Latest Review Date: January 2024

Category:  Surgery                                                                  

POLICY:

Single autologous hematopoietic cell transplantation may be considered medically necessary as salvage therapy for germ-cell tumors:

• In individuals with favorable* prognostic factors that have failed a previous course of conventional-dose salvage chemotherapy; OR
• In individuals with unfavorable** prognostic factors as initial treatment of first relapse (i.e., without a course of conventional-dose salvage chemotherapy) and in individuals with platinum-refractory disease.

Tandem or sequential autologous hematopoietic cell transplantation may be considered medically necessary for the treatment of testicular tumors either as salvage therapy or with platinum-refractory disease.

Autologous hematopoietic cell transplantation is considered investigational as a component of first-line treatment for poor-risk germ-cell tumors, or as initial treatment of a first relapse (i.e., in lieu of a course of conventional chemotherapy).

Except as noted above for treatment of certain testicular tumors, tandem or sequential autologous hematopoietic cell transplantation is considered investigational to treat germ-cell tumors of any stage.

Allogeneic hematopoietic cell transplantation is considered investigational to treat germ-cell tumors, including, but not limited to its use as therapy after a prior failed autologous hematopoietic stem-cell transplantation.

POLICY GUIDELINES:

*Individuals with favorable prognostic factors include those with a testis or retroperitoneal primary site, a complete response to initial chemotherapy, low levels of serum markers and low volume disease.

**Individuals with unfavorable prognostic factors are those with an incomplete response to initial therapy or relapsing mediastinal nonseminomatous germ-cell tumors.

Tandem transplantation is defined as a HCT procedure where the preplanned intent for therapy involves two sequential HCTs. The “tandem” involves a very short preplanned interval between the two transplants, as well as the therapeutic intent to do two transplants from the outset of therapy. These may be autologous followed by a second autologous (auto-auto) transplantation, autologous followed by allogeneic (auto-allo) transplantation, or autologous followed by RIC-allogeneic (auto–RIC-allo) transplantation.

DESCRIPTION OF PROCEDURE OR SERVICE:

Therapy for germ-cell tumors is generally dictated by several factors, including disease stage, tumor histology, site of primary tumor and response to chemotherapy. Patients with unfavorable prognostic factors may be candidates for hematopoietic cell transplantation.

Germ-Cell Tumors

Germ-cell tumors (GCT) are composed primarily of testicular neoplasms (seminomas or nonseminomatous) but also include ovarian and extragonadal GCTs (e.g., retroperitoneal or mediastinal tumors). Germ-cell tumors are classified according to their histology, stage, prognosis, and response to chemotherapy.

The most common testicular germ cell tumors are seminomas; all other histologic types are collectively referred to as non-seminomatous tumors. Non-seminomatous tumor types include embryonal cell tumor, yolk sac tumor, and teratomas. Malignant germ cell tumors of ovarian origin are classified as dysgerminomas or nondysgerminomas. Similarly, nondysgerminomas include immature teratomas, embryonal cell tumors, yolk sac tumor, polyembryoma, and mixed germ cell tumors.

Staging

Stage depends on location and extent of the tumor, using the American Joint Committee on Cancer’s TNM system. TNM stages, modified by serum concentrations of markers for tumor burden (S0-3) when available, are grouped by similar prognoses. Markers used for GCTs include human beta-chorionic gonadotropin (HCG), lactate dehydrogenase (LDH), and alpha-fetoprotein (AFP). However, most patients with pure seminoma have normal AFP concentrations. For testicular tumors, Stages IA-B have tumors limited to the testis (no involved nodes or distant metastases) and no marker elevations (S0); Stages IIA-C have increasing size and number of tumor-involved lymph nodes, and at least one marker moderately elevated above the normal range (S1); and Stages IIIA-C have distant metastases and/or marker elevations greater than specified thresholds (S2-3).

Germ-cell tumors also are divided into good-, intermediate-, or poor-risk categories based on histology, site, and extent of primary tumor, and serum marker levels. Good-risk pure seminomas can be at any primary site, but are without nonpulmonary visceral metastases or marker elevations. Intermediate-risk pure seminomas have nonpulmonary visceral metastases with or without elevated HCG and/or LDH. There are no poor-risk pure seminomas, but mixed histology tumors and seminomas with elevated AFP (due to the mixture with nonseminomatous components) are managed as nonseminomatous GCTs. Good- and intermediate-risk non-seminomatous GCTs have testicular or retroperitoneal tumors without nonpulmonary visceral metastases, and either S1 (good risk) or S2 (intermediate) levels of marker elevations. Poor-risk tumors have mediastinal primary tumors, or nonpulmonary visceral metastases, or the highest level (S3) of marker elevations.

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 radiation therapy.  Hematopoietic stem cells may be obtained from the transplant recipient (autologous HCT) or from a donor (allogeneic HCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood and placenta 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).The use of cord blood is discussed in Medical Policy #439: Placental/Umbilical Cord Blood as a Source of Stem Cells.

Immunologic compatibility between infused stem cells and the recipient is not an issue in autologous HCT. However, immunologic compatibility between donor and patient is a critical factor for achieving a good outcome of allogeneic HCT. Compatibility is established by typing of human leukocyte antigens (HLA) using cellular, serologic, or molecular techniques. HLA refers to the gene complex expressed at the HLA-A, -B, and -DR (antigen-D related) 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 (with the exception of umbilical cord blood).

Conditioning for Hematopoietic Cell Transplantation

Conventional Conditioning

The conventional (“classical”) practice of allo-HCT involves administration of cytotoxic agents (e.g., cyclophosphamide, busulfan) with or without total body irradiation at doses sufficient to cause bone marrow ablation in the recipient. The beneficial treatment effect of this procedure is due to a combination of the initial eradication of malignant cells and subsequent graft-versus-malignancy effect mediated by non-self-immunologic effector cells. While the slower graft-versus-malignancy effect is considered the potentially curative component, it may be overwhelmed by existing disease in the absence of pretransplant conditioning. Intense conditioning regimens are limited to patients who are sufficiently medically fit to tolerate substantial adverse effects. These include opportunistic infections secondary to loss of endogenous bone marrow function and organ damage or failure caused by cytotoxic drugs. Subsequent to graft infusion in allo-HCT, immunosuppressant drugs are required to minimize graft rejection and graft-versus-host disease, which increases susceptibility to opportunistic infections.

The success of autologous HCT is predicated on the potential of cytotoxic chemotherapy, with or without radiotherapy, to eradicate cancerous cells from the blood and bone marrow. This permits subsequent engraftment and repopulation of the bone marrow with presumably normal hematopoietic stem cells obtained from the patient before 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 also susceptible to chemotherapy-related toxicities and opportunistic infections before engraftment, but not graft-versus-host disease.

Reduced-Intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

Reduced-intensity conditioning (RIC) refers to the pretransplant use of lower doses of cytotoxic drugs or less intense regimens of radiotherapy than are used in traditional full-dose myeloablative conditioning treatments. Although the definition of RIC is variable, with numerous versions employed, all regimens seek to balance the competing effects of relapse due to residual disease and non-relapse mortality. The goal of RIC is to reduce disease burden and to minimize associated treatment-related morbidity and non-relapse mortality in the period during which the beneficial graft-versus-malignancy effect of allogeneic transplantation develops. RIC regimens range from nearly total myeloablative to minimally myeloablative with lymphoablation, with intensity tailored to specific diseases and patient condition. Patients who undergo RIC with allo-HCT initially demonstrate donor cell engraftment and bone marrow mixed chimerism. Most will subsequently convert to full-donor chimerism. In this review, the term reduced-intensity conditioning will refer to all conditioning regimens intended to be nonmyeloablative.

KEY POINTS:

This policy has been updated regularly with searches of the PubMed database. The most recent literature update was performed through November 30, 2023.

Summary of Evidence

For individuals who have previously untreated germ cell tumors who receive autologous HCT as first-line therapy, the evidence includes randomized controlled trials (RCTs). Relevant outcomes are overall survival, disease-specific survival, and treatment-related mortality and morbidity. Results from the RCTs have shown that autologous HCT as initial therapy for germ cell tumors did not significantly improve outcomes compared with alternative therapy (e.g., standard-dose chemotherapy). Study sample sizes were relatively small and might have been underpowered to detect differences between groups. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have relapsed or refractory germ cell tumors who receive autologous HCT, the evidence includes an RCT and several case series. Relevant outcomes are overall survival, disease-specific survival, and treatment-related mortality and morbidity. The single published RCT did not find improved outcomes with HDC and autologous HCT compared with standard-dose HCT. Case series had a wide range of sample sizes. Progression-free and OS rates varied by prior treatment experience, prognostic factors, number of HDC and autologous stem cell transplantation cycles and whether additional consolidation treatment such as radiation therapy was included. However, 2- and 3-year progression-free survival rates of 50% to 60% have consistently been achieved. Additionally, clinical input has been obtained from specialty societies and academic medical centers which had a general agreement of medical necessity regarding the use of single autologous HCST as salvage therapy for germ cell tumors. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have germ cell tumors who receive tandem autologous transplantation and sequential HDC, the evidence includes an RCT, several retrospective cohort studies, and a comparative effectiveness review. Relevant outcomes are overall survival, disease-specific survival, and treatment-related mortality and morbidity. The RCT reported a higher rate of treatment-related mortality with sequential HDC compared with single HDC. However, 5-year survival outcomes did not differ significantly between groups. Overall, the available studies have included heterogeneous patient populations, in different salvage treatment settings (i.e., first vs subsequent salvage therapy), and have lacked a universally accepted prognostic scoring system to risk-stratify patients. Tandem autologous transplant or transplant with sequential HDC has not shown a benefit in patients with primary mediastinal germ cell tumors.Clinical input obtained in 2010 found strong support for autologous HCT as a treatment of relapsed or refractory germ cell tumors, and for tandem autologous transplant or transplant with sequential HDC as salvage therapy for testicular tumors and as treatment of platinum-refractory testicular tumors. Input was generally consistent with recommendations in national and international guidelines. Thus, these indications may be considered medically necessary. 

For individuals who have germ cell tumors who receive allogeneic HCT, the evidence includes a case report. Relevant outcomes are overall survival, disease-specific survival, and treatment-related mortality and morbidity. There were no RCTs or non-RCTs evaluating allogeneic HCT for germ cell tumors. One 2007 case report described successful treatment of a refractory mediastinal gem cell tumor with allogeneic HCT. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN) Guidelines

Current NCCN guidelines on ovarian cancer (v.2.2023) state that high-dose chemotherapy with stem cell support is among preferred regimens as potentially curative therapy for recurrent malignant germ cell tumors.

Current National Comprehensive Cancer Network guidelines on testicular cancer (v.1.2023) state that for patients with unfavorable prognostic features (including incomplete response to first-line treatment, high levels of serum markers, high-volume disease, and presence of extratesticular primary tumor), high-dose chemotherapy followed by autologous hematopoietic cell transplant (HCT) is a treatment option.

American Society for Transplantation and Cellular Therapy

In 2020, the guidelines by the American Society for Transplantation and Cellular Therapy were published on indications for autologous and allogeneic HCT. Recommendations were intended to describe the current consensus on use of HCT within and outside of the clinical trial setting. Recommendations on germ cell tumors are listed in Table 1.

Table 1. ASBMT Recommendations on Allogeneic and Autologous HCT

Indications	Allogeneic HCT	Autologous HCT
Pediatric
Germ cell tumor, relapse	D	C
Germ cell tumor, refractory	D	C
Adult
Germ cell tumor, relapse	N	S
Germ cell tumor, refractory	N	S

ASBMT: American Society for Blood and Marrow Transplantation; C: clinical evidence available, standard of care; D: developmental (i.e. promising); N: not generally recommended.

U.S. Preventive Services Task Force Recommendations

N/A

KEY WORDS:

Germ-Cell Tumors, High-Dose Chemotherapy, Seminoma, Testicular Cancer, hematopoietic cell transplantation, HCT, nonseminomatous, autologous stem cell transplant, ASCT, allogeneic stem cell transplant

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 Code of Federal Regulation, title 21, parts 1270 and 1271. Hematopoietic stem 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
38208	Transplant preparation of hematopoietic progenitor cells; 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	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor
38241	; autologous transplantation
86812-86821	Histocompatibility studies code range

HCPCS:

S2140	Cord blood harvesting for transplantation, allogeneic
S2142	Cord blood-derived stem-cell transplantation, allogeneic
S2150	Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre and post-transplant care in the global definition

REFERENCES:

1. Adra N, Abonour R, Althouse SK, et al. High-Dose Chemotherapy and Autologous Peripheral-Blood Stem-Cell Transplantation for Relapsed Metastatic Germ Cell Tumors: The Indiana University Experience. J Clin Oncol. Apr 1 2017; 35(10):1096-1102.
2. Agrawal V, Abonour R, Abu Zaid M, et al. Survival outcomes and toxicity in patients 40 years old or older with relapsedmetastatic germ cell tumors treated with high-dose chemotherapy and peripheral blood stem cell transplantation. Cancer. Oct 15 2021; 127(20): 3751-3760.
3. Baek HJ, Park HJ, Sung KW et al. Myeloablative chemotherapy and autologous stem cell transplantation in patients with relapsed or progressed central nervous system germ cell tumors: results of Korean Society of Pediatric Neuro-Oncology (KSPNO) S-053 study. J Neuroonco.l Sept 2013; 114(3):329-338.
4. Chovanec M, Cheng L. Advances in diagnosis and treatment of testicular cancer. BMJ. Nov 28 2022; 379: e070499
5. Daugaard G, Skoneczna I, Aass N et al. A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974). Ann Oncol. May 2011; 22(5):1054-1061.
6. Droz JP, Kramar A, Biron P, et al. Failure of high-dose cyclophosphamide and etoposide combined with double-dose cisplatinand bone marrow support in patients with high-volume metastatic nonseminomatous germ-cell tumours: mature results of arandomised trial. Eur Urol. Mar 2007; 51(3): 739-46; discussion 747-8.
7. Einhorn LH, Williams SD, Chamness A, et al. High-dose chemotherapy and stem cell rescue for metastatic germ-cell tumors. N Engl J Med. Jul 26 2007; 357(4):340-348.
8. Goodwin A, Gurney H and Gottlieb D. Allogeneic bone marrow transplant for refractory mediastinal germ cell tumour: Possible evidence of graft-versus-tumour effect. Intern Med J.Feb 2007; 37(2):127-129.
9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
10. International Germ Cell Consensus Classification: A prognostic factor-based staging system for metastatic germ cell cancers. J Clin Oncol. Feb 1997; 15(2):594-603.
11. 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.
12. Lazarus HM, Stiff PJ, Carreras J, et al. Utility of single versus tandem autotransplants for advanced testes/germ cell cancer: A Center for International Blood and Marrow Transplant Research (CIBMTR) analysis. Biol Blood Marrow Transplant. Jul 2007; 13(7):778-779.
13. Lorch A, Kleinhans A, Kramar A et al. Sequential versus single high-dose chemotherapy in patients with relapsed or refractory germ cell tumors: long-term results of a prospective randomized trial. J Clin Oncol. March 10 2012; 30(8):800-805.
14. Lorch A, Kollmannsberger C, Hartmann JT et al. Single versus sequential high-dose chemotherapy in patients with relapsed or refractory germ cell tumors: a prospective randomized multicenter trial of the German Testicular Cancer Study Group. J Clin Oncol. Jul 01 2007; 25(19):2778-2784.
15. Lotz JP, Andre T, Donsimoni R, et al. High dose chemotherapy with ifosfamide, carboplatin and etoposide combined with autologous bone marrow transplantation for the treatment of poor prognosis germ cell tumors and metastatic trophoblastic disease in adults. Cancer. Mar 1995; 75(3):874-885.
16. Motzer RJ, Nichols CJ, Margolin KA, et al. Phase III randomized trial of conventional-dose chemotherapy with or without high-dose chemotherapy and autologous hematopoietic stem-cell rescue as first-line treatment for patients with poor-prognosis metastatic germ cell tumors. J Clin Oncol. Jan 20 2007; 25(3):247-256. 
17. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Ovarian Cancer, v2.2023 
18. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Testicular Cancer, v1.2023.www.nccn.org/professionals/physician_gls/pdf/testicular.pdf.
19. Nieto Y, Tu SM, Bassett R, et al. Bevacizumab/high-dose chemotherapy with autologous stem-cell transplant for poor-risk relapsed or refractory germ-cell tumors. Ann Oncol. Dec 2015; 26 (12):2507-2508.
20. Pal SK, Yamzon J, Sun V et al. Paclitaxel-based high-dose chemotherapy with autologous stem cell rescue for relapsed germ cell tumor: clinical outcome and quality of life in long-term survivors. Clin Genitourin Cancer. June 2013; 11(2):121-127.
21. Pico JL, Rosti G, Kramar A, et al. A randomized trial of high-dose chemotherapy in the salvage treatment of patients failing first-line platinum chemotherapy for advanced germ cell tumours. Ann Oncol.Jul  2005; 16(7):1152-1159.
22. Ratko TA, Belinson SE, Brown HM et al. Hematopoietic Stem-Cell Transplantation in the Pediatric Population. Agency for Healthcare Research and Quality (AHRQ): Rockville (MD), 2012.
23. Seftel MD, Paulson K, Doocey R et al. Long-term follow-up of patients undergoing auto-SCT for advanced germ cell tumor: a multicentre cohort study. Bone Marrow Transplant. Jun 2011; 46(6):852-857.
24. Suleiman Y, Siddiqui BK, Brames MJ et al. Salvage therapy with high-dose chemotherapy and peripheral blood stem cell transplant in patients with primary mediastinal nonseminomatous germ cell tumors. Biol Blood Marrow Transplant. Jan 2013; 19(1):161-163. 
25. Veneris JT, Mahajan P, Frazier AL. Contemporary management of ovarian germ cell tumors and remaining controversies. Gynecol Oncol. Aug 2020; 158(2): 467-475
26. Zschabitz S, Distler FA, Krieger B, et al. Survival outcomes of patients with germ cell tumors treated with high-dose chemotherapy for refractory or relapsing disease. Oncotarget. Apr 27 2018; 9(32):22537-22545.

POLICY HISTORY:

Medical Policy Group, February 2010 (2)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Panel, April 2010

Medical Policy Group, April 2010 (2)

Medical Policy Administration Committee, May 2010

Available for comment May 26-July 9, 2010

Medical Policy Group, December 2011 (3): 2012 Code Updates: Updated Codes 38208, 38209 & 38230; Added Code 38323

Medical Policy Panel April 2012

Medical Policy Group, October 2012 (2): 2012 Updates to Key Points and References

Medical Policy Group, April 2013 (2): 2013 Update to Key Points and References

Medical Policy Group, January 2014 (1): 2014 Coding Update: added current codes Q2049 and Q2050 to coding section; new codes are included in the chemotherapy drug code range

Medical Policy Panel, April 2014

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

Medical Policy Panel, April 2015

Medical Policy Group, April 2015 (2): 2015 Updates to Description, Key Points, and References, no change in policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, March 2017 (7): 2017 Updates to Title, Key Points and References; removed “after a failed course of high dose chemotherapy” from criteria for allogeneic HCT – criteria remains investigational; no change in intent of policy statement. 

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. Created Previous Coding section and moved deleted CPT code 86822 to this section.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (7): 2018 Updates to Description, Key Points, Approved by Governing Bodies and References, no change in policy statement.

Medical Policy Panel, January 2019

Medical Policy Group, February 2019 (3): 2019 Updates to Description, Key Points, Practice Guidelines and Position Statements, References and Key Words: added: hematopoietic cell transplantation, HCT, nonseminomatous, autologous stem cell transplant, ASCT, allogeneic stem cell transplant. No changes to policy statement or intent.

Medical Policy Panel, January 2020

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

Medical Policy Panel, January 2021

Medical Policy Group, January 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements and References. Policy statement updated to remove “not medically necessary,” no change to policy statement or intent.

Medical Policy Panel, January 2022

Medical Policy Group, February 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, and References; Policy statements unchanged.

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (3): 2023 Updates to Key Points and References. Removed Previous Coding section- CPT 86822 was deleted in 2017. No change in Policy Statement.

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (3): Updates to Description, Key Points, Benefit Application, References, Policy Statement and Policy Guidelines updated verbiage- changed patients to individuals. No change in the 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.