Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare & Medicaid Services (CMS), has conducted post-payment review of claims for Medicare Part B billed on dates of service from January 1, 2019, through December 31, 2019. Below are the review results:

Background

Chronic Venous Insufficiency (CVI) is a cause of abnormalities of the venous system producing edema, skin changes, or venous ulcers and may be associated with varicose veins. Varicose veins of the lower extremities are a manifestation of chronic venous disease (CVD). Varicose veins may be caused by primary venous disease with local or multifocal structural weakness of the vein wall leading to valvular insufficiency or valvular reflux.

Venous valvular insufficiency results in dilated, tortuous, superficial vessels that protrude from the skin of the lower extremities. Venous insufficiency and varicosities may cause painful lesions in the lower extremities due to its effect on the skin and adjacent tissue. This results in inflammation, ulceration, hemorrhage, skin deterioration, and recurrent phlebitis, affecting disability and deterioration of health-related quality of life.

Vein Ablation services consist of four treatment modalities: Endoluminal Radiofrequency Ablation (ERFA), Mechanochemical Vein Ablation, Laser Vein Ablation, and Transcatheter Chemical Adhesive Ablation.

Medicare covers items and services that are reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member. Medicare does not provide coverage for cosmetic surgery.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical record review of chronic venous insufficiency claims. The SMRC performed medical record review on submitted documentation to determine if vein ablation was reasonable and necessary.

Common Reasons for Denial

• Medical Necessity
  • The Social Security Act (SSA) Title XVIII, Section 1862(a)(1)(a), provides the guidance that:
    
    “No payment may be made under Part A or Part B for any expenses incurred for items or services which, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”
    
    Claims were denied when submitted documentation did not support the requirements in applicable Local Coverage Determination (LCD). Documentation did not contain medical records to support a trial of conservative measures and/or duplex scan to confirm the pathology of the vascular anatomy.
• Non-Response to the Documentation Request
  • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8, requires providers/suppliers to respond to requests for documentation within 45 calendar days of the additional documentation request. The documentation was not submitted or not submitted timely.

Resources

Social Security Act (SSA) Title XVIII

• § 1833(e) Payment of Benefits.
• § 1862 (a) (7) Excludes routine physical examinations and services.
• §§ 1862(a)(1)(A), (a)(10) Exclusions from Coverage and Medicare as Secondary Payer.
• § 1879 (a)(1) Limitation on Liability of Beneficiary Where Medicare Claims
• Are Disallowed.

Code of Federal Regulations (CFR) Title 42

• § 411.15(k)(1) Services Excluded from Coverage.
• § 424.5(a)(6) Sufficient Information.

Medicare National Coverage Determinations Manual (MNCDM), Pub. No. 100-03

• Ch 1, § 220.5 Ultrasound Diagnostic Procedures.

Medicare Benefit Policy Manual (MBPM), Pub. No. 100-02

• Ch 15, § 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests.
• Ch 16, § 20 Services Not Reasonable and Necessary.
• Ch 16, § 120 Cosmetic Surgery.

Medicare Program Integrity Manual (MPIM), Pub. No. 100-08

• Ch 13, § 13.5.4 Reasonable and Necessary Provision in an LCD.
• Ch 3, § 3.6.2.2 Reasonable and Necessary Criteria.
• Ch 3, § 3.4.1.3 Diagnosis Code Requirements.
• Ch 3, § 3.3.2.4 Signature Requirements.
• Ch 3, § 3.2.3.8 The Requested Records Were Not Received.

Local Coverage Determination (LCD)

• L33454 Varicose Veins of the Lower Extremities.
• L33575 Treatment of Varicose Veins of the Lower Extremity.
• L33762 Treatment of Varicose Veins of the Lower Extremity.
• L34010 Treatment of Varicose Veins of the Lower Extremity.
• L34082 Treatment of Varicose Veins of the Lower Extremity.
• L34209 Treatment of Varicose Veins of the Lower Extremity.
• L34536 Treatment of Varicose Veins of the Lower Extremities.
• L34924 Treatment of Varicose Veins and Venous Stasis Disease of the Lower Extremities.
• L38720 Treatment of Chronic Venous Insufficiency of the Lower Extremities.

Local Coverage Article (LCA)

• A52870 Billing and Coding: Treatment of Varicose Veins of the Lower Extremity.
• A55229 Treatment of Chronic Venous Insufficiency of the Lower Extremities.
• A56368 Billing and Coding: Varicose Veins of the Lower Extremities.
• A56914 Billing and Coding: Treatment of Varicose Veins of the Lower Extremities.
• A57305 Billing and Coding: Treatment of Varicose Veins of the Lower Extremity.
• A57706 Billing and Coding: Treatment of Varicose Veins of the Lower Extremity.
• A57707 Billing and Coding: Treatment of Varicose Veins of the Lower Extremities.
• A57781 Billing and Coding: Treatment of Varicose Veins of the Lower Extremity.
• A58250 Billing and Coding: Treatment of Chronic Venous Insufficiency of the Lower Extremities.

Last Updated Feb 3, 2023