Getting Started

This page contains information for interested parties on how to work with CMS to navigate the processes CMS uses to determine coding, coverage, and payment. It provides an overview of the Medicare program, a description of different groups within CMS, and key considerations for interested parties to note while working with CMS to bring their products to Medicare beneficiaries.

Many new technologies will integrate into the existing infrastructure for claims adjudication based on existing codes, coverage, and payment structure. For some new technologies, differential coding and definitive coverage at a local or national level may be warranted based on clinical evidence, and interested parties may seek to obtain a new code and definitive coverage.

How Coverage, Coding, & Payment Work Together

Coding, coverage, and payment of technologies and services are distinct, but related aspects under Medicare. The regulation that CMS published on August 17, 2000 (45 CFR 162.10002) to implement the HIPAA requirement for standardized coding systems established the HCPCS Level II codes as the standardized coding system for describing and identifying health care equipment and supplies in the health care transactions that are not identified by the HCPCS Level I Current Procedural Terminology (CPT®) codes. HCPCS Level II is a standardized coding system that is used primarily to identify drugs, biologicals and non-drug and non-biological items, supplies, and services not included in the CPT® code set jurisdiction, such as ambulance services and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a physician's office. Coverage refers to whether Medicare is authorized to pay for a medically necessary item or service. Medicare also pays for some services, such as preventive services, that are exempt from the reasonable and necessary requirements in section 1862(a)(1)(A) of the Act. Payment refers to the amount and conditions for providers and suppliers to receive payment based on the codes and applicable coverage policies.

It is critical for interested parties to understand how these concepts interact. For example, a new technology may obtain a Level II code from CMS to identify its use in a procedure or service; however, the reporting of that code on a Medicare claim does not automatically result in Medicare coverage for that technology, nor does it result in an established Medicare payment rate for the technology. In the absence of a national coverage policy for a particular technology, coverage is determined at the local level.

Eligibility for coverage under Medicare is prescribed by law. That is, in order for Medicare to cover a particular item or service, such item or service must meet a “benefit category” under Title XVIII of the Act and must not be otherwise excluded from coverage. Interested parties who are seeking coding, coverage, or pricing of a new technology may request a benefit category determination (BCD) when it is uncertain whether or which benefit category applies. There are further resources in the Coverage section of this site.

Refer to the sections on Coding, Coverage, and Payment for more detailed information on requirements, timelines, and other considerations.

Engagement with CMS

It is important to start engaging with CMS when a product is approaching when FDA market authorization is officially requested or when marketing authorization is obtained. Timelines and procedures for Medicare coding, coverage, and payment decisions are separate, and are not necessarily carried out in any particular order. In other words, steps may be sequential or concurrent.