Kidney Transplants, Pancreas Transplants, and Simultaneous ......transplantation (pancreas after kidney, i.e., PAK); or 3) a non-uremic diabetic patient with specific severely disabling

MEDICAL POLICY

POLICY TITLE KIDNEY TRANSPLANTS, PANCREAS TRANSPLANTS, AND SIMULTANEOUS

KIDNEY/PANCREAS TRANSPLANTS

POLICY NUMBER MP- 9.005

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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

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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

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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

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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*

http://www.cms.gov/CertificationandComplianc/20_Transplant.asp

http://bluewebportal.bcbs.com/landingpagelevel3/504100?docId=23980

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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.

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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

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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

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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.

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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.

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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.”


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

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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

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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

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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.”

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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.

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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

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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.

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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.


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.

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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


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


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.

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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.

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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.

Documents

Kidney Transplants, Pancreas Transplants, and Simultaneous ......transplantation (pancreas after kidney, i.e., PAK); or 3) a non-uremic diabetic patient with specific severely disabling