Currentblue cross blue shield - tennesseePolicy N/A

Erectile_Dysfunction_Reimbursement_Policy

Customize your policy alerts

Sign up for all blue cross blue shield - tennessee policy alerts

Know when blue cross blue shield - tennessee releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

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

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

Currentblue cross blue shield - tennesseePolicy N/A

Erectile_Dysfunction_Reimbursement_Policy

Customize your policy alerts

Sign up for all blue cross blue shield - tennessee policy alerts

Know when blue cross blue shield - tennessee releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

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

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

Coding

No codes specified in policymixed

No codes listed

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.

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

Revision history

2023-07-01Adoption/Effective Date

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