HCPCS Level II Coding Procedures
View the HCPCS Level II Coding Procedures to learn about the HCPCS Level II coding process, procedures, and criteria.
On October 31, 2025, 42 CFR 49507 established that, effective January 1, 2026, CMS will review complete HCPCS Level II coding applications for products regulated and/or cleared by the Food and Drug Administration as human cells, tissues, and cellular and tissue-based (HCT/P) products, 510(k) cleared skin substitute products, and Premarket Approval (PMA) skin substitute products in the bi-annual non-drug and non-biological products coding cycles. The application submission deadline is the first business day of January and July for non-drug and non-biologicals. In addition, these products will be subjected to the public meeting process established for non-drug and non-biological products HCPCS Level II coding applications.
On August 17, 2000, 45 CFR 162.1002 established the HCPCS Level II codes as part of the regulation to implement the Health Insurance Portability and Accountability Act (HIPAA) requirement for standardized coding systems.
- The HCPCS Level II codes were established so providers and suppliers can submit claims for services, supplies, and equipment that aren’t identified by the HCPCS Level I Current Procedural Terminology (CPT®) codes.
- CMS maintains HCPCS Level II codes, including decisions about additions, revisions, and deletions to the codes.