This educational article provides detailed guidance on the proper use and understanding of HCPCS Level II codes, which are used for billing and coding of medical products and services under Medicare. It clarifies the nature of these codes, their assignment, and the responsibilities of providers to ensure correct coding practices.

Overview

HCPCS Level I (CPT®) codes are maintained exclusively by the American Medical Association (AMA).

HCPCS Level II codes are established and maintained exclusively by the Centers for Medicare & Medicaid Services (CMS).

The Medicare Administrative Contractors (MACs) have received numerous inquiries from industry stakeholders seeking clarification on billing and coding practices for marketed services and supplies. The Centers for Medicare & Medicaid Services (CMS) rarely assigns or designates HCPCS Level II codes to specific products or devices. HCPCS Level II codes are inherently product-agnostic. During the process of official rule making or HCPCs workgroup deliberation, if a code was established for a specific proprietary item/service, it will be noted in publication and/or will explicitly include within the code descriptor the brand or trade name based on its unique or proprietary characteristics.

HCPCS Level II Code Assignment

The procedures for HCPCS Level II coding specify that code descriptors "identify a category of like items or services and typically do not identify specific products or brand/trade names."¹ In addition, the assignment or deletion of a HCPCs code is an independent process and is in no way considered a methodology or system for making coverage or payment determinations. "The existence of a code does not, of itself, determine coverage or non-coverage for an item/service."¹

Provider Responsibilities

Providers must use the HCPCS Level II code that most accurately reflects the item or service provided, based specifically on descriptor terminology and criteria stated in the code.

Summary

In summary, CMS is the sole authority responsible for determining which items are included within each HCPCS Level II code category. The authority to establish, define, and maintain HCPCS codes does not extend to manufacturers, consultants, specialty societies, or any organizations outside CMS.

No organizations other than CMS or the MACs are permitted to define coverage, assign products to codes, or create billing interpretations that suggest—without direct reference—an officially sanctioned CMS or MAC coding determination.

Providers, billers, and coders are encouraged to exercise caution when reviewing information from manufacturers, consultants, or marketing materials that claim CMS and/or MAC authorization or endorsement of a code assignment without available supporting documentation.

Resources

1. 2026 HCPCs Level II Codebook
2. 42 CFR § 414.40(a)
3. 45 CFR 162.1002