CMS Guide for Medical Technology Companies and Other Interested Parties

CMS Guide for Medical Technology Companies and Other Interested Parties

Note: This guide is for coding, coverage, and payment information and considerations with regard to Medicare Part A and Part B Fee-for-Service only.

Note: This guide does not reflect the issuance of the proposed procedural notice of the Transitional Coverage of Emerging Technologies (TCET) coverage pathway. This guide will be updated to reflect the TCET information after the updated subsequent final notice.

This website provides interested parties including, but not limited to, medical device, pharmaceutical, and biotechnology companies, with information about Medicare’s processes for determining coding, coverage, and payment as well as other key considerations.

This site is organized into four sections:

Section Description
Getting Started Provides background information on Medicare and different offices within CMS that are involved in the processes for determining coding, coverage, and payment. This section explains how coding, coverage, and payment policies interact and includes information about common milestones (such as Food and Drug Administration (FDA) market authorization) for new and/or existing products that are seeking payment from the Medicare program as well as key considerations to note throughout the process.
Coding Provides an overview of the six standard, national medical coding and classification systems specified under the Health Insurance Portability and Accountability Act (HIPAA) for use by all entities submitting or processing electronic medical claims. Provides more detailed information pertaining to the subset of standard, national coding systems maintained and updated by CMS, specifically, the Healthcare Common Procedure Coding System (HCPCS) Level II codes and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD–10–PCS). All payers use HIPAA code sets, not just Medicare. This section also includes information on the process to apply for new codes and when to begin engaging with CMS.
Coverage Provides an overview of Medicare’s coverage pathways. Medicare is a defined benefit program. In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (§1862(a)(1)(A) of the Social Security Act (the Act)).

Provides an overview of Medicare’s fee-for-service payment systems, things to consider regarding the availability of additional payments for innovative technologies that meet certain criteria, and the process for working with CMS through the payment determination process. Payment rates for most of Medicare’s fee-for-service payment systems are generally adjusted on an annual basis and reflect the average costs to provide a service, based on the most recently available Medicare data, or CPI-U. In certain cases, there may be temporary payments provided for new technologies as authorized by law.

IMPORTANT: This information is only intended as a general summary and is not intended to grant rights or impose obligations nor is it intended to establish or change any substantive legal standards established under statutory or regulatory authority. This site contains references and links to certain statutes, regulations, and other policy materials, but it is not intended to be an all-inclusive listing or take the place of applicable statutory law or regulations. We encourage readers to review the specific statutes, regulations, and other interpretive materials for a full and accurate statement of their contents.


Page Last Modified:
09/14/2023 02:42 PM