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Risk-Reducing Mastectomy

Policy Number: MP-174

Latest Review Date: October 2024

Category:  Surgery                                                              

POLICY:

Note: It is strongly recommended that all candidates for risk-reducing mastectomy undergo counseling regarding cancer risks from a health professional skilled in assessing cancer risk other than the operating surgeon. Cancer risk should be assessed by performing a complete family history, use of the Gail or Claus model to estimate the risk of cancer, and discussion of the various treatment options, including increased surveillance or chemoprevention with tamoxifen or raloxifene.

Risk-reducing mastectomy may be considered medically necessary in individuals with such extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy is impossible.

Risk-reducing mastectomy may be considered medically necessary in individuals at high risk or moderately increased risk of breast cancer as defined below.

High risk of breast cancer may be defined as one or more of the following:

  • Two or more first-degree relatives with breast cancer or ovarian cancer;
  • One first-degree relative and two or more second-degree or third-degree relatives with breast cancer;
  • One first-degree relative with breast cancer before the age of 45 years and one other relative with breast cancer;
  • One first-degree relative with breast cancer and one or more relatives with ovarian cancer;
  • Two second-degree or third-degree relatives with breast cancer and one or more with ovarian cancer;
  • One second-degree or third-degree relative with breast cancer and two or more with ovarian cancer;
  • Three or more second-degree or third-degree relatives with breast cancer;
  • One first-degree relative with bilateral breast cancer;
  • Lobular carcinoma in situ;
  • Presence of a BRCA1 or BRCA2 mutation in the individual;
  • At high risk of a BRCA1 or BRCA2 mutation due to a known BRCA1 or 2 mutation in a family member with breast or ovarian cancer;
  • Presence of gene mutation associated with increased risk (e.g., PTEN, TPS3, CDH1, STK11)
  • High risk (lifetime risk about 20% or greater) of developing breast cancer as identified by models that are largely defined by family history; 
  • Received radiation therapy to the chest between the ages of 10 and 30 years.

Moderate risk of breast cancer may be defined as follows:

  • Those who do not meet the definition of high risk, but nonetheless are considered at moderately increased risk based on family history with or without breast lesions along with any one of these risk factors may be indicative of moderate risk, including, but not limited to:
    • atypical hyperplasia
    • breast cancer diagnosed in the opposite breast

Risk-reducing mastectomy is considered investigational for all other indications, including but not limited to contralateral prophylactic mastectomy in individuals with breast cancer who do not meet the above criteria.

DESCRIPTION OF PROCEDURE OR SERVICE:

Risk-reducing mastectomy is defined as the removal of the breast in the absence of malignant disease to reduce the risk of breast cancer occurrence.

Risk-reducing mastectomy may be considered in women thought to be at high-risk of developing breast cancer, either due to family history, presence of genetic variants (e.g., BRCA1, BRCA2), having received radiotherapy to the chest, or the presence of lesions associated with an increased cancer risk such as lobular carcinoma in situ. Therefore, bilateral risk-reducing mastectomy may be performed to eliminate the risk of cancer arising elsewhere; chemoprevention and close surveillance are alternative risk-reduction strategies. Risk-reducing mastectomies are typically bilateral but can also describe a unilateral mastectomy in a patient who has previously undergone or is currently undergoing a mastectomy in the opposite breast for invasive cancer (i.e., contralateral risk-reducing mastectomy). Use of contralateral risk-reducing mastectomy has increased in the United States. An analysis of data from the National Cancer Database found that the rate of contralateral risk-reducing mastectomy in women diagnosed with unilateral stage I, II, or III breast cancer increased from approximately 4% in 1998 to 9.4% in 2002.

The appropriateness of a risk-reducing mastectomy is a complicated risk-benefit analysis that requires estimates of a patient’s risk of breast cancer, typically based on the patient’s family history of breast cancer and other factors. Several models are available to assess risk of breast cancer. The specific risk factors included in the models vary, but all incorporate characteristics related to age, reproductive history and family history. In addition to the patient’s risk assessment, the choice of a risk-reducing mastectomy is based on patient tolerance for risk, consideration of changes to appearance and need for additional cosmetic surgery, and the risk-reduction offered by mastectomy vs other options.

KEY POINTS:

The policy has been updated regularly with searches of the MEDLINE database. The most recent literature review was performed throughAugust 5, 2024. The following is a summary of the key literature.

Summary of Evidence

For individuals who have a high risk of breast cancer or extensive mammographic abnormalities precluding excision or biopsy who receive a risk-reducing mastectomy, the evidence includes systematic reviews and observational studies. Relevant outcomes are overall survival, disease-specific survival, functional outcomes, and treatment-related morbidity. Studies have found that a risk-reducing mastectomy lowers subsequent breast cancer incidence and increases survival in select high-risk patients. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have unilateral breast cancer but are not otherwise at high risk who receive a contralateral risk-reducing mastectomy, the evidence includes systematic reviews and observational studies. Relevant outcomes are overall survival, disease-specific survival, functional outcomes, and treatment-related morbidity. Available studies do not demonstrate a consistent survival benefit in women without high-risk criteria. Moreover, there are risks associated with a contralateral risk-reducing mastectomy for both the primary surgical and reconstruction procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Society for Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology

In 2020, the American Society for Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology published joint guidelines on management of hereditary breast cancer. The guideline discusses management of patients with breast cancer with germline mutations in breast cancer susceptibility genes (e.g., BRCA1/2, ATM, TP53) and makes the following recommendations regarding risk-reducing mastectomy:

"Surgical management of the index malignancy (... contralateral risk-reducing mastectomy [CRRM]) in BRCA1/2 mutation carriers should be discussed, considering the increased risk of CBC and possible increased risk of an ipsilateral new primary breast cancer compared with noncarriers (Type: formal consensus; Evidence quality: intermediate; Strength of recommendation: strong)."

"For women with breast cancer who have a BRCA1/2 mutation and who have been treated or are being treated with unilateral mastectomy, CRRM should be offered. CRRM is associated with a decreased risk of CBC; there is insufficient evidence for improved survival."

"Decisions regarding risk-reducing mastectomy (bilateral or contralateral) are highly personal and must be individualized for every patient. Studies show that women who opt for prophylactic mastectomy report positive outcomes, including decreased concern about developing breast cancer. This benefit must be weighed against possible problems with implants or reconstructive therapy and potential adverse feelings related to body image, femininity, and sexuality. Most patients who opt for prophylactic mastectomy demonstrate satisfaction with their decision."

"For women with breast cancer who have a mutation in a moderate-penetrance breast cancer predisposition gene and who have been treated or are being treated with unilateral mastectomy, the decision regarding [contralateral risk-reducing mastectomy] CRRM should not be based predominantly on mutation status. Additional factors that predict CBC such as age at diagnosis and family history should be considered, as they are in all cases. The impact of CRRM on decreasing risk of CBC is dependent on the risk of CBC for each individual gene. Data regarding the risk of CBC resulting from moderate-penetrance genes are limited (Type: formal consensus; Evidence quality: low; Strength of recommendation: moderate)."

The guideline also provides recommendations for assessing the risk of CBC and role of risk-reducing mastectomy in BRCA1/2mutation carriers (Evidence quality: low; Strength of recommendation: moderate) and in women with breast cancer who have aBRCA1/2 mutation who have been treated or are being treated with unilateral mastectomy when considering contralateral risk-reducing mastectomy (Evidence quality: intermediate; Strength of recommendation: moderate). The guideline recommends consideration of the following:

  • Age at diagnosis (the strongest predictor of future CBC)
  • Family history of breast cancer
  • Overall prognosis from this or other cancers (e.g., ovarian)
  • Ability of patient to undergo appropriate breast surveillance (magnetic resonance imaging [MRI])
  • Comorbidities
  • Life expectancy.

Society of Surgical Oncology

The Society of Surgical Oncology published an updated position statement on prophylactic mastectomy in 2017. The position statement concluded the following about risk-reducing mastectomy:

“There is no single-risk threshold above which risk-reducing mastectomy is clearly indicated, and it is important for treating physicians and surgeons to explain to individuals not only the risk assessment but also all available treatment strategies to facilitate a shared decision-making process.”

“The available data suggest that BMP [bilateral prophylactic mastectomy] confers a survival advantage in women with the highest risk who undergo the procedure at a relatively early age … the impact of CPM [contralateral prophylactic mastectomy] in women with invasive breast cancer is more difficult to assess … however, CPM does not appear to confer a survival advantage.”

National Cancer Institute

The National Cancer Institute updated its fact sheet in 2013 on risk-reducing surgery for breast cancer. The fact sheet stated women with the following characteristics may consider bilateral prophylactic mastectomy:

  • Deleterious variant in BRCA1 or BRCA2
  • Strong family history of breast cancer
  • Lobular carcinoma in situ and family history of breast cancer
  • Radiotherapy to the chest before the age of 50 years.

Considering contralateral risk-reducing mastectomy, the Institute stated: “Given that women with breast cancer have a low risk of developing the disease in their contralateral breast, women who are not known to be at a very high risk but who remain concerned about cancer development in their other breast may want to consider options other than surgery to further their risk of a contralateral breast cancer.”

American Society of Breast Surgeons

A 2016 consensus statement from the American Society of Breast Surgeons made the following recommendations on contralateral risk-reducing mastectomy:

CPM should be considered for the following individuals at significant risk of contralateral breast cancer:

  • Documented BRCA1 or BRCA2 carrier
  • Strong family history in the absence of genetic testing
  • History of chest radiation before age 30

CPM can be considered for the following individuals at lower risk of contralateral breast cancer:

  • Carrier of CHEK2, PALB3, TP53, or CDHI
  • Strong family history in BRCA-negative patients without known BRCA family member

CPM may be considered for other reasons:

  • “To limit contralateral breast surveillance (dense breasts, failed surveillance, recall fatigue).
  • To improve breast symmetry in reconstruction.
  • To manage risk aversion … [or] extreme anxiety.” (Note: anxiety may better be measured through psychological support.)

CPM should be discouraged in the following situations:

  • “Average-risk women with unilateral breast cancer
  • Women with advanced stage index cancer….
  • Women at high risk of surgical complications (e.g., … comorbidities, obesity, smoking, diabetes)”
  • BRCA-negative, with BRCA-positive family members
  • “Males with breast cancer, including BRCA carriers.”

National Comprehensive Cancer Network

NCCN has made recommendations on several cancers relevant to this evidence review. On breast cancer risk-reduction (v.1.2023), NCCN recommends:

“Risk-reducing mastectomy should generally be considered only in women with a genetic mutation conferring a high risk for breast cancer..., compelling family history, or possibly with LCIS [lobular carcinoma in situs] or prior thoracic radiation therapy at <30 years of age. The value of risk-reducing mastectomy in in individuals with pathogenic/likely pathogenic mutations in other genes associated with a 2-fold or greater risk for breast cancer in the absence of a compelling family history of breast cancer is unknown.”

For invasive breast cancer (v.4.2023) NCCN has discouraged contralateral risk-reducing mastectomy, except for certain high-risk situations (noted in the risk-reduction guideline previously discussed). The guidelines state:

“risk reduction mastectomy of a breast contralateral to a known unilateral breast cancer treated with mastectomy is discouraged by the panel. The use of a prophylactic mastectomy contralateral to a breast treated with lumpectomy is very strongly discouraged.”

As part of genetic/familial high-risk assessment for breast and ovarian cancer (v.3.2023), NCCN recommends that the option of risk-reduction mastectomy be discussed in women with BRCA-related breast and/or ovarian syndrome, Li-Fraumeni syndrome, and Cowden syndrome or PTEN hamartoma tumor syndrome. In addition, NCCN guidelines recommend that risk-reducing mastectomy be considered based on family history in women with certain genetic variants including CHEK2, and CDH1.

American College of Genetics and Genomics

In 2021, the American College of Genetics and Genomics published a guideline on management of individuals with PALB2 variants, which recommends that risk-reducing mastectomy be considered as an option based on personal risk.

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force published recommendations for breast cancer screening, entitled BRCA-Related Cancer Risk Assessment, Genetic Counseling and Genetic Testing, in December 2013. They have also issued a recommendation stating that women at increased risk for breast cancer and at low risk for adverse medication effects, clinicians should offer to prescribe risk-reducing medications such as tamoxifen or raloxifene. Prophylactic mastectomy was not addressed.

KEY WORDS:

female mastectomy as a prophylaxis, mastectomy,prophylaxis for breast cancer, prophylactic mastectomy (PM), contralateral prophylactic mastectomy (CPM), risk-reducing mastectomy

APPROVED BY GOVERNING BODIES:

Mastectomy is a surgical procedure and, as such, is not subject to regulation by the U.S Food and Drug Administration.

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:

19303

Mastectomy, simple, complete

 

Previous Coding:

19304

Mastectomy, subcutaneous

 

References:

  1. Baskin AS, Wang T, Bredbeck BC, et al. Trends in Contralateral Prophylactic Mastectomy Utilization for Small Unilateral Breast Cancer. J Surg Res. Jun 2021; 262: 71-84.
  2. Boughey JC, Attai DJ, Chen SL, et al. Contralateral Prophylactic Mastectomy (CPM) Consensus Statement from the AmericanSociety of Breast Surgeons: Data on CPM Outcomes and Risks. Ann Surg Oncol. Oct 2016; 23(10): 3100-5.
  3. Carbine NE, Lostumbo L, Wallace J, et al. Risk-reducing mastectomy for the prevention of primary breast cancer. CochraneDatabase Syst Rev. Apr 05 2018; 4: CD002748.
  4. Eck DL, Perdikis G, Rawal B, et al. Incremental risk associated with contralateral prophylactic mastectomy and the effect on adjuvant therapy. Ann Surg Oncol. Oct 2014; 21(10):3297-3303.
  5. Fayanju OM, Stoll CR, Fowler S, et al. Contralateral prophylactic mastectomy after unilateral breast cancer: a systematic review and meta-analysis. Ann Surg. Dec 2014; 260(6):1000-1010.
  6. Hanson H, Astiazaran-Symonds E, Amendola LM, et al. Management of individuals with germline pathogenic/likely pathogenic variantsin CHEK2: A clinical practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. Oct 2023;25(10): 100870.
  7. Honold F, Camus M. Prophylactic mastectomy versus surveillance for the prevention of breast cancer in women's BRCA carriers. Medwave. 2018 Jul 9;18(4):e7161.
  8. Hunt KK, Euhus DM, Boughey JC, et al. Society of Surgical Oncology Breast Disease Working Group Statement on prophylactic (risk-reducing) mastectomy. Ann Surg Oncol. Feb 2017;24(2):375-397.
  9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  10. Kruper L, Kauffmann RM, Smith DD, et al. Survival analysis of contralateral prophylactic mastectomy: a question of selection bias. Ann Surg Oncol. Oct 2014; 21(11):3448-3456.
  11. Kurian AW, Canchola AJ, Ma CS, et al. Magnitude of reduction in risk of second contralateral breast cancer with bilateralmastectomy in patients with breast cancer: Data from California, 1998 through 2015. Cancer. Mar 01 2020; 126(5): 958-970.
  12. Li X, You R, Wang X, et al. Effectiveness of prophylactic surgeries in BRCA1 or BRCA2 mutation carriers: a meta-analysis and systematic review. Clin Cancer Res. Aug 01 2016; 22(15):3971-3981.
  13. Ludwig KK, Neuner J, Butler A, et al. Risk reduction and survival benefit of prophylactic surgery in BRCA mutation carriers, a systematic review. Am J Surg. Oct 2016; 212(4):660-669.
  14. McCarthy AM, Guan Z, Welch M, et al. Performance of Breast Cancer Risk-Assessment Models in a Large Mammography Cohort. J Natl Cancer Inst. May 01 2020; 112(5): 489-497.
  15. Miller ME, Czechura T, Martz B, et al. Operative risks associated with contralateral prophylactic mastectomy: a single institution experience. Ann Surg Oncol. Dec 2013; 20(13):4113-4120.
  16. Molina-Montes E, Perez-Nevot B, Pollan M, et al. Cumulative risk of second primary contralateral breast cancer in BRCA1/BRCA2 mutation carriers with a first breast cancer: A systematic review and meta-analysis. Breast. Dec 2014; 23(6):721-742.
  17. Murphy AI, Asadourian PA, Mellia JA, et al. Complications Associated with Contralateral Prophylactic Mastectomy: A Systematic Reviewand Meta-Analysis. Plast Reconstr Surg. Oct 01 2022; 150: 61S-72S.
  18. National Cancer Institute. Fact Sheet: Surgery to Reduce the Risk of Breast Cancer. 2013; https://www.cancer.gov/types/breast/risk-reducing-surgery-fact-sheet.
  19. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer.Version 4.2023. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
  20. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Genetic/FamilialHigh-Risk Assessment: Breast, Ovarian, and Pancreatic. Version 3.2023.https://www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf.
  21. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer RiskReduction. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/breast_risk.pdf.
  22. Nichols HB, Berrington de Gonzalez A, Lacey JV, Jr., et al. Declining incidence of contralateral breast cancer in the United States from 1975 to 2006. J Clin Oncol. Apr 20 2011; 29(12):1564-1569.
  23. Pesce C, Liederbach E, Wang C, et al. Contralateral prophylactic mastectomy provides no survival benefit in young women with estrogen receptor-negative breast cancer. Ann Surg Oncol. Oct 2014; 21(10):3231-3239.
  24. Schroeder MC, Tien YY, Erdahl LM, et al. The relationship between contralateral prophylactic mastectomy and breastreconstruction, complications, breast-related procedures, and costs: A population-based study of health insurance data.Surgery. Nov 2020; 168(5): 859-867.
  25. Silva AK, Lapin B, Yao KA, et al. The effect of contralateral prophylactic mastectomy on perioperative complications in women undergoing immediate breast reconstruction: a NSQIP analysis. Ann Surg Oncol. Oct 2015; 22(11):3474-3480.
  26. Tischkowitz M, Balmana J, Foulkes WD, et al. Management of individuals with germline variants in PALB2: a clinical practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. Aug 2021; 23(8): 1416-1423.
  27. Tung NM, Boughey JC, Pierce LJ, et al. Management of Hereditary Breast Cancer: American Society of Clinical Oncology,American Society for Radiation Oncology, and Society of Surgical Oncology Guideline. J Clin Oncol. Jun 20 2020; 38(18):2080-2106.
  28. Watt GP, John EM, Bandera EV, et al. Race, ethnicity and risk of second primary contralateral breast cancer in the United States. Int J Cancer. Jun 01 2021; 148(11): 2748-2758.
  29. Wong SM, Freedman RA, Sagara Y, et al. Growing use of contralateral prophylactic mastectomy despite no improvement in long-term survival for invasive breast cancer. Ann Surg. Mar 2017;265(3):581-589.
  30. Yang Y, Pan L, Shao Z. Trend and survival benefit of contralateral prophylactic mastectomy among men with stage I-III unilateral breast cancer in the USA, 1998-2016. Breast Cancer Res Treat. Dec 2021; 190(3): 503-515.
  31. Yao K, Winchester DJ, Czechura T, et al. Contralateral prophylactic mastectomy and survival: report from the National Cancer Data Base, 1998-2002. Breast Cancer Res Treat. Dec 2013; 142(3):465-476.

POLICY HISTORY:

Medical Policy Group, July 2011

Medical Policy Administration Committee, July 2011

Available for comment July 6 through August 22, 2011

Medical Policy Group, February 2012 (1): Update to Description, Key Points and References related to MPP update; no change in policy statement.

Medical Policy Panel, March 2013

Medical Policy Group, September 2013 (1): Update to Descriptions, Key Points and References; no change to policy statement.

Medical Policy Panel, March 2015

Medical Policy Administration Committee, April 2015

Medical Policy Group, April 2015 (3): Update to Description, Key Points, and References; no change to policy statement.

Medical Policy Group, July 2015 (3):  editing correction – policy statement bullet should have been two bullets as follows: 1) Presence of a BRCA1 or BRCA2 mutation in the patient; 2) At high risk of a BRCA1 or BRCA2 mutation due to a known BRCA1 or 2 mutation in a family member with breast or ovarian cancer; no change in policy statement intent.

Medical Policy Panel, February 2016

Medical Policy Group, March 2016 (2): Update to Key Points, Key Words, and References; policy section updated - merged coverage statement for lobular carcinoma in situ and lifetime risk criteria into high risk group and updated moderate risk criteria; no change in intent.

Medical Policy Panel, July 2017

Medical Policy Group, August 2017 (7): Update to Description, Key Points, and References. No change in policy statement.

Medical Policy Panel, July 2018

Medical Policy Group, August 2018 (7): Update to Description, Key Points, and References. Added Key Words- “risk-reducing mastectomy”. Title changed to “Risk-Reducing Mastectomy”. “Prophylactic” mastectomy changed to “Risk-Reducing” mastectomy throughout policy statement to reflect preferred terminology in the literature and by NCCN; intent of Policy statements remain unchanged.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (7): Update to Key Points, and References. No change in Policy Statement.

Medical Policy Group, December 2019: 2020 Annual Coding Update. Moved CPT code 19304 from Current coding section.  Created Previous coding section to include code 19304. No change in Policy Statement.

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (7): Update to Key Points and References. No change in Policy Statement.

Medical Policy Panel, July 2021

Medical Policy Group, August 2021 (7): Update to Key Points and References. Removed “not medically necessary” verbiage from the Policy Statement. No change in intent.

Medical Policy Panel, July 2022

Medical Policy Group, July 2022 (7): Update to Key Points and References. Minor update to Policy Statement- replaced “patient” with “individual.” No change in intent.

Medical Policy Panel, July 2023

Medical Policy Group, July 2023 (7): Update to Key Points, Benefit Application and References. No change in Policy Statement.

Medical Policy Panel, September 2024

Medical Policy Group, October 2024 (7): Update to Key Points and References. No change to Policy Statement.

 

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.