As required by the December 2016 21st Century Cures law, CMS has appointed an ombudsman for "pharmaceutical and technology" e.g. industry, issues. Section 4011 of 21CC (here) required CMS to appoint an "ombudsman" for complaints, grievances, and requests for "pharmaceutical, biotechnology, medical device or diagnostic products" for which coverage is sought, with respect to "coverage, coding, or payment" concerns.
The appointment may be from February 2018. See the Ombudsman webpage for full contact info, here. The Ombudsman is James Bailey, who is also found on the Ombudsman section of the webpage for Hearings and Inquiries, here.
From the CMS ombudsman page:
We are pleased to announce that James Bailey is currently serving as the new Medicare Pharmaceutical and Technology Ombudsman, a role that was established by the 21st Century Cures Act to help support customer service and innovation in the Medicare program. This Ombudsman will receive, and look into, concerns and questions from pharmaceutical, biotechnology, medical device, diagnostic product manufacturers and other stakeholders regarding Medicare coverage, coding, and payment for products already covered or for which coverage is being sought. The Medicare Pharmaceutical and Technology Ombudsman will collaborate closely with our other Medicare program ombudspersons in the CMS Offices of Hearings and Inquiries.
In addition to helping stakeholders navigate the Medicare Program, James is also interested in hearing about their experiences and sharing this information with CMS policy makers as appropriate, helping to promote transparency and predictability.
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 bring to the attention of policy makers any feedback 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.
