Latest Review Date: December 2024

Category:  Medicine 

POLICY:

Dermatoscopy, using either direct inspection, digitization of images or computer-assisted analysis as a technique to evaluate or serially monitor pigmented skin lesions is considered investigational.

Total (Whole) Body Photography is considered investigational.

Computer-based optical imaging devices (e.g., multispectral digital skin lesion analysis) used as a technique to evaluate or serially monitor pigmented skin lesions are considered investigational.

Dermatoscopy and computer-based optical imaging devices for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision are considered investigational.

Refer to policy # 616, Multispectral Digital Skin Lesion Analysis for additional information on MelaFind®.

DESCRIPTION OF PROCEDURE OR SERVICE:

There is interest in noninvasive devices that will improve the diagnosis of malignant skin lesions. One technique is dermatoscopy (dermoscopy, epiluminescence microscopy, in vivo cutaneous microscopy), which enables the clinician to perform a direct microscopic examination of diagnostic features in pigmented skin lesions. Another approach is the use of computer-based light imaging systems. These techniques have the potential to improve diagnostic accuracy for suspicious skin lesions and may increase the detection rate of malignant skin lesions and/or reduce the rate of unnecessary biopsies.

Dermatoscopy

Dermatoscopy, also known as dermoscopy, describes a family of noninvasive techniques that allow in vivo microscopic examination of skin lesions, and is intended to help distinguish between benign and malignant pigmented skin lesions. The technique involves the application of immersion oil to the skin, which eliminates light reflection from the skin surface and renders the stratum corneum transparent. Using a magnifying lens, the structures of the epidermis and epidermal-dermal junction can then be visualized. A handheld or stereomicroscope may be used for direct visual examination. Digitization of images, typically after initial visual assessment, permits storage and facilitates their retrieval and is often used for comparison purposes if a lesion is being followed over time.

A variety of dermatoscopic features have been identified that are suggestive of malignancy, including pseudopods, radial streaming, the pattern of the pigment network, and black dots. These features in combination with other standard assessment criteria of pigmented lesions, such as asymmetry; borders; and color, have been organized into algorithms to enhance the differential diagnosis of pigmented skin lesions. Dermatoscopic images may be assessed by direct visual examination or by review of standard or digitized photographs. Digitization of images, either surface or dermatoscopic images, may permit qualitative image enhancement for better visual perception and discrimination of certain features, or actual computer-assisted diagnosis.

Interpretation of dermatoscopy findings has evolved. Initially, lesions were evaluated using pattern analysis. More recently several algorithms were developed, including the asymmetry, border, color and dermatoscopic structures (ABCD) rule of dermatoscopy, the 3-point and 7-point checklists of dermatoscopy by Argenziano, the Menzies method, and the CASH algorithm. There remains a lack of consensus in the literature regarding the optimal dermatoscopic criteria for malignancy.

Dermatoscopy is also proposed in the serial assessment of lesions over time and for defining peripheral margins prior to surgical excision of skin tumors.

Computer-Based Optical Diagnostic Devices

A U.S. Food and Drug Administration (FDA)-approved multispectral digital skin lesion analysis (MSDSLA) device uses a handheld scanner to shine visible light on the suspicious lesion. The light is often wavelengths, varying from blue (430nm) and near infrared (950nm). The light can penetrate up to 2.5mm under the surface of the skin. The data acquired by the scanner are analyzed by a data processor; the characteristics of each lesion are evaluated using proprietary computer algorithms. Lesions are classified as positive (i.e., high degree of morphologic disorganization) or negative (i.e., low degree of morphologic disorganization) according to the algorithms. Positive lesions are recommended for biopsy. For negative lesions, other clinical factors are considered in the decision of whether to refer to a biopsy. The FDA-approved system (see additional details in the Governing Bodies section) is intended only for suspicious pigmented lesions on intact skin and for use only by trained dermatologists.

Total Body Photography

Total Body Photography is another development for diagnosing and tracking melanoma but is separate and distinct from dermoscopy. This is a photographic display system on CD-ROM, designed to serve as an adjunct to the physical examination when following patients who are at high risk for developing cutaneous melanoma. This method is the MoleMapCD and marketed by DigitalDerm, Inc. This allows rapid display of thirty-three high-resolution color images of the patient’s skin surface and permits efficient comparison of the patient’s current condition with a set of baseline images. The use and focus of total body photography imaging is a significant change from the use of dermatoscopy and should not be considered a component of dermatoscopy or be evaluated as the same as MoleMap II, MS 500 B Micro-Scopeman, Moritex or any other instrument used for dermatoscopy. Total Body Photography looks at the total body surface and dermatoscopy looks at single moles. Dermatoscopy describes a family of noninvasive techniques that allow in vivo microscopic examination of skin lesions, and is intended to help distinguish between benign and malignant pigmented skin lesions. Dermatoscopy may also be referred to as dermoscopy, skin surface microscopy, epiluminescence microscopy (ELM). This involves the application of immersion oil to the skin, which eliminates light reflection from the skin surface and renders the stratum corneum transparent.

Total Body Photography is a service that offers a comprehensive photographic archive of the patient’s skin surface at a particular time. A professional photographer takes a series of thirty-three images of the patient’s body. The images are forwarded on 2 CDs to the physician. The physician keeps 1 disk and gives the other disk to the individual during the follow-up visit and may be instructed on the best use of the MoleMapCD for home self-examination.

KEY POINTS:

The literature search for this policy was performed through December 11, 2024.

Summary of Evidence

The evidence on dermatoscopy for selecting or deselecting lesions for excision includes many diagnostic accuracy studies and several meta-analyses. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The literature suggests that dermatoscopy is more accurate than a naked-eye examination when used in an expert clinical setting. The available evidence from prospective randomized controlled trials (RCTs) and other studies suggests that dermatoscopy used by specialists may lead to a decrease in the number of benign lesions excised and when used by primary care physicians, may lead to fewer benign lesions being referred to specialists. The number of studies on the impact of dermatoscopy on patient management and clinical outcomes remains limited. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence on computer-based optical diagnostic devices for selecting or deselecting lesions for excision includes a published diagnostic accuracy study and simulation study. Relevant outcomes are overall survival, disease-specific survival, test accuracy and change in disease status. In the diagnostic accuracy study, 10% of samples were not evaluable and the simulation study had some potential biases. There are no studies comparing patient management decisions and health outcomes with and without these devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence on dermatoscopy and computer-based optical diagnostic devices for serial monitoring suspicious lesions includes no published studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. No studies were found that specifically addressed diagnostic accuracy or clinical utility in this population. The evidence is insufficient to determine the effects of the technology on health outcomes.

The evidence on dermatoscopy and computer-based optical diagnostic devices for defining peripheral margins of basal cell carcinomas or squamous cell carcinomas prior to surgery includes 1 RCT and several observational studies. Relevant outcomes include overall survival, disease-specific survival, and treatment-related morbidity. The single RCT did not report superior outcomes using dermatoscopy compared with visual inspection or curettage. The published studies were all conducted outside of the United States and at least 2 did not use U.S. Food and Drug Administration‒approved devices. None addressed computer-based optical devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

In July 2007, the International Dermoscopy Society (IDS) embarked on creating a consensus document for the standardization and recommended criteria necessary to be able to effectively convey dermatoscopic findings to consulting physicians and colleagues. The final items included in the document are as follows:

1. pertinent personal and family history (recommended);
2. clinical description of the lesion (recommended);
3. the two-step method of dermatoscopy differentiating melanocytic from nonmelanocytic tumors (recommended);
4. the use of standardized terms to describe structures (recommended);
5. the dermatoscopic algorithm used (optional);
6. information on the imaging equipment and magnification (recommended);
7. clinical and dermatoscopic images of the tumor (recommended);
8. a diagnosis or differential diagnosis (recommended);
9. decision concerning the management (recommended);
10. specific comments for the pathologist when excision and histopathologic examination are recommended (optional).

The National Comprehensive Cancer Network® (NCCN) melanoma guideline does not mention dermatoscopy. A biopsy is recommended for suspicious pigmented lesions.

The American Academy of Dermatology (AAD) 2011 guidelines of care and treatment of melanoma do not mention dermatoscopy in the discussion of determining surgical margins before surgery. The guidelines did not address the evaluation of suspicious lesions.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Dermoscopy, dermatoscopy, epiluminescence light microscopy, ELM, pigmented skin lesions, PSLs, and digital epiluminescence light microscopy, DELM, Episcope, Nevoscope, Dermascope, MoleMax™, melanomagram, total body photography, optical diagnostic devices, computer-based optical imaging devices, MelaFind®, MoleMapCD, Vivascope, RCM, Reflectance confocal microscopy

APPROVED BY GOVERNING BODIES:

Dermatoscopic devices cleared by the FDA include:

• Episcope™ (Welch Allyn, Inc.) approved in 1995, intended use to illuminate body surfaces and cavities during medical examination
• Nevoscope™ (TRANSLITE) approved in 1996, intended use is to view skin lesions by either illumination or transillumination
• Dermascope™ (American Diagnostic Corp.) approved in 1999, intended use is to enlarge images for medical purposes
• MoleMax™ (Derma Instruments) approved in 1999, intended use is to enlarge images for medical purposes
• MelaFind® (MelaSciences, Inc. Irvington, NY) approved in 2011, intended use to evaluate pigmented lesions with clinical or histological characteristics suggestive of melanoma by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) and only those who have additionally successfully completed training on the MelaFind device.

MelaFind is not intended for lesions with a diagnosis of melanoma or likely melanoma.

The FDA documents further note:

“MelaFind is indicated only for use on lesions with a diameter between 2mm and 22mm, lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e., not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar or fibrosis consistent with previous trauma, lesions where the skin is intact (i.e., non-ulcerated or non-bleeding lesions), lesions greater than 1cm away from the eye, lesions which do not contain foreign matter, and lesions not on special anatomic sites (i.e., not for use on acral, palmar, plantar, mucosal, or subungual areas). MelaFind is not designed to detect pigmented non-melanoma skin cancers, so the dermatologist should rely on clinical experience to diagnose such lesions.”

BENEFIT APPLICATION:

Coverage is subject to the 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 the member’s benefit plan.

CURRENT CODING:

CPT codes:

Whole body photography represents one component of dermatoscopy. CPT code 96904 may also be submitted to describe whole body photography without dermatoscopy.

REFERENCES:

1. American Academy of Dermatology. MELANOMA CLINICAL GUIDELINE. 2024. www.aad.org/member/clinical-quality/guidelines/melanoma
2. Andreassi, Lucio, et al. Digital dermoscopy analysis for the differentiation of atypical nevi and early melanoma: A new quantitative semiology. Archives of Dermatology, December 1999, Vol. 135 (12), pp. 1459-1465.
3. Annessi G, Bono R, Sampogna F et al. Sensitivity, specificity, and diagnostic accuracy of three dermoscopic algorithmic methods in the diagnosis of doubtful melanocytic lesions: the importance of light brown structureless areas in differentiating atypical melanocytic nevi from thin melanomas. J Am Acad Dermatol 2007; 56(5):759-767.
4. Argenyi, Zsolt B. Dermoscopy (epiluminescence microscopy) of pigmented skin lesions. January 1997, Dermatologic Clinics, Vol. 15, No. 1.
5. Argenziano Puig et al. Dermoscopy improves accuracy of primary care physicians to triage lesions suggestive of skin cancer. J Clin Oncol. Apr 20 2006; 24(12):1877-1882.
6. Argenziano, Fabbrocini, et al. Epiluminescence microscopy for the diagnosis of doubtful melanocytic skin lesions: Comparison of the ABCD rule of dermatoscopy and a new 7-point checklist based on pattern analysis. Archives of Dermatology, December 1998, Vol. 134 (12), pp. 1563-1570
7. Argenziano, Ferrara, et al. Dermoscope: the ultimate tool for melanoma diagnosis. Seminars in Cutaneous Medicine and Surgery. September 2009, Vol. 28, Issue 3, pp. 142-148.
8. Ascierto, et al.  Sensitivity and specificity of epiluminescence microscopy: Evaluation on a sample of 2,731 excised cutaneous pigmented lesions. British Journal of Dermatology, May 2000, Vol. 142 (5), pp. 893-898.
9. Asilian A, Momeni I. Comparison between examination with naked eye, curretage and dermoscopy in determining tumor extension before Mohs micrographic surgery. Adv Biomed Res. 2013; 2:2.
10. Bahmer FA, Fritsch P, Kreusch J et al. Terminology in surface microscopy. J Am Acad Dermatol 1990; 23(6 pt 1):1159-1162.
11. Binder, Puespoeck-Schwartz, et al.  Epiluminescence microscopy of small pigmented skin lesions: Short-term formal training improves the diagnostic performance of dermatologists, Journal of the American Academy of Dermatology, February 1997, Vol. 36, No. 2.
12. Binder, Schwarz, et al.  Epiluminescence microscopy: A useful tool for the diagnosis of pigmented skin lesions for formally trained dermatologists. Archives of Dermatology, March 1995, Vol. 131 (3), pp. 286-291
13. Carducci , Bozzetti , Foscolo, et al. Margin detection using digital dermatoscopy improves the performance of traditional surgical excision of basal cell carcinomas of the head and neck. Dermatol Surg 2011; 37(2):280-285.
14. Carducci, Bozzetti, de Marco, et al. Preoperative margin detection by digital dermoscopy in the traditional surgical excision of cutaneous squamous cell carcinomas. J Dermatolog Treat 2013; 24(3):221-226.
15. Caresana G and Giardini R. Dermoscopy-guided surgery in basal cell carcinoma. J Eur Acad Dermatol Venereol 2010; 24(12); 1395-1399.
16. Carli, de Giorgi, et al. Addition of dermoscopy to conventional naked-eye examination in melanoma screening: a randomized study. J Am Acad Dermatol. May 2004; 50(5):683-689.
17. Carli, Paolo, et al. Preoperative assessment of melanoma thickness by ABCD score of Dermatoscopy. Journal of the American Academy of Dermatology, September 2000, Vol. 43, No. 3.
18. Coit, et al. Cutaneous Melanoma, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Apr 1;17(4):367-402.
19. Csány G, Gergely LH, Kiss N, Szalai K, Lőrincz K, Strobel L, Csabai D, Hegedüs I, Marosán-Vilimszky P, Füzesi K, Sárdy M, Gyöngy M. Preliminary Clinical Experience with a Novel Optical-Ultrasound Imaging Device on Various Skin Lesions. Diagnostics (Basel). 2022 Jan 15;12(1):204. 
20. De Giorgi V, Grazzini M, Rossari S et al. Adding dermatoscopy to naked eye examination of equivocal melanocytic skin lesions: effect on intention to excise by general dermatologists. Clin Exp Dermatol 2011; 36(3):255-259.
21. Dreiseitl, et al. Applying a decision support system in clinical practice: Results from melanoma diagnosis. AMIA Annu Symp Proc. 2007 Oct 11;2007:191-195.
22. Goodson AG and Grossman D. Strategies for early melanoma detection: Approaches to the patient with nevi. J Am Acad Dermatol, May 2009; 60(5): 719-735.
23. Grichnik, James M. Difficult early melanomas. Dermatologic Clinics,2001 April;19(2):319-325.
24. Grin, Caron M., et al. Dermoscopy: a review. Dermatologic Clinics, 2002 Oct;20(4):641-646, viii.
25. Gust, et al. Line-Field Confocal Optical Coherence Tomography Increases the Diagnostic Accuracy and Confidence for Basal Cell Carcinoma in Equivocal Lesions: A Prospective Study. Cancers (Basel). 2022 Feb 21;14(4):1082.
26. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
27. Kardynal A, Olszewska M. Modern non-invasive diagnostic techniques in the detection of early cutaneous melanoma. J Dermatol Case Rep. 2014 Mar 31, 8(1):1-8.
28. Kittler, et al. Diagnostic accuracy of dermoscopy. Lancet Oncology, 2002 Mar;3(3):159-165.
29. Kittler, et al. Follow-up of melanocytic skin lesions with digital epiluminescence microscopy: Patterns of modifications observed in early melanoma, atypical nevi, and common nevi. Journal of the American Academy of Dermatology, 2000 Sep;43(3):467-476.
30. Koelink et al. Diagnostic accuracy and cost-effectiveness of dermoscopy in primary care: a cluster randomized clinical trial. J Eur Acad Dermatol Venereol. 2014 Nov;28(11):1442-1449.
31. Langley RGB, Walsh N, et al. The diagnostic accuracy of in vivo confocal scanning laser microscopy compared to dermoscopy of benign and malignant melanocytic lesions: A prospective study. Dermatology 2007;215(4): 365-372.
32. Lee JB and Hirokawa D. Dermatoscopy: Facts and controversies. Clin Dermatol, 2010 May-June; 28(3): 303-310.
33. Mackie, et al. The use of the dermatoscope to identify early melanoma using the three-colour test. British Journal of Dermatology 2002 Mar;146 (3), pp. 481-4.
34. Malvehy, et al. Dermoscopy report: proposal for standardization. Results of a consensus meeting of the International Dermoscopy Society. J Am Acad Dermatol, July 2007; 57(1): 84-95.
35. Menzies, et al. Dermoscopic evaluation of amelanotic and hypomelanotic melanoma. Arch Dermatol 2008 Sept; 144(9): 1120-1127
36. National Comprehensive Cancer Network. (2023, October 27). Melanoma: Cutaneous. Melanoma: Cutaneous. www.nccn.org/guidelines/guidelines-detail?category=1&id=1492
37. Rabinovitz, Harold S., et al. Introduction to dermoscopy, Dermatologic Clinics, Apr;19(2):221-58. doi: 10.1016/s0733-8635(05)70263-1.
38. Rajpara SM, Botello AP, et al. Systematic review of dermoscopy and digital dermoscopy/artificial intelligence for the diagnosis of melanoma. Br J Dermatol, September 2009; 161(3): 591-604.
39. Rigel, et al. Impact of guidance from a computer-aided multispectral digital skin lesion analysis device on decision to biopsy lesions clinically suggestive of melanoma. Arch Dermatol 2012; 148(4):541-543.
40. Roesch, et al. Dermatoscopy of “dysplastic nevi”: A beacon in diagnostic darkness. Eur J Dermatol 2006; Sept- Oct;16(5): 479-93.
41. Rosendahl, et al. Diagnostic accuracy of dermatoscopy for meloncytic and nonmelanocytic pigmented lesions. J Am Acad Dermatol 2011;Jun; 64(6):1068-1073.
42. Salerni, et al. Meta-analysis of digital dermoscopy follow-up of melanocytic skin lesions: a study on behalf of the International Dermoscopy Society. J Eur Acad Dermatol Venereol. 2013 Jul; 27(7):805-814.
43. Salopek, et al. Differentiation of atypical moles (dysplastic nevi) from early melanomas by dermoscopy. Dermatologic Clinics, 2001 Apr;19(2):337-45.
44. Schuh S, Ruini C, Perwein MKE, Daxenberger F, Gust C, Sattler EC, Welzel J. Line-Field Confocal Optical Coherence Tomography: A New Tool for the Differentiation between Nevi and Melanomas? Cancers (Basel). 2022 Feb 23;14(5):1140. 
45. Stanganelli, et al. Intraobserver agreement in interpretation of digital epiluminescence microscopy. J Am Acad Dermatol 1995; 33(4):584-589.
46. Suzuki HS, Serafini SZ, Sato MS. Utility of dermoscopy for demarcation of surgical margins in Mohs micrographic surgery. An Bras Dermatol. 2014 Jan-Feb; 89(1):38-43.
47. U.S. Preventive Services Task Force. Screening for skin cancer: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine, 2009 February 3;150(3): 188-193.
48. Unlu E, Akay BN, Erdem C. Comparison of dermatoscopic diagnostic algorithms based on calculation: The ABCD rule of dermatoscopy, the seven-point checklist, the three-point checklist and the CASH algorithm in dermatoscopic evaluation of melanocytic lesions. J Dermatol. 2014 Jul; 41(7):598-603.
49. Vestergaard ME, Macaskill P, Holt PE and Menzies SW. Dermoscopy compared with naked eye examination for the diagnosis of primary melanoma: A meta-analysis of studies performed in a clinical setting. Br J Dermatology. 2008 Sept; 159(3): 669-676.
50. Weber P, Tschandl P, Sinz C, Kittler H. Dermatoscopy of Neoplastic Skin Lesions: Recent Advances, Updates, and Revisions. Curr Treat Options Oncol. 2018 Sep 20;19(11):56. 
51. Wells , et al. Comparison of diagnostic and management sensitivity to melanoma between dermatologists and MelaFind: a pilot study. Arch Dermatol. 2012 Sept; 148(9):1083-1084.
52. Williams NM, Navarrete-Dechent C, Marchetti MA, De Bedout V, Jaimes N. Diagnostic utility of circumferential peripheral globules under dermoscopy in adults. J Am Acad Dermatol. 2021;85(5):1300-1302.
53. Wolff Tracy, Tai Eric and Miller Therese. Screening for skin cancer: An update of the evidence for the U.S. Preventive Services Task Force. Annals of Internal Medicine, Feb 3;150(3): 194-198.
54. Zalaudek , et al. Dermoscopy for challenging melanoma; how to raise the ‘red flag’ when melanoma clinically looks benign. Br J Dermatol 2005 Jul; 153(1): 200-202.

POLICY HISTORY:

Medical Policy Group, May 2003 (1)

Medical Policy Administration Committee, May 2003

Available for comment June 12-July 28, 2003

Medical Policy Group, June 2005

Medical Policy Administration Committee, June 2005

Available for comment June 18-August 2, 2005

Medical Policy Group, March 2009 (1)

Medical Policy Group, August 2009 (1)

Medical Policy Group, September 2010 (1): Updated Description, added non-coverage statement for dermatoscopy to define peripheral margins of basal cell carcinomas, updated Key Points

Medical Policy Administration Committee, September 2010

Available for comment September 22-November 5, 2010

Medical Policy Group, September 2011 (1): Update to Key Points and References

Medical Policy Panel, September 2012

Medical Policy Group, March 2013 (1): Update to Title, Description, Policy, Key Points, Key Words, Governing Bodies and References related to computer-based optical imaging devices and removing the specific phrase of basal cell carcinoma to the more generic phrase of skin lesions suspected of malignancy

Available for comment March 5 through April 18, 2013

Medical Policy Panel, October 2013

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

Medical Policy Panel, September 2014

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

Medical Policy Panel, September 2015

Medical Policy Group, October, 2015 (2): 2015 Updates to Key Points, Current Coding- added new codes 0400T and 0401T, and References; no change to policy statement.

Medical Policy Group, October, 2015: Policy moved to Retired – no longer scheduled for regular updates effective November 1, 2015.

Medical Policy Group, November 2015: 2016 Annual Coding Update.  Added key words and new CPT codes 96931 – 96936 to the current coding section.

Medical Policy Group, January 2016 (2): added reference to medical policy #616 for additional information on MelaFind®.

Medical Policy Group, July 2019 (7): Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy. Removed Previous Coding section. 

Medica Policy Group, January 2021 (5): Reviewed by consensus. Updates to Key Points. There is no new published peer reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2021 (5): Created Previous Coding section. Moved CPT codes 0400T and 0401T from Current Coding section to Previous Coding section. 

Medical Policy Group, January 2022 (5): Reviewed by consensus. Updates to Key Points. There is no new published peer reviewed literature available that would alter the coverage statement in this policy. Policy Statement updated to remove “not medically necessary,” no change in policy intent.

Medical Policy Group, December 2022 (5): Reviewed by consensus. Updates to Key Points and References. There is no new published peer reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, January 2024 (9): Reviewed by consensus. There is no new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Key Points, Key Words, Benefit Application and References. No change to policy intent.

Medical Policy Group, December 2024 (5): Reviewed by consensus. Updates to Key Points and References. There is no new published peer reviewed literature available that would alter the coverage statement in this policy. Policy Statement updated to replace “not medically necessary” verbiage with “investigational.” No change 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.