Currentblue cross blue shield - tennesseePolicy N/A

Erectile_Dysfunction_Reimbursement_Policy

Defines which laboratory tests meet or do not meet coverage criteria for the diagnosis and evaluation of erectile dysfunction (ED), includes guidance on assay standardization and references to guideline recommendations and regulatory notes. Applies to plan benefit determinations with Medicare/Medicaid overrides noted.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyErectile_Dysfunction_Reimbursement_Policy

Policy CodePolicy N/A

Change TypeAdoption

Effective DateJul 1, 2023

Next Review Date

Key ActionSerum total testosterone testing is strongly recommended to be performed on an assay certified by the CDC HoSt/Testosterone program; see CDC HoSt website for certified assays.

SourceLink

POLICY UPDATE CHANGES

EFFECTIVE DATE 7/1/2023 - Adopted Avalon policy recommendation

9Lab tests meeting coverage

4Lab tests not meeting coverage

±6.4%CDC HoSt tolerance

Coverage summary

Subject: Laboratory testing for diagnosis and evaluation of erectile dysfunction (ED). Purpose: to define which laboratory tests meet coverage criteria and which do not for the evaluation of ED and to provide guidance on assay standardization and related recommendations. Applicability: these coverage criteria apply to plan benefit determinations for laboratory testing used in the diagnosis and evaluation of ED; application depends on an individual’s benefit coverage at the time of request. Note: Medicare and Medicaid specifications may override this policy and, when there is a conflict, the applicable government policy will be used to make determinations.

Thresholds and evidence summary

CDC assay standardization tolerance for total testosterone±6.4% of the CDC total testosterone reference standard

Recommendation on assay useSerum total testosterone testing is STRONGLY RECOMMENDED to be performed on an assay certified by the CDC HoSt/Testosterone program; list of certified assays available on CDC HoSt website

Sensitivity of history and physical95% sensitivity (and 50% specificity) for determining cause of ED

Projected worldwide prevalenceApproximately 150 million men currently, projected to increase to 322 million by 2025

Medical-necessity criteria for laboratory testing

Covered laboratory tests for diagnosis of erectile dysfunction

The following lab tests MEET COVERAGE CRITERIA in the diagnosis of erectile dysfunction:

ALL of the following

Blood glucose (Fasting / HbA1c)
Complete blood count
Creatinine and Blood Urea Nitrogen
Hepatic panel
Lipid profile
Prostate specific antigen
Serum testosterone (Total / Free or Bioavailable)
See Note 1 regarding assay standardization and CDC HoSt/Testosterone certification recommendation
Thyroid function studies
Urinalysis

Not covered laboratory tests for diagnosis of erectile dysfunction

The following tests DO NOT MEET COVERAGE CRITERIA because their effectiveness has not been established:

ALL of the following

Angiotensin-converting enzyme insertion/deletion polymorphism testing
Endothelial nitric oxide synthase polymorphism (4 VNTR, G894T, and T786C) testing for estimating risk of erectile dysfunction
Iron binding capacity
Prostatic acid phosphatase

Provider actions and documentation requirements

Documentation Required

Use of CDC-certified testosterone assays recommended

Serum total testosterone testing is strongly recommended to be performed on an assay that has been certified by the CDC HoSt/Testosterone program. The CDC HoSt program standardizes total testosterone assays to within ±6.4% of the CDC reference standard. A list of CDC-certified assays is available on the CDC HoSt website.

CDC HoSt certified participants list: https://www.cdc.gov/labstandards/hs_certified_participants.html

Prior Authorization

Benefit applicability dependent on member coverage

Application of these coverage criteria depends on the individual's benefit coverage at the time of the request. Medicare and Medicaid specifications may override the policy; see Section VII for applicable government (Medicare/Medicaid) policies and websites.

Denial Risk

Tests with unestablished effectiveness will not meet coverage

Claims for tests listed as having unestablished effectiveness do not meet coverage criteria and may be denied.

Angiotensin-converting enzyme insertion/deletion polymorphism testing
Endothelial nitric oxide synthase polymorphism testing (4 VNTR, G894T, T786C)
Iron binding capacity
Prostatic acid phosphatase

Background and definitions

ED is common and expected to increase worldwide; it may indicate underlying diseases such as diabetes, hypertension, or atherosclerosis and results from problems in endocrine, cardiovascular, neurologic, vascular, traumatic, or surgical pathways. Causes specifically noted include disruption of nitric oxide synthesis and blood flow, diabetic-related abnormalities, penile trauma, spinal cord injury, penile fibrosis/Peyronie’s disease, veno-occlusive dysfunction, and radical pelvic surgery (e.g., radical prostatectomy).

Evaluation of ED relies primarily on sexual history and physical examination (reported sensitivity ~95% and specificity ~50% for determining cause) and may be supplemented by laboratory testing to identify treatable contributing factors (for example, fasting glucose or HbA1c, CBC, renal/hepatic function, lipid profile, TSH, and serum testosterone).

Proprietary commercial ED panels and laboratory-developed tests (LDTs) are available from private vendors and laboratories that bundle biomarkers (examples include panels from Walk-In Lab, Genova, GX Sciences, and AccesaLabs). LDTs are developed and validated in-house by laboratories and are regulated by CMS as high-complexity tests under CLIA '88; they are not FDA-approved/cleared for clinical use, and FDA clearance/approval is not currently required for clinical use.

Because of variability in certain assays, guidance is provided for assay standardization (for example, recommendation to use CDC-certified assays for total testosterone to ensure standardization within ±6.4% of the CDC reference standard).

Definitions

EDErectile dysfunction: inability to achieve or maintain an erection sufficient for penetration and completion of the sexual act

LDTLaboratory-developed test: tests developed and validated by labs, regulated by CMS as high-complexity under CLIA '88 and not approved or cleared by the FDA