Medical Device Regulatory Policy: Breakthrough Technologies, STeP and — Wait for It — Reimbursement – Webinar Recording/Transcript
Are you an innovator… or a follower? Getting your device into the FDA’s Breakthrough Devices Program or Safer Technologies Program (STeP) for Medical Devices could mean the difference.
For inclusion, you must know the relevant eligibility criteria for participating and the benefits of each, as well as an understanding of submission timing and content requirements. What if you have two devices with the same intended use? Or a combination product?
Not to mention the reimbursement implications: the pathway for Medicare coverage of breakthrough devices is not completely clear and the delay of the Medicare Coverage of Innovative Technology (MCIT) program has strategic reimbursement considerations.
Kristin Davenport and Rujul Desai, both of counsel at Covington & Burling LLP, will share what you must know and do to get your devices included. Using their expertise from the Medical Devices and Diagnostics area of the firm’s Food, Drug and Device practice, they’ll also discuss associated reimbursement strategies and how MCIT fits into larger market access issues.
- STeP and breakthrough criteria, including the submission timing and content requirements for obtaining a breakthrough designation or inclusion into STeP
- Benefits of breakthrough designation and inclusion into STeP, including expediting approval time
- Pathway for nationwide coverage of breakthrough devices, and its impact on your device development program
- Strategic reimbursement considerations, including how to optimize payment
Obtaining a breakthrough designation or STeP inclusion — not to mention reimbursement — can be a game changer for your devices. This presentation is your best move.
Meet Your Presenters
Kristin Davenport, of counsel at Covington & Burling LLP, advises medical device companies regarding premarket strategies and pathways, the premarket submission process, advertising and promotion, compliance and enforcement matters and import/export issues. She has extensive experience with 510(k) premarket notifications, de novo petitions, premarket approval applications, investigational device exemptions, device modifications, 513(g) Requests for Information, MDR reporting, device recalls and Part 806 reports. Ms. Davenport regularly prepares 513(g) requests for information to obtain FDA’s views regarding the classification and applicable regulatory requirements for novel devices, such as mobile medical applications. She develops successful premarket strategies for clients and frequently participates in pre-submission meetings with CDRH. She navigates issues that arise during the premarket review process and has successfully represented device companies in administrative appeals.
Rujul Desai, of counsel at Covington & Burling LLP, advises clients on drug pricing, market access, reimbursement, strategic contracting and regulatory solutions for drugs, biologicals, devices and diagnostics. He brings deep experience with biopharma, specialty pharmacy and pharmacy benefit management (PBM) companies. Mr. Desai has held a number of leadership roles in the biopharma, PBM and specialty pharmacy industry, including with CVS Caremark, UCB and most recently as vice president at Avalere Health. He has led engagements across a wide range of U.S. and global market access and reimbursement issues, including optimizing new product launches, pricing, PBM and payer formulary access, value-based contracting, distribution network design, patient access and hub services, affordability programs, e-prescribing, digital health and the use of health economic data and modeling.
Who Will Benefit
- Regulatory personnel
- Quality professionals
- Compliance specialists
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Sept. 21, 2021