Latest Review Date:  January 2024

Category:  Surgery                                                                

POLICY:

Allogenic hematopoietic cell transplantation may be considered medically necessary to treat chronic lymphocytic leukemia or small cell lymphocytic leukemia in individuals with markers of poor-risk disease.

Autologous hematopoietic cell transplantation is considered investigational to treat chronic lymphocytic leukemia or small lymphocytic lymphoma.

POLICY GUIDELINES:

Staging and Prognosis of CLL/SLL

Two scoring systems are used to determine stage and prognosis of individuals with CLL/SLL.

As outlined in Table 1, the Rai and Binet staging systems classify individuals into three risk groups with different prognoses and are used to make therapeutic decisions.

Table 1.  Rai and Binet Classification for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Rai Stage	Risk	Description	Median Survival, y	Binet Stage	Description	Median Survival, y
0	Low	Lymphocytosis	>10	A	≤3 lymphoid areas, normal hemoglobin and platelets	>10
I	Int	Lymphocytosis + lymphadenopathy	7-9	B	≥3 lymphoid areas, normal hemoglobin and platelets	7
II	Int	Lymphocytosis + splenomegaly ± lymphadenopathy	7-9
III	High	Lymphocytosis + anemia ± lymphadenopathy or splenomegaly	1.5-5	C	Any number of lymphoid areas, anemia, thrombocytopenia	5
IV	High	Lymphocytosis + thrombocytopenia ± anemia, splenomegaly, or lymphadenopathy	1.5-5

The prognosis of patients varies within the different Rai and Binet classifications, other prognostic markers are used in conjunction with staging to determine clinical management.

The National Comprehensive Cancer Network guideline on CLL/SLL stated the following as unfavorable prognostic factors: DNA sequencing with mutated TP53 or ≤2% immunoglobulin heavy-chain variable (IGHV) mutation; interphase cytogenetics with del17p or deletion of 11q (del11q); or complex karyotype (≥3 unrelated chromosome abnormalities in more than 1 cell on karyotype).

DESCRIPTION OF PROCEDURE OR SERVICE:

Risk stratification of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) guides therapy decisions, which may include hematopoietic cell transplantation for those with poor risk features.

Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are neoplasms of hematopoietic origin characterized by the accumulation of lymphocytes with a mature, generally well-differentiated morphology. In CLL, these cells accumulate in blood, bone marrow, lymph nodes, and spleen, while in SLL they are generally confined to lymph nodes. The Revised European-American/WHO Classification of Lymphoid Neoplasms considers B-cell CLL and SLL a single disease entity.

CLL and SLL share many common features and are often referred to as blood and tissue counterparts of each other, respectively. Both tend to present as asymptomatic enlargement of the lymph nodes, tend to be indolent in nature, but can undergo transformation to a more aggressive form of disease (e.g., Richter’s transformation). The median age at diagnosis of CLL is approximately 72 years, but it may present in younger individuals, often as poor-risk disease with significantly reduced life expectancy.

Treatment regimens used for CLL are generally the same as those used for SLL, and outcomes of treatment are comparable for the two diseases. Both low- and intermediate-risk CLL and SLL demonstrate relatively good prognoses with median survivals of six to ten years, while the median survival of high-risk CLL or SLL may be only two years. Although typically responsive to initial therapy, CLL and SLL are rarely cured by conventional therapy, and nearly all patients ultimately die of their disease. This natural history prompted investigation of hematopoietic cell transplantation as a possible curative regimen.

Hematopoietic Cell Transplantation

Hematopoietic cell transplantation (HCT) refers to a procedure in which hematopoietic stem cells are infused to restore bone marrow function in cancer patients who receive bone marrow-toxic doses of cytotoxic drugs, with or without whole-body radiotherapy. Hematopoietic stem cells may be obtained from the transplant recipient (autologous HCT, auto-HCT) or from a donor (allogeneic HCT, allo-HCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly after delivery of neonates. Although cord blood is an allogeneic source, the stem cells in it are antigenically “naïve” and thus are associated with a lower incidence of rejection or graft-versus-host disease (GVHD). Cord blood is discussed in greater detail in Medical Policy #439: Placental/ Umbilical Cord Blood as a Source of Stem Cells.

Immunologic compatibility between infused hematopoietic stem cells and the recipient is not an issue in auto-HCT. However, immunologic compatibility between donor and patient is a critical factor for achieving a good outcome of allo-HCT. Compatibility is established by typing of human leukocyte antigens (HLA) using cellular, serologic, or molecular techniques. HLA refers to the tissue type expressed at the HLA A, B, and DR loci on each arm of chromosome 6. Depending on the disease being treated, an acceptable donor will match the patient at all or most of the HLA loci.

Conditioning for HCT

Conventional Conditioning for HCT

The conventional practice of allogeneic HCT involves administration of cytotoxic agents (e.g., cyclophosphamide, busulfan) with or without total-body irradiation at doses sufficient to destroy endogenous hematopoietic capability in the recipient. The beneficial treatment effect in this procedure is due to a combination of initial eradication of malignant cells and subsequent graft-versus-malignancy (GVM) effect that develops after engraftment of allogeneic stem cells within the patient’s bone marrow space. The slower GVM effect is considered the potentially curative component, but it may be overwhelmed by extant disease without the use of pretransplant conditioning. However, intense conditioning regimens are limited to patients who are sufficiently fit medically to tolerate substantial adverse effects that include pre-engraftment opportunistic infections secondary to loss of endogenous bone marrow function and organ damage and failure caused by the cytotoxic drugs. Furthermore, in any allogeneic HCT, immune suppressant drugs are required to minimize graft rejection and GVHD, which also increases susceptibility of the patient to opportunistic infections.

The success of autologous HCT is predicated on the ability of cytotoxic chemotherapy with or without radiation to eradicate cancerous cells from the blood and bone marrow. This permits subsequent engraftment and repopulation of bone marrow space with presumably normal hematopoietic stem cells obtained from the patient prior to undergoing bone marrow ablation. Therefore, autologous HCT is typically performed as consolidation therapy when the patient’s disease is in complete remission. Patients who undergo autologous HCT are susceptible to chemotherapy-related toxicities and opportunistic infections prior to engraftment, but not GVHD.

Reduced-Intensity Conditioning for Allogeneic HCT

Reduced-intensity conditioning (RIC) refers to the pretransplant use of lower doses or less intense regimens of cytotoxic drugs or radiation than are used in conventional full-dose myeloablative conditioning treatments. The goal of RIC is to reduce disease burden but also to minimize as much as possible associated treatment-related morbidity and non-relapse mortality (NRM) in the period during which the beneficial GVM effect of allogeneic transplantation develops. Although the definition of RIC remains arbitrary, with numerous versions employed, all seek to balance the competing effects of NRM and relapse due to residual disease. RIC regimens can be viewed as a continuum in effects, from nearly totally myeloablative to minimally myeloablative with lymphoablation, with intensity tailored to specific diseases and patient condition. Patients who undergo RIC with allogeneic HCT initially demonstrate donor cell engraftment and bone marrow mixed chimerism. Most will subsequently convert to full-donor chimerism, which may be supplemented with donor lymphocyte infusions to eradicate residual malignant cells. For the purposes of this Policy, the term “reduced-intensity conditioning” will refer to all conditioning regimens intended to be nonmyeloablative, as opposed to fully myeloablative (conventional) regimens.

Some patients for whom a conventional myeloablative allotransplant could be curative may be considered candidates for RIC allogeneic HCT. These include those patients whose age (typically older than 60 years) or comorbidities (e.g., liver or kidney dysfunction, generalized debilitation, prior intensive chemotherapy, low Karnofsky Performance Status) preclude use of a standard myeloablative conditioning regimen. A patient who relapses following a conventional myeloablative allogeneic HCT could undergo a second myeloablative procedure if a suitable donor is available and his or her medical status would permit it. However, this type of patient would likely undergo RIC prior to a second allogeneic HCT if a complete remission could be re-induced with chemotherapy.

The ideal allogeneic donors are HLA-identical siblings, matched at the HLA-A, B, and DR loci (six of six). Related donors mismatched at one locus are also considered suitable donors. A matched, unrelated donor identified through the National Marrow Donor Registry is typically the next option considered. Recently, haploidentical donors, typically a parent or a child of the patient, with whom usually there is sharing of only three of the six major histocompatibility antigens, have been under investigation as a stem cell source. Most patients will have such a donor; however, the risk of GVHD and overall morbidity of the procedure may be severe, and experience with these donors is not as extensive as that with matched donors.

KEY POINTS:

The latest literature review was conducted through November 27, 2023.

Summary of Evidence

For individuals who have CLL/SLL and markers of poor-risk disease who receive allogeneic hematopoietic cell transplantation (allo-HCT), the evidence includes single-arm prospective and registry-based studies. Relevant outcomes are overall survival, disease-specific survival, change in disease status, and treatment-related mortality and morbidity. Data have suggested that allo-HCT can provide long-term disease control and overall survival in patients with poor-risk CLL/SLL. High rates of treatment-related morbidity discourage this approach in lower-risk disease, particularly among older patients whose health status typically precludes the use of myeloablative conditioning. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have CLL/SLL who receive autologous HCT, the evidence includes randomized controlled trials and a systematic review. Relevant outcomes are overall survival, disease-specific survival, change in disease status, and treatment-related mortality and morbidity. Autologous HCT is feasible in younger patients but is not curative, particularly in those with poor-risk CLL. Studies of autologous HCT published to date have not shown improvement in overall survival in patients with CLL/SLL, and results must be considered in the context of improved outcomes with the use of newer chemoimmunotherapy agents. Furthermore, evidence from the European Intergroup randomized controlled trial has suggested quality of life issues are important in selecting patients for autologous HCT and may dictate the management course for patients who are otherwise candidates for this approach. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Society for Blood and Marrow Transplantation

In 2015, the American Society for Blood and Marrow Transplantation (ASBMT) published guidelines on indications for autologous and allogeneic hematopoietic cell transplantation (allo-HCT). Recommendations describe the current consensus on use of HCT within and outside of the clinical trial setting. Treatment recommendations for chronic lymphocytic leukemia (CLL) are shown in Table 2.

Table 2: ASBMT 2015 Recommendations for Allogeneic and Autologous HCT for CLL

Adult Indications	Allogeneic HCT	Autologous HCT
High risk, first or greater remission	C	N
T cell, prolymphocytic leukemia	R	R
B cell, prolymphocytic leukemia	R	R
Transformation to high-grade lymphoma	C	C

C: standard of care, clinical evidence available, N: Not generally recommended; R: standard of care, rare indication; HCT: hematopoietic cell transplantation.

In 2016, ASBMT published clinical practice recommendations with additional detail on allo-HCT for CLL. Recommendations are shown in Table 3.

Table 3: ASBMT 2016 Recommendations for Allogeneic HCT for CLL

Indications	Allogeneic HCT
High-risk CLL	Not recommended in the first-line consolidation setting
	Not recommended for patients who relapse after first-line therapy and demonstrate sensitive disease after second line therapy (not BCR inhibitors)
	Recommended for patients who relapse after first-line therapy, have refractory disease after second-line therapy (not BCR inhibitors) and show an objective response to BCR inhibitors or to a clinical trial
	Recommended for patients who relapse after first-line therapy, have refractory disease after second-line therapy (including BCR inhibitors but not BCL-2 inhibitors) and show an objective response to BCL-2 inhibitors or to a clinical trial
	Recommended when there is a lack of response or there is progression after BCL-2 inhibitors
Richter transformation	Recommended after achieving an objective response to anthracycline-based chemotherapy
Purine analogue relapsed and/or refractory disease	Not recommended

BCR: B cell receptor; BCL-2: B cell lymphoma 2; CLL: chronic lymphocytic leukemia

HCT: hematopoietic cell transplantation.

American Society for Transplantation and Cellular Therapy

In 2020, the American Society for Transplantation and Cellular Therapy (ASTCT) published guidelines on indications for HCT and immune effector cell therapy.  Recommendations for CLL are shown in Table 4.

Table 4. 2020 Recommendations for Allogeneic HCT for CLL

Adult Indications	Allogeneic HCT	Autologous HCT
High-risk, first or greater remission	S	N
T cell, prolymphocytic leukemia	S	R
B cell, prolymphocytic leukemia	R	R
Transformation to high-grade lymphoma	C	S

 

C: standard of care, clinical evidence available; HCT: hematopoietic cell transplantation; N: not generally recommended; R: standard of care, rare indication; S: standard of care

National Comprehensive Cancer Network (NCCN) Guidelines

Current National Comprehensive Cancer Network guidelines (v.1.2024) for CLL and small lymphocytic lymphoma (SLL) state the following regarding HCT:

• "Allogeneic HCT can be considered for CLL/SLL refractory to small-molecule therapy in patients without significant comorbidities."
• "For patients with CLL/SLL with del(17p) or TP53 mutation, a discussion of allogeneic HCT could be considered for patients in remission with or after ibrutinib therapy, if complex karyotype [CK] (≥3 abnormalities) is present. However, available data suggest that CK (≥5 abnormalities) is associated with inferior overall survival [OS] and event-free survival [EFS] following allogeneic HCT with reduced-intensity conditioning in patients with high-risk interphase cytogenetics."
• In patients with histologic transformation (Richter's) and progression, allogeneic HCT can be considered for certain patients with disease responding to initial chemotherapy. In addition, "autologous HCT may also be appropriate for patients with disease responding to initial therapy but who are not candidates for allogeneic HCT due to age, comorbidities, or lack of a suitable donor."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), hematopoietic cell transplantation, autologous HCT, allogeneic HCT, high-dose chemotherapy

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under the Code of Federal Regulation title 21, parts 1270 and 1271. Hematopoietic cells are included in 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:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:   

38204	Management of recipient hematopoietic cell donor search and cell acquisition
38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection, allogeneic
38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection, autologous
38207	Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage
38208	; thawing of previously frozen harvest, without washing; per donor
38209	; thawing of previously frozen harvest, with washing; per donor
38210	; specific cell depletion with harvest, T-cell depletion
38211	; tumor cell depletion
38212	; red blood cell removal
38213	; platelet depletion
38214	; plasma (volume) depletion
38215	;cell concentration in plasma, mononuclear, or buffy coat layer
38220	Diagnostic bone marrow; aspiration(s)
38221	Diagnostic bone marrow; biopsy(ies),
38222	Diagnostic bone marrow; biopsy(ies) and aspiration(s)
38230	Bone marrow harvesting for transplantation; allogeneic
38232	Bone marrow harvesting for transplantation; autologous
38240	Bone marrow or blood-derived peripheral stem-cell transplantation; allogeneic
38241	Bone marrow or blood-derived peripheral stem-cell transplantation; autologous
38242	; allogeneic donor lymphocyte infusions

                    

HCPCS:

S2140	Cord blood harvesting for transplantation, allogeneic
S2142	Cord blood-derived stem cell transplantation, allogeneic
S2150	Bone marrow or blood-derived peripheral stem-cell harvesting and transplantation, allogeneic or autologous, including pheresis, high-dose chemotherapy, and the number of days of post-transplant care in the global definition (including drugs; hospitalization; medical, surgical, diagnostic, and emergency services)

                      

REFERENCES:

1. Brown JR, Kim HT, Li S et al. Predictors of improved progression-free survival after nonmyeloablative allogeneic stem cell transplantation for advanced chronic lymphocytic leukemia. Biol Blood Marrow Transplant. Oct 2006; 12(10):1056-1064.
2. de Wreede LC, Watson M, van Os M et al. Improved PFS after autologous stem cell transplantion does not translate into better Quality of Life in CLL: lessons from the randomized EBMT-Intergroup study. Am J Hematol. Feb 2014; 89(2):174-180.
3. Delgado J, Milligan DW, Dreger P. Allogeneic hematopoietic cell transplantation for chronic lymphocytic leukemia: ready for prime time? Blood. Sep 24 2009; 114(13):2581-2588.
4. Delgado J, Thomson K, Russell N et al. Results of alemtuzumab-based reduced-intensity allogeneic transplantation for chronic lymphocytic leukemia: a British Society of Blood and Marrow Transplantation Study. Blood. Feb 15 2006; 107(4):1724-1730.
5. Dreger P, Brand R, Hansz J et al. Treatment-related mortality and graft-versus-leukemia activity after allogeneic stem cell transplantation for chronic lymphocytic leukemia using intensity-reduced conditioning. Leukemia. May 2003; 17(5):841-848.
6. Dreger P, Dohner H, Ritgen M et al. Allogeneic stem cell transplantation provides durable disease control in poor-risk chronic lymphocytic leukemia: long-term clinical and MRD results of the German CLL Study Group CLL3X trial. Blood. Oct 7 2010; 116(14):2438-2447.
7. Dreger P. Allotransplantation for chronic lymphocytic leukemia. Hematology Am Soc Hematol Educ Program 2009:602-609.
8. Gine E, Moreno C, Esteve J, et al. The role of stem-cell transplantation in chronic lymphocytic leukemia risk-adapted therapy. Best Pract Res Clin Haematol. Sep 2007; 20(3): 529-543.
9. Gladstone DE, Fuchs E. Hematopoietic stem cell transplantation for chronic lymphocytic leukemia. Curr Opin Oncol. Mar 2012; 24(2):176-181.
10. Gribben JG. The role of stem cell transplantation in chronic lymphocytic leukemia. American Society of Clinical Oncology (ASCO) Education Book 2008; pp. 291-296.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. Kanate AS, Majhail NS, Savani BN, et al. Indications for Hematopoietic Cell Transplantation and Immune Effector Cell Therapy: Guidelines from the American Society for Transplantation and Cellular Therapy. Biol Blood Marrow Transplant. Jul 2020; 26(7): 1247-1256. 
13. Kharfan-Dabaja MA, Anasetti C and Santos ES.  Hematopoietic cell transplantation for chronic lymphocytic leukemia: An evolving concept.  Biol Blood Marrow Transpl. Apr 2007; 13(4): 373-385.
14. Kharfan-Dabaja MA, Kumar A, Hamadani M, et al. Clinical practice recommendations for use of allogeneic hematopoietic cell transplantation in chronic lymphocytic leukemia on behalf of the Guidelines Committee of the American Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. Dec 2016; 22(12):2117-2125.
15. Khouri IF, Saliba RM, Admirand J et al. Graft-versus-leukemia effect after non-myeloablative hematopoietic transplantation can overcome the unfavorable expression of ZAP-70 in refractory chronic lymphocytic leukaemia. Br J Haematol. May 2007; 137(4):355-363.
16. Majhail NS, Farnia SH, Carpenter PA, et al. Indications for Autologous and Allogeneic Hematopoietic Cell Transplantation: Guidelines from the American Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. Nov 2015; 21(11):1863-1869.
17. Michallet M, Dreger P, Sutton L et al. Autologous hematopoietic stem cell transplantation in chronic lymphocytic leukemia: results of European intergroup randomized trial comparing autografting versus observation. Blood. Feb 3 2011; 117(5):1516-1521.
18. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: chronic lymphocytic leukemia/small lymphocytic lymphoma. Version 1.2024. www.nccn.org/professionals/physician_gls/pdf/cll.pdf. 
19. Reljic T, Kumar A, Djulbegovic B, et al. High-dose therapy and autologous hematopoietic cell transplantation as front-line consolidation in chronic lymphocytic leukemia: a systematic review. Bone Marrow Transplant. Aug 2015; 50(8):1144.
20. Schetelig J, Thiede C, Bornhauser M et al. Evidence of a graft-versus-leukemia effect in chronic lymphocytic leukemia after reduced-intensity conditioning and allogeneic stem-cell transplantation: the Cooperative German Transplant Study Group. J Clin Oncol. Jul 15 2003; 21(14):2747-2753.
21. Sorror ML, Storer BE, Sandmaier BM et al. Five-year follow-up of patients with advanced chronic lymphocytic leukemia treated with allogeneic hematopoietic cell transplantation after nonmyeloablative conditioning. J Clin Oncol. Oct 20 2008; 26(30):4912-4920.

POLICY HISTORY:

Medical Policy Group, February 2010 (3)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group, December 2011 (3): 2012 Coding Update – updated codes 38208 & 38209

Medical Policy Group, February 2012 (3): 2012 Updates- Description, Policy, Key Points, References

Medical Policy Administration Committee, February 2012

Available for comment February 22 through April 7, 2012

Medical Policy Panel, January 2013

Medical Policy Group, January 2013 (3): 2013 Updates: Key Points and References

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (3): Updates to Description, Key Points and References; no change in policy statement

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (2): 2015 Updates to Key Points and Coding section, no change in policy statement.

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (7): 2016 Updates to Key Points, Key Words, Coding section- added 38207, References, no change in policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): Updates to Description, Key Points, Approved by Governing Bodies & References; No change in policy statement. (Removed policy statement prior to February 1, 2012)

Medical Policy Group, December 2017. Annual Coding Update 2018. Added new CPT code 38222 effective 1/1/18 to the Current Coding section.  Updated verbiage for revised CPT codes 38220 and 38221.

Medical Policy Panel, January 2018

Medical Policy Group, January 2018 (7): 2018 Updates to Key Points & References; No change in policy statement.

Medical Policy Panel, January 2019

Medical Policy Group, February 2019 (3): 2019 Updates to Key Points, Practice Guidelines and Position Statements and References. No changes to policy statement or intent. Corrected typo in Key Words and relinked corrected “allogeneic” to policy.

Medical Policy Panel, January 2020

Medical Policy Group, February 2020 (3): 2020 Updates to Description and Key Points. Added Policy Guidelines section. No changes to policy statement or intent.

Medical Policy Panel, January 2021

Medical Policy Group, February 2021 (3): 2021 Updates to Description, Key Points, and Practice Guidelines and Position Statements. Policy statement updated to remove “not medically necessary, “no other changes to policy statement or intent.

Medical Policy Panel, January 2022

Medical Policy Group, January 2022 (3): 2022 Updates to Key Points and Practice Guidelines and Position Statements. No changes to policy statement or intent.

Medical Policy Panel, January 2023

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

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (3): Updates to Policy and Policy Guidelines- updated verbiage changed patients to individuals, Key Points, Benefit Application and References. No changes to policy 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.