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Hematopoietic Cell Transplantation for Miscellaneous Solid Tumors in Adults

Policy Number: MP-469

Latest Review Date: February 2022

Category: Surgical                                                                 

POLICY:

Autologous or allogeneic hematopoietic cell transplants are considered investigational for the following malignancies in adults:

  • Lung cancer, any histology

  • Colon cancer

  • Rectal cancer

  • Pancreas cancer

  • Stomach cancer

  • Esophageal cancer

  • Gall bladder cancer

  • Cancer of the bile duct

  • Renal cell cancer

  • Cervical cancer

  • Uterine cancer

  • Cancer of the fallopian tubes

  • Prostate cancer

  • Nasopharyngeal cancer

  • Paranasal sinus cancer

  • Neuroendocrine tumors

  • Soft tissue sarcomas

  • Thyroid tumors

  • Tumors of the thymus

  • Tumors of unknown primary origin

  • Malignant melanoma

POLICY GUIDELINES:

Hematopoietic Cell Transplants as a treatment of ovarian cancer, germ cell tumors, ependymoma, breast cancer, or malignant glioma are addressed in separate corresponding policies.

DESCRIPTION OF PROCEDURE OR SERVICE:

Hematopoietic cell transplantation (HCT) is an established treatment for certain hematologic malignancies and has been investigated for a variety of adult solid tumors. Interest continues in exploring nonmyeloablative allogeneic HCT for a graft-versus-tumor effect of donor-derived T cells in metastatic solid tumors.

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) or from a donor (allogeneic HCT). They can be harvested from bone marrow, peripheral blood, or from 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 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 (HLAs) using cellular, serologic, or molecular techniques. HLA refers to the tissue type 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 HCT

Conventional Conditioning

The conventional (“classical”) 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 a result of a combination of initial eradication of malignant cells and subsequent graft-versus-malignancy (GVM) effect mediated by non-self-immunologic effector cells that develop after engraftment of allogeneic stem cells within the patient’s bone marrow space. While the slower GVM effect is considered the potentially curative component, it may be overwhelmed by extant disease without the use of pretransplant conditioning. However, intense conditioning regimens are limited to patients who are medically fit 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 immune reactivity between donor T cells and malignant cells that is responsible for the GVM effect also leads to acute and chronic GVHD.

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 evidence review, RIC will refer to all conditioning regimens intended to be nonmyeloablative, as opposed to fully myeloablative (conventional) regimens.

HCT in Solid Tumors in Adults

HCT is an established treatment for certain hematologic malignancies; its use in solid tumors is less well established, although it has been investigated for a variety of solid tumors. With the advent of nonmyeloablative allogeneic transplant, interest has shifted to exploring the generation of alloreactivity to metastatic solid tumors via a graft-versus-tumor effect of donor-derived T cells.

This evidence review collectively addresses other solid tumors of adults for which HCT has been investigated. This includes: lung cancer, malignant melanoma, tumors of the gastrointestinal tract (including colon, rectum, pancreas, stomach, esophagus, gallbladder, and bile duct), male and female genitourinary systems (e.g., renal cell carcinoma, cervical carcinoma, cancer of the uterus, fallopian tubes, and prostate gland), tumors of the head and neck, soft tissue sarcoma, thyroid tumors, tumors of the thymus, and tumors of unknown primary origin.

KEY POINTS:

This policy receives updates periodically with literature reviews. The most recent update occurred through December 1, 2021.

Summary of Evidence

Autologous Hematopoietic Cell Transplantation

For individuals who have adult soft tissue sarcomas who receive autologous HCT, the evidence includes two RCTs, a number of phase two single-arm studies (some of which have been summarized in a systematic review), and a retrospective registry study. Relevant outcomes are overall survival (OS), disease-specific survival, and treatment-related mortality and morbidity. Although a small phase 2 RCT reported longer survival for patients treated with autologous HCT than with standard chemotherapy, this trial did not show a survival benefit with HCT. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have small cell lung cancer who receive autologous HCT, the evidence includes several RCTs, and systematic reviews of these studies. Relevant outcomes are OS, disease-specific survival, and treatment-related mortality and morbidity. Studies have not reported increased OS for patients with small-cell lung cancer treated with autologous HCT. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Allogeneic Hematopoietic Cell Transplantation

For individuals who have renal cell carcinoma, colorectal cancer, pancreatic cancer, or nasopharyngeal cancer who receive allo-HCT, the evidence includes small single-arm series. Relevant outcomes are OS, disease-specific survival, and treatment-related mortality and morbidity. The evidence for allo-HCT to treat renal cell carcinoma, colorectal cancer, pancreatic cancer, and nasopharyngeal cancer has been limited to small case series. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

Current National Comprehensive Cancer Network guidelines (2021) on the tumors addressed in this evidence review do not discuss hematopoietic cell transplantation (HCT) as a treatment option.

American Society for Blood and Marrow Transplantation

In 2015, the American Society for Blood and Marrow Transplantation (ASBMT) issued guidelines related to indications for autologous and allogeneic hematopoietic cell transplantation. The tumors addressed in this review for which ASBMT provides recommendations are as follows:

Table 1. Recommendations for Use of Autologous and Allogeneic HCT

Condition

Treatment Options

Recommendation

Ewing sarcoma, high-risk

Allogeneic HCT

Not generally recommended

 

Autologous HCT (See MP#-403)

Standard of care, clinical evidence available

Renal cancer, metastatic

Allogeneic HCT

Developmental

 

Autologous HCT

Not generally recommended

HCT: hematopoietic cell transplantation.

U.S. Preventive Services Task Force Recommendations

Hematopoietic stem-cell transplantation is not a preventive service.

KEY WORDS:

High-Dose Chemotherapy, Miscellaneous Solid Tumors, Lung Cancer, Stem-Cell Transplant, Adults, HCT, autologous HCT, Allogeneic HCT, cancer of the bile duct, cancer of fallopian tubes, cervical cancer, esophageal cancer, colon cancer, gall bladder cancer, malignant melanoma, nasopharyngeal cancer, neuroendocrine cancer, pancreatic cancer, prostate cancer, rectal cancer, soft tissue sarcoma, stomach cancer, thyroid tumors, tumors of thymus, tumor of unknown primary origin, uterine cancer, paranasal sinus cancer

APPROVED BY GOVERNING BODIES:

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 (CFR) 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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

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) (Effective 01/01/2018)

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

HCPCS Codes:

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. Abe Y, Ito T, Baba E et al. Nonmyeloablative allogeneic hematopoietic stem cell transplantation as immunotherapy for pancreatic cancer. Pancreas 2009; 38(7):815-819.

  2. Aglietta M, Barkholt L, Schianca FC et al. Reduced-intensity allogeneic hematopoietic stem cell transplantation in metastatic colorectal cancer as a novel adaptive cell therapy approach. The European Group for Blood and Marrow Transplantation experience. Biol Blood Marrow Transplant 2009; 15(3):326-335.

  3. Airoldi M, De Crescenzo A, Pedani F et al. Feasibility and long-term results of autologous PBSC transplantation in recurrent undifferentiated nasopharyngeal carcinoma. Head Neck 2001; 23(9):799-803.

  4. American Society for Blood and Marrow Transplantation. Guidelines, policy statements and reviews. www.asbmt.org?guidelinestatements.

  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). High-dose chemotherapy with autologous stem-cell support for miscellaneous solid tumors in adults. TEC Assessments 1995; Volume 10, Tab 4.

  6. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Salvage HDC/AlloSCS for relapse following HDC/AuSCS for non-lymphoid solid tumors. 1999 TEC Assessments 1999; Volume 14, Tab 11.

  7. Bregni M, Bernardi M, Servida P et al. Long-term follow-up of metastatic renal cancer patients undergoing reduced-intensity allografting. Bone Marrow Transplant Feb 23 2009. [Epub ahead of print]

  8.  Bregni M, Bernardi M, Servida P, et al. Long-term follow-up of metastatic renal cancer patients undergoing reduced-intensity allografting. Bone Marrow Transplant. Aug 2009; 44(4):237-242.

  9. Bui-Nguyen B, Ray-Coquard I, Chevreau C, et al. High-dose chemotherapy consolidation for chemosensitive advanced soft tissue sarcoma patients: an open-label, randomized controlled trial. Ann Oncol. Mar 2012; 23(3):777-784.

  10. Carnevale-Schianca F, Ricchiardi A, Capaldi A et al. Allogeneic hemopoietic stem cell transplantation in solid tumors. Transplant Proc 2005; 37(6):2664-2666.

  11. Childs R, Chernoff A, Contentin N et al. Regression of metastatic renal cell carcinoma after nonmyeloablative allogeneic peripheral blood stem cell transplantation. N Engl J Med 2000; 343(11):750-758.

  12. Crivellari G, Monfardini S, Stragliotto S et al. Increasing chemotherapy in small-cell lung cancer: from dose intensity and density to megadoses. Oncologist 2007; 112(1):79-89.

  13. Demirer T, Barkholt L, Blaise D et al. Transplantation of allogeneic hematopoietic stem cells: an emerging treatment modality for solid tumors. Nat Clin Pract Oncol 2008; 5(5):256-267.

  14. Dirksen U, Brennan B, Le Deley MC, et al. High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008. J Clin Oncol. Dec 01 2019; 37(34): 3192-3202.

  15. Food and Drug Administration (FDA). Tissues and tissue products. www.fda.gov/biologicsbloodvaccines/tissuetissueproducts/.

  16. Hartmann JT, Horger M, Kluba T, et al. A non-comparative phase II study of dose intensive chemotherapy with doxorubicin and ifosfamide followed by high dose ICE consolidation with PBSCT in non-resectable, high grade, adult type soft tissue sarcomas. Invest New Drugs. Dec 2013; 31(6):1592-1601.

  17. Heilig CE, Badoglio M, Labopin M, et al. Haematopoietic stem cell transplantation in adult soft-tissue sarcoma: an analysis from the European Society for Blood and Marrow Transplantation. ESMO Open. Oct 2020; 5(5).

  18. Imanguli MM, Childs RW. Hematopoietic stem cell transplantation for solid tumors. Update Cancer Ther 2006; 1(3):343-352.

  19. Jiang J, Shi HZ, Deng JM et al. Efficacy of intensified chemotherapy with hematopoietic progenitors in small-cell lung cancer: a meta-analysis of the published literature. Lung Cancer 2009; 65(2):214-218.

  20. 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.

  21. Kanda Y, Omuro Y, Baba E et al. Allo-SCT using reduced-intensity conditioning against advanced pancreatic cancer: a Japanese survey. Bone Marrow Transplant 2008; 42(2):99-103.

  22. Kasper B, Dietrich S, Mechtersheimer G et al. Large institutional experience with dose-intensive chemotherapy and stem cell support in the management of sarcoma patients. Oncology 2007; 73(1-2):58-64.

  23. Kasper B, Scharrenbroich I, Schmitt T et al. Consolidation with high-dose chemotherapy and stem cell support for responding patients with metastatic soft tissue sarcomas: prospective, single-institutional phase II study. Bone marrow Transplant 2010; 45(7): 1234-1238.

  24. Lee JA, Choi SY, Kang HJ, et al. Treatment outcome of osteosarcoma after bilateral retinoblastoma: a retrospective study of eight cases. Br J Opthalmol. Oct 2014; 98(10):1355-1359.

  25. Lorigan P, Woll PJ, O’Brien ME et al. Randomized phase III trial of dose-dense chemotherapy supported by whole-blood hematopoietic progenitors in better-prognosis small-cell lung cancer. J Natl Cancer Inst 2005; 97(9):666-674.

  26. 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.

  27. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology.2015. Available online at www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed December 12, 2017.

  28. National Comprehensive Cancer Network. NCCN Guidelines Version 1.2018. Soft tissue sarcoma 2015. www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Accessed November 27, 2019.

  29. National Comprehensive Cancer Network. NCCN Guidelines Version 2.2016. Kidney cancer 2016. www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed November 11, 2019.

  30. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed December 18, 2018.

  31. Nieto Y, Shpall EJ. Autologous stem-cell transplantation for solid tumors in adults. Hematol Oncol Clin North Am 1999; 13(5):939-968.

  32. Nishimura M, Nasu K, Ohta H et al. High dose chemotherapy for refractory urothelial carcinoma supported by peripheral blood stem cell transplantation. Cancer 1999; 86(9):1827-1831.

  33. Omazic B, Ayoglu B, Lohr M, et al. A preliminary report: radical surgery and stem cell transplantation for the treatment of patients with pancreatic cancer. J Immunother. Mar 23 2017.

  34. Omazic B, Remberger M, Barkholt L, et al. Long-Term Follow-Up of Allogeneic Hematopoietic Stem Cell Transplantation for Solid Cancer. Biol Blood Marrow Transplant. Apr 2016; 22(4):676-681.

  35. Pedrazzoli P, Ledermann JA, Lotz JP et al. High dose chemotherapy with autologous hematopoietic stem cell support for solid tumors other than breast cancer in adults. Ann Oncol 2006; 17(10):1479-88.

  36. Pedrazzoli P, Rosti G, Secondino S et al. High-dose chemotherapy with autologous hematopoietic stem cell support for solid tumors in adults. Semin Hematol 2007; 44(4):286-295.

  37. Peinemann F, Enk H, Smith LA. Autologous hematopoietic stem cell transplantation following high-dose chemotherapy for nonrhabdomyosarcoma soft tissue sarcomas. Cochrane Database Syst Rev. Apr 13 2017; 4:CD008216.

  38. Peinemann F, Labeit AM. Autologous haematopoietic stem cell transplantation following high-dose chemotherapy for non-rhabdomyosarcoma soft tissue sarcomas: a Cochrane systematic review*. BMJ Open.2014; 4(7):e005033.

  39. Rosti G, Ferrante P, Ledermann J et al. High-dose chemotherapy for solid tumors: results of the EBMT. Crit Rev Oncol Hematol 2002; 41(2):129-140.

  40. Schlemmer M, Wendtner CM, Falk M et al. Efficacy of consolidation high-dose chemotherapy with ifosfamide, carboplatin and etoposide (HD-ICE) followed by autologous peripheral blood stem cell rescue in chemosensitive patients with metastatic soft tissue sarcomas. Oncology 2006; 71(1-2):32-39.

  41. Toh HC, Chia WK, Sun L et al. Graft-vs-tumor effect in patients with advanced nasopharyngeal cancer treated with nonmyeloablative allogeneic PBSC transplantation. Bone Marrow Transplant 2011; 46(4): 573-579.

  42. Transplantation ASfBaM. Guidelines, Policy Statements and Reviews. www.asbmt.org/?GuidelineStatements.

  43. Tsujimura H, Miyaki T, Yamada S, et al. Successful treatment of histiocytic sarcoma with induction chemotherapy consisting of dose-escalated CHOP plus etoposide and upfront consolidation auto-transplantation. Int J Hematol. Jul 26 2014.

  44. Tsujimura H, Miyaki T, Yamada S, et al. Successful treatment of histiocytic sarcoma with induction chemotherapy consisting of dose-escalated CHOP plus etoposide and upfront consolidation auto-transplantation. Int J Hematol. Nov 2014; 100(5):507-510. 

  45. Verma S, Younus J, Stys-Norman D et al. Dose-intensive chemotherapy with growth factor or autologous bone marrow/stem cell transplant support in first-line treatment of advanced or metastatic adult soft tissue sarcoma: a systematic review. Cancer 2008; 112(6):1197-1205.

POLICY HISTORY:

Medical Policy Panel, September 2010

Medical Policy Group, January 2011 (2):  New policy

Medical Policy Administration Committee, February 2011

Available for comment February 24th through April 11, 2011

Medical Policy Group, September 2011 (3): Updated Key Points, Key Words & HCPC Codes

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

Medical Policy Panel, October 2012.

Medical Policy Group, January 2013 (3): 2012 Update to Key Points & References

Medical Policy Panel, October 2013

Medical Policy Group, October 2013 (3):  2013 Update to Key Points; no change in policy statement

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (3): Update to Description, Key Points and References. No change in policy statement.

Medical Policy Panel, January 2016

Medical Policy Group, February 2016 (2): Updates to Description, Key Points, Approved Governing Bodies, Key Words and References. Removed HCPCS codes Q0083-Q0085 and J9000-J9999 from policy; No change to policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): Updates to Title, Description, Key Points, and References; No change to 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.

Medical Policy Panel, January 2018

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

Medical Policy Panel, January 2019

Medical Policy Group, February 2019 (3): 2019 Updates to Key Points, References and Key Words: added: Paranasal Sinus Cancer. No changes to policy statement or intent. Removed effective dates in coding section from 2012.

Medical Policy Panel, January 2020

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

Medical Policy Panel, January 2021

Medical Policy Group, February 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. No changes to policy statement or 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.