Transplantation of Lung Or Lobar Lung

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Medical Policy

Transplantation of Lung or Lobar Lung

Policy Number: OCA 3.24 Version Number: 18 Version Effective Date: 06/01/21

Product Applicability All Plan+ Products

Well Sense Health Plan Boston Medical Center HealthNet Plan Well Sense Health Plan MassHealth ACO MassHealth MCO Qualified Health Plans/ConnectorCare/Employer Choice Direct

Senior Care Options ◊

Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options.

Policy Summary The Plan considers lung transplantation for end-stage pulmonary disease for adults and children to be medically necessary when applicable Plan medical criteria are met, including lobar lung transplant and lung transplantation (single-lung or double-lung replacement). All transplant-related consults, evaluations, procedures, and post-transplant follow-up services should be managed within the Plan’s provider network or at the most appropriate preferred transplant facility (depending upon the type of transplant and clinical appropriateness) and according to the administrative guidelines specified in the Plan’s Transplant Administration policy, policy number OCA 3.10. Prior authorization is required for ALL transplantation services provided to a Plan member (even when a separate Plan authorization Transplantation of Lung or Lobar Lung

+ Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. 1 of 37

has already been obtained for an inpatient admission but the authorization does NOT include transplantation services), with final approval required by a Plan Medical Director. It will be determined during the Plan’s prior authorization process if the specific transplant service is considered medically necessary for the requested indication within the Plan’s provider network, as appropriate. Heart-lung transplantation requires Plan Medical Director review.

Prior authorization requests for transplantation services for Plan members are evaluated utilizing medical necessity criteria in the applicable Plan medical policy. If there is no Plan medical policy for the requested type of transplantation (e.g., simultaneous pancreas and lung transplantation, combined lung-kidney transplant for a lung transplant candidate with chronic kidney disease), the Plan uses InterQual® criteria to determine the medical necessity of the requested transplantation services. The Plan conducts an individual evaluation of the member’s medical condition based on the guidelines outlined in the Plan’s Clinical Review Criteria administrative policy, policy number OCA 3.201, when there is no applicable Plan medical policy and InterQual® criteria are not established for the requested type of transplantation. When a member is deemed to be an appropriate candidate for transplantation services based on the Plan’s applicable medical necessity criteria and the evaluation conducted by the treating provider, final approval is required by a Plan Medical Director for the member’s transplantation. In addition, Plan Medical Director review is required when the Plan’s applicable medical necessity criteria are not met for requested transplantation services.

The Plan’s Clinical Technology Evaluation administrative policy, policy number OCA 3.13, outlines the Plan’s process for evaluating new technology and the new application of existing technology. The Plan’s Medically Necessary medical policy, policy number OCA 3.14, indicates the product-specific definitions of medically necessary treatment, and the Plan’s Experimental and Investigational Treatment medical policy, policy number OCA 3.12, specifies the product-specific definitions of experimental or investigational treatment.

Plan prior authorization is required for genetic testing according to the guidelines specified in the Plan’s Genetic/Genomic Testing and Pharmacogenetics medical policy, policy number OCA 3.727, rather than criteria included in this Plan policy and are based on the type of genetic test requested, indication(s) for testing, and if the test is ordered, administered, and processed by participating providers and participating laboratories (or non-participating providers and non-participating laboratories); this includes all genetic testing associated with pre-and/or post-transplantation services (e.g., genetic testing of transplant recipients to identify the probability of active rejection using tests such as AlloMap® by CareDx, AlloSure® by CareDx, or myTAIHEART by TAI Diagnostics). Genetic/ genomic testing is considered medically necessary when the Plan’s applicable medical policy criteria are met or Plan-adopted InterQual® criteria are met for the requested genetic test when criteria are not included in a Plan medical policy. Plan Medical Director review is required for individual consideration when clinical review criteria are not established for the requested genetic test and/or specified indication(s) for testing.

Transplantation of Lung or Lobar Lung

The Plan member must meet the eligibility criteria from the transplanting institution. The eligibility criteria of the transplanting institution must comply with the applicable United Network for Organ Sharing (UNOS) guidelines and recipient selection criteria developed by the International Society of Heart and Lung Transplantation (ISHLT). The hospital in which the organ transplants are performed must be a member of the Organ Procurement and Transplantation Network (OPTN) in accordance with the Public Health Service Act, comply with applicable OPTN organ allocation and procurement guidelines, and follow the Centers for Medicare & Medicaid Services (CMS) applicable conditions of participation for the specified organ to be transplanted (including but not limited to the following Code of Federal Regulations: 42 CFR Parts 405, 482, 488, and 498). The transplant program (including affiliated transplant facility, transplant surgeons, transplant physicians, and staff) must follow the designated UNOS/OPTN transplant program criteria for the applicable transplant service and comply with all applicable UNOS/OPTN professional and clinical standards. Senior Care Options members will have access to transplant services according all applicable CMS guidelines, including but not limited to the provisions specified in the Medicare Managed Care Manual, Chapter 4 – Benefits and Beneficiary Protections, 10.11 Transplant Services.

Review the member’s applicable benefit documents available at www.bmchp.org for benefit coverage and associated transplant guidelines for a BMC HealthNet Plan member, at www.SeniorsGetMore.org for a Senior Care Options member, and at www.wellsense.org for a Well Sense Health Plan member. If a transplant is requested for a Well Sense Health Plan member and authorized by the Plan as medically necessary, a Plan-approved transplant center will review the case to determine the member’s status as a candidate for a transplant at that facility (based on the clinical guidelines utilized by the transplant program).

Description of Item or Service Lung Transplantation: The surgical replacement of lung from a deceased donor into a recipient. A lung transplant consists of replacing all or part of diseased lung(s) with healthy lung(s). A lung transplant refers to single-lung or double-lung replacement. In a single-lung transplant, only one (1) lung from a deceased donor is provided to the recipient. In a double-lung transplant, both of the recipient's lungs are removed and replaced by the donor's lungs.

Lobar Lung Transplantation: The surgical replacement of one (1) or both lungs in a recipient after removal of the right or left lower lung lobe from one (1) or two (2) donors (living donor or deceased donor). Lobar lung transplantation is usually reserved for pediatric patients who are not expected to survive the waiting time for a deceased donor transplant. In a lobar transplant, a lobe of the donor’s lung is excised, sized appropriately for the recipient’s thoracic dimensions, and transplanted. Donors for lobar transplant have primarily been living-related donors, with one (1) lobe obtained from each of two (2) donors when bilateral transplantation is required. The living donor is left with four lung lobes, and the patient receives one of the donor’s lower lobes. When medically necessary, the recipient has both of the individual’s diseased lungs removed and receives two new lung lobes, one from each of two donors. There are also cases of cadaver lobe transplants.

Transplantation of Lung or Lobar Lung

Medical Policy Statement When a member is deemed an appropriate candidate for transplantation services based on the Plan’s applicable medical necessity criteria and the evaluation conducted by the treating provider, final approval is required by a Plan Medical Director for the member’s transplantation. In addition, Plan Medical Director review is required when the Plan’s applicable medical necessity criteria are not met for requested transplantation services. An evaluation for transplantation services conducted by the treating provider is defined as a consultation and diagnostic testing or other testing required to assess a member’s appropriateness and readiness for transplantation; an evaluation does not include care required as part of the course of treatment for the underlying medical condition. Review the Policy Statement section of the Plan’s Transplant Administration policy, administrative policy number OCA 3.10, for guidelines on how the Plan processes requests for evaluations by participating providers and non-participating providers.

The Plan member must meet eligibility criteria from the transplanting institution for the requested transplantation services. The eligibility criteria of the transplanting institution must follow applicable United Network for Organ Sharing (UNOS) guidelines. The hospital in which the organ transplant is performed must be a member of the Organ Procurement and Transplantation Network (OPTN) and comply with applicable OPTN organ allocation and procurement guidelines. Lobar lung (from one [1] or two [2] donors) or lung transplantation (single-lung or double-lung replacement) is considered medically necessary when the medical record documentation supports that the member, as assessed by the transplant surgeon or a designee of the multidisciplinary transplant team, meets ALL of the following applicable criteria for transplant clearance, as specified below in item A (Initial Transplantation and Re-transplantation Criteria for Adult and Pediatric Members) and item B (Disease- Specific Criteria for Adult and Pediatric Members):

A. Initial Transplantation and Re-transplantation Criteria for Adult and Pediatric Members:

See applicable criteria below, EITHER item 1 for criteria for an initial transplantation or item 2 for criteria for re-transplantation.

1. Initial Transplantation Criteria:

ALL of the following criteria must be met for an initial transplant for each adult or pediatric member based on the treating transplant provider’s evaluation and clinical judgment, as specified below in items a through n:

a. Diagnosis of end-stage lung disease for which maximum medical therapy is ineffective or unavailable; AND

b. Limited life expectancy of no more than two (2) years; AND

c. The likelihood of surviving at least 90 days after lung transplantation; AND

Transplantation of Lung or Lobar Lung

d. Substantial limitation of daily activities; AND

e. Evaluation demonstrating absence of potential complications and/or non-pulmonary medical comorbidity that could diminish the success of transplantation and limit the life expectancy substantially in the first five (5) years after transplantation; AND

f. Evaluation of symptomatic gastroesophageal reflux disease (GERD); AND

g. Acceptable nutritional status; AND

h. Good rehabilitation potential; AND

i. Compliance with medical management; AND

j. Satisfactory psychosocial profile and emotional support system; AND

k. Abstinence from smoking for at least six (6) months when history includes smoking; AND

l. Pre-surgical clearance by a cardiologist for the transplantation; AND

m. All the transplanting institution’s eligibility criteria are met; AND

n. The transplant meets ONE (1) of the following criteria, as specified below as item (1) or item (2):

(1) A deceased donor will be used for the lung transplant (single-lung or double-lung replacement) or lobar lung transplant; OR

(2) A living donor will be used rather than a deceased donor for lobar lung transplantation when the transplant team has determined that the member is a suitable candidate for a living donor transplant and at least ONE (1) of the following criteria are met, as specified below as item (a), item (b), or item (c):

(a) A deceased donor is unavailable; OR

(b) Member is deteriorating clinically to the point of transplant ineligibility while waiting for deceased donor organ donation; OR

Transplantation of Lung or Lobar Lung

2. Re-transplantation Criteria:

Re-transplantation is covered when BOTH of the following criteria are met, as specified below in items a and b:

a. ALL criteria are met for the initial transplantation (as specified in item A1 above, Initial Transplantation Criteria); AND

b. The member has at least ONE (1) of the following indications, as specified below in item (1), item (2), or item (3):

(1) Graft failure of an initial lung or lobular lung transplant due to EITHER of the following, as specified below as item (a) or item (b):

(a) Technical reason, excluding serious reportable event and/or provider- preventable condition; † OR

† Note: Review the Plan’s Provider Preventable Conditions and Serious Reportable Events reimbursement policy for definitions of serious reportable events and provider-preventable conditions (policy number 4.610 for BMC HealthNet Plan members, policy number SCO 4.610 for Senior Care Options members, and policy number WS 4.29 for Well Sense Health Plan members).

(b) Hyperacute rejection (see Definitions section); OR

(2) Chronic rejection (see Definitions section); OR

(3) Recurrent disease; AND

B. Disease-Specific Criteria for Adult and Pediatric Members:

BOTH of the following criteria must be met, as specified below in items 1 and 2:

1. ALL applicable transplant criteria are met for EITHER an initial transplantation (as specified above in item A1) or re-transplantation (as specified above in item A2); AND

2. The member has at least ONE (1) of the following diseases∆ and ALL applicable criteria are met for that disease, as specified below in items a through e:

∆ Note: Other medical conditions may require lobar lung or lung transplantation. Plan Medical Director review is required for all transplantation services for individual consideration. For the Plan Medical Director to determine the medical necessity of the transplant services, the treating provider must submit medical record documentation that supports the member’s Transplantation of Lung or Lobar Lung

diagnosis, past medical history (including previous medical, surgical, and pharmacological interventions and corresponding clinical outcomes), diagnostic test results, clinical indications for the transplant, written assessment by the transplant surgeon or a designee of the multidisciplinary transplant team confirming that the member is an appropriate candidate for the transplant, and documentation that the member has met the applicable criteria at the transplant center where the procedure is expected to be performed. The eligibility criteria of the transplanting institution must comply with the applicable United Network for Organ Sharing (UNOS) guidelines and recipient selection criteria developed by the International Society of Heart and Lung Transplantation (ISHLT).

a. Bronchiectatic Disease:

Includes but is not limited to cystic fibrosis, acquired bronchiectasis, or congenital bronchiectasis with ALL of the following clinical indications, as specified below in items (1) through (4):

(1) Forced expiratory volume in 1 second (FEV1) ≤ 30% of predicted value or rapid respiratory deterioration with FEV1 >30%; AND

(2) paCO2 > 50 mm Hg; AND

(3) paO2 < 55 mm Hg; AND

(4) Increasing frequency and severity of exacerbations; OR

b. Nonbronchiectatic Disease:

Includes but is not limited to COPD, emphysema, alpha-1 antitrypsin disease, bronchiolitis obliterans syndrome (BOS), or chronic bronchitis with ALL of the following clinical indications, as specified below in items (1) through (5):

(1) FEV1 < 25% of the predicted value; AND

(2) paCO2 ≥ 55 mm Hg; AND

(3) paO2 < 55-60 mm Hg; AND

(4) Elevated pulmonary artery pressures (secondary pulmonary hypertension); AND

(5) Clinical course - rapid rate of decline in FEV1 or life-threatening exacerbations; OR

Transplantation of Lung or Lobar Lung

c. Interstitial Lung Disease:

Includes but is not limited to idiopathic pulmonary fibrosis (IPF), interstitial pulmonary fibrosis, sarcoidosis, scleroderma, lymphangiomyomatosis, eosinophilic granuloma, pneumoconiosis or other lung disease due to external agents such as asbestos, crystalline silica, organic coal dust, or histiocytosis X with ALL of the following clinical indications, as specified below in items (1) through (5):

(1) Symptomatic, progressive disease with failure to respond to optimal medical treatment; AND

(2) Vital capacity < 60% to 65% of predicted value; AND

(3) Diffusing capacity of the lung for carbon monoxide (DLCO) < 50% to 60% of predicted value; AND

(4) Resting hypoxemia with PaO2 < 55 mm Hg; AND

(5) Rapid progression of IPF warrants early referral; OR

d. Pulmonary Hypertension:

Includes but is not limited to primary or secondary due to cardiac disease, idiopathic pulmonary hypertension, pulmonary emboli, or Eisenmenger’s syndrome with ALL of the following clinical indications, as specified below in items (1) through (5):

(1) New York Heart Association functional class III or IV; AND

(2) Mean right atrial pressure of greater than 10 mm Hg; AND

(3) Mean pulmonary arterial pressure of greater than 50 mm Hg; AND

(4) Cardiac index of less than 2.5 L/min/m2; AND

(5) Failure of therapy with long-term prostacyclin infusion; OR

e. Untreatable End-Stage Pulmonary Disease of Any Etiology

Transplantation of Lung or Lobar Lung

Limitations All transplant-related consultations, evaluations, procedures, and post-transplant follow-up services should be managed within the Plan’s provider network or at the most appropriate preferred transplant facility (depending upon the type of transplant) and according to the administrative guidelines specified in the Plan’s Transplant Administration policy, administrative policy number OCA 3.10. Prior authorization is required for ALL transplantation services provided to a Plan member (even when a separate Plan authorization has already been obtained for an inpatient admission but the authorization does NOT include transplantation services), with final approval required by a Plan Medical Director. The Plan member must meet the eligibility criteria from the transplanting institution. The eligibility criteria of the transplanting institution and must comply with all applicable United Network for Organ Sharing (UNOS) guidelines and recipient selection criteria developed by the International Society of Heart and Lung Transplantation (ISHLT).

1. Heart-Lung Transplantation:

Plan Medical Director review is required for each prior authorization request for a heart-lung transplantation. For the Plan Medical Director to determine the medical necessity of the procedure, the treating provider must submit medical record documentation that supports the member’s diagnosis, past medical history (including previous medical, surgical, and pharmacological interventions and corresponding clinical outcomes), diagnostic test results, clinical indications for a heart-lung transplant, written assessed by the transplant surgeon or a designee of the multidisciplinary transplant team that the member is an appropriate candidate for a heart-lung transplant, and documentation that the member has met the applicable criteria at the transplant center where the procedure is expected to be performed. The eligibility criteria of the transplanting institution must comply with the applicable United Network for Organ Sharing (UNOS) guidelines and recipient selection criteria developed by the International Society of Heart and Lung Transplantation (ISHLT).

Transplantation of Lung or Lobar Lung

Candidates for heart-lung transplantation are individuals with end-stage cardiopulmonary failure not amenable to conventional medical therapy or surgical repair. Causes of end-stage cardiopulmonary failure may include irreparable congenital cardiac anomalies with pulmonary hypertension (Eisenmenger complex), primary pulmonary hypertension with irreversible right- heart failure, cystic fibrosis with severe heart failure, chronic obstructive pulmonary disease with heart failure, emphysema with severe heart failure, pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure, or sarcoidosis involving only the heart and lungs. The age of 60 years is the conventional upper limit for most candidates for heart-lung transplantation; however, transplant centers with more experience may evaluate patients older than 60 years on an individual basis.

2. Individual Consideration by Plan Medical Director for Lobar Lung or Lung Transplantation:

Any request for a lobar lung or lung transplantation that does NOT meet applicable medical necessity criteria specified in the Medical Policy Statement section of this policy requires individual consideration by a Plan Medical Director. The Plan Medical Director will evaluate the individual member’s clinical needs and circumstances based on the guidelines included in the Plan’s Clinical Review Criteria administrative policy, policy number OCA 3.201.

3. Genetic Testing:

Plan prior authorization is required for genetic testing according to the guidelines specified in the Plan’s Genetic/Genomic Testing and Pharmacogenetics medical policy, policy number OCA 3.727, rather than criteria included in this Plan policy and are based on the type of genetic test requested, indication(s) for testing, and if the test is ordered, administered, and processed by participating providers and participating laboratories (or non-participating providers and non- participating laboratories); this includes all genetic testing associated with pre-and/or post- transplantation services (e.g., genetic testing of transplant recipients to identify the probability of active rejection using tests such as AlloMap® by CareDx, AlloSure® by CareDx, or myTAIHEART by TAI Diagnostics). Genetic/genomic testing is considered medically necessary when the Plan’s applicable medical policy criteria are met or Plan-adopted InterQual® criteria are met for the requested genetic test when criteria are not included in a Plan medical policy. Plan Medical Director review is required for individual consideration when clinical review criteria are not established for the requested genetic test and/or specified indication(s) for testing.

4. Experimental and Investigational Services:

The Plan considers ANY of the following services experimental and investigational, as specified below in items a through c:

Transplantation of Lung or Lobar Lung

a. Lung transplantation for an individual with coronary artery disease not amenable to percutaneous intervention or bypass grafting, or an individual with coronary artery disease associated with significant impairment of left ventricular function is considered experimental and investigational.

b. Lung xenotransplantation (e.g., porcine xenografts) is considered experimental and investigational for any indication.

c. Prophylactic anti-reflux surgery to improve lung function and survival in lung transplant recipient without gastroesophageal reflux disease is considered experimental and investigational.

See the Plan’s Experimental and Investigational Treatment medical policy, policy number OCA 3.12, for the product-specific definitions of experimental or investigational treatment.

5. Contraindications:

Many factors can affect the outcome of organ transplantation. Fairly rigid selection criteria are required to obtain optimal results for each patient. The treating provider must submit clinical documentation to the Plan Medical Director explaining why the member with any of these contraindications is an appropriate candidate for the requested transplant. Contraindications to lung transplantation include but are not limited to ANY of the following, as specified below in item a or item b:

a. Absolute contraindications, where there is generally no reasonable circumstance for undertaking transplant surgery, include at least ONE (1) of the following, as specified below in items (1) through (3):

(1) Irreversible end-stage disease not attributed to lung disease; OR

(2) Immunosuppressed or potentially exacerbated by immunosuppression with at least ONE (1) of the following conditions, as specified below in items (a) through (i):

(a) Known active malignancy, including metastatic cancer, other than non- melanomatous skin cancer; OR

(b) Recently treated malignancy within two (2) years of curative treatment with NO evidence of recurrence (within five [5] years for breast cancer, colorectal cancer, or melanoma); this absolute contraindication does NOT include an early stage cancer in which the cancerous growth or tumor is still confined to the site from which it started, and has not spread to surrounding tissue or other organs in the body (i.e., carcinoma in situ, cancer in situ, preinvasive carcinoma, in situ lesions); ** OR Transplantation of Lung or Lobar Lung

** Note: The assessment of risk recurrence must be determined by the transplant team; the transplant team must then submit a written statement to the Plan explaining why the member with a recently treated malignancy or a member with a moderate or high risk of recurrence is an appropriate candidate for transplant surgery.

(d) AIDS (diagnosis based on CDC definition of CD4 count, 200cells/mm3) unless ALL of the following are noted in the member’s medical record, as specified below in items i through iv:

i. CD4 count >200cells/mm3 for more than 6 months; AND

ii. HIV-1 RNA undetectable; AND

iii. On stable anti-retroviral therapy more than 3 months; AND

iv. No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioide-mycosis, resistant fungal infections, Kaposi's sarcoma or other neoplasm); OR

(e) Complicated or uncontrolled diabetes mellitus; OR

(f) Hepatitis B virus antigen positive (surface, core or both) based on criteria established by the transplantation center; OR

(g) Cirrhosis; OR

(h) Significant untreatable infection present outside the lungs and outside the upper respiratory tract; OR

(i) Other systemic disease that could be exacerbated by immunosuppression.

(3) The member has at least ONE (1) of the following other conditions specified below in items (a) through (q):

(a) Active substance abuse or active smoking within the last six (6) months (including drug, alcohol, or tobacco); OR

Transplantation of Lung or Lobar Lung

(b) Psychosocial or other conditions affecting the member’s ability to adhere to the therapeutic regimen necessary to preserve the transplant, including but not limited to compliance with the prescribed medication regimen, monitoring for signs and symptoms of complications, avoidance of risk factors that may result in adverse clinical outcomes, and/or attendance at regular clinical checkups; OR

(d) Active/symptomatic coronary artery disease with any ONE (1) of the following, as specified below in items i through iii:

i. Not amendable to percutaneous intervention or bypass grafting; OR

ii. Associated with significant impairment of left ventricular function; OR

iii. Without cardiac clearance for transplantation; OR

(e) Active systemic collagen vascular (connective tissue) disease; OR

(f) Body mass index 35kg/m2 or higher; ◊ OR

◊ Note: This policy also includes a relative contraindication of BMI less than 17 kg/m2 or BMI 30 kg/m2 to or 34.9 kg/m2; †

(g) Cardiac insufficiency - right or left ventricular ejection fraction less than 20 percent; OR

(h) Demonstrated patient noncompliance which would place the organ at risk by not adhering to medical recommendations; OR

(i) Non-rehabilitative pulmonary disability; OR

(j) Donor recipient incompatible as proven by positive cross match testing; OR

(k) Member lack of acceptance of potential complications from immunosuppressive medications; OR

(l) Significantly impaired hepatic function characterized by persistent and marked elevation of international normalized ratio (INR) or severe liver dysfunction caused by antituberculous therapy; OR

(m) Surgically remediable chronic thromboembolic disease; OR

Transplantation of Lung or Lobar Lung

(n) For a pediatric member (less than age 18 on the date of service), dysfunction of major organs other than the lung, particularly renal dysfunction with creatinine clearance of < 50, because of the impact of immunosuppressive drugs on renal function (and multiple-organ transplant may be considered as an alternative, when clinically appropriate); OR

(o) For an adult member (age 18 or older on date of service), extra-pulmonary, end- stage organ disease (and multiple-organ transplant may be considered as an alternative, when clinically appropriate); OR

(p) Active mycobacterium tuberculosis; OR

(q) Member is receiving high dose steroid therapy (more than 40 mg daily) that cannot be tapered or discontinued.

b. Relative contraindications are listed below in items (1) through (8). Any ONE (1) of these contraindications puts the member at a higher risk of complications; this risk may be outweighed by other medical considerations and therefore transplant surgery may be considered after Medical Director review and approval if other Plan criteria are met:

(1) Body mass index (BMI) less than 17 kg/m2 or BMI 30 kg/m2 to or 34.9 kg/m2; ◊ OR

◊ Note: This policy also includes an absolute contraindication of BMI 35 kg/m2 or higher.

(2) Dependence on mechanical ventilation with clinically unstable pulmonary function tests; OR

(3) Age greater than 65 years old on the date of service for lobar lung transplant, single lung transplant, or double lung transplant; OR

(4) Significant chest wall or spinal deformity; OR

(5) Previous pleurodesis, pleurectomy, or complicated cardiothoracic surgery (excluding simple pneumothorax treated with closed tube thoracostomy, open lung biopsy, or uncomplicated lobectomy) which increases the technical difficulty of extracting the native lung and the operative risk of lung transplantation; OR

(6) Presence of significant esophageal dysfunction with ineffective esophageal motility that is likely to cause chronic rejection manifested as bronchiolitis obliterans syndrome, as determined by the treating provider or transplant surgeon; OR

Transplantation of Lung or Lobar Lung

(7) For a pediatric member (less than age 18 on the date of service), severe musculoskeletal disease affecting the thorax (e.g., kyphoscoliosis) and progressive neuromuscular disease; OR

(8) Member with another medical condition that may cause end-organ damage (such has systemic hypertensions, epilepsy, central venous obstruction, peptic ulcer disease, or gastroesophageal reflux) when the condition is not optimally treated before transplantation.

Definitions Carcinoma In Situ: A group of abnormal cells that remain in the place where they first formed and have not spread. These abnormal cells may become cancer and spread into nearby normal tissue and is also called stage 0 disease.

Cardiac Index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.

Collagen Vascular Disease (CVD): A diverse group of autoimmune disorders (i.e., the body is allergic to itself) including: systemic lupus erythematosus, rheumatoid arthritis, progressive systemic sclerosis, dermatomyositis /polymyositis, ankylosing spondylitis, Sjögren syndrome, or mixed connective tissue diseases. Many CVDs involve the lungs either directly or as a complication of treatment of the CVD. Many parts of the respiratory system may be involved, including the airways, blood vessels, lung tissue, the tissue lining around the lungs and chest cavity, and/or respiratory muscles.

Double Lung Transplant (Bilateral): The surgical replacement of both lungs in the recipient by both lungs from a deceased donor. In general, this procedure may be appropriate for any ONE (1) of the following conditions, as specified below in items 1 through 3:

1. End-stage chronic obstructive pulmonary disease: Emphysema

2. Infectious lung disease:

a. Bronchiectasis

b. Cystic fibrosis

Transplantation of Lung or Lobar Lung

3. Pulmonary vascular disease:

a. Eisenmenger’s syndrome with cardiac repair

b. Primary pulmonary hypertension

Lung Allocation Score (LAS): The United Network for Organ Sharing (UNOS) has developed a system for prioritizing patients for lung transplants called the Lung Allocation Score System or LAS. The LAS system prioritizes lung transplant candidates age 12 and older for donor lung offers by assigning them a score from 0 to 100. The score is based on each patient's individual medical information that reflects both the seriousness of each patient's medical condition before transplant and the likelihood of success after a transplant; the score includes patient diagnosis, comorbidities, laboratory values, test results, and other clinical measures (including forced vital capacity, pulmonary artery and capillary wedge pressures, oxygen at rest, age, body mass index, functional status, six minute walk, serum creatinine, and if assisted ventilation is required). The candidate with the highest LAS in a particular age group will receive first priority for a donor lung offer.

New York Heart Association (NYHA) Functional Class: Functional classification system of heart failure that categorizes a patient’s condition and cardiovascular disability based on severity of symptoms and limitations during physical activity, as specified below in items 1 through 4:

1. NYHA Functional Class I (Mild): Patient with cardiac disease without limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.

2. NYHA Functional Class II (Mild): Patient with cardiac disease with slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.

3. NYHA Functional Class III (Moderate): Patient with cardiac disease producing marked limitation of physical activity. Comfortable at rest; less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.

4. NYHA Functional Class IV (Severe): Patient with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or angina are present at rest; symptoms are increased with physical activity.

Transplantation of Lung or Lobar Lung

Single Lung Transplant (Unilateral): The surgical removal of a single lung from a deceased donor or living donor to replace one (1) lung in the recipient. In general, single lung transplantation may be appropriate for at least ONE (1) of the following conditions, as specified below in items 1 through 3:

1. Chronic obstructive pulmonary disease:

Emphysema with or without alpha1-antitrypsin deficiency; OR

2. Interstitial lung disease:

a. Eosinophilic granuloma; OR

b. Idiopathic interstitial pulmonary fibrosis; OR

c. Sarcoidosis; OR

d. Lymphangioleiomyomatosis; OR

3. Pulmonary vascular disease:

a. Eisenmenger's syndrome with cardiac repair; OR

b. Primary pulmonary hypertension

Transplant Rejection: A process in which a transplant recipient's immune system attacks the transplanted organ or tissue. There are three (3) clinicopathologic stages of rejection:

1. Hyperacute Rejection: A recipient’s immune reaction that occurs within a few minutes after the transplant when the antigens are completely unmatched, resulting in organ failure within the first hours after transplantation. The tissue must be removed right away so the recipient does not die.

2. Acute Rejection: A recipient’s immune reaction that occurs any time from the first week after the transplant (during which the immune response increases in intensity) and generally up to 60 to 90 days after organ transplantation. It may be Grade I (mild), Grade II (moderate) or Grade III (severe). All recipients have some amount of acute rejection.

3. Chronic Rejection: A recipient’s immune reaction that occurs more than 60 days after transplantation and can take place over many years. This is the body's constant immune response against the new organ that slowly damages the transplanted tissues or organ.

Transplantation of Lung or Lobar Lung

Xenotransplantation: According to the U.S. Public Health Service, xenotransplantation is defined as any procedure that involves the transplantation, implantation, or infusion into a human recipient of either of the following, as specified below in item 1 or item 2:

1. Live cells, tissues, or organs from a non-human animal source; OR

2. Human body fluids, cells, tissues or organs that have had ex vivo contact with live non-human animal cells, tissues, or organs. (See this policy’s Limitations section.)

Applicable Coding The Plan uses and adopts up-to-date Current Procedural Terminology (CPT) codes from the American Medical Association (AMA), International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes developed by the World Health Organization and adapted in the United Stated by the National Center for Health Statistics (NCHS) of the Centers for Disease Control under the U.S. Department of Health and Human Services, and the Health Care Common Procedure Coding System (HCPCS) established and maintained by the Centers for Medicare & Medicaid Services (CMS). Since the AMA, NCHS, and CMS may update codes more frequently or at different intervals than Plan policy updates, the list of applicable codes included in this Plan policy is for informational purposes only, may not be all inclusive, and is subject to change without prior notification. Whether a code is listed in the Applicable Coding section of this Plan policy does not constitute or imply member coverage or provider reimbursement. Providers are responsible for reporting all services using the most up-to-date industry-standard procedure and diagnosis codes as published by the AMA, NCHS, and CMS at the time of the service.

Providers are responsible for obtaining prior authorization for the services specified in the Medical Policy Statement section and Limitation section of this Plan policy, even if an applicable code appropriately describing the service that is the subject of this Plan policy is not included in the Applicable Coding section of this Plan policy. Coverage for services is subject to benefit eligibility under the member’s benefit plan. Please refer to the member’s benefits document in effect at the time of the service to determine coverage or non-coverage as it applies to an individual member. See Plan reimbursement policies for Plan billing guidelines.

CPT Codes Description: Codes Covered When Medically Necessary 32851 Lung transplant, single; without cardiopulmonary bypass 32852 Lung transplant, single; with cardiopulmonary bypass 32853 Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary bypass 32854 Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass

Transplantation of Lung or Lobar Lung

HCPCS Codes Description: Codes Covered When Medically Necessary S2060 Lobar lung transplantation

Plan note: This code is NOT payable for the Senior Care Options product. S2061 Donor lobectomy (lung) for transplantation, living donor

Plan note: This code is NOT payable for the Senior Care Options product.

Clinical Background Information Lung transplantation may be appropriate for patients with advanced lung disease whose clinical status has progressively declined despite maximal medical or surgical therapy with a limited life expectancy over the next two (2) years. Candidates are usually symptomatic during activities of daily living and ideally should be free of any other organ dysfunction or medical problem that would substantially jeopardize the outcome of transplantation. (Source: Hachem RR. UpToDate®). Lung transplantation has become a viable treatment option for selected patients with end-stage lung disease due to a wide variety of underlying disorders. Single, double, and lobar-lung transplantation have all been performed successfully. The type of lung transplantation procedure used (i.e., lobar, single, or double) and donor type (i.e., deceased or living) are based upon the candidate's condition and indication for transplantation, and the availability of donor organs. As donor organs are scarce relative to the number of candidates needing transplantation, conservation of acceptable donor organs is also taken into consideration. Deceased donor lung transplantation, also known as cadaveric donor lung transplantation, is most commonly performed. Individuals older than age 12 are allocated donated deceased donor lungs using the Lung Allocation Score based on survival benefit and medical condition. Organ allocation to children under age 12 is based solely on waiting time.

Living donor lobar lung transplantation has shown success and addresses the shortage of deceased donor organs. Living donor lobar lung transplantation is less commonly performed. A transplant from living donors usually involves three operations, one on each of two donors and one on the recipient. The lower lobe of the right lung is removed from one donor and the lower lobe of the left lung is removed from the other donor. Both lungs are then removed from the recipient and are replaced by the lung implants from the donors in a single operation. Although deceased donor lung transplantation is preferred to avoid risk to two healthy donors, living donor lobar lung transplant may be an acceptable alternative when the recipient (usually a child or adolescent) is not likely to survive long enough to receive deceased donor lungs.

The goal of lung transplantation is to improve quality of life and long-term survival in patients with end-stage pulmonary disease. Advances in donor and recipient selection, new immunosuppressive medications, new and improved surgical techniques, and increased medical management of infections have improved the overall survival in patients after lung transplantation. Consideration for lung transplantation is based on an evaluation for potential complications that could diminish its success.

Transplantation of Lung or Lobar Lung

Lung transplantation is an effective treatment for end stage lung disease. However, long-term survival is limited by the development of chronic rejection manifested as bronchiolitis obliterans syndrome (BOS). GER and altered motility has long been associated with lung disease and are common among patients and the post lung transplant population. The evidence collected to date strongly supports a role for the aspiration of gastric contents as a causative or additive etiology to developing BOS. Common in advanced lung disease, changes in diaphragmatic position, decreased lower esophageal sphincter pressure, and changes in intrathoracic pressure are proposed mechanisms favoring reflux. Ineffective esophageal motility (IEM) is the most common motility disorder in patients with GER- associated respiratory symptoms. Aspiration secondary to GER and altered foregut motility have been identified as potential contributors to lung allograft dysfunction. Lung transplant recipients appear to be at increased risk of GER and aspiration through the following mechanisms: (1) The cough reflexes and mucociliary clearance which are the normal defense mechanisms against aspiration are dramatically impaired; (2) mucociliary clearance is less than normal in transplanted lungs (measured to be less than 15% of normal); and (3) it is hypothesized that even small amounts of aspiration can lead to significant injury, particularly with multiple repeated episodes over time (with a causative or additive etiology to develop BOS).

The U.S. Department of Health and Human Services (DHHS) has oversight responsibility for the organ allocation system in the United States. Congress established the Organ Procurement and Transplantation Network (OPTN) when it enacted the National Organ Transplant Act (NOTA) of 1984. The Act called for a unified transplant network to be operated by a private, nonprofit organization under federal contract. United Network for Organ Sharing (UNOS) was awarded the initial OPTN contract in 1986 and continues to administer the OPTN.

At the time of the Plan’s most recent policy review, no national coverage determination (NCD) or local coverage determination (LCD) was found from the Centers for Medicare & Medicaid Services (CMS) for single, double, and/or lobar lung transplantation. CMS requires that services be performed at a Medicare-approved facility for lung transplant services (as specified in 42 CFR Parts 405, 482, 488, and 498 Medicare Program, Hospital Conditions of Participation: Requirements for Approval and Re- Approval of Transplant Centers to Perform Organ Transplants, Final Rule, March 30, 2007). CMS evaluates detailed criteria for facility participation that include but are not limited to the following: Clinical experience, patient selection of suitable candidates, patient management with good patient outcomes, experience and survival rates, maintenance of data, organ procurement, laboratory services, and billing guidelines. Senior Care Options members will have access to transplant services according all applicable CMS guidelines, including but not limited to the provisions specified in the Medicare Managed Care Manual, Chapter 4 – Benefits and Beneficiary Protections, 10.11 Transplant Services. Verify applicable CMS criteria are in effect for lung transplant services in an NCD or LCD on the date of the prior authorization request for a Senior Care Options member.

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Chan EY, Goodarzi A, Sinha N, Nguyen DT, Youssef JG, Suarez EE, Kaleekal T, Graviss EA, Bruckner BA, MacGillivray TE, Scheinin SA. Long-Term Survival in Bilateral Lung Transplantation for Scleroderma- Related Lung Disease. Ann Thorac Surg. 2018 Mar;105(3):893-900. doi: 10.1016/ j.athoracsur.2017.09.038. Epub 2018 Feb 1. PMID: 29394994.

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Transplantation of Lung or Lobar Lung

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Kistler KD, Nalysnyk L, Rotella P, Esser D. Lung transplantation in idiopathic pulmonary fibrosis: a systematic review of the literature. BMC Pulm Med. 2014;14:139. doi: 10.1186/1471-2466-14-139. PMID: 25127540.

Koprivanac M, Budev MM, Yun JJ, Kelava M, Pettersson GB, McCurry KR, Johnston DR, Mangi AA, Houghtaling PL, Blackstone EH, Murthy SC. How important is coronary artery disease when considering lung transplant candidates? J Heart Lung Transplant. 2016 Dec;35(12):1453-61. doi: 10.1016/j.healun.2016.03.011. Epub 2016 Mar 30. PMID: 27266805.

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Lane CR, Tonelli AR. Lung transplantation in chronic obstructive pulmonary disease: patient selection and special considerations. Int J Chron Obstruct Pulmon Dis. 2015 Oct 9;10:2137-46. doi: 10.2147/COPD.S78677. PMID: 26491282.

Lederer DJ, Kawut SM, Wickersham N, Winterbottom C, Bhorade S, Palmer SM, Lee J, Diamond JM, Wille KM, Weinacker A, Lama VN, Crespo M, Orens JB, Sonett JR, Arcasoy SM, Ware LB, Christie JD; Lung Tansplant Oucomes Group. Obesity and primary graft dysfunction after lung transplantation: the Lung Transplant Outcomes Group Obesity Study. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1055- 61. doi: 10.1164/rccm.201104-0728OC. PMID: 21799077.

Lehr CJ, Zaas DW, Cheifetz IM, Turner DA. Ambulatory extracorporeal membrane oxygenation as a bridge to lung transplantation: walking while waiting. Chest. 2015 May;147(5):1213-8. doi: 10.1378/chest.14-2188. PMID: 25940249.

Mancini MC. Heart-Lung Transplantation. Medscape. 2017 Jun 7. Accessed at: https://emedicine.medscape.com/article/429188-overview

MCG Health. Care Guidelines. Inpatient Surgical Care. 25th Edition. Lung Transplant. S-1300. Accessed at: https://www.mcg.com/care-guidelines/care-guidelines/

MedicineNet.com. Definition of Cardiac Index. 2017 Jan 25. Accessed at: http://www.medterms.com/script/main/art.asp?articlekey=39852

Medline Plus. Lung Transplantation. 2018 Aug 2. Accessed at: https://medlineplus.gov/lungtransplantation.html

MedlinePlus. Transplant Rejection. 2020 Feb 25. Accessed at: https://medlineplus.gov/ency/article/000815.htm

National Cancer Institute (NCI). National Institutes of Health. NCI Dictonary of Cancer Terms. Carcinoma In Situ. Accessed at: https://www.cancer.gov/publications/dictionaries/cancer- terms/def/carcinoma-in-situ

National Institute for Health and Clinical Excellence (NICE). Living-donor lung transplantation for end- stage lung disease. Interventional Procedure Guidance (IPG) 170. 2006 May. Accessed at: https://www.nice.org.uk/Guidance/IPG170

New Hampshire Department of Health and Human Services. Billing Manuals. Accessed at: https://nhmmis.nh.gov/portals/wps/portal/BillingManuals

New Hampshire Department of Health and Human Services. Provider Notices. Accessed at: https://www.dhhs.nh.gov/ombp/pharmacy/notices.htm

Transplantation of Lung or Lobar Lung

Organ Procurement and Transplantation Network (OPTN). Allocation Calculators. Calculated Panel Reactive Antibody (CPRA) Calculator, Estimated Post Transplant Survival (EPTS) Calculator, Kidney Donor Profile Index (KDPI) Calculator, Lung Allocation Score (LAS) Calculator, Model for End- Stage Liver Disease (MELD) and Pediatric End-Stage Liver Disease (PELD) Calculators, Archived Allocation Calculator Resources. Accessed at: https://optn.transplant.hrsa.gov/resources/allocation- calculators/

Organ Procurement and Transplantation Network (OPTN). Bylaws. Accessed at: https://optn.transplant.hrsa.gov/governance/bylaws/

Organ Procurement and Transplantation Network (OPTN). Organ Procurement and Transplantation Network. Accessed at: https://optn.transplant.hrsa.gov/

Organ Procurement and Transplantation Network (OPTN). Policies. Accessed at: https://optn.transplant.hrsa.gov/governance/policies/

Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS). OPTN/UNOS Ethics Committee. Ethical Principles in the Allocation of Human Organs. 2015 Jun 2. Accessed at: https://optn.transplant.hrsa.gov/resources/ethics/ethical-principles-in-the-allocation-of-human- organs/

Organ Procurement and Transplantation Network (OPTN). View Data Reports. Accessed at: https://optn.transplant.hrsa.gov/data/view-data-reports/

Paraskeva MA, Edwards LB, Levvey B, Stehlik J, Goldfarb S, Yusen RD, Westall GP, Snell GI. Outcomes of adolescent recipients after lung transplantation: An analysis of the International Society for Heart and Lung Transplantation Registry. J Heart Lung Transplant. 2018 Mar;37(3):323-31. doi: 10.1016/ j.healun.2017.02.017. Epub 2017 Feb 17.PMID: 28320631.

Patel N, DeCamp M, Criner GJ. Lung transplantation and lung volume reduction surgery versus transplantation in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008 May 1;5(4):447- 53. doi: 10.1513/pats.200707-107ET. PMID: 18453354.

Patti MG, Vela MF, Odell DD, Richter JE, Fisichella PM, Vaezi MF. The Intersection of GERD, Aspiration, and Lung Transplantation. J Laparoendosc Adv Surg Tech A. 2016 Jul;26(7):501-5. doi: 10.1089/lap.2016.0170. Epub 2016 May 24. PMID: 27218671.

Plantier L, Skhiri N, Biondi G, Jebrak G, Himbert D, Castier Y, Lesèche G, Mal H, Thabut G, Fournier M. Impact of previous cardiovascular disease on the outcome of lung transplantation. J Heart Lung Transplant. 2010 Nov;29(11):1270-6. doi: 10.1016/j.healun.2010.05.010. Epub 2010 Jul 1. PMID: 20580260.

Transplantation of Lung or Lobar Lung

Schaffer JM, Singh SK, Reitz BA, Zamanian RT, Mallidi HR. Single- vs double-lung transplantation in patients with chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis since the implementation of lung allocation based on medical need. JAMA. 2015 Mar 3;313(9):936-48. doi: 10.1001/jama.2015.1175. PMID: 25734735.

Scientific Registry of Transplant Recipients (SRTR) and Organ Procurement and Transplantation Network (OPTN). The SRTR/OPTN Annual Data Report. Statistics on donation and transplantation in the United States. Current report and archived reports. 2020 Jan 2. Accessed at: https://www.srtr.org/reports-tools/srtroptn-annual-data-report/

Shah P, Orens JB. Impact of nutritional state on lung transplant outcomes: The weight of the evidence. J Heart Lung Transplant. 2013 Aug;32(8):755-6. doi: 10.1016/j.healun.2013.06.001. PMID: 23856213.

Singer JP, Chen H, Phelan T, Kukreja J, Golden JA, Blanc PD. Survival following lung transplantation for silicosis and other occupational lung diseases. Occup Med (Lond). 2012 Mar;62(2):134–7. doi: 10.1093/occmed/kqr171. PMID: 22071439.

Singer JP, Peterson ER, Snyder ME, Katz PP, Golden JA, D'Ovidio F, Bacchetta M, Sonett JR, Kukreja J, Shah L, Robbins H, Van Horn K, Shah RJ, Diamond JM, Wickersham N, Sun L, Hays S, Arcasoy SM, Palmer SM, Ware LB, Christie JD, Lederer DJ. Body composition and mortality after adult lung transplantation in the United States. Am J Respir Crit Care Med. 2014 Nov 1;190(9):1012-21. doi: 10.1164/rccm.201405-0973OC. PMID: 25233138.

Thabut G, Mal H. Outcomes after lung transplantation. J Thorac Dis. 2017 Aug;9(8):2684-91. doi: 10.21037/jtd.2017.07.85. PMID: 28932576.

Tomaszek SC, Fibla JJ, Dierkhising RA, Scott JP, Shen KR, Wigle DA, Cassivi SD. Outcome of lung transplantation in elderly recipients. Eur J Cardiothorac Surg. 2011 May;39(5):726-31. doi: 10.1016/j.ejcts.2010.08.034. Epub 2010 Nov 16. PMID: 21084198.

Toyoda Y, Toyoda Y. Heart-lung transplantation: adult indications and outcomes. J Thorac Dis. 2014 Aug;6(8):1138–42. doi: 10.3978/j.issn.2072-1439.2014.06.01. PMID: 25132981.

United Network for Organ Sharing (UNOS). Annual Reports. Accessed at: https://unos.org/about/annual-report/

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United Network for Organ Sharing (UNOS). Policy. Accessed at: https://unos.org/policy/

United Network for Organ Sharing (UNOS). Transplant Trends. Accessed at: https://unos.org/data/transplant-trends/

Transplantation of Lung or Lobar Lung

U.S. Food and Drug Administration. Vaccines, Blood & Biologics. Information and Recommendations for Physicians Involved in the Co-Culture of Human Embryos with Non-Human Animal Cells. 2019 Mar 28. Accessed at: https://www.fda.gov/vaccines-blood-biologics/xenotransplantation

U.S. Food and Drug Administration. Vaccines, Blood & Biologics. Xenotransplantation. 2018 Feb 5. Accessed at: https://www.fda.gov/biologicsbloodvaccines/xenotransplantation/default.htm

Valour F, Brault C, Abbas-Chorfa F, Martin C, Kessler L, Kanaan R, Mosnier-Pudar H, Coltey B, Nove- Josserand R, Durupt S, Colin C, Durieu I. Outcome of cystic fibrosis-related diabetes two years after lung transplantation. Respiration. 2013;86(1):32-8. doi: 10.1159/000339928. Epub 2012 Aug 25. PMID: 22922226.

Van Raemdonck D, Vos R, Yserbyt J, Decaluwe H, De Leyn P, Verleden GM. Lung cancer: a rare indication for, but frequent complication after lung transplantation. J Thorac Dis. 2016 Nov;8(Suppl 11):S915–24. doi: 10.21037/jtd.2016.11.05. PMID: 27942415.

Vermeijden JW, Zijlstra JG, Erasmus ME, van der Bij W, Verschuuren EA. Lung transplantation for ventilator-dependent respiratory failure. J Heart Lung Transplant. 2009 Apr;28(4):347-51. doi: 10.1016/j.healun.2009.01.012. PMID: 19332261.

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Policy History Original Effective Original Approval Original Policy Date* and Version Policy Owner Date Approved by Number Regulatory Approval: N/A 10/02/05 Medical Policy Manager Quality and Clinical Version 1 as Chair of Medical Policy, Management Committee Internal Approval: Criteria, and Technology (Q&CMC) 08/02/05 Assessment Committee (MPCTAC) *Effective Date for the BMC HealthNet Plan Commercial Product(s): 01/01/12 *Effective Date of the Well Sense Health Plan New Hampshire Medicaid Product(s): 01/01/13 *Effective Date for Senior Care Options Product(s): 01/01/16

Policy formerly titled Lung Transplant until 07/31/13.

Policy Revisions History Revision Effective Date Review Date Summary of Revisions Approved by and Version Number 02/06/07 Updated template and references. Version 2 02/06/07: Q&CMC

02/19/08 Revised clinical criteria. Version 3 02/19/08: MPCTAC 02/26/08: Utilization Management Committee (UMC) 03/12/08: QIC 02/24/09 Updated clinical criteria for HIV. Version 4 02/24/09: MPCTAC Updated coding and references. 02/24/09: UMC 03/25/09: QIC 02/01/10 Updated references. Version 5 02/22/10: MPCTAC 03/24/10: QIC 03/01/11 Updated references. Updated the Version 6 03/16/11: MPCTAC clinical guideline statement and the 04/27/11: QIC medically appropriate indications with additional criteria. Updated the

Transplantation of Lung or Lobar Lung

Policy Revisions History contraindications. 03/12/12 Updated references and clinical Version 7 03/21/12: MPCTAC guideline statement. Updated and 04/25/12: QIC clarified contraindications and added relative contraindications. 08/01/12 Off cycle review for Well Sense Health Version 8 08/13/12: MPCTAC Plan. Reformatted Medical Policy 09/06/12: QIC Statement, revised Applicable Coding introduction, updated code list, and revised Limitations section. 04/01/13 Review for effective date 08/01/13. 08/01/13 04/17/13: MPCTAC Revised title, removed redundant text Version 9 05/16/13: QIC in Clinical Background Information section, revised Summary and Description of Item or Service sections, added clinical criteria and limitations, revised and added definitions, updated language in Applicable Coding section and revised applicable code list, added text to Clinical Background Information section, and added and updated references. Referenced Medically Necessary policy, Experimental and Investigational Treatment policy, and Reimbursement Guidelines: Serious Reportable Event/Provider Preventable Condition. 03/01/14 Review for effective date 07/01/14. 07/01/14 03/19/14: MPCTAC Updated Summary and References Version 10 04/16/14: QIC sections. Revised criteria in the Medical Policy Statement section and the Limitations section. 03/01/15 Review for effective 05/01/15. 05/01/15 03/18/15: MPCTAC Updated Summary and References Version 11 04/08/15: QIC sections. Removed Commonwealth Care, Commonwealth Choice, and Employer Choice from the list of applicable products because the products are no longer available. 11/25/15 Review for effective date 01/01/16. 01/01/16 11/18/15: MPCTAC Updated template with list of Version 12 11/25/15: MPCTAC applicable products and notes. (electronic vote) Revised language in the Applicable 12/09/15: QIC Coding section.

Transplantation of Lung or Lobar Lung

Policy Revisions History 03/01/16 Review for effective date 07/01/16. 07/01/16 03/16/16: MPCTAC Updated Summary, Definitions, Clinical Version 13 04/13/16: QIC Background Information, References, and References to Applicable Laws and Regulations sections. Administrative changes made to the Medical Policy Statement section. Revised criteria in the Limitations section. 03/01/17 Review for effective date 06/07/17. 06/07/17 03/15/17: MPCTAC Updated Summary, Definitions, Clinical Version 14 Background Information, and References sections. Revised criteria in the Medical Policy Statement and Limitations sections. Plan notes added to the Applicable Coding section. 03/01/18 Review for effective date 04/01/18. 04/01/18 03/21/18: MPCTAC Administrative changes made to the Version 15 Medical Policy Statement and Limitations sections. Updated the Policy Summary, References, and Other Applicable Policies sections. 03/01/19 Review for effective date 06/01/19. 06/01/19 03/20/19: MPCTAC Administrative changes made to the, Version 16 Policy Summary, References, Other Applicable Policies, and Reference to Applicable Laws and Regulations sections. Criteria revised in the Medical Policy Statement and Limitations sections. 03/01/20 Review for effective date 04/01/20. 04/01/20 03/12/20: MPCTAC Administrative changes made to the Version 17 (electronic vote) Policy Summary, Limitations, References, Other Applicable Policies, and Reference to Applicable Laws and Regulations sections. 03/01/21 Review for effective date 06/01/21. 06/01/21 03/17/21: MPCTAC Criteria revised in the Medical Policy Version 18 Statement and Limitations sections. Administrative changes made to the References section.

Last Review Date 03/01/21 Transplantation of Lung or Lobar Lung

Next Review Date 03/01/22

Authorizing Entity MPCTAC

Other Applicable Policies Administrative Policy - Clinical Review Criteria, policy number OCA 3.201 Administrative Policy - Clinical Technology Evaluation, policy number OCA 3.13 Administrative Policy - Transplantation Administration, policy number OCA 3.10 Medical Policy - Experimental and Investigational Treatment, policy number OCA 3.12 Medical Policy - Genetic/Genomic Testing and Pharmacogenetics, policy number OCA 3.727 Medical Policy - Medical Nutrition Therapy in the Outpatient or Office Setting, policy number OCA 3.66 Medical Policy - Medically Necessary, policy number OCA 3.14 Medical Policy - Transplantation of Pancreas or Pancreas-Kidney, policy number OCA 3.25 Medical Policy - Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs, policy number OCA 3.26 Reimbursement Policy - Anesthesia, policy number 4.103 Reimbursement Policy - Anesthesia, policy number SCO 4.103 Reimbursement Policy - Anesthesia, policy number WS 4.11 Reimbursement Policy - Bilateral and Multiple Procedure Reductions, policy number 4.607 Reimbursement Policy - Bilateral and Multiple Procedure Reductions, policy number SCO 4.607 Reimbursement Policy - Diabetes Self-Management Training (DSMT)/Medical Nutrition Therapy (MNT), policy number 4.32 Reimbursement Policy - Diabetes Self-Management Training (DSMT)/Medical Nutrition Therapy (MNT), policy number WS 4.32 Reimbursement Policy - General Billing and Coding Guidelines, policy number 4.31 Reimbursement Policy - General Billing and Coding Guidelines, policy number SCO 4.31 Reimbursement Policy - General Billing and Coding Guidelines, policy number WS 4.17 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy number 4.108 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy SCO 4.108 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy number WS 4.18 Reimbursement Policy - Hospital, policy number WS 4.21 Reimbursement Policy - Inpatient Hospital, policy number 4.110 Reimbursement Policy - Inpatient Hospital, policy number SCO 4.110 Reimbursement Policy - Non-Participating Provider, policy number WS 4.5

Transplantation of Lung or Lobar Lung

Reimbursement Policy - Non-Reimbursed Codes, policy number 4.38 Reimbursement Policy - Non-Reimbursed Codes, policy number WS 4.38 Reimbursement Policy - Outpatient Hospital, policy number 4.17 Reimbursement Policy - Outpatient Hospital, policy number SCO 4.17 Reimbursement Policy - Physician and Non-Physician Practitioner Services, policy number 4.608 Reimbursement Policy - Physician and Non-Physician Practitioner Services, policy number SCO 4.608 Reimbursement Policy - Physician and Non-Physician Practitioner Services, policy number WS 4.28 Reimbursement Policy - Professional Bilateral and Multiple Procedure Reductions, policy number WS 4.24 Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number 4.610 Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number SCO 4.610 Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number WS 4.29

Reference to Applicable Laws and Regulations 42 CFR 405, 482, 488, and 498. Code of Federal Regulations. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Hospital Conditions of Participation: Requirements for Approval and Re- Approval of Transplant Centers to Perform Organ Transplants. Final Rule. 2007 Mar 30.

42 US Code § 274. United States Code. Public Health Service (PHS) Act. Organ Procurement and Transplantation Network.

78 FR 48164-69. Federal Register. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Revised Process for Making National Coverage Determinations. 2013 Aug 7.

130 CMR 415.400. Code of Massachusetts Regulations. Division of Medical Assistance. MassHealth Provider Manual Series. Acute Inpatient Hospital Manual.

130 CMR 433.000. Commonwealth of Massachusetts. Code of Massachusetts Regulations. Division of Medical Assistance. MassHealth Provider Manual Series. Physician Manual.

130 CMR 450.000. Code of Massachusetts Regulations. Division of Medical Assistance. Administrative and Billing Regulations.

Commonwealth of Massachusetts. General Laws. Accessed at: https://malegislature.gov/Laws/GeneralLaws

Commonwealth of Massachusetts. Massachusetts General Laws Mandating that Certain Health Benefits Be Provided By Commercial Insurers, Blue Cross and Blue Shield and Health Maintenance Organizations. Regulatory Citations. 2017 Oct 24. Accessed at: Transplantation of Lung or Lobar Lung

https://www.mass.gov/files/documents/2017/10/27/mndatben.pdf

He-W 500. New Hampshire Code of Administrative Rules. Medical Assistance.

He-W 530.01(e). New Hampshire Code of Administrative Rules. Medical Assistance. Service Limits, Co- Payments, and Non-Covered Services. Definitions. Medically Necessary.

He-W 531. New Hampshire Code of Administrative Rules. Medical Assistance. Physician Services.

He-W 543. New Hampshire Code of Administrative Rules. Medical Assistance. Hospital Services.

New Hampshire Department of Health and Human Services (DHHS). Certified Administrative Rules. Accessed at: https://www.dhhs.nh.gov/oos/bhfa/rules.htm

RSA Chapter 420-E. New Hampshire Revised Statutes. Insurance. Licensure of Medical Utilization Review Entitles.

Disclaimer Information: + Medical Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the individual Member’s health care needs. Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.

Transplantation of Lung or Lobar Lung