spend on the waiting list.
Allogeneic Pancreas Transplant
A combined pancreas-kidney transplant may be considered medically necessary in insulin-
dependent diabetic patients with uremia.
Pancreas transplant after a prior kidney transplant may be considered medically necessary in
patients with insulin dependent diabetes.
Pancreas transplant alone may be considered medically necessary in patients with severely
disabling and potentially life-threatening complications due to hypoglycemia unawareness and
labile insulin dependent diabetes that persists in spite of optimal medical management.
Pancreas retransplant after a failed primary pancreas transplant may be considered medically
necessary.
POLICY GUIDELINES
General
Potential contraindications subject to the judgment of the transplant center:
1. Known current malignancy, including metastatic cancer
2. Recent malignancy with high risk of recurrence
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 3
3. Untreated systemic infection making immunosuppression unsafe, including chronic
infection
4. Other irreversible end-stage disease not attributed to kidney disease
5. History of cancer with a moderate risk of recurrence
6. Systemic disease that could be exacerbated by immunosuppression
7. Psychosocial conditions or chemical dependency affecting ability to adhere to therapy
Pancreas Specific
Candidates for pancreas transplant alone should additionally meet 1 of the following severity of
illness criteria:
Documentation of severe hypoglycemia unawareness as evidenced by chart notes or
emergency room visits; OR
Documentation of potentially life-threatening labile diabetes as evidenced by chart notes
or hospitalization for diabetic ketoacidosis.
In addition, the vast majority of pancreas transplant patients will have type 1 diabetes mellitus.
Those transplant candidates with type 2 diabetes mellitus, in addition to being insulin-dependent,
should also not be obese (body mass index [BMI] should be 32 or less). According to
International Registry data, in 2010, 7% of pancreas transplant recipients had type 2 diabetes. (3)
Multiple Transplants
Although there are no standard guidelines regarding multiple pancreas transplants, the following
information may aid in case review:
If there is early graft loss resulting from technical factors (e.g., venous thrombosis), a
retransplant may generally be performed without substantial additional risk.
Long-term graft losses may result from chronic rejection, which is associated with
increased risk of infection following long-term immunosuppression, and sensitization,
which increases the difficulty of finding a negative cross-match. Some transplant centers
may wait to allow reconstitution of the immune system before initiating retransplant with
an augmented immunosuppression protocol
Cross-reference: MP-9.002 Organ and Tissue Transplantation Services
MP-9.012 Islet Transplantation
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 4
II. PRODUCT VARIATIONS TOP [N] = No product variation, policy applies as stated
[Y] = Standard product coverage varies from application of this policy, see below
*Refer to Medicare National Coverage Determination Manual, 260.3, Pancreas Transplants. Effective for
services performed on or after 4/26/06, pancreas transplants alone are reasonable and necessary for
Medicare beneficiaries in certain limited circumstances.
* For kidney transplants: an oral or dental examination performed on an inpatient basis as part of a
comprehensive workup prior to renal transplant surgery is a covered service. Refer to Centers for
Medicare and Medicaid (CMS) National Coverage Determination (NCD) 260.6, Dental Examination
Prior to Kidney Transplantation.
* Kidney transplants, pancreas transplants, and combined kidney/pancreas transplants must be performed
in Medicare (CMS) approved transplant facilities. For a list of approved kidney transplant and/or
pancreas transplant facilities, please see:
http://www.cms.gov/CertificationandComplianc/20_Transplant.asp
** Refer to FEP Medical Policy Manual MP-7.03.01 Kidney Transplant and 7.03.02 Allogeneic
Pancreas Transplant. The FEP Medical Policy manual can be found at:
http://bluewebportal.bcbs.com/landingpagelevel3/504100?docId=23980
III. DESCRIPTION/BACKGROUND TOP
Kidney Transplant
A kidney transplant involves the surgical removal of a kidney from a cadaver, living-related, or
living-unrelated donor and transplantation into the recipient.
Based on data from the Organ Procurement and Transplantation Network in 2011, about a third
of kidney transplants in the U.S. (5,769 of 16,812) were performed using organs from living
donors. (1) As of March 23, 2012, the 5-year survival rate for kidney transplants performed
between 1997 and 2004 was 66.5% for organs from deceased donors and 79.7% for organs from
living donors.
[N] Capital Cares 4 Kids [N] Indemnity
[N] PPO [N] SpecialCare
[N] HMO [N] POS
[Y] SeniorBlue HMO* [Y] FEP PPO**
[Y] SeniorBlue PPO*
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 5
Allogeneic Pancreas Transplant
Transplantation of a normal pancreas is a treatment method for patients with insulin-dependent
diabetes mellitus. Pancreas transplantation can restore glucose control and is intended to prevent,
halt, or reverse the secondary complications from diabetes mellitus.
Achievement of insulin independence with resultant decreased morbidity and increased quality
of life is the primary health outcome of pancreas transplantation. While pancreas transplantation
is generally not considered a life-saving treatment, in a small subset of patients who experience
life-threatening complications from diabetes, pancreas transplantation could be considered life-
saving. Pancreas transplant alone (PTA) has also been investigated in patients following total
pancreatectomy for chronic pancreatitis. In addition to the immune rejection issues common to
all allograft transplants, autoimmune destruction of beta cells has been observed in the
transplanted pancreas, presumably from the same mechanism responsible for type 1 diabetes. (1)
Pancreas transplantation occurs in several different scenarios such as: 1) a diabetic patient with
renal failure who may receive a cadaveric simultaneous pancreas/kidney transplant (SPK); 2) a
diabetic patient who may receive a cadaveric or living-related pancreas transplant after a kidney
transplantation (pancreas after kidney, i.e., PAK); or 3) a non-uremic diabetic patient with
specific severely disabling and potentially life-threatening diabetic problems who may receive a
PTA. The total number of adult pancreas transplants (pancreas and pancreas/kidney) in the U.S.
peaked at 1,484 in 2004; the number has since declined. (2) In 2011, there were 287 pancreas
transplants and 795 pancreas/kidney transplants in the U.S.
According to International Registry data, the proportion of pancreas transplant recipients
worldwide who have type 2 diabetes has increased over time, from 2% in 1995 to 7% in 2010.
(3) In 2010, approximately 8% of SPK, 5% of PAK, and 1% of PTA were performed in patients
with type 2 diabetes.
The approach to retransplantation varies according to the cause of failure. Surgical/technical
complications such as venous thrombosis are the leading cause of pancreatic graft loss among
diabetic patients. Graft loss from chronic rejection may result in sensitization, increasing both the
difficulty of finding a cross-matched donor and the risk of rejection of a subsequent transplant.
Each center has its own guidelines based on experience; some transplant centers may wait to
allow reconstitution of the immune system before initiating retransplant with an augmented
immunosuppression protocol.
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 6
IV. RATIONALE TOP
Kidney Transplant
Organ donation
Kidney transplant is an accepted treatment of end-stage renal (ESRD) disease that results from a
variety of etiologies, most commonly diabetic nephropathy. An insufficient supply of donor
organs continues to be a challenge. Potential strategies for increasing organ donation, as
described in a 2009 review by Shrestha, include providing adequate information on the process
and benefits of donation and the use of kidneys from donors who do not fulfill the criteria for
brain death. (2) Other strategies discussed include the use of desensitization protocols in patients
with antihuman leukocyte antigen antibodies, matching age, sex, and human leukocyte antigens
between donor and recipient, lowering the rate of delayed graft function by such methods as
hypothermic machine perfusion of transplanted kidneys, reducing the incidence of acute
rejection and calcineurin inhibitor toxicity, identification and treatment of viral infections, and
treatment regimens that reduce the risk of post-transplant new-onset diabetes after transplant. A
2012 review article by Schold and Segev focused on strategies to increase the pool of organs
available for kidney transplantation from deceased donors. (3) Interventions discussed included
an “opt-out” policy in which individuals are presumed to give consent to organ donation unless
they specify non-consent, expanded use of donors such as commercial sex workers who are
considered to be at increased risk of disease transmission by using rigorous screening and
expanded use of donors with documented infections in selected situations e.g. transplantation of
organs from HIV-positive donors to HIV-positive recipients.
Living donors
Several papers have reported on long-term outcomes in live kidney donors. For example, Segev
and colleagues analyzed data from a national registry of 80,347 live donors in the U.S who
donated organs between April 1, 1994 and March 31, 2009 and compared them with data from
9,364 participants of the National Health and Nutrition Examination Survey (NHANES)
(excluding those with contraindications to kidney donation). (4) There were 25 deaths within 90
days of live kidney donation during the study period. Surgical mortality from live kidney
donation was 3.1 per 10,000 donors (95% confidence interval [CI]: 2.0-4.6) and did not change
during the last 15 years, despite differences in practice and selection. Long-term risk of death
was no higher for live donors than for age- and comorbidity-matched NHANES III participants
for all patients and also stratified by age, sex, and race.
In 2012, Fournier and colleagues in France reported on long-term follow-up of individuals who
had donated a kidney between 1952 and 2008. (5) Of a total of 398 donors at a single institution,
266 (67%) were alive, 44 (11%) were documented as having died and 88 (22%) were lost to
follow-up. Among individuals who were known to have died, death occurred at a mean of 29.6
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 7
years after donation. Donor survival did not differ from that of the general population in France.
Fifty-nine of 68 (87%) living individuals who had donated a kidney more than 30 years ago
responded to a questionnaire. According to questionnaire responses, the mean serum creatinine
level was 93.2 +/- 22.5 umol/L, no patient had an estimated GFR less than 30 mL/min per 1.73
m2 and none had ESRD.
Kidney Transplant in HIV-Positive Patients
In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed
that HIV-positive patients who meet the following criteria, could be considered candidates for
kidney transplantation. (6) (These criteria may be extrapolated to other organs.)
CD4 count >200 cells per cubic millimeter for >6 months
HIV-1 RNA undetectable
On stable anti-retroviral therapy >3 months
No other complications from AIDS (e.g., opportunistic infection, including aspergillus,
tuberculosis, coccidiosis mycosis, resistant fungal infections, Kaposi’s sarcoma, or other
neoplasm).
Meeting all other criteria for transplantation.
A 2011 review article by European authors stated that there are adequate data suggesting that
renal transplantation in adequately selected HIV-positive patients is safe in the short- and
medium-term and that patient and graft survival rates are similar to those in HIV-negative
patients. (7) Moreover, data do not suggest that immunosuppressive therapy has a negative
impact on the course of HIV infection. However, rates of acute rejection after kidney
transplantation are higher in HIV-positive patients. In addition, little is known about the
management of co-infection with hepatitis C or about the optimal antiretroviral and
immunosuppressive regimens. The authors concluded that more studies are needed to address
these issues as well as long-term outcomes.
Several case series have evaluated outcomes of kidney transplantation in HIV-positive patients.
For example, in 2010, Stock and colleagues published findings of the largest prospective study to
date of outcomes following kidney and liver transplantation in HIV-positive recipients. (8) A
total of 150 patients underwent kidney transplantation at 19 centers in the United States; 102
received kidneys from deceased donors and 48 from living donors. Twenty-eight (19%) of
patients were hepatitis C virus (HCV)-positive. Patients were followed for up to 3 years. The
median follow-up of survivors was 1.7 years. At the time data were analyzed, 53 patients had
completed 3 years of follow-up. The patient survival rate at 1 year was 94.6% (standard
deviation [SD]=2.0%) and at 3 years was 88.2% (SD=3.8%). Eleven patients died; the graft was
still functioning at the time of death in 8 patients. There were 7 deaths among the 122 HCV-
negative patients (6%) and 4 deaths among the 28 HCV-positive patients (14%); the p-value for
the difference in survival by HCV status was 0.09. Forty-nine of 150 (33%) patients had 67 acute
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 8
rejection episodes. The cumulative incidence of allograft rejection was 31% (95% CI: 24 to 40)
at 1 year and 41% (95% CI: 32 to 52) at 3 years. The time to first acute allograft rejection did not
differ significantly among HCV-positive and HCV-negative patients, p=0.36 (exact numbers not
reported). There was a low rate of HIV disease progression. Two patients had newly diagnosed
cutaneous Kaposi’s sarcoma, 2 had newly diagnosed HIV-associated nephropathy, and 3 patients
had other new HIV-related diagnoses. Infections requiring hospitalization were reported for 57
of 150 (38%) of patients. Patients who were HCV-positive had a higher rate of serious infection
per follow-up year than those who were HCV-negative (0.8 and 0.5, respectively, p=0.02). The
authors noted that that the rate of rejection was 2 to 3 times higher in this group of HIV-infected
patients than in non-HIV infected patients who participated in a larger study by the research
team. They concluded that kidney transplantation is feasible in carefully selected HIV-infected
patients and that better strategies are needed for minimizing rejection and for controlling
infections in patients who are co-infected with hepatitis C virus.
In 2011, a case-control study from France was published by Mazuecos and colleagues. (9)
Outcomes in 20 HIV-positive patients who received kidney transplantation were compared to a
matched cohort of 40 HIV-negative patients. Matching was done on a number of variables
including type of donor, donor and recipient age, pre-transplantation laboratory values, hepatitis
B and C status, and treatment at the same center within a short amount of time. There was a
mean follow-up of 40.4 months among HIV-positive patients and 39.8 months among HIV-
negative patients. Eight (40%) patients in the HIV-positive group and 9 (22.5%) in the HIV-
negative group experienced acute rejection; this difference was not statistically significant,
p=0.16. There were 4 graft failures (20%) in the HIV-positive group and 2 (5%) in the HIV-
negative group; p=0.89. One patient (5%) died in the HIV-positive group, and there were no
deaths in the HIV-negative group.
Kidney Retransplant
According to data from the Organ Procurement and Transplantation Network (OPTN), rates of 1-
year, 3-year and 5-year survival are similar after a primary kidney transplant and a repeat
transplant. (10) For example, for transplants performed between 2002 and 2004, the 1-year
survival rate was 95.9% (95% CI: 95.7 to 96.1%) after primary transplantation (n=37,504) and
95.8% (95% CI: 95.3-96.4%) after repeat transplantation (n=4,924). Among patients undergoing
transplantation between 1997 and 2000, the 5-year survival rate was 84.8% (95% CI: 84.5% to
85.2%) after primary kidney transplantation (n=29,422) and 85.1% (95% CI: 84.1 to 86.1%)
after repeat kidney transplantation (n=3,697).
In 2009, Barocci and colleagues in Italy reported on long-term survival after kidney
retransplantation. (11) There were 100 (0.8%) second transplants out of 1,302 kidney transplants
performed at a single center between January 1983 and June 2007. Among the second kidney
recipients, 1-, 5- and 10-year patient survival was 100%, 96%, and 92%, respectively. Graft
survival rates at 1, 5 and 10 years were 85%, 72% and 53%, respectively.
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 9
A 2013 study by Johnston and colleagues compared outcomes in 3,509 patients who underwent a
preemptive second kidney transplant, defined as transplantation after fewer than 7 days of
dialysis following graft failure, to outcomes in 14,075 patients who underwent a non-preemptive
second kidney transplant. (12) Data from the U.S. Renal Data System (USRDS) were reviewed.
In the first year after retransplantation, there was a significantly lower risk of acute rejection in
patients receiving a preemptive second transplant (12%) compared to those with a non-
preemptive second transplant (16%), p<0.0001. In a multivariate analysis adjusting for
demographic differences between groups, there was a significantly lower risk of allograft failure
by any cause including death after preemptive second transplants compared to non-preemptive
second transplants (hazard ratio [HR]: 0.88, 95% CI: 0.81 to 0.96).
Summary
Kidney transplant is an accepted treatment of end-stage renal disease in appropriately selected
patients and thus may be considered medically necessary. Registry and national survey data
suggest that live donors of kidneys for transplantation do not have an increased risk of mortality
or ESRD.
Kidney retransplantation after a failed primary transplant may be considered medically
necessary, as national data suggest similar survival rates after initial and repeat transplants.
Kidney transplantation is not medically necessary in patients in whom the procedure is expected
to be futile due to comorbid disease or in whom post-transplantation care is expected to
significantly worsen comorbid conditions. Case series and case-control data indicate that HIV-
infection is not an absolute contraindication to kidney transplant; for patients who meet selection
criteria, these studies have demonstrated patient and graft survival rates are similar to those in the
general population of kidney transplant recipients.
Practice Guidelines and Position Statements
In 2006, the British HIV Association and the British Transplantation Society Standards
Committee published guidelines for kidney transplantation in patients with HIV disease. (13)
The guidelines recommend that any patient with end-stage renal disease with a life expectancy of
at least 5 years is considered appropriate for transplantation under the following conditions:
CD4 >200 cells/mL for at least 6 months
Undetectable HIV viremia (<50 HIV-1 RNA copies/mL) for at least 6 months
Demonstrable adherence and a stable HAART regimen for at least 6 months
Absence of AIDS-defining illness following successful immune reconstitution after
HAART.
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 10
The document lists general and disease-specific exclusion criteria and immunosuppressant
protocols. These recommendations are based on level III evidence (observational studies and
case reports).
Medicare National Coverage
The Medicare Benefit Policy Manual includes a chapter on end-stage renal disease. (14) In a
section on identifying candidates for transplantation (140.1), it states, “After a patient is
diagnosed as having ESRD, the physician should determine if the patient is suitable for
transplantation. If the patient is a suitable transplant candidate, a live donor transplant is
considered first because of the high success rate in comparison to a cadaveric transplant.
Whether one or multiple potential donors are available, the following sections provide a general
description of the usual course of events in preparation for a live-donor transplant.”
Allogeneic Pancreas Transplant
This policy is based in part on a 1998 TEC Assessment, which focused on pancreas graft
survival and health outcomes associated with both pancreas transplant alone (PTA) and pancreas
after kidney transplant (PAK). (4) A 2001 TEC Assessment focused on the issue of pancreas
retransplant. (5) The assessments and subsequent evidence offer the following observations and
conclusions:
Pancreas after Kidney (PAK) Transplant
PAK transplantation allows the uremic patient the benefits of a living-related kidney graft, if
available and the benefits of a subsequent pancreas transplant that is likely to result in improved
quality of life compared to a kidney transplant alone. Uremic patients for whom a cadaveric
kidney graft is available, but a pancreas graft is not simultaneously available benefit similarly
from a later pancreas transplant. Based on International Pancreas Registry data, at 5 years post-
transplant, the patient survival rate after PAK is 83%. (3)
In 2009, Fridell and colleagues reported a retrospective review (n=203) of a single center’s
experience with PAK and SPK since 2003, when current induction/tacrolimus
immunosuppressive strategies became standard. (6) Of the cases studied, 61 (30%) were PAK
and 142 (70%) were SPK. One-year patient survival rates were 98% and 95% (PAK and SPK,
respectively; p=0.44). Pancreas graft survival rates at 1 year were observed to be 95% and 90%,
respectively (p=0.28). The authors concluded that in the modern immunosuppressive era, PAK
should be considered as an acceptable alternative to SPK in candidates with an available living
kidney donor.
In 2012, Bazarbachi and colleagues reviewed a single center’s experience with PAK and SPK.
(7) Between 2002 and 2010, 172 pancreas transplants were performed in diabetic patients; 123
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 11
SPK and 49 PAK. The median length of time between kidney and pancreas transplantation in the
PAK group was 4.8 years. Graft and patient survival rates were similar in the 2 groups. Death-
censored pancreas graft survival rates for SPK and PAK were 94% and 90% at 1 year, 92% and
90% at 3 years, and 85% and 85% at 5 years (all respectively, p=0.93). Patient survival rates
(calculated beginning at the time of pancreas transplantation) in the SPK versus PAK groups
were 98.3% and 100% after 1 year, 96.4% and 100% after 3 years, and 94.2% and 100% after 5
years (all respectively, p=0.09).
Kleinclauss and colleagues retrospectively examined data from diabetic kidney transplant
recipients (n=307) from a single center and compared renal graft survival rates in those who
subsequently received a pancreatic transplant to those who did not. (8) The comparative group
was analyzed separately depending on whether they were medically eligible (KTA-E) for
pancreas transplant, but chose not to proceed for financial or personal reasons, or were ineligible
(KTA-I) for medical reasons. The KTA-I (n=57) group differed significantly at baseline from
both the PAK group (n=175) and the KTA-E group (n=75) with respect to age, type of diabetes,
and dialysis experience; kidney graft survival rates were lower than either of the other groups,
with 1-, 5-, and 10-year rates of 75%, 54%, and 22%, respectively (p<0.0001). The PAK and
KTA-E groups were similar in age, race, type of diabetes, and dialysis experience. The authors
compared 1--, 5-, and 10-year kidney graft survival rates in PAK patients with those in the KTA-
E group: 98%, 82%, and 67% versus 100%, 84%, and 62%, respectively, and concluded that the
subsequent transplant of a pancreas after a living donor kidney transplant does not adversely
affect patient or kidney graft survival rates.
Pancreas Transplant Alone (PTA)
PTA graft survival has improved in recent years. According to International Registry data 1-year
graft function increased from 51.5% in 1987-1993 to 77.8% in 2006-2010 (p<0.0001). (3) One-
year immunologic graft loss remains higher (6%) after PTA than PAK (3.7%) or SPK (1.8%). In
carefully selected patients with insulin dependent diabetes mellitus (IDDM) and severely
disabling and potentially life-threatening complications due to hypoglycemia unawareness and
labile diabetes that persists despite optimal medical management, the benefits of PTA were
judged to outweigh the risk of performing pancreas transplantation with subsequent
immunosuppression.
The majority of patients undergoing PTA are those with either hypoglycemic unawareness or
labile diabetes. However, other exceptional circumstances may exist where nonuremic IDDM
patients have significant morbidity risks due to secondary complications of diabetes (i.e.,
peripheral neuropathy) that exceed those of the transplant surgery and subsequent chronic
immunosuppression. Because there is virtually no published evidence regarding outcomes of
medical management in this very small group of exceptional diabetic patients, it is not possible
to generalize about which circumstances represent appropriate indications for pancreas
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 12
transplantation alone. Case-by-case consideration of each patient’s clinical situation may be the
best option for determining the balance of risks and benefits.
Noting that nephrotoxic immunosuppression may exacerbate diabetic renal injury after PTA, in
2008 Scalea et al. reported a single institutional review of 123 patients who received 131 PTA
for development of renal failure. (9) Mean graft survival was 3.3 years (range, 0–11.3), and 21
patients were lost to follow-up. Mean estimated glomerular filtration rate (eGFR) was 88.9 pre-
transplantation versus 55.6 post-transplantation, with mean follow-up of 3.7 years. All but 16
patients had a decrease in eGFR, and mean decrement was 32.1 mg/min/1.73. Thirteen
developed end-stage renal disease, which required kidney transplantation at a mean of 4.4 years.
The authors suggested that patients should be made aware of the risk and only the most
appropriate patients offered PTA. Future updates of this policy will continue to follow this
clinical topic.
Simultaneous Pancreas/Kidney (SPK) Transplant
According to International Registry data through 2005, recent 5-year graft survival rates for SPK
transplants are 72% for the pancreas and 80% for the kidney. (10) Ten-year graft survival rates
have reached almost 60% for SPK transplants.
In 2010, Mora and colleagues described the long-term outcome of 12 patients 15 years following
SPK transplant. (11) Metabolic measures of glucose control were measured at 1, 5, 10, and 15
years following the procedure. Of this subset of patients, 6 (50%) had non-diabetic glucose
challenge tests. Basal serum insulin levels declined over this period as well, from 24 mU/L to 16
mU/L at 1 and 15 years, respectively. The authors conclude that in a select group of patients
whose pancreatic graft continued to function after 15 years, some glycemic control continued,
albeit in a diminished fashion. It should be noted that this represents a small fraction of the 367
patients receiving the SPK transplant at this single center (12 of 367 SPK; 3.3%). The number of
allograft survivals at 5 or more, and 10 or more years in this study was 43 (11.7%) and 28
(7.6%), respectively.
The improved glycemic control that may occur in SPK transplant patients, principally in those
with labile disease while on medical therapy alone, is purported to reduce risk of complications
from the diabetic disease. In 2009, Davenport and colleagues published results of a registry
review (n=58) on cardiovascular risk factors in an Irish study of SPK transplant recipients. (12)
Glycosylated hemoglobin values fell from a mean of 8.1 to 5.2 (p<0.0001) from pre-transplant
levels. Similar statistically significant declines were seen in total cholesterol, triglycerides, and
creatinine. Systolic and diastolic blood pressures were likewise improved but with a greater
range of pre- and post-transplant variability. These endpoints are commonly accepted as
surrogates for cardiovascular risk. The authors compared both a surgical method (bladder vs.
enteric drainage) and mode of immunosuppression (cyclosporine vs. tacrolimus) on changes to
blood pressure and cholesterol. No significant differences were found in either measure based on
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 13
surgical drainage method, nor did immunosuppressive therapy have an impact on blood pressure
reduction. Cholesterol reduction was greater in the cyclosporine than the tacrolimus group (-1.3
to -0.2, respectively), favoring the less contemporary strategy. The authors note that this is in
contrast to other recently published studies favoring both enteric drainage and tacrolimus. While
this single-arm study suggests beneficial cardiovascular effects from transplant, other factors
such as rejection rates are more likely to influence the conditions under which transplantations
take place, and this study’s data do not lead to conclusions that would change the policy
statement.
In 2011, Sampaio and colleagues published an analysis of data from the United Network for
Organ Sharing (UNOS) database. (13) The investigators compared outcomes in 6,141 patients
with type 1 diabetes and 582 patients with type 2 diabetes who underwent SPK between 2000
and 2007. In adjusted analyses, outcomes were similar in the 2 groups. After adjusting for other
factors such as body weight; dialysis time; and cardiovascular comorbidities, type 2 diabetes was
not associated with an increased risk of pancreas or kidney graft survival, or mortality compared
to type 1 diabetes.
Pancreas Retransplantation
The U.S.-based Organ Procurement Transfer Network (OPTN) reported data on transplants
performed between 1997 and 2004. (2) Patient survival rates after repeat transplants were similar
to survival rates after primary transplants. For example, the 1-year survival rate was 94.0% (95%
confidence interval [CI]: 92.6 to 95.3%) after a primary pancreas transplant and 95.6% (95% CI:
92.7 to 98.5%) after a repeat pancreas transplant. The numbers of patients transplanted was not
reported, but the OPTN data stated that 1,217 patients were alive 1 year after primary transplant
and 255 after repeat transplants. Three-year patient survival rates were 89.5% (95% CI: 87.8 to
91.2%) after primary transplants and 89.7% (95% CI: 85.9 to 93.5) after repeat transplants. One-
year graft survival rates were 78.2% (95% CI: 76.0 to 80.5%) after primary pancreas transplants
and 70.4% (95% CI: 64.8 to 76.0%) after repeat transplants.
Data are similar for patients receiving combined kidney/pancreas transplants, but follow-up data
are only available on a small number of patients who had repeat kidney/pancreas transplants so
estimates of survival rates in this group are imprecise. Three-year patient survival rates were
90.0% (95% CI: 89.0 to 91.0%) after primary combined transplant and 79.9% (95% CI: 63.8 to
95.9%) after a repeat combined transplant. The number of patients who were living 3 years after
transplant was 2,907 after a primary combined procedure and 26 after a repeat combined
procedure.
In 2013, Buron and colleagues reported on their experience with pancreas retransplantation in
France and Geneva. (14) Between 1976 and 2008, 568 pancreas transplants were performed at 2
centers, including 37 repeat transplants. Patient survival after a repeat pancreas transplant was
100% after 1 year and 89% after 5 years. Graft survival was 64% at 1 year and 46% at 5 years.
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Among the 17 patients who underwent a second transplant in a later time period i.e., between
1995 and 2007, graft survival was 71% at 1 year and 59% at 5 years. In this more recently
transplanted group, graft survival rates were similar to primary pancreas transplants, which was
79% at 1 year and 69% at 5 years.
Immunosuppressive Regimen
Pancreas transplantation requires T cell autoantibody induction, which most solid organ
transplantations do not. As a consequence, a variety of studies, including RCTs, have examined
various immunosuppressive regimens. (15-20) This high-quality evidence adds to our
understanding of transplant management but does not compare pancreas transplant to alternatives
and therefore does not contribute to the evidence base for this policy.
HIV+ Transplant Recipients
The Organ Procurement Transfer Network (OPTN) policy on Identification of Transmissible
Diseases in Organ Recipients states: “Potential candidate for organ transplantation whose test for
HIV is positive should not be excluded from candidacy for organ transplantation unless there is a
documented contraindication to transplantation based on local policy.” (21)
In 2006, the British HIV Association and the British Transplantation Society Standards
Committee published guidelines for kidney transplantation in patients with human
immunodeficiency virus (HIV) disease. (22) As described above, these criteria may be
extrapolated to other organs. The guidelines recommend that any patient with end-stage organ
disease with a life expectancy of at least 5 years is considered appropriate for transplantation
under the following conditions:
CD4 count greater than 200 cells/microliter for at least 6 months
Undetectable HIV viremia (<50 HIV-1 RNA copies/mL) for at least 6 months
Demonstrable adherence and a stable HAART [highly active antiretroviral therapy]
regimen for at least 6 months
Absence of AIDS [acquired immunodeficiency syndrome]-defining illness following
successful immune reconstitution after HAART.
Age
Several 2011 studies addressed pancreas transplantation in individuals 50 years of age or older.
A study by Afaneh and colleagues reviewed data on 17 individuals at least 50 years-old and 119
individuals younger than 50 years who had a pancreas transplant at a single institution in the U.S.
(23) The 2 groups had similar rates of surgical complications, acute rejection and non-surgical
infections. Overall patient survival was similar. Three- and 5-year survival rates were 93% and
90% in the younger group and 92% and 82%, all consecutively, in the older group. Schenker and
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colleagues in Germany compared outcomes in 69 individuals at least 50 years-old and 329
individuals younger than 50 years who had received a pancreas transplant. (24) Mean duration of
follow-up was 7.7 years. One-, 5-, and 10-year patient and graft survival rates were similar in the
2 groups. For example, the 5-year patient survival rate was 89% in both groups. The 5-year
pancreas grant survival rate was 76% in the older group and 72% in the younger group. The
authors of both studies, as well as the authors of a commentary accompanying the Schenker
article, (25) agreed that individuals age 50 years and older are suitable candidates for pancreas
transplantation.
Summary
The literature, consisting primarily of case series and registry data, demonstrate graft survival
rates comparable to other solid organ transplants, as well as attendant risks associated with the
immunosuppressive therapy necessary to prevent allograft rejection. No randomized controlled
trials have compared any form of pancreas transplant to insulin therapy. Pancreas transplant may
be considered medically necessary in patients who are undergoing, or have undergone, kidney
transplantation for renal failure. It may also be considered medically necessary as a stand-alone
treatment in patients with hypoglycemia unawareness and labile diabetes despite optimal medical
therapy and in whom severe complications have developed.
Practice Guidelines and Position Statements
In 2010, the Board of Directors of OPTN/UNOS approved changes to address concerns related
to local variations in the allocation system for pancreas transplant. (26) The policy changes
attempt to reduce the discarding of pancreas donations that have been declined in the context of
PTA but which may have been utilized if offered in the setting of SPK. The effect of the policy
changes on availability of pancreas donations for transplant alone or in combination with kidney
transplants is unknown.
A technology assessment was produced by the Canadian Agency for Drugs and Technology in
Health in 2007. (27) The authors did not identify any studies that would contribute additional
evidence to this policy. The assessment states: “Given that pancreas transplantation has been
widely disseminated for years, it is unlikely that well-designed RCTs that examine pancreas
transplantation will occur because ethical and logical complications will prevent this…Pancreas
transplantation is an accepted treatment for patients with type I diabetes and end-stage renal
disease (ESRD). This has occurred despite the absence of high quality, robust evidence.”
MEDICAL POLICY
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Medicare National Coverage
Allogeneic pancreas transplant is covered under Medicare when performed in a facility that is
approved by Medicare as meeting institutional coverage criteria. (28) The Centers for Medicare
and Medicaid Services (CMS) has made the following national coverage decision regarding
pancreas transplant for Medicare recipients:
A. General
Pancreas transplantation is performed to induce an insulin-independent, euglycemic state in
diabetic patients. The procedure is generally limited to those patients with severe secondary
complications of diabetes, including kidney failure. However, pancreas transplantation is
sometimes performed on patients with labile diabetes and hypoglycemic unawareness.
B. Nationally Covered Indications
Effective for services performed on or after July 1, 1999, whole organ pancreas transplantation is
nationally covered by Medicare when performed simultaneous with or after a kidney transplant.
If the pancreas transplant occurs after the kidney transplant, immunosuppressive therapy begins
with the date of discharge from the inpatient stay for the pancreas transplant.
Effective for services performed on or after April 26, 2006, pancreas transplants alone (PA) are
reasonable and necessary for Medicare beneficiaries in the following limited circumstances (29):
1. PA will be limited to those facilities that are Medicare-approved for kidney
transplantation.
2. Patients must have a diagnosis of type I diabetes:
o Patient with diabetes must be beta cell autoantibody positive; or
o Patient must demonstrate insulinopenia defined as a fasting C-peptide level that is
less than or equal to 110% of the lower limit of normal of the laboratory's
measurement method. Fasting C-peptide levels will only be considered valid with
a concurrently obtained fasting glucose <225 mg/dL;
3. Patients must have a history of medically-uncontrollable labile (brittle) insulin-dependent
diabetes mellitus with documented recurrent, severe, acutely life-threatening metabolic
complications that require hospitalization. Aforementioned complications include
frequent hypoglycemia unawareness or recurring severe ketoacidosis, or recurring severe
hypoglycemic attacks;
4. Patients must have been optimally and intensively managed by an endocrinologist for at
least 12 months with the most medically-recognized advanced insulin formulations and
delivery systems;
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5. Patients must have the emotional and mental capacity to understand the significant risks
associated with surgery and to effectively manage the lifelong need for
immunosuppression; and,
6. Patients must otherwise be a suitable candidate for transplantation.
C. Nationally Non-Covered Indications
The following procedure is not considered reasonable and necessary within the meaning of
section 1862(a)(1)(A) of the Social Security Act:
Transplantation of partial pancreatic tissue or islet cells (except in the context of a clinical trial
(see section 260.3.1 of the National Coverage Determinations Manual.
V. DEFINITIONS TOP
ABSOLUTE CONTRAINDICATION- A reason for not performing a particular therapeutic
intervention which is so compelling or carries such a grave risk that its performance would be
reasonably regarded as constituting malpractice.
BLUE DISTINCTION CENTERS FOR TRANSPLANT (BDCT) is a cooperative effort of the Blue
Cross and Blue Shield Plans, the Blue Cross and Blue Shield Association and participating
medical institutions to provide patients who need transplants with access to leading centers
through a coordinated, streamlined program of transplant management.
CADAVER refers to a dead body or corpse.
END-STAGE RENAL DISEASE (ESRD) is a point at which the kidney is so badly damaged or
scarred that hemodialysis or transplantation is required for patient survival.
IMMUNOSUPPRESSIVE refers to any treatment used to block abnormal or excessive immune
responses.
INSULIN is a hormone secreted by the beta cells of the pancreas that controls the metabolism and
cellular uptake of sugars, proteins and fat.
RELATIVE CONTRAINDICATION- A relative contraindication is a condition which makes a
particular treatment or procedure somewhat inadvisable but does not rule it out.
UREMIC pertains to a toxic level of urea (nitrogenous waste) in the blood.
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VI. BENEFIT VARIATIONS TOP
The existence of this medical policy does not mean that this service is a covered benefit under
the member's contract. Benefit determinations should be based in all cases on the applicable
contract language. Medical policies do not constitute a description of benefits. A member’s
individual or group customer benefits govern which services are covered, which are excluded,
and which are subject to benefit limits and which require preauthorization. Members and
providers should consult the member’s benefit information or contact Capital for benefit
information.
VII. DISCLAIMER TOP
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical
advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of
members. Members should discuss any medical policy related to their coverage or condition with their provider
and consult their benefit information to determine if the service is covered. If there is a discrepancy between this
medical policy and a member’s benefit information, the benefit information will govern. Capital considers the
information contained in this medical policy to be proprietary and it may only be disseminated as permitted by
law.
VIII. CODING INFORMATION TOP
Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The
identification of a code in this section does not denote coverage as coverage is determined by the terms
of member benefit information. In addition, not all covered services are eligible for separate
reimbursement.
Covered when medically necessary:
CPT Codes® 48550 48554 50300 50320 50323 50325 50327 50328 50329
50340 50360 50365 50380 50547
Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved.
MEDICAL POLICY
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Investigational; therefore not covered:
CPT Codes® 48551 48552
Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved.
HCPCS
Code Description
S2065 SIMULTANEOUS PANCREAS KIDNEY TRANSPLANTATION
S2152
SOLID ORGAN(S), COMPLETE OR SEGMENTAL, SINGLE ORGAN OR COMBINATION OF
ORGANS; DECEASED OR LIVING DONOR (S), PROCUREMENT, TRANSPLANTATION, AND
RELATED COMPLICATIONS; INCLUDING: DRUGS; SUPPLIES; HOSPITALIZATION WITH
OUTPATIENT FOLLOW-UP; MEDICAL/SURGICAL, DIAGNOSTIC, EMERGENCY, AND
REHABILITATIVE SERVICES, AND THE NUMBER OF DAYS OF PRE AND
POSTTRANSPLANT CARE IN THE GLOBAL DEFINITION
ICD-9-CM
Diagnosis
Code*
Description
189.0 Malignant neoplasm of kidney, except pelvis
203.01 Myeloma in remission
250.01 Diabetes mellitus without mention of complication, type i [juvenile type], not stated as uncontrolled
250.03 Diabetes mellitus without mention of complication, type i [juvenile type], uncontrolled
250.11 Diabetes with ketoacidosis, type i [juvenile type], not stated as uncontrolled
250.13 Diabetes with ketoacidosis, type i [juvenile type], uncontrolled
250.21 Diabetes with hyperosmolarity, type i [juvenile type], not stated as uncontrolled
250.23 Diabetes with hyperosmolarity, type i [juvenile type], uncontrolled
250.31 Diabetes with other coma, type i [juvenile type], not stated as uncontrolled
250.33 Diabetes with other coma, type i [juvenile type], uncontrolled
250.41 Diabetes with renal manifestations, type i [juvenile type], not stated as uncontrolled
250.42 Diabetes with renal manifestations, type ii or unspecified type, uncontrolled
250.43 Diabetes with renal manifestations, type i [juvenile type], uncontrolled
250.51 Diabetes with ophthalmic manifestations, type i [juvenile type], not stated as uncontrolled
250.53 Diabetes with ophthalmic manifestations, type i [juvenile type], uncontrolled
250.61 Diabetes with neurological manifestations, type i [juvenile type], not stated as uncontrolled
250.63 Diabetes with neurological manifestations, type i [juvenile type], uncontrolled
250.71 Diabetes with peripheral circulatory disorders, type i [juvenile type], not stated as uncontrolled
250.73 Diabetes with peripheral circulatory disorders, type i [juvenile type], uncontrolled
250.81 Diabetes with other specified manifestations, type i [juvenile type], not stated as uncontrolled
250.83 Diabetes with other specified manifestations, type i [juvenile type], uncontrolled
250.91 Diabetes with unspecified complication, type i [juvenile type], not stated as uncontrolled
250.93 Diabetes with unspecified complication, type i [juvenile type], uncontrolled
270.0 Disturbances of amino-acid transport
271.8 Other specified disorders of carbohydrate transport and metabolism
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272.7 Lipidoses
274.10 Gouty nephropathy, unspecified
275.4 Disorders of calcium metabolism
277.3 Amyloidosis
283.11 Hemolytic-uremic syndrome
287.0 Allergic purpura
403.10 Hypertensive chronic kidney disease, benign, with chronic kidney disease stage i through stage iv,
or unspecified
403.90 Hypertensive chronic kidney disease, unspecified, with chronic kidney disease stage i through stage
iv, or unspecified
446.0 Polyarteritis nodosa
446.4 Wegener's granulomatosis
553.3 Diaphragmatic hernia without mention of obstruction or gangrene
581.81 Nephrotic syndrome with other specified pathological lesion in kidney in diseases classified
elsewhere
582.1 Chronic glomerulonephritis with lesion of membranous glomerulonephritis
583.6 Nephritis and nephropathy, not specified as acute or chronic, with lesion of renal cortical necrosis
583.89 Other nephritis and nephropathy, not specified as acute or chronic, with specified pathological
lesion in kidney
583.9 Nephritis and nephropathy, not specified as acute or chronic, with unspecified pathological lesion in
kidney
584.5 Acute renal failure with lesion of tubular necrosis
584.7 Acute renal failure with lesion of renal medullary (papillary) necrosis
585.1 Chronic kidney disease, stage i
590.00 Chronic pyelonephritis without lesion of renal medullary necrosis
593.81 Vascular disorders of kidney
599.6 Urinary obstruction
710.0 Systemic lupus erythematosus
753.0 Congenital renal agenesis and dysgenesis
753.12 Congenital polycystic kidney, unspecified type
753.13 Congenital polycystic kidney, autosomal dominant
753.14 Congenital polycystic kidney, autosomal recessive
753.16 Congenital medullary cystic kidney
753.3 Other specified congenital anomalies of kidney
759.5 Tuberous sclerosis
866.00 Unspecified kidney injury without mention of open wound into cavity
866.13 Complete disruption of kidney parenchyma, with open wound into cavity
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses.
The following ICD-10 diagnosis codes will be effective October 1, 2013
ICD-10-CM
Diagnosis
Code*
Description
C64.0 Malignant neoplasm of right kidney, except renal pelvis
C64.1 Malignant neoplasm of right kidney, except renal pelvis
C64.9 Malignant neoplasm of unspecified kidney, except renal pelvis
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ICD-10-CM
Diagnosis
Code*
Description
C90.10 Plasma cell leukemia not having achieved remission
D59.3 Hemolytic-uremic syndrome
D69.0 Allergic purpura
E08.21 Diabetes mellitus due to underlying condition with diabetic nephropathy
E08.22 Diabetes mellitus due to underlying condition with diabetic chronic kidney disease
E08.29 Diabetes mellitus due to underlying condition with other diabetic kidney complication
E09.21 Drug or chemical induced diabetes mellitus with diabetic nephropathy
E09.22 Drug or chemical induced diabetes mellitus with diabetic chronic kidney disease
E09.29 Drug or chemical induced diabetes mellitus with other diabetic kidney complication
E10.10 Type 1 diabetes mellitus with ketoacidosis without coma
E10.11 Type 1 diabetes mellitus with ketoacidosis with coma
E10.21 Type 1 diabetes mellitus with diabetic nephropathy
E10.22 Type 1 diabetes mellitus with diabetic chronic kidney disease
E10.29 Type 1 diabetes mellitus with other diabetic kidney complication
E10.311 Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E10.319 Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema
E10.321 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema
E10.329 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema
E10.331 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema
E10.339 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema
E10.341 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema
E10.349 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema
E10.351 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema
E10.359 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema
E10.36 Type 1 diabetes mellitus with diabetic cataract
E10.39 Type 1 diabetes mellitus with other diabetic ophthalmic complication
E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified
E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy
E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy
E10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy
E10.44 Type 1 diabetes mellitus with diabetic amyotrophy
E10.49 Type 1 diabetes mellitus with other diabetic neurological complication
E10.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene
E10.52 Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene
E10.59 Type 1 diabetes mellitus with other circulatory complications
E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy
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ICD-10-CM
Diagnosis
Code*
Description
E10.618 Type 1 diabetes mellitus with other diabetic arthropathy
E10.620 Type 1 diabetes mellitus with diabetic dermatitis
E10.621 Type 1 diabetes mellitus with foot ulcer
E10.622 Type 1 diabetes mellitus with other skin ulcer
E10.628 Type 1 diabetes mellitus with other skin complications
E10.630 Type 1 diabetes mellitus with periodontal disease
E10.638 Type 1 diabetes mellitus with other oral complications
E10.641 Type 1 diabetes mellitus with hypoglycemia with coma
E10.649 Type 1 diabetes mellitus with hypoglycemia without coma
E10.65 Type 1 diabetes mellitus with hyperglycemia
E10.69 Type 1 diabetes mellitus with other specified complication
E10.8 Type 1 diabetes mellitus with unspecified complications
E10.9 Type 1 diabetes mellitus without complications
E11.21 Type 2 diabetes mellitus with diabetic nephropathy
E11.65 Type 2 diabetes mellitus with hyperglycemia
E72.00 Disorders of amino-acid transport, unspecified
E72.01 Cystinuria
E72.02 Hartnup's disease
E72.03 Lowe's syndrome
E72.04 Cystinosis
E72.09 Other disorders of amino-acid transport
E72.52 Trimethylaminuria
E72.53 Hyperoxaluria
E74.4 Disorders of pyruvate metabolism and gluconeogenesis
E74.8 Other specified disorders of carbohydrate metabolism
E75.21 Fabry (-Anderson) disease
E75.22 Gaucher disease
E75.240 Niemann-Pick disease type A
E75.241 Niemann-Pick disease type B
E75.242 Niemann-Pick disease type C
E75.243 Niemann-Pick disease type D
E75.248 Other Niemann-Pick disease
E75.249 Niemann-Pick disease, unspecified
E75.3 Sphingolipidosis, unspecified
E77.0 Defects in post-translational modification of lysosomal enzymes
E77.1 Defects in glycoprotein degradation
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ICD-10-CM
Diagnosis
Code*
Description
E77.8 Other disorders of glycoprotein metabolism
E77.9 Disorder of glycoprotein metabolism, unspecified
E83.50 Unspecified disorder of calcium metabolism
E85.9 Amyloidosis, unspecified
I12.9 Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or
unspecified chronic kidney disease
K44.9 Diaphragmatic hernia without obstruction or gangrene
M10.30 Gout due to renal impairment, unspecified site
M10.311 Gout due to renal impairment, right shoulder
M10.312 Gout due to renal impairment, left shoulder
M10.319 Gout due to renal impairment, unspecified shoulder
M10.321 Gout due to renal impairment, right elbow
M10.322 Gout due to renal impairment, left elbow
M10.329 Gout due to renal impairment, unspecified elbow
M10.331 Gout due to renal impairment, right wrist
M10.332 Gout due to renal impairment, left wrist
M10.339 Gout due to renal impairment, unspecified wrist
M10.341 Gout due to renal impairment, right hand
M10.342 Gout due to renal impairment, left hand
M10.349 Gout due to renal impairment, unspecified hand
M10.351 Gout due to renal impairment, right hip
M10.352 Gout due to renal impairment, left hip
M10.359 Gout due to renal impairment, unspecified hip
M10.361 Gout due to renal impairment, right knee
M10.362 Gout due to renal impairment, left knee
M10.369 Gout due to renal impairment, unspecified knee
M10.371 Gout due to renal impairment, right ankle and foot
M10.372 Gout due to renal impairment, left ankle and foot
M10.379 Gout due to renal impairment, unspecified ankle and foot
M10.38 Gout due to renal impairment, vertebrae
M10.39 Gout due to renal impairment, multiple sites
M30.0 Polyarteritis nodosa
M30.1 Polyarteritis with lung involvement [Churg-Strauss]
M30.2 Juvenile polyarteritis
M30.8 Other conditions related to polyarteritis nodosa
M31.30 Wegener's granulomatosis without renal involvement
M31.31 Wegener's granulomatosis with renal involvement
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ICD-10-CM
Diagnosis
Code*
Description
M31.7 Microscopic polyangiitis
M32.0 Drug-induced systemic lupus erythematosus
M32.10 Systemic lupus erythematosus, organ or system involvement unspecified
M32.11 Endocarditis in systemic lupus erythematosus
M32.12 Pericarditis in systemic lupus erythematosus
M32.13 Lung involvement in systemic lupus erythematosus
M32.14 Glomerular disease in systemic lupus erythematosus
M32.15 Tubulo-interstitial nephropathy in systemic lupus erythematosus
M32.19 Other organ or system involvement in systemic lupus erythematosus
M32.8 Other forms of systemic lupus erythematosus
M32.9 Systemic lupus erythematosus, unspecified
N03.1 Chronic nephritic syndrome with focal and segmental glomerular lesions
N03.3 Chronic nephritic syndrome with diffuse mesangial proliferative glomerulonephritis
N05.0 Unspecified nephritic syndrome with minor glomerular abnormality
N05.1 Unspecified nephritic syndrome with focal and segmental glomerular lesions
N05.6 Unspecified nephritic syndrome with dense deposit disease
N05.7 Unspecified nephritic syndrome with diffuse crescentic glomerulonephritis
N05.8 Unspecified nephritic syndrome with other morphologic changes
N05.9 Unspecified nephritic syndrome with unspecified morphologic changes
N06.0 Isolated proteinuria with minor glomerular abnormality
N06.1 Isolated proteinuria with focal and segmental glomerular lesions
N06.6 Isolated proteinuria with dense deposit disease
N06.7 Isolated proteinuria with diffuse crescentic glomerulonephritis
N06.8 Isolated proteinuria with other morphologic lesion
N06.9 Isolated proteinuria with unspecified morphologic lesion
N07.0 Hereditary nephropathy, not elsewhere classified with minor glomerular abnormality
N07.1 Hereditary nephropathy, not elsewhere classified with focal and segmental glomerular lesions
N07.6 Hereditary nephropathy, not elsewhere classified with dense deposit disease
N07.7 Hereditary nephropathy, not elsewhere classified with diffuse crescentic glomerulonephritis
N07.8 Hereditary nephropathy, not elsewhere classified with other morphologic lesions
N07.9 Hereditary nephropathy, not elsewhere classified with unspecified morphologic lesions
N08 Glomerular disorders in diseases classified elsewhere
N11.0 Nonobstructive reflux-associated chronic pyelonephritis
N11.8 Other chronic tubulo-interstitial nephritis
N13.9 Obstructive and reflux uropathy, unspecified
N14.0 Analgesic nephropathy
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ICD-10-CM
Diagnosis
Code*
Description
N14.1 Nephropathy induced by other drugs, medicaments and biological substances
N14.2 Nephropathy induced by unspecified drug, medicament or biological substance
N14.3 Nephropathy induced by heavy metals
N14.4 Toxic nephropathy, not elsewhere classified
N15.0 Balkan nephropathy
N15.8 Other specified renal tubulo-interstitial diseases
N15.9 Renal tubulo-interstitial disease, unspecified
N17.0 Acute kidney failure with tubular necrosis
N17.1 Acute kidney failure with acute cortical necrosis
N17.2 Acute kidney failure with medullary necrosis
N18.1 Chronic kidney disease, stage 1
N28.0 Ischemia and infarction of kidney
Q60.0 Renal agenesis, unilateral
Q60.1 Renal agenesis, bilateral
Q60.2 Renal agenesis, unspecified
Q60.3 Renal hypoplasia, unilateral
Q60.4 Renal hypoplasia, bilateral
Q60.5 Renal hypoplasia, unspecified
Q60.6 Potter’s syndrome
Q61.11 Cystic dilatation of collecting ducts
Q61.19 Other polycystic kidney, infantile type
Q61.2 Polycystic kidney, adult type
Q61.3 Polycystic kidney, unspecified
Q61.5 Medullary cystic kidney
Q63.0 Accessory kidney
Q63.1 Lobulated, fused and horseshoe kidney
Q63.2 Ectopic kidney
Q63.3 Hyperplastic and giant kidney
Q63.8 Other specified congenital malformations of kidney
Q63.9 Congenital malformation of kidney, unspecified
Q85.1 Tuberous sclerosis
S31.001a Unspecified open wound of lower back and pelvis with penetration into retroperitoneum, initial
encounter
S37.001a Unspecified injury of right kidney, initial encounter
S37.002a Unspecified injury of left kidney, initial encounter
S37.009a Unspecified injury of unspecified kidney, initial encounter
S37.069a Major laceration of unspecified kidney, initial encounter
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 26
ICD-10-CM
Diagnosis
Code*
Description
T45.8x1a Poisoning by other primarily systemic and hematological agents, accidental (unintentional), initial
encounter
T45.8x2a Poisoning by other primarily systemic and hematological agents, intentional self-harm, initial
encounter
T45.8x3a Poisoning by other primarily systemic and hematological agents, assault, initial encounter
T45.8x4a Poisoning by other primarily systemic and hematological agents, undetermined, initial encounter
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses
IX. REFERENCES TOP
Kidney Transplant
1. U.S. Department of Health and Human Services Organ Procurement and
Transplantation Network. Available online at:
http://optn.transplant.hrsa.gov/latestData/step2.asp. Last accessed April, 2013.
2. Shrestha BM. Strategies for reducing the renal transplant waiting list: a review. Exp Clin
Transplant 2009; 7(3):173-9.
3. Schold JD, Segev DL. Increasing the pool of deceased donor organs for kidney
transplantation. Nat Rev Nephrol 2012; 8(6):325-31.
4. Segev DL, Muzaale AD, Caffo BS et al. Perioperative mortality and long-term survival
following live kidney donation. JAMA 2010; 303(10):959-66.
5. Fournier C, Pallet N, Cherqaoui Z et al. Very long-term follow-up of living kidney
donors. Transpl Int 2012; 25(4):385-90.
6. Steinman TI, Becker BN, Frost AE et al. Guidelines for the referral and management of
patients eligible for solid organ transplantation. Transplantation 2001; 71(9):1189-204.
7. Trullas JC, Cofan F, Tuset M et al. Renal transplantation in HIV-infected patients: 2010
update. Kidney Int 2011; 79(8):825-42.
8. Stock PG, Barin B, Murphy B et al. Outcomes of kidney transplantation in HIV-infected
recipients. N Engl J Med 2010; 363(21):2004-14.
9. Mazuecos A, Fernandez A, Andres A et al. HIV infection and renal transplantation.
Nephrol Dial Transplant 2011; 26(4):1401-7.
10. Organ Procurement and Transplantation Network. Data reports. Available online at:
http://optn.transplant.hrsa.gov/latestData/step2.asp? Last accessed April, 2013.
11. Barocci S, Valente U, Fontana I et al. Long-term outcome on kidney retransplantation: a
review of 100 cases from a single center. Transplant Proc 2009; 41(4):1156-8.
12. Johnston O, Rose CL, Gill JS et al. Risks and benefits of preemptive second kidney
transplantation. Transplantation 2013; 95(5):705-10.
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 27
13. Bhagani S, Sweny P, Brook G. British H. I. V. Association Guidelines for kidney
transplantation in patients with H. I. V. disease. HIV Med 2006; 7(3):133-9.
14. Medicare Benefit Policy Manual. Chapter 11- End Stage Renal Disease (ESRD).
Available online at: http://www.cms.gov/manuals/Downloads/bp102c11.pdf. Last
accessed April, 2013.
Allogeneic Pancreas Transplant
1. Hirshberg B. The cardinal features of recurrent autoimmunity in simultaneous pancreas-
kidney transplant recipients. Curr Diab Rep 2010; 10(5):321-2.
2. Organ Procurement and Transplantation Network (OPTN). Available online at:
http://optn.transplant.hrsa.gov. Last accessed January, 2013.
3. Gruessner AC. 2011 update on pancreas transplantation: Comprehensive trend analysis
of 25,000 cases followed up over the course of twenty-four years at the International
Pancreas Transplant Registry. Rev Diabet Stud 2011; 8(1):6-16.
4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pancreas
Transplantation. TEC Assessments 1998; Volume 13, Tab 7.
5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pancreas
Retransplantation. TEC Assessments 2001; Volume 16, Tab 23.
6. Fridell JA, Mangus RS, Hollinger EF et al. The case for pancreas after kidney
transplantation. Clin Transplant 2009; 23(4):447-53.
7. Bazerbachi F, Selzner M, Marquez MA et al. Pancreas-After-Kidney Versus Synchronous
Pancreas-Kidney Transplantation: Comparison of Intermediate-Term Results.
Transplantation 2012.
8. Kleinclauss F, Fauda M, Sutherland DE et al. Pancreas after living donor kidney
transplants in diabetic patients: impact on long-term kidney graft function. Clin
Transplant 2009; 23(4):437-46.
9. Scalea JR, Butler CC, Munivenkatappa RB et al. Pancreas transplant alone as an
independent risk factor for the development of renal failure: a retrospective study.
Transplantation 2008; 86(12):1789-94.
10. Gruessner AC, Sutherland DE, Gruessner RW. Long-term outcome after pancreas
transplantation. Curr Opin Organ Transplant 2012; 17(1):100-5.
11. Mora M, Ricart MJ, Casamitjana R et al. Pancreas and kidney transplantation: long-
term endocrine function. Clin Transplant 2010; 24(6):E236-40.
12. Davenport C, Hamid N, O'Sullivan EP et al. The impact of pancreas and kidney
transplant on cardiovascular risk factors (analyzed by mode of immunosuppression and
exocrine drainage). Clin Transplant 2009; 23(5):616-20.
13. Sampaio MS, Kuo HT, Bunnapradist S. Outcomes of simultaneous pancreas-kidney
transplantation in type 2 diabetic patients. Clin J Am Soc Nephrol 2011; 6(5):1198-206.
14. Buron F, Thaunat O, Demuylder-Mischler S et al. Pancreas Retransplantation: A Second
Chance for Diabetic Patients? Transplantation 2013; 95(2):347-52.
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 28
15. Girman P, Lipar K, Koznarova R et al. Similar early complication rate in simultaneous
pancreas and kidney recipients on tacrolimus/mycophenolate mofetil versus
tacrolimus/sirolimus immunosuppressive regimens. Transplant Proc 2010; 42(6):1999-
2002.
16. Kaufman DB, Iii GW, Bruce DS et al. Prospective, randomized, multi-center trial of
antibody induction therapy in simultaneous pancreas-kidney transplantation. Am J
Transplant 2003; 3(7):855-64.
17. Knight RJ, Kerman RH, Zela S et al. Thymoglobulin, sirolimus, and reduced-dose
cyclosporine provides excellent rejection prophylaxis for pancreas transplantation.
Transplantation 2003; 75(8):1301-6.
18. Reddy KS, Stablein D, Taranto S et al. Long-term survival following simultaneous
kidney-pancreas transplantation versus kidney transplantation alone in patients with type
1 diabetes mellitus and renal failure. Am J Kidney Dis 2003; 41(2):464-70.
19. Stratta RJ, Alloway RR, Lo A et al. Two-dose daclizumab regimen in simultaneous
kidney-pancreas transplant recipients: primary endpoint analysis of a multicenter,
randomized study. Transplantation 2003; 75(8):1260-6.
20. Cantarovich D, Vistoli F. Minimization protocols in pancreas transplantation. Transpl
Int 2009; 22(1):61-8.
21. Organ Procurement and Transplantation Network (OPTN). Identification of
Transmissible Diseases in Organ Recipients. Available online at:
http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_16.pdf. Last
accessed January, 2013.
22. Bhagani S, Sweny P, Brook G. Guidelines for kidney transplantation in patients with HIV
disease. HIV Med 2006; 7(3):133-9.
23. Afaneh C, Rich BS, Aull MJ et al. Pancreas transplantation: does age increase
morbidity? J Transplant 2011; 2011:596801.
24. Schenker P, Vonend O, Kruger B et al. Long-term results of pancreas transplantation in
patients older than 50 years. Transplant Int 2011; 24(2):136-42.
25. Gruessner AC, Sutherland DE. Access to pancreas transplantation should not be
restricted because of age. Transplant Int 2011; 24(2):134-35.
26. Organ Procurement and Transplantation Network (OPTN). Policies and Bylaws:
Allocation of Deceased Kidneys. Available online at:
http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_7.pdf. . Last
accessed January, 2013.
27. Canadian Agency for Drugs and Technology in Health. Pancreas Transplantation to
Restore Glucose Control: Review of Clinical and Economic Evidence. 2007. Available
online at: http://cadth.ca/media/pdf/I3005_Pancreatic_Transplantation_tr_e.pdf. Last
accessed January, 2013.
28. Centers for Medicare and Medicaid Services (CMS). Medicare approved pancreas and
kidney/pancreas transplant centers. Available online at:
http://www.cms.gov/CertificationandComplianc/Downloads/ApprovedTransplantProgra
ms.pdf. . Last accessed January, 2013.
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 29
29. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination
(NCD) for pancreas Transplants (260.3). Effective 4/26/2006. Available online at:
www.cms.gov. Last accessed January, 2013.
X. POLICY HISTORY TOP
MP 9.055 CAC 7/27/04
CAC 8/30/05
CAC 9/27/05
CAC 7/25/06
CAC 7/31/07
CAC 5/27/08
CAC 5/26/09
CAC 5/25/10 Consensus
CAC 4/26/11 Consensus
CAC 11/22/11 Minor revision. A list of absolute contraindications for kidney
transplantation considered not medically necessary added to the policy. A list of not
medically necessary indications and relative contraindications were added to
pancreas transplant criteria.
04/08/2013- Codes reviewed-skb
7/18/13 Admin code review complete--rsb
CAC 11/26/13 Minor revision. BCBSA policy adopted. Policy wording
revised to state that kidney transplants with either a living or cadaver donor
may be considered medically necessary for carefully selected candidates with
end-stage renal disease. Kidney retransplant after a failed primary transplant
was added as a new medically necessary indication. For allogeneic pancreas
transplant, not medically necessary statements were removed. Policy
guidelines and rationale were added. FEP variation revised. Policy coded.
MEDICAL POLICY
POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS
KIDNEY/PANCREAS TRANSPLANTS
POLICY NUMBER MP- 9.005
Page 30
Top
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance
Company®, Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent licensees of the
BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs
and provider relations for all companies.
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