Highlights

On November 11th and 12th, the Medical Device Manufacturers Association (MDMA) held its 11th Annual Coverage, Reimbursement, and Health Policy Conference in Washington, DC. The Conference presented a unique opportunity for attendees to interact with leading stakeholders and decision makers in the reimbursement arena. Participants were treated to in-depth presentations on basic Medicare reimbursement concepts, the international reimbursement landscape, the role of private investment and venture capital in developing reimbursement strategies, coding concerns, and the role of private payers of medical devices.

The conference began on November 11th with an afternoon of Reimbursement 101, a review of basic concepts of the reimbursement process including primers on coding, coverage and payment, developing a reimbursement strategy and answering questions from investors about reimbursement. Judy Rosenbloom of JR Associates presented the basics of coding, coverage and payment for medical technologies. Carla Monacelli of Argenta Advisors highlighted principles manufacturers should consider when developing a reimbursement plan. Ron Podraza of Reimbursement Principles, Inc. touched on important issues for medical device companies in attempting to attract venture capital, including answering many attendee questions about what federal reimbursement decisions mean for moving forward with an investment plan.

On November 12th, the conference began with an overview of the Medicare inpatient and outpatient prospective payment systems. On hand to discuss recent changes were Marc Hartstein, Deputy Director of the Hospital and Ambulatory Policy Group, Center for Medicare Management at CMS, and Carrie Bullock, an Analyst in the Hospital and Ambulatory Policy Group, Division of Outpatient Care. Conference attendees also heard from leading experts in coding reform. Marcia Nusgart, President of Nusgart Consulting, discussed the growing difficulties in obtaining appropriate HCPCS codes for medical technologies. Judy Rosenbloom of JR Associates spoke on the Correct Coding Initiative and its impact on the CPT coding process.

The mid-morning session included a broad based discussion on the role of working with private and commercial insurers. The panel began with an overview of issues by Barbara Raley of ANS, Inc. Barbara was followed by Mary Corkins, President of the Reimbursement Group who discussed developing reimbursement strategies specifically targeting private payers. The panel concluded with a presentation by Dr. Brent O’Connell of Argenta Advisors. Dr. O’Connell shared his perspective into what manufacturers should expect when seeking private payer reimbursement coverage.

Erik Rasmussen, a Professional Staff Member from the House of Representatives Committee on Ways and Means, highlighted issues that Congress is likely to address in the 111th Congress. Mr. Rasmussen discussed his thoughts on broad based health care reform measures and the prospects of achieving such with new Democratic majorities in both the White House and Congress.

The afternoon sessions began with a discussion of international issues affecting device manufacturers. Jo Ellen Slurzberg, Vice President of Reimbursement and Health Policy at Guided Delivery Systems and an MDMA board member, discussed commercialization and reimbursement challenges in health systems within the European Union. Paul Barry of Boston Scientific described the outlook and opportunities for device manufacturers in health systems in Asia-Pacific markets.

Planning on how and when to focus on reimbursement efforts as a start-up company was the focus of the conversation on the “How Venture-backed Companies Navigate the Reimbursement Process” panel. Rob Kieval, Founder and Chief Technology Officer of CVRx and MDMA board member, discussed CVRx experience in planning for reimbursement. Garrett Schwab of Emphasys Medical also shared his knowledge and advice on what companies can proactively do to address reimbursement issues in the early stage process. The panel was concluded with a presentation by David Blaszczak who discussed the investment outlook for medical technologies in light of a challenging economic landscape.

Comparative effectiveness research was the subject of a presentation by Michael Gaba of Holland and Knight. Mr. Gaba discussed in depth the concept of comparative effectiveness and what the impact could be on the future innovation of medical technologies. The conference concluded with a presentation by Tony Maida of the Department of Health and Human Services, Office of Inspector General. Mr. Maida talked about ongoing efforts by the OIG office to address fraud and abuse in the Medicare program.