Asset Publisher

mp-374

print Print

Lung and Lobar Lung Transplant

Policy Number: MP-374

Latest Review Date: September 2024

Category: Surgery                                                                  

POLICY:

Lung transplantation may be considered medically necessary for carefully selected individuals with irreversible, progressively disabling, end-stage lung disease unresponsive to maximum medical therapy.

A lobar lung transplant from a living or cadaver donor may be considered medically necessary for carefully selected individuals with end-stage lung disease.

Lung or lobar lung retransplantation may be considered medically necessary after a failed lung or lobar lung transplant in individuals who meet criteria for lung transplantation.

Lung or lobar lung transplantation in all other situations is considered investigational.

POLICY GUIDELINES:

Contraindications

Potential contraindications for solid organ transplant subject to the judgment of the transplant center include the following:

  • Known current malignancy, including metastatic cancer;
  • Recent malignancy with high incidence of recurrence;
  • History of cancer with a moderate risk of recurrence;
  • Systemic disease that could be exacerbated by immunosuppression;
  • Untreated systemic infection making immunosuppression unsafe, including chronic infection;
  • Other irreversible end-stage disease not attributed to lung disease; or
  • Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

Policy-specific

  • Coronary artery disease (CAD) not amenable to percutaneous intervention or bypass grafting, or associated with significant impairment of left ventricular function; or
  • Colonization with highly resistant or highly virulent bacteria, fungi, or mycobacteria

Individuals must meet United Network for Organ Sharing guidelines for a Lung Allocation Score greater than zero.

Lung-Specific Guidelines

Bilateral lung transplantation is typically required when chronic lung infection and disease is present (i.e., associated with cystic fibrosis and bronchiectasis). Some, but not all, cases of pulmonary hypertension will require bilateral lung transplantation.

Bronchiolitis obliterans is associated with chronic lung transplant rejection, and thus may be the etiology of a request for lung retransplantation.

DESCRIPTION OF PROCEDURE OR SERVICE:

Solid organ transplantation offers a treatment option for individuals with different types of end stage organ failure that can be lifesaving or provide significant improvements to an individual's quality of life. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Individuals are prioritized for transplant by mortality risk and severity of illness criteria developed by Organ Procurement and Transplantation Network and United Network of Organ Sharing.

Lung Transplant

In 2023, 46,630 transplants were performed in the United States procured from more than 16,000 deceased donors and 6,900 living donors. Lung transplants were the fourth most common procedure with 302 transplants performed from both deceased and living donors in 2023.

End-stage lung disease may derive from different etiologies. The most common indications for lung transplantation are chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, a1-antitrypsin deficiency, and idiopathic pulmonary arterial hypertension. Before consideration for transplant, individuals should be receiving maximal medical therapy, including oxygen supplementation, or surgical options, such as lung volume reduction surgery for chronic obstructive pulmonary disease. Lung or lobar lung transplantation is an option for individudals with end-stage lung disease despite these measures.

A lung transplant refers to single-lung or double-lung replacement. In a single-lung transplant, only one lung from a deceased donor is provided to the recipient. In a double-lung transplant, both the recipient's lungs are removed and replaced by the donor's lungs. 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 lobe obtained from each of two donors (generally friends or family members) in cases for which bilateral transplantation is required. There are also cases of cadaver lobe transplants.

Potential recipients who are 12 years of age and older are ranked according to the Lung Allocation Score. A score may range between 0 and 100 and incorporates predicted survival after transplantation and predicted survival on the waiting list; the Lung Allocation Score takes into consideration the individuals disease and clinical parameters. The waiting list incorporates the Lung Allocation Score, geography, and blood type classifications. Children younger than 12 years old receive a priority for lung allocation. Under this system, children younger than 12 years old with respiratory lung failure and/or pulmonary hypertension who meet criteria are considered "priority 1", and all other candidates in the age group are considered "priority 2". A lung review board has the authority to adjust scores on appeal for adults and children.

Potential Contraindications to Transplantation

Malignancy

Malignancies are common after lung transplantation, with 21% and 40% of individuals reporting one or more malignancies at 5 and 10 years posttransplantation, respectively.4, Skin cancer occurred most frequently, and lymphoproliferative disorders were the malignancies most associated with morbidity posttransplantation.

Human Immunodeficiency Virus Infection

Current OPTN policy allows human immunodeficiency virus (HIV)-positive transplant candidates. The 2020 US Public Health Service guideline also permits transplantation in HIV-positive recipients with proper screenings and effective regimens for HIV infections; it recommended that all transplant candidates receive HIV, Hepatitis B virus (HBV), and Hepatitis C virus (HCV) testing during hospital admission for transplant surgery. In 2022, the US Public Health Service published updated guidance for testing transplant candidates aged less than 12 years of age. They recommended that children less than 12 years of age who have received postnatal infectious disease testing are exempt from repeat pre-transplant HIV, HBV, and HCV testing during hospital admission for transplant surgery.

Other Infections

Infection with Burkholderia cenocepacia is associated with increased mortality in some transplant centers, a factor that may be considered when evaluating the overall risk of transplant survival. Two articles have evaluated the impact of infection with various species of Burkholderia on outcomes for lung transplantation for cystic fibrosis. In a study by Murray et al (2008), multivariate Cox survival models were applied to 1026 lung transplant candidates and 528 transplant recipients. Of the transplant recipients, 88 were infected with Burkholderia. Among transplant recipients infected with B. cenocepacia, only those infected with non-epidemic strains (n=11) had significantly greater posttransplant mortality than uninfected individuals (hazard ratio [HR], 2.52; 95% confidence interval [CI], 1.04 to 6.12; p=.04). Transplant recipients infected with Burkholderia gladioli (n=14) also had significantly greater posttransplant mortality than uninfected individuals (HR , 2.23; 95% CI, 1.05 to 4.74; p=.04). When adjustments for specific species or strains were included, the Lung Allocation Scores of Burkholderia multivorans-infected transplant candidates were comparable with uninfected candidate scores, and scores for individuals infected with non-epidemic B. cenocepacia or B. gladioli were lower. In a smaller study of 22 individuals colonized with Burkholderia cepacia complex who underwent lung transplantation in 2 French centers, Boussaud et al (2008) reported that the risk of death by univariate analysis was significantly higher for the 8 individuals infected with B. cenocepacia than for the other 14 colonized individuals (11 of whom had B. multivorans).

An analysis of international registry data by Yusen et al (2016) found that non-cytomegalovirus (CMV) infection is a major cause of mortality within 30 days of a lung transplant in adults. A total of 655 (19%) of 3424 deaths after transplants between 1990 and 2015 were due to non-CMV infection. Only 3 (0.1%) of the deaths were due to CMV infection.

Etiologies of end stage lung disease include, but are not limited to, the following:

Table 1: Etiologies of End-Stage Lung Disease

Diagnosis

Bilateral bronchiectasis

 

Alpha-1 antitrypsin deficiency

 

Primary pulmonary hypertension

 

Cystic fibrosis (both lungs to be transplanted)

 

Bronchopulmonary dysplasia

 

Post inflammatory pulmonary fibrosis

 

Idiopathic or interstitial pulmonary fibrosis

 

Sarcoidosis

 

Scleroderma

 

Lymphangiomyomatosis

 

Emphysema

 

Eosinophilic granuloma

 

Bronchiolitis obliterans

 

Recurrent pulmonary embolism

 

Pulmonary hypertension due to cardiac disease

 

Chronic obstructive pulmonary disease

 

Eisenmenger syndrome

 

KEY POINTS:

The most recent literature update was performed through June 18, 2024.

Summary of Evidence

For individuals who have end-stage pulmonary disease who receive lung transplantation, the evidence includes case series and registry studies. Relevant outcomes are overall survival (OS), change in disease status, and treatment-related mortality and morbidity. International registry data on a large number of individuals receiving lung transplantation (>50,000) found relatively high individual survival rates, especially among individuals who survived the first year posttransplant. After adjusting for potential confounding factors, survival did not differ significantly after single or bilateral lung transplant. Lung transplantation may be the only option for some individuals with end-stage lung disease. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have end-stage pulmonary disease who receive lobar lung transplantation, the evidence includes case series and systematic reviews. Relevant outcomes are overall survival, change in disease status, and treatment-related mortality and morbidity. There are less data on lung lobar transplants than on whole-lung transplants, but several case series have reported reasonably similar survival outcomes between the procedures, and lung lobar transplants may be the only option for patients unable to wait for a whole-lung transplant. A 2017 systematic review found 1-year survival rates in the available published studies ranging from 50% to 100%. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a prior lung or lobar transplant who meet criteria for a lung transplant who receive a lung or lobar lung retransplant, the evidence includes case series and registry studies. Relevant outcomes are overall survival, change in disease status, treatment-related mortality and morbidity. Data from registries and case series have found favorable outcomes with lung retransplantation in individuals who meet criteria for initial lung transplantation. Given the exceedingly poor survival without retransplantation of individuals who have exhausted other treatments, evidence of a moderate level of posttransplant survival is sufficient in this individual population. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

International Society for Heart and Lung Transplantation

Initial Transplant

In 2021, the International Society for Heart and Lung Transplantation published updated consensus-based guidelines on the selection of lung transplant candidates. The guidelines states that:

  • "Lung transplantation should be considered for adults with chronic, end-stage lung disease who meet all the following general criteria:
  1. High (>50%) risk of death from lung disease within 2 years if lung transplantation is not performed.
  2. High (>80%) likelihood of 5-year post-transplant survival from a general medical perspective provided that there is adequate graft function."

The guideline also notes risk factors to be considered in the evaluation of transplant candidates, along with pediatric and disease-specific considerations.

Retransplant

The 2021 guideline update briefly addressed lung retransplantation, with the consensus statement noting that "The outcomes after re-transplants are inferior compared to first lung transplants, particularly if the re-transplant is done within the first year after the original transplant or for patients with restrictive allograft syndrome (RAS) [...] In the pre-transplant evaluation of such patients, particular emphasis should be focused on understanding the possible reasons for the graft failure, such as alloimmunization, poor adherence, gastroesophageal reflux, or repeated infections". 

American Thoracic Society et al

Evidence-based recommendations from the American Thoracic Society and three international cardiac societies were published in 2011 for the diagnosis and management of patients with idiopathic fibrosis. For appropriately selected individuals with idiopathic pulmonary fibrosis, the international guideline panel recommended lung transplantation (strong recommendation, low-quality evidence). An updated to this document was published in 2015 in which the committee did not make a recommendation regarding single versus bilateral lung transplantation in individuals with idiopathic fibrosis. The committee stated, "it is unclear whether single or bilateral lung transplantation is preferential for long-term outcomes".

In 2022, the American Thoracic Society along with the three other international cardiac societies published updated guidance on diagnosis and management of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. In terms of treatment considerations, the committee stated that "patients at increased risk of mortality should be referred for lung transplantation at diagnosis".

In 2014, the American Thoracic Society published guidelines on the management of bronchiolitis obliterans syndrome in lung transplant recipients in conjunction with the International Society for Heart and Lung Transplantation and the European Respiratory Society. The guideline recommends referral to a transplant surgeon to be evaluated for retransplantation for end-stage bronchial obliterans syndrome that is refractory to other therapies.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Lung Lobar Transplant, Lung and Lobar, Lung Transplant, Single Lung Transplant, SLT, Bilateral Lung Transplant, BLT, Cadaveric Lobar Transplant (CLT)

APPROVED BY GOVERNING BODIES:

Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration (FDA).

The FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

32850

Donor pneumonectomy(ies) (including cold preservation), from cadaver donor

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

32855

Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus, unilateral

32856

Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; bilateral

HCPCS:

S2060          

Lobar lung transplantation

S2061          

Donor lobectomy (lung) for transplantation, living donor

REFERENCES:

  1. Alexander BD, Petzold EW, Reller LB, et al. Survival after lung transplantation of cystic fibrosis patients infected with Burkholderia cepacia complex. Am J Transplant. May 2008; 8(5):1025-1030.
  2. Barr ML, Schenkel FA, Bowdish ME et al. Living donor lobar lung transplantation: current status and future directions. Transplant Proc 2005; 37(9):3983-3986.
  3. Biswas Roy S, Panchanathan R, Walia R, et al. Lung retransplantation for chronic rejection: a single-center experience. Ann Thorac Surg. Jan 2018; 105(1):221-227.
  4. Black MC, Trivedi J, Schumer EM, et al. Double lung transplants have significantly improved survival compared with single lung transplants in high lung allocation score patients. Ann Thorac Surg. Nov 2014; 98(5):1737-1741.
  5. Black CK, Termanini KM, Aguirre O, et al. Solid organ transplantation in the 21 st century. Ann Transl Med. Oct 2018; 6(20): 409.
  6. Boussaud V, Guillemain R, Grenet D, et al. Clinical outcome following lung transplantation in patients with cystic fibrosis colonized with Burkholderia cepacia complex: Results from two French centres. Thorax 2008; 63(8):732-737.
  7. Date H, Sato M, Aoyama A, et al. Living-donor lobar lung transplantation provides similar survival to cadaveric lung transplantation even for very ill patients. Eur J Cardiothorac Surg. Jun 2015; 47(6):967-972; discussion 972-973.
  8. Date H, Shiraishi T, Sugimoto S et al. Outcome of living-donor lobar lung transplantation using a single donor. J Thorac Cardiovasc Surg. Sept 2012; 144(3):710-715.
  9. Date H. Update on living-donor lobar lung transplantation. Curr Opin Organ Transplant. Sept 2011; 16(5):453-457.
  10. Eberlein M, Reed RM, Chahla M, et al. Lobar lung transplantation from deceased donors: A systematic review. World J Transplant. Feb 24 2017; 7(1):70-80.
  11. Free RJ, Levi ME, Bowman JS, et al. Updated U.S. Public Health Service Guideline for testing of transplant candidates aged 12 years for infection with HIV, hepatitis B virus, and hepatitis C virus - United States, 2022. Am J Transplant. Sep 2022; 22(9): 2269-2272.
  12. Goldfarb SB, Levvey BJ, Edwards LB, et al. The Registry of the International Society for Heart and Lung Transplantation: Nineteenth Pediatric Lung and Heart-Lung Transplantation Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant. Oct 2016; 35(10):1196-1205.
  13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  14. Jones JM, Kracalik I, Levi ME et al. Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection - U.S. Public Health Service Guideline, 2020. MMWR Recomm Rep. Jun 26 2020; 69(4).
  15. Kawut SM. Lung retransplantation. Clin Chest Med. Jun 2011; 32(2):367-377.
  16. Kilic A, Beaty CA, Merlo CA et al. Functional status is highly predictive of outcomes after redo lung transplantation: an analysis of 390 cases in the modern era. Ann Thorac Surg 2013; 96(5):1804- 1811.
  17. Leard LE, Holm AM, Valapour M, et al. Consensus document for the selection of lung transplant candidates: An update from the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. Nov 2021; 40(11): 1349-1379.
  18. Meyer KC, Raghu G, Verleden GM, et al. An international ISHLT/ATS/ERS clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Eur Respir J. Dec 2014; 44(6): 1479-503.
  19. Murray S, Charbeneau J, Marshall BC, et al. Impact of Burkholderia infection on lung transplantation in cystic fibrosis. Am J Respir Crit Care Med 2008; 178(4):363-371.
  20. Organ Procurement and Transplantation Network (OPTN). Policy 10: Allocation of Lungs. optn.transplant.hrsa.gov/media/1200/optn_policies.pdf.
  21. Organ Procurement and Transplantation Network (OPTN). National Data. n.d.; optn.transplant.hrsa.gov/data/view-data-reports/national-data/.
  22. Paraskeva MA, Edwards LB, Levvey B, et al. Outcomes of adolescent recipients after lung transplantation: An analysis of the International Society for Heart and Lung Transplantation Registry. J Heart Lung Transplant. Feb 17 2018; 37(3):323-331.
  23. Raghu G, Collard HR, Egan JJ, et al. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. Mar 15 2011; 183(6):788-824.
  24. Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. May 01 2022; 205(9): e18-e47.
  25. Raghu G, Rochwerg B, Zhang Y, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med. Jul 15 2015; 192(2): e3-19.
  26. Shafii AE, Mason DP, Brown CR, et al. Too high for transplantation? Single-center analysis of the lung allocation score. Ann Thorac Surg. Nov 2014; 98(5):1730-1736.
  27. Slama A, Ghanim B, Klikovits T, et al. Lobar lung transplantation--is it comparable with standard lung transplantation? Transpl Int. Sep 2014; 27(9):909-916.
  28. Thabut G, Christie JD, Kremers WK, et al. Survival differences following lung transplantation among US transplant centers. JAMA. Jul 07 2010; 304(1): 53-60.
  29. Transplant trends. United Network for Organ Sharing website. unos.org/data/transplant-trends/.
  30. Working Party of the British Transplantation Society. Kidney and Pancreas Transplantation in Patients with HIV. Second Edition (Revised). British Transplantation Society Guidelines. Macclesfield, UK: British Transplantation Society; 2017.
  31. Yu H, Bian T, Yu Z, et al. Bilateral Lung Transplantation Provides Better Long-term Survival and Pulmonary Function Than Single Lung Transplantation: A Systematic Review and Meta-analysis. Transplantation. Dec 2019; 103(12): 2634-2644.
  32. Yusen RD, Christie JD, Edwards LB et al. The Registry of the International Society for Heart and Lung Transplantation: thirtieth adult lung and heart-lung transplant report--2013; focus theme: age. J Heart Lung Transplant 2013; 32(10):965-978.
  33. Yusen RD, Edwards LB, Dipchand AI, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-third Adult Lung and Heart-Lung Transplant Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant. Oct 2016; 35(10):1170-1184.
  34. Yusen RD, Shearon TH, Qian Y et al. Lung transplantation in the United States, 1999-2008. Am J Transplant. Apr 2010; 10(4 Pt 2):1047-1068.

POLICY HISTORY:

Medical Policy Group, July 2009 (2)

Medical Policy Administration Committee, August 2009

Available for comment August 10-September 23, 2009

Medical Policy Group, December 2010 (1): Description updated, Key Points updated, Policy statement added

Medical Policy Administration Committee, January 2011

Available for comment January 25 through March 7, 2011

Medical Policy Panel, December 2012

Medical Policy Group, January 2013 (2): Update to Policy (removed “children and adolescents”), updated Key Points and References

Medical Policy Administration Committee Meeting February 2013

Available for comment February 21 through April 7, 2013

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (3):  Updates to Description, Policy Statement, Key Points and References; policy statement updated to include lung or lobar retransplantation after a failed lung or lobar lung transplant coverage and to add lung or lobar lung transplantation in all other situations other than those listed is considered investigational

Medical Policy Administration Committee, February 2014

Available for comment January 24 through March 10, 2014

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (2): 2015 Updates to Key Points, References, and removed policy statement for dates of service prior to December 10, 2010; no change in policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (7): 2017 Updates to Description, Key Words, and References. Policy statement- Added HIV criteria; clarified absolute contraindications; removed old criteria from 2012 and 2014.

Medical Policy Administration Committee, October 2017

Available for comment October 3 through November 16, 2017

Medical Policy Panel, 2018

Medical Policy Group, August 2018 (3): Updates to Description, Key Points, Approved by Governing Bodies, References, and Key Words: added SLT, Bilateral Lung Transplant, BLT, Cadaveric Lobar Transplant, and CLT. No changes to policy statement or intent.

Medical Policy Panel, August 2019

Medical Policy Group, September 2019 (3): 2019 Updates to Key Points. No changes to policy statement or intent.

Medical Policy Panel, August 2020

Medical Policy Group, September 2020 (3): 2020 Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (3): 2021 Updates to Description and Key Points. Policy statement updated to remove “not medically necessary”, no other changes to policy statement.

Medical Policy Panel, August 2022

Medical Policy Group, September 2022 (3): 2022 Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Removed HIV positive patient criteria from policy section to reflect standard of care guidelines from the American Society of Transplantation. Removed absolute contraindications in policy guidelines and changed verbiage to “Potential contraindications for solid organ transplant subject to the judgment of the transplant center.” No other changes to policy statement or intent.

Medical Policy Panel, August 2023

Medical Policy Group, August 2023 (3): 2023 Updates to Description, Key Points, Practice Guidelines and Position Statements, Benefit Applications, and References. No changes to policy statement or intent.

Medical Policy Panel, August 2024

Medical Policy Group, September 2024 (3): Updates to Description, Key Points, and References. Policy statement verbiage changed from patient to individual. No change to the intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.