Last weekBioOhio President & CEO John Lewis and our federal government partners G2G traveled to Washington, D.C. for the AdvaMed Capitol Hill Fly-In. The AdvaMed Capitol Hill Fly-In convened life science associations from across the country for an update on the most pressing issues for the medical device industry at the federal level, capped off by a series of legislative meetings with members of Congress and their staff on the Hill. 

Happening at the same time was Rare Disease Day, an event taking place the last day of February to raise awareness for rare diseases and improve access to treatment and medical representation for individuals with rare diseases and their families. The National Organization for Rare Disorders (NORD) was in D.C., and Ohio patient groups within industry, venture, and academia represented our state well.

BioOhio President & CEO John Lewis with Representative Anthony Gonzalez.

It’s always nice to start a congressional meeting with a thank you, not an ask, and it was well received. We thanked legislators for the 10 year, bipartisan process that was repealing the Medical Device Tax. The tax was repealed on 12/20/19, and will be a great success for Ohio’s job growth. 

The following current issues were also discussed:

  • H.R. 5333 Ensuring Patient Access to Critical Breakthrough Products 

21st Century Cures Act Allows FDA Breakthrough Designation but no current reimbursement process (CMS) – several Ohio companies have received FDA Breakthrough designation but no CMS approval code. 

Legislation: Once Breakthrough Device is approvedCMS provides immediate, temporary coverage (3 years) and CMS specifies additional data needed 

  • Device Sterilization –EtO

56 percent of all medical device types are sterilized using EtO, totaling more than 25 billion devices annually.

For many medical devices, due to their size, shape, complexity or material composition, ethylene oxide is the only option for sterilization. For these products, alternatives such as steam, radiation or other sterilants do not achieve the needed levels of sterility assurance. In addition, for some medical devices, using non-EtO sterilization methods will result in material degradation, rendering the products potentially unsafe for patients. 

  • Value-Based Health Care –Include Med Device and Durable Medical Equipment
  • International Drug Pricing Index (IPI) 
  • Coronavirus – Ohio ties to existing therapy – very timely and exciting opportunity to meet a global pandemic but most important to play a critical roll in the cure. 

From left to right: BioOhio President & CEO John Lewis with Representative Troy Balderson, Representative Bob Gibbs, and Representative Steve Stivers.