Download Solid Organ Transplant

JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
ACTION:
☐ New Policy
☒ Revising Policy Number: CMS19.05
☐ Superseding Policy Number
☐ Archiving Policy Number
☐ Retiring Policy Number
Policy Number
CMS19.05
Page 1 of 17
Effective Date: 03/2003
Review Dates: 10/22/04, 10/21/05,
10/19/06, 6/25/08, 6/4/09, 6/4/10, 1/07/11,
8/20/13, 12/6/13, 9/4/2015
Johns Hopkins HealthCare (JHHC) provides a full spectrum of health care products and services
for Employer Health Programs, Priority Partners, and US Family Health Plan. Each line of
business possesses its own unique contract and guidelines which, for benefit and payment
purposes, should be consulted to know what benefits are available for reimbursement. Specific
contract benefits, guidelines or policies supersede the information outlined in this policy.
POLICY:
For US Family Health Plan see TRICARE Policy Manual 6010.57-M, February 1, 2008,
Heart-Lung and Lung Transplantation: Chapter 4, Section 24.1;
Simultaneous Pancreas-Kidney (SPK), Pancreas-after-Kidney (PAK) and Pancreas
Transplant Alone (PTA), and Pancreatic Islet Cell Transplantation: Chapter 4, Section 24.7;
Combined Liver-Kidney Transplantation (CLKT): Chapter 4, Section 24.6;
Heart Transplantation: Chapter 4, Section 24.2;
Small Intestine (SI), Combined Small Intestine-Liver (SI/L) and Multivisceral
Transplantation: Chapter 4, Section 24.4;
Combined Heart-Kidney Transplantation (CHKT): Chapter 4, Section 24.3;
Kidney Transplantation: Chapter 4, Section 24.8;
High Dose Chemotherapy (HDC) and Stem Cell Transplantation: Chapter 4, Section 23.1;
Liver Transplantation: Chapter 4, Section 24.5.
I.
All transplants must be performed at a facility certified for the type of organ transplant
requested.
II.
All solid organ transplants require Medical Director review for authorization prior to
listing. A comprehensive medical and psychosocial evaluation is required in order to
address the general contraindications in Section III (below) as well as any organ specific
medical necessity criteria. The evaluation must also specifically address the patient’s life
expectancy with transplant and ability to benefit from transplantation.
III.
The following contraindications apply to all solid organ transplants:
A.
B.
C.
Major psychiatric illness that cannot be managed sufficiently to allow posttransplant care and safety
Evidence of significant non-compliance
Multiple uncorrectable congenital anomalies
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
D.
E.
F.
G.
H.
IV.
Policy Number
CMS19.05
Page 2 of 17
Severe neurological deficit
Life expectancy with transplant < 5 years
Active substance abuse (drugs, alcohol)
1. All patients with a current or past history of drug and/or alcohol abuse must
have a comprehensive evaluation by a psychiatrist or psychologist with
expertise in the diagnosis and treatment of addiction; AND
2. Patients with current drug and/or alcohol abuse must comply with the
treatment recommendations based on the assessment for a minimum of 90
days. Documentation of compliance and sobriety must be submitted with the
request for listing; AND
3. Patients with current drug and/or alcohol abuse must have a plan for on-going
monitoring and treatment during the pre- and post-transplant period
Advanced cardiopulmonary disease
Significant organ system failure (other than the organ being transplanted)
Once the evaluation has been completed, JHHC will make a determination regarding
approval of the transplant using the organ-specific criteria below:
A.
When benefits are provided under the member’s contract, Johns Hopkins
HealthCare, (JHHC) considers HEART TRANSPLANTATION medically
necessary when the member meets the above listed requirements AND the
transplanting institution's protocol eligibility criteria
1. In the absence of a protocol, JHHC considers heart transplantation medically
necessary for heart failure with irreversible underlying etiology when the
member meets the above listed criteria in sections I, II and III, AND when
ALL of the following criteria are met:
a. New York Heart Association (NYHA) classification of heart failure III or
IV (see Appendix), -- does not apply to pediatric members; AND
b. Member has potential for conditioning and rehabilitation after transplant
(i.e., member is not moribund); AND
c. No malignancy (except for non-melanomatous skin cancers) or
malignancy has been completely resected or (upon individual case review)
malignancy has been adequately treated with no substantial likelihood of
recurrence with acceptable future risks; AND
d. Adequate pulmonary, liver and renal function; AND
e. Absence of active infections that are not effectively treated; AND
f. Member has any of the following conditions (not an all-inclusive list):
i. Cardiac arrhythmia
ii. Cardiac re-transplantation due to graft failure
iii. Cardiomyopathy due to nutritional, metabolic, hypertrophic or
restrictive etiologies
iv. Congenital heart disease
v. End-stage ventricular failure
vi. Idiopathic dilated cardiomyopathy
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
vii.
viii.
ix.
x.
xi.
xii.
B.
Policy Number
CMS19.05
Page 3 of 17
Inability to be weaned from temporary cardiac-assist devices after
myocardial infarction or non-transplant cardiac surgery
Intractable coronary artery disease
Myocarditis
Post-partum cardiomyopathy
Right ventricular dysplasia/cardiomyopathy
Valvular heart disease
When benefits are provided under the member’s contract, Johns Hopkins
HealthCare, (JHHC) considers HEART-LUNG TRANSPLANTATION
medically necessary when the member meets the above listed requirements AND
the transplanting institution's protocol eligibility criteria.
1. In the absence of a protocol, JHHC considers heart-lung transplantation
medically necessary for severe refractory heart failure plus either end-stage
lung disease or irreversible pulmonary hypertension when the member meets
the above listed criteria in sections I, II and III, AND when ALL of the
following criteria are met:
a. Absence of chronic high-dose steroid therapy. Due to problems in
bronchial healing, persons receiving high-dose steroids are considered
inappropriate candidates; AND
b. Absence of acute or chronic active infections that are not effectively
treated; AND
c. Absence of malignancy (other than non-melanomatous skin cancers) or
malignancy has been completely resected or (upon medical review) it is
determined that malignancy has been treated with small likelihood of
recurrence and acceptable future risks; AND
d. Adequate functional status. Active rehabilitation is considered important
to the success of transplantation. Under established guidelines,
mechanically ventilated or otherwise immobile persons are considered
poor candidates for transplantation; however, bridge to transplant with
ambulatory ECMO does not, in itself, rule out candidacy for heart-lung
transplantation; AND
e. Member has any of the following conditions (not an all-inclusive list):
i. Chronic obstructive pulmonary disease with severe heart failure*
ii. Congenital heart disease associated with pulmonary hypertension
that are not amenable to lung transplantation and repair by standard
cardiac surgery
iii. Cystic fibrosis with severe heart failure*
iv. Eisenmenger’s complex with irreversible pulmonary hypertension
and severe heart failure*
v. Irreversible primary pulmonary hypertension with severe heart
failure*
vi. Connective tissue disease or other causes of severe pulmonary
fibrosis with uncontrollable pulmonary hypertension or severe heart
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number
CMS19.05
Page 4 of 17
failure*
vii. Severe coronary artery disease or cardiomyopathy with irreversible
pulmonary hypertension
2. Heart-lung transplantation is considered not medically necessary where lung
transplantation alone will restore right ventricular function; every attempt
should be made to preserve the heart.
3. Heart-lung transplantation may be considered medically necessary for other
congenital cardiopulmonary anomalies upon individual case review.
* Note ~ Severe (New York Heart Association (NYHA) classification III or IV (see Appendix))
heart failure where right ventricular function would not be restored with lung transplant alone.
C.
When benefits are provided under the member’s contract, Johns Hopkins
HealthCare, (JHHC) considers PANCREAS TRANSPLANTATION ALONE
(PTA) WITHOUT KIDNEY TRANSPLANT medically necessary when the
member meets the above listed requirements in sections I, II and III, AND the
transplanting institution's protocol eligibility criteria.
1. In the absence of a protocol, JHHC considers pancreas transplantation alone
(PTA) without kidney transplant medically necessary when the member meets
the above listed criteria in sections I, II and III, AND when ALL of the
following criteria are met:
a. Absence of ongoing or recurrent active infections that are not effectively
treated; AND
b. Member has adequate cardiac status (e.g., no angiographic evidence of
significant coronary artery disease, ejection fraction greater than or equal
to 40 %, no myocardial infarction in last 6 months, negative stress test);
AND
c. No malignancy (except for non-melanomatous skin cancers) or
malignancy has been completely resected OR (upon medical review)
malignancy has been adequately treated such that the risk of recurrence is
small; AND
d. Member has a history of labile (brittle) insulin-dependent diabetes
mellitus (IDDM); AND
e. Member has recurrent, acute and severe metabolic and potentially lifethreatening complications requiring medical attention, as documented by
chart notes, frequent emergency room visits and/or hospitalizations. They
may include:
i. Hyperglycemia; OR
ii. Hypoglycemia; OR
iii. Hypoglycemic unawareness associated with high risk of injury;OR
iv. Ketoacidosis; AND
f. Member has consistent failure of exogenous insulin-based management,
defined as inability to achieve sufficient glycemic control (HbA1c of
greater than 8.0) or recurrent hypoglycemic unawareness, despite
aggressive conventional therapy including all of the following:
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
2.
3.
4.
5.
6.
D.
Policy Number
CMS19.05
Page 5 of 17
i. Adjusting frequencies and amounts of insulin injected; AND
ii. Measuring multiple blood glucose levels on a daily basis; AND
iii. Modifying diet and exercise; AND
iv. Monitoring HgbA1c levels.
Pancreas retransplantation after a failed primary pancreas transplant is
considered medically necessary when member meets the selection criteria
stated above.
Pancreas retransplantation after 2 or more prior failed pancreas transplants may
be considered medically necessary upon individual case review.
Pancreas transplant is considered medically necessary for members with the
following relative contraindications to pancreas transplant only if the
requesting physician documents that these relative contraindications were
considered, and has determined that the benefits of pancreas transplant
outweigh the risks in these members. Relative contraindications to PTA
include the following:
a.
Ejection fraction 35 % to 40 %; OR
b.
Severe peripheral vascular disease.
Islet cell autotransplantation (i.e., transplantation of the member's own islet
cells) medically necessary for members undergoing near-total or total
pancreatic resection for severe, refractory chronic pancreatitis.
Partial pancreas transplant from a living donor is considered an acceptable
alternative to cadaveric transplant for persons who meet medical necessity
criteria for pancreas transplant.
When benefits are provided under the member’s contract, Johns Hopkins
HealthCare, (JHHC) considers SIMULTANEOUS PANCREAS KIDNEY
TRANSPLANTATION (SPK) and SIMULTANEOUS CADAVER-DONOR
PANCREAS and LIVING-DONOR KIDNEY (SPLK) TRANSPLANTATION
medically necessary for members with diabetes and end-stage renal disease
(ESRD) who meet the above listed requirements in sections I, II and III AND the
transplanting institution's protocol eligibility criteria.
1. In the absence of a protocol, JHHC considers SPK transplantation and SPLK
transplantation medically necessary in persons with diabetes and ESRD when
the member meets the above listed criteria in sections I, II and III, AND when
ALL of the following criteria are met:
a. Member has a creatinine clearance (Clcr), calculated by the CockcroftGault formula (see Appendix), of less than 20 ml/min, or a directly
measured glomerular filtration rate (GFR) of less than 20 ml/min; AND
b. Member has ESRD and requires dialysis or is expected to require dialysis
in the next 12 months.
2. JHHC considers SPK and PAK transplantation medically necessary for persons
with any of the following relative contraindications if the attending physician
determines and documents that the potential benefits of SPK transplantation
outweigh the risks. Relative contraindications to SPK transplantation include:
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
a.
b.
c.
d.
e.
f.
g.
h.
E.
Policy Number
CMS19.05
Page 6 of 17
Chronic liver disease
Clinical evidence of severe cerebrovascular or peripheral vascular disease
(e.g., ischemic ulcers, previous amputation secondary to vascular
disease). Adequate peripheral arterial supply should be determined by
standard evaluation in the vascular laboratory including Doppler
examination and plethysmographic readings of systolic blood pressure.
Past psychosocial abnormality
Persons with body mass index (BMI) of 35 or higher and type 2 diabetes
Structural genito-urinary abnormality or recurrent urinary tract infection
Substance abuse history (other than persistent substance abuse as
indicated in Section III, F.)
Treated malignancy (SPK transplantation is considered medically
necessary in persons with malignant neoplasm if the neoplasm has been
adequately treated and the risk of recurrence is small)
Uncontrolled hypertension
When benefits are provided under the member’s contract, Johns Hopkins
HealthCare, (JHHC) considers KIDNEY TRANSPLANTATION medically
necessary for members who meet the above listed requirements in sections I, II and
III AND the transplanting institution's protocol eligibility criteria, AND meets ALL
of the following criteria:
1. Absence of malignancy or the malignancy has had curative therapy (e.g.,
surgical resection of non-invasive squamous cell or basal cell skin cancer) or
the estimated risk of recurrence of the malignancy is less than 10 % within the
next 2 years. For example, renal cell carcinoma treated by nephrectomy with
no evidence of metastatic disease 2 years after the nephrectomy, prostate
cancer with negative prostate-specific antigen levels after treatment, surgically
treated colon cancer, thyroid cancer with normal thyroglobulin levels after
therapy, and others. Women should have a negative Pap smear within the
past 3 years and mammography, where indicated, within the past 2 years; AND
2. Absence of systemic infection; AND
3. Attending physician determines that there is no prohibitive cardiovascular,
pulmonary and hepatic risk; AND
4. Severity of disease is equal to at least ONE of the following:
a. Member is already on hemodialysis or continuous ambulatory peritoneal
dialysis (CAPD); OR
b. Member has chronic renal failure with anticipated deterioration to end
stage renal disease, where member is seeking precertification for
cadaveric kidney transplantation**; OR
c. Member has end stage renal disease, evidenced by a creatinine clearance
below 20 ml/min or development of symptoms of uremia, and member is
seeking precertification for a living donor kidney transplantation.
5. Given waiting periods for cadaveric donors averaging 1 to 4 years, kidney
transplantation is considered medically necessary for persons with severe
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number
CMS19.05
Page 7 of 17
chronic renal failure with anticipated progression to end stage renal
disease. Severe chronic renal failure is defined as a creatinine clearance of less
than 30 ml/min.
F.
When benefits are provided under the member’s contract, Johns Hopkins
HealthCare, (JHHC) considers COMBINED KIDNEY/PANCREAS
TRANSPLANTATION medically necessary for members who meet the above
listed requirements in sections I, II and III AND the transplanting institution's
protocol eligibility criteria for persons undergoing kidney transplantation due to
diabetic nephropathy.
G.
When benefits are provided under the member’s contract, Johns Hopkins
HealthCare, (JHHC) considers LIVER TRANSPLATATION medically necessary
for the indications listed below for adolescents and adults with either (i) a Model of
End-stage Liver Disease (MELD) score (see Appendix) greater than 10; or (ii) who
are approved for transplant by the United Network for Organ Sharing (UNOS)
Regional Review Board, and for children less than 12 years of age who meet the
transplanting institution's selection criteria. Requests for liver transplantation for
adolescents and adults with a MELD score of 10 or less who have not been
approved by the UNOS Regional Review Board are subject to medical necessity
review. In the absence of an institution's selection criteria, JHHC considers liver
transplantation medically necessary for adolescents and adults with a MELD score
greater than 10 or who are approved by the UNOS Regional Review Board and for
children who meet the medical necessity criteria specified below using orthotopic
(normal anatomical position) liver transplantation (with cadaveric organ, reducedsize organ, living related organ, and split liver) for members with end-stage liver
disease (ESLD) due to any of the following conditions, (not an all-inclusive list):
1.
Cholestatic diseases:
a. Biliary atresia
b. Familial cholestatic syndromes
c. Primary biliary cirrhosis
d. Primary sclerosing cholangitis with development of secondary biliary
cirrhosis
2.
Hepatocellular diseases:
a. Alcoholic cirrhosis
b. Chronic active hepatitis with cirrhosis (hepatitis B or C)
c. Cryptogenic cirrhosis
d. Idiopathic autoimmune hepatitis
e. Post-necrotic cirrhosis due to hepatitis B surface antigen negative state
3.
Malignancies:
a. Primary hepatocellular carcinoma confined to the liver when all of the
following criteria are met:
i. Any lung metastases that have been shown to be responsive to
chemotherapy; AND
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
4.
5.
6.
7.
8.
9.
10.
11.
Policy Number
CMS19.05
Page 8 of 17
ii. Member is not a candidate for subtotal liver resection; AND
iii. Member meets UNOS criteria for tumor size and number; AND
iv. There is no identifiable extra-hepatic spread of tumor to
surrounding lymph nodes, abdominal organs, bone or other sites;
AND
v. There is no macrovascular involvement
vi. These criteria are intended to be consistent with UNOS guidelines
for selection of liver transplant candidates for hepato-cellular
carcinoma (HCC).
Hepatoblastomas in children when all of the following criteria are met:
a. Member is not a candidate for subtotal liver resection; AND
b. Member meets UNOS criteria for tumor size and number; AND
c. There is no identifiable extra-hepatic spread of tumor to surrounding
lungs, abdominal organs, bone or other sites. (Note: Spread of
hepatoblastoma to veins and lymph nodes does not disqualify a member
for coverage of a liver transplant.)
Epithelioid hemangioendotheliomas
Intra-hepatic cholangiocarcinomas (i.e., cholangiocarcinomas confined to the
liver);
Large, unresectable fibrolamellar HCCs;
Metastatic neuroendocrine tumors (carcinoid tumors, apudomas, gastrinomas,
glucagonomas) in persons with severe symptoms and with metastases
restricted to the liver, who are unresponsive to adjuvant therapy after
aggressive surgical resection including excision of the primary lesion and
reduction of hepatic metastases.
Vascular diseases such as Budd-Chiari syndrome, Veno-occlusive disease
Metabolic disorders and metabolic liver diseases with cirrhosis such as (not an
all-inclusive list):
a. Alpha 1-antitrypsin deficiency
b. Hemochromatosis
c. Inborn errors of metabolism
d. Protoporphyria
e. Wilson's disease
Miscellaneous:
a. Familial amyloid polyneuropathy
b. Polycystic disease of the liver
c. Porto-pulmonary hypertension (pulmonary hypertension associated with
liver disease or portal hypertension) in persons with a mean pulmonary
artery pressure by catheterization of less than 35 mm Hg
d. Toxic reactions (fulminant hepatic failure due to mushroom poisoning,
acetaminophen (Tylenol) overdose, etc.)
e. Trauma
f. Hepato-pulmonary syndrome when ALL of the following selection
criteria are met:
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
12.
H.
Policy Number
CMS19.05
Page 9 of 17
i. Arterial hypoxemia (PaO2 less than 60 mm Hg or AaO2 gradient
greater than 20 mm Hg in supine or standing position); AND
ii. Chronic liver disease with non-cirrhotic portal hypertension; AND
iii. Intrapulmonary vascular dilatation (as indicated by contrastenhanced echocardiography, technetium-99 macroaggregated
albumin perfusion scan, or pulmonary angiography)
Retransplantation is considered medically necessary following a failed liver
transplant if the initial transplant was performed for a covered indication.
When benefits are provided under the member’s contract, JHHC considers LUNG
TRANSPLANTATION medically necessary for the following conditions when
the member meets the above listed criteria in sections I, II and III, AND when ALL
of the following criteria are met:
1.
Qualifying Conditions for Lung Transplantation:
a. Alpha1-antitrypsin deficiency: Persons who meet the emphysema/alpha1antitrypsin deficiency disease-specific selection criteria below
b. Broncho-pulmonary dysplasia
c. Congenital heart disease (Eisenmenger's defect or complex): Persons
who meet the disease-specific criteria for Eisenmenger's below
d. Cystic fibrosis: Persons who meet the disease-specific selection criteria
for cystic fibrosis
e. Graft-versus-host disease or failed primary lung graft
f. Lymphangioleiomyomatosis (LAM) with end-stage pulmonary disease
g. Obstructive lung disease (e.g., bronchiectasis, bronchiolitis obliterans,
chronic obstructive pulmonary disease (COPD), emphysema): For
persons with pulmonary fibrosis, see the disease-specific selection
criteria for pulmonary fibrosis below
h. Primary pulmonary hypertension: Persons who meet the disease-specific
selection criteria for primary pulmonary hypertension
i. Restrictive lung disease (e.g., allergic alveolitis, asbestosis, collagen
vascular disease, desquamative interstitial fibrosis, eosinophilic
granuloma, idiopathic pulmonary fibrosis, post-chemotherapy,
sarcoidosis, and systemic sclerosis [scleroderma]): For persons with
sarcoidosis, see the disease-specific selection criteria below.
2.
Disease-Specific Selection Criteria:
a. Lung transplant for CYSTIC FIBROSIS (CF) is considered medically
necessary for persons who meet the general selection criteria for lung
transplantation and exhibit AT LEAST 2 of the following signs and
symptoms of clinical deterioration:
i.
Cycling intravenous antibiotic therapy
ii. Decreasing forced expiratory volume in 1 second (FEV1)
iii. Development of carbon dioxide (CO2) retention (pCO2 greater
than 50 mm Hg)
iv.
FEV1 less than 30 % predicted
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
v.
vi.
b.
c.
d.
Policy Number
CMS19.05
Page 10 of 17
Increasing frequency of hospital admission
Increasing severe exacerbation of CF -- especially an episode
requiring hospital admission
vii. Initiation of supplemental enteral feeding by percutaneous
endoscopic gastrostomy or parenteral nutrition
viii. Non-invasive nocturnal mechanical ventilation
ix. Recurrent massive hemoptysis
x. Worsening arterial-alveolar (A-a) gradient requiring increasing
concentrations of inspired oxygen (FiO2)
xi. Recurrent pneumothorax
Lung transplant for EMPHYSEMA (including alpha 1-antitrypsin
deficiency) is considered medically necessary for persons who meet the
general criteria for lung transplantation AND BOTH of the following
clinical criteria:
i.
Hospitalizations for exacerbation of COPD associated with
hypercapnia in the preceding year. Hypercapnia is defined as
pCO2 greater than or equal to 50 mm Hg with hospitalizations
AND/OR the following associated factors:
• Declining body mass index
• Increasing oxygen requirements
• Reduced serum albumin
• Presence of cor pulmonale (defined as clinical diagnosis by a
physician or any 2 of the following:
 enlarged pulmonary arteries on chest X-ray
 mean pulmonary artery pressure by right heart
catheterization of greater than 25 mm Hg at rest or 30 mm
Hg with exercise
 pedal edema or jugular venous distention
 right ventricular hypertrophy or right atrial enlargement
on EKG
 BODE index of 7 or above (indicating 2 years or less
survival) (see appendix).
Lung transplant for EISENMENGER’S COMPLEX is considered
medically necessary for persons who meet the general criteria for lung
transplantation and ANY of the following disease-specific criteria:
i. Marked deterioration in functional capacity (New York Heart
Association (NYHA) Class III)
ii. Pulmonary hypertension with mean pulmonary artery pressure by
right heart catheterization greater than 25 mm Hg at rest or 30 mm
Hg with exercise
iii. Signs of right ventricular failure - progressive hepatomegaly,
ascites
Lung transplant for PULMONARY FIBROSIS is considered medically
necessary for persons who meet the general criteria for lung
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
e.
f.
g.
I.
Policy Number
CMS19.05
Page 11 of 17
transplantation and ANY of the following disease-specific criteria:
i. Diffusing capacity for carbon monoxide (DLCO) less than 60 %
predicted
ii. Presence of cor pulmonale (indicative of severe pulmonary fibrosis)
or pulmonary hypertension
iii. Total lung capacity (TLC) less than 70 % predicted
Lung transplant for PULMONARY HYPERTENSION is considered
medically necessary for persons who meet the general criteria for lung
transplantation plus ANY of the following criteria, and valvular disease
has been excluded by echocardiography:
i. Persons who are NYHA III, failing conventional vasodilators
(calcium channel blockers or endothelin receptor antagonists)
ii. Persons who are NYHA III, and have initiated or being considered
for initiation of parenteral or subcutaneous vasodilator therapy
iii. Pulmonary hypertension with mean pulmonary artery pressure by
right heart catheterization of greater than 25 mm Hg at rest or 30
mm Hg with exercise, or pulmonary artery systolic pressure of 50
mm Hg or more defined by echocardiography or pulmonary
angiography
Lung transplant for SARCOIDOSIS is considered medically necessary
for persons who meet the general criteria for lung transplantation plus
ANY of the following disease-specific criteria:
i. DLCO less than 60 % predicted
ii. Presence of cor pulmonale (indicative of severe pulmonary fibrosis)
or pulmonary hypertension
iii. Total lung capacity less than 70 % predicted
JHHC considers LOBAR (from living-related donors or cadaver
donors) LUNG TRANSPLANTATION medically necessary for
persons with end-stage pulmonary disease when above listed criteria in
sections I, II and III are met.
When benefits are provided under the member’s contract, Johns Hopkins
HealthCare, (JHHC) considers INTESTINAL TRANSPLANTATION medically
necessary when the member meets the above listed requirements in sections I, II
and III, AND the transplanting institution's protocol eligibility criteria.
1.
In the absence of a protocol, JHHC considers heart transplantation medically
necessary for heart failure with irreversible underlying etiology when the
member meets the above listed criteria in sections I, II and III, AND when
ALL of the following criteria are met:
a. failed total parenteral nutrition (TPN); AND
b. Absence of acute or chronic active infections that are not effectively
treated; AND
c. Adequate cardiovascular function (ejection fraction greater than or equal
to 40 %); AND
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
2.
3.
4.
Policy Number
CMS19.05
Page 12 of 17
A combined intestinal and liver transplant is considered medically necessary
for persons with advanced liver disease necessitating liver transplantation
In candidates for a combined transplant, adequacy of renal function should be
assessed with a measured glomerular filtration rate (GFR), as a calculated
GFR is inaccurate in advanced liver disease.
Multi-visceral transplants from deceased donors are considered medically
necessary for adults and children who meet criteria for the combined small
bowel/liver transplant and require 1 or more abdominal visceral organs to be
transplanted due to concomitant organ failure or anatomical abnormalities that
preclude a small bowel/liver transplant.
APPENDIX:
New York Heart Association (NYHA) classification:
A.
B.
Class III: Persons with cardiac disease resulting in marked limitation of physical
activity. They are comfortable at rest. Less than ordinary activity (i.e., mild
exertion) causes fatigue, palpitation, dyspnea, or anginal pain
Class IV: Persons with cardiac disease resulting in inability to carry on any physical
activity without discomfort. Symptoms of cardiac insufficiency or of the anginal
syndrome may be present even at rest. If any physical activity is undertaken,
discomfort is increased.
MELD Score Calculator:
https://optn.transplant.hrsa.gov/resources/allocation-calculators/meld-calculator/
The BODE Index (Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise) is a
multidimensional capacity index for COPD. The index uses the four factors for predicting the
risk of death from the disease: FEV1, body mass index, dyspnea score and 6 minute walk test.
BACKGROUND:
Organ transplants are responsible for saving countless lives every year. Transplants are
authorized when the health of a patient’s organ is deteriorating and needs to be replaced by
another matching, healthy organ. The most common organs that are subject to transplant
procedure include the lungs, heart, liver, and kidneys.
Patients that show signs of infections, heart problems, or substance abuse are not often
considered candidates for transplant procedures. The success of organ transplants depends on
numerous factors. These include organ type, the amount of organs being replaced, and the
disease or condition that caused organ failure. Prior to surgery, physicians often consult with
numerous medical professionals and psychiatrists to ensure the patient is considered an ideal
candidate for organ transplant surgery.
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number
CMS19.05
Page 13 of 17
CODING INFORMATION:
CPT Copyright 2016 American Medical Association. All rights reserved. CPT is a registered
trademark of the American Medical Association.
Note: The following CPT/HCPCS codes are included below for informational
purposes. Inclusion or exclusion of a CPT/HCPCS code(s) below does not signify or imply
member coverage or provider reimbursement. The member's specific benefit plan
determines coverage and referral requirements. All inpatient admissions require preauthorization.
PRE- AUTHORIZATION REQUIRED
Compliance with the provision in this policy may be monitored and addressed through post
payment data analysis and/or medical review audits
Employer Health
Programs (EHP) **See
Specific Summary Plan
Description (SPD)
CPT ®
CODES
32850
32851
32852
32853
32854
32855
32856
33930
33933
33935
33940
Priority Partners (PPMCO)
refer to COMAR guidelines
and PPMCO SPD then
apply policy criteria
US Family Health Plan
(USFHP), TRICARE Medical
Policy supersedes JHHC Medical
Policy. If there is no Policy in
TRICARE, apply the Medical
Policy Criteria
DESCRIPTION
Donor pneumonectomy(s) (including cold preservation), from cadaver donor
Lung transplant, single; without cardiopulmonary bypass
Lung transplant, single; with cardiopulmonary bypass
Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary
bypass
Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary
bypass
Backbench standard preparation of cadaver donor lung allograft prior to
transplantation, including dissection of allograft from surrounding soft tissues to
prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; unilateral
Backbench standard preparation of cadaver donor lung allograft prior to
transplantation, including dissection of allograft from surrounding soft tissues to
prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; bilateral
Donor cardiectomy-pneumonectomy (including cold preservation)
Backbench standard preparation of cadaver donor heart/lung allograft prior to
transplantation, including dissection of allograft from surrounding soft tissues to
prepare aorta, superior vena cava, inferior vena cava, and trachea for implantation
Heart-lung transplant with recipient cardiectomy-pneumonectomy
Donor cardiectomy (including cold preservation)
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
33944
33945
47133
47135
47140
47141
47142
47143
47144
47145
47146
47147
48160
48550
48551
Policy Number
CMS19.05
Page 14 of 17
Backbench standard preparation of cadaver donor heart allograft prior to
transplantation, including dissection of allograft from surrounding soft tissues to
prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left
atrium for implantation
Heart transplant, with or without recipient cardiectomy
Donor hepatectomy (including cold preservation), from cadaver donor
Liver allotransplantation; orthotopic, partial or whole, from cadaver or living donor,
any age
Donor hepatectomy (including cold preservation), from living donor; left lateral
segment only (segments II and III)
Donor hepatectomy (including cold preservation), from living donor; total left
lobectomy (segments II, III and IV)
Donor hepatectomy (including cold preservation), from living donor; total right
lobectomy (segments V, VI, VII and VIII)
Backbench standard preparation of cadaver donor whole liver graft prior to
allotransplantation, including cholecystectomy, if necessary, and dissection and
removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic
artery, and common bile duct for implantation; without trisegment or lobe split
Backbench standard preparation of cadaver donor whole liver graft prior to
allotransplantation, including cholecystectomy, if necessary, and dissection and
removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic
artery, and common bile duct for implantation; with trisegment split of whole liver
graft into 2 partial liver grafts (ie, left lateral segment [segments II and III] and right
trisegment [segments I and IV through VIII])
Backbench standard preparation of cadaver donor whole liver graft prior to
allotransplantation, including cholecystectomy, if necessary, and dissection and
removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic
artery, and common bile duct for implantation; with lobe split of whole liver graft
into 2 partial liver grafts (ie, left lobe [segments II, III, and IV] and right lobe
[segments I and V through VIII])
Backbench reconstruction of cadaver or living donor liver graft prior to
allotransplantation; venous anastomosis, each
Backbench reconstruction of cadaver or living donor liver graft prior to
allotransplantation; arterial anastomosis, each
Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or
pancreatic islet cells
Donor pancreatectomy (including cold preservation), with or without duodenal
segment for transplantation
Backbench standard preparation of cadaver donor pancreas allograft prior to
transplantation, including dissection of allograft from surrounding soft tissues,
splenectomy, duodenotomy, ligation of bile duct, ligation of mesenteric vessels, and
Y-graft arterial anastomoses from iliac artery to superior mesenteric artery and to
splenic artery
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
48552
48554
48556
50300
50320
50323
50325
50327
50328
50329
50340
50360
50365
50370
50380
HCPCS
CODES
G0341
G0342
G0343
S2053
S2054
S2055
S2060
S2061
S2065
S2152
Policy Number
CMS19.05
Page 15 of 17
Backbench reconstruction of cadaver donor pancreas allograft prior to
transplantation, venous anastomosis, each
Transplantation of pancreatic allograft
Removal of transplanted pancreatic allograft
Donor nephrectomy (including cold preservation); from cadaver donor, unilateral or
bilateral
Donor nephrectomy (including cold preservation); open, from living donor
Backbench standard preparation of cadaver donor renal allograft prior to
transplantation, including dissection and removal of perinephric fat, diaphragmatic
and retroperitoneal attachments, excision of adrenal gland, and preparation of
ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary
Backbench standard preparation of living donor renal allograft (open or laparoscopic)
prior to transplantation, including dissection and removal of perinephric fat and
preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as
necessary
Backbench reconstruction of cadaver or living donor renal allograft prior to
transplantation; venous anastomosis, each
Backbench reconstruction of cadaver or living donor renal allograft prior to
transplantation; arterial anastomosis, each
Backbench reconstruction of cadaver or living donor renal allograft prior to
transplantation; ureteral anastomosis, each
Recipient nephrectomy (separate procedure)
Renal allotransplantation, implantation of graft; without recipient nephrectomy
Renal allotransplantation, implantation of graft; with recipient nephrectomy
Removal of transplanted renal allograft
Renal autotransplantation, reimplantation of kidney
DESCRIPTION
Percutaneous islet cell transplant, includes portal vein catheterization and infusion
Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion
Laparotomy for islet cell transplant, includes portal vein catheterization and infusion
Transplantation of small intestine and liver allografts
Transplantation of multivisceral organs
Harvesting of donor multivisceral organs, with preparation and maintenance of
allografts; from cadaver donor
Lobar lung transplantation
Donor lobectomy (lung) for transplantation, living donor
Simultaneous pancreas kidney transplantation
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 post-transplant care in the global definition
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number
CMS19.05
Page 16 of 17
REFERENCES STATEMENT:
Analyses of the scientific and clinical references cited below were conducted and utilized by the
Johns Hopkins HealthCare (JHHC) Medical Policy Team during the development and
implementation of this medical policy. Per NCQA standards, the Medical Policy Team will
continue to monitor and review any newly published clinical evidence and adjust the references
below accordingly if deemed necessary.
CLINICAL:
1.
2.
3.
4.
Scheffert, J., Raza, K. (2014). Immunosupression in lung transplantation. J Thorac
Dis, 6(8), 1039-1053.
Hachem, R., Edwards, L., et al. (2008). The impact of induction on survival after
lung transplantation: an analysis of the International Society for Heart and Lung
Transplantation Registry. Clin. Transplant, 22(5), 603-608.
Hayes, Inc. (2010). Medical Technology Directory: Lung Transplantation Induction
and Maintenance Immunosuppressive Therapy.
Hayes, Inc., Medical Technology Directory, (2008). Simultaneous Pancreas-Kidney
(SPK) Transplantation in Diabetic Patients.
HEALTH PLAN:
5.
6.
7.
8.
9.
CIGNA. (2015). Medical Coverage Policy: Heart, Lung, Heart-Lung
Transplantation. Policy Number 0129. Retrieved:
https://cignaforhcp.cigna.com/public/content/pdf/coveragePolicies/medical/mm_01
29_coveragepositioncriteria_heart_transplantation.pdf
Aetna. (2015). Medical Coverage Policy: Kidney Transplantation. Policy Number
0493. Retrieved: http://www.aetna.com/cpb/medical/data/400_499/0493.html
Aetna. (2015). Medical Coverage Policy: Liver Transplantation. Policy Number
0596. Retrieved: http://www.aetna.com/cpb/medical/data/500_599/0596.html
Aetna. (2015). Medical Coverage Policy: Heart Transplantation. Policy Number
0586. Retrieved: http://www.aetna.com/cpb/medical/data/500_599/0586.html
Anthem. (2015). Medical Coverage Policy: Heart/Lung Transplantation. Policy
Number 00026. Retrieved:
http://www.anthem.com/medicalpolicies/policies/mp_pw_a053840.htm
REGULATORY:
10.
11.
U.S. Department of Health and Human Services. (2015). United Network for Organ
Sharing Website. Policy Management and Policies. Retrieved:
http://optn.transplant.hrsa.gov/policiesAndBylaws/ policies.asp
TRICARE Policy Manual 6010.54M, Chapter 4. Section 24.3,- 24.4,TransplantsKidney, Combined Heart-Kidney Transplantation, Heart-Lung And Lung
Transplantation, Combined Heart-Kidney Transplantation, etc. : http://manuals.
JOHNS HOPKINS HEALTHCARE
Medical Policy: Solid Organ Transplantation
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
12.
13.
Policy Number
CMS19.05
Page 17 of 17
tricare.osd.mil/.
COMAR. 10.30.02.02 Transplant Centers. Retrieved: http://www.
dsd.state.md.us/comar
Centers for Medicare and Medicaid (CMS). National Coverage Determinations
(NCD) Chapter 1, Part 3, (Sections 170-190.34), 190-Pathology and Laboratory,
Histocompatibility Testing, Rev.1. 10/03.03, Typing or Matching for Preparation
for Kidney, Bone Marrow Transplantation and Blood Platelet Transfusions, at:
http://www.cms.gov/manuals/downloads/ncd103c1_Part3.pdf