Medicare Pharmaceutical and Technology Ombudsman

The 21st Century Cures Act established the Medicare Pharmaceutical and Technology Ombudsman within the Center for Medicare & Medicaid Services (CMS).  The Ombudsman has been in place since late 2017.  The role for this ombudsman is to receive and assist with inquiries and complaints from pharmaceutical, biotechnology, medical device, diagnostic product manufacturers, and other stakeholders regarding coverage, coding, and/or payment for products that are covered by Medicare, or for which Medicare coverage is being sought [42 U.S.C. Section 1395b-9]. 

In addition to helping stakeholders navigate the Medicare Program, the new Medicare Pharmaceutical and Technology Ombudsman is also interested in hearing about their experiences and sharing this information with others in CMS towards helping to promote transparency and predictability of the processes. For concerns and questions from pharmaceutical, biotechnology, medical device, diagnostic product manufacturers and other stakeholders regarding Medicare coverage, coding, and payment for medical products and services, please contact the CMS Pharmaceutical & Technology Ombudsman (PTO) mailbox (PharmTechOmbud@cms.hhs.gov).  

As a natural expansion of the PTO role, in fall 2020, a small team of liaisons was created. The New Technology Liaisons are dedicated to assisting new medical technology and pharmaceutical manufacturers with navigating Medicare coding, coverage and payment matters. The New technology team engages with these various CMS policy components and healthcare industry stakeholders to promote information sharing, facilitate internal agency coordination, review and respond to program inquiries, and answer any questions regarding coding, coverage, and payment. To connect with CMS for help regarding products or medical services please contact the CMS New Technology Liaison Mailbox (MedicareInnovation@cms.hhs.gov).  

We have recently updated CMS.gov with a web-based version of the CMS Innovators’ Guide entitled the CMS Guide for Medical Technology Companies and Other Interested Parties. This Guide is meant to provide an overview on the processes for determining coding, coverage, and payment; how coding, coverage, and payment policies interact; and common milestones for new and/or existing products that are seeking payment from the Medicare program, as well as key considerations to note throughout the process.

• This guide is for coding, coverage, and payment information and considerations regarding Medicare Part A and Part B Fee-for-Service only.
• This guide does not reflect the issuance of the proposed procedural notice of the Transitional Coverage for Emerging Technologies  (TCET) pathway. 

Note: The Ombudsman does not duplicate or replace existing processes such as grievance procedures, appeals, judicial hearings, or other formal avenues stakeholders may access. However, the Ombudsman may look into how procedures were followed in these processes, and provide any feedback to others in CMS regarding what works well and opportunities for improvement. This Ombudsman cannot advocate for new coverage, coding or payment within the Medicare Program, but can facilitate information exchange.

For People with Medicare

Medicare’s Pharmaceutical and Technology Ombudsman works with various manufacturers and other stakeholders regarding Medicare coverage, coding, and payment for pharmaceutical and medical technology products. Concerns or questions related to individuals with Medicare should be directed to 1-800-MEDICARE (1-800-633-4227) for assistance. TTY users can call 1‑877‑486‑2048.  Additional information and assistance can also be found at the Medicare.gov website.