Leaders from Capitol Hill and the Medtech Industry discuss how the overhaul of the health care system might impact device companies. Discussions center around value-based care, reimbursement and the possible repeal of the device tax.
Congressman Erik Paulsen, Representative – Minnesota’s Third Congressional District
Ralph F. Hall, Professor of Practice – University of Minnesota Law School
Mark Leahey, President & CEO – Medical Device Manufacturers Association (MDMA)
Kathleen Harrington, Division Chair, Government Relations – Mayo Clinic
Shaye Mandle, CEO – LifeScience Alley
Shaye Mandle has served as the President & CEO for LifeScience Alley since May 1, 2014. Previously, Mr. Mandle served as the Association’s Executive Vice President & COO and was responsible for aligning internal operations with organizational strategy and overseeing advocacy efforts and key external relationships.
In January 2015, Congressman Erik Paulsen was sworn in to serve his fourth term representing Minnesota’s Third Congressional District. Paulsen’s legislative agenda parallels the initiatives that make Minnesota a great place to live, work and raise a family: a strong economic climate for job growth, a fairly-funded and accountable education system, a well-preserved environment, safe communities, and tax reform for taxpayers and businesses.
Ralph F. Hall
Professor Ralph F. Hall is a professor of practice at the Law School and is Of Counsel to the law firm of Faegre Baker Daniels where he counsels clients in the area of drug and medical device regulation and corporate compliance matters.
Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents hundreds of research-driven medical technology companies.
Kathleen Harrington is the Chair of the Division of Government Relations at Mayo Clinic. In this role she oversees a team that develops health policy recommendations, and advocates for Mayo Clinic and its patients at the federal and state levels.
3:00 – Congressman Erik Paulsen, Representative – Minnesota’s Third Congressional District– Says environment is very challenging but opportunity to make it better. Things are better at FDA, but CMS remains a challenge.
4:49 – Kathleen Harrington, Division Chair, Government Relations of Mayo Clinic says the times are very promising because of the change of the sustainable growth rate. “We are going to have tremendous opportunity and liability at the same time.”
7:30 – Mark Leahey, President & CEO of Medical Device Manufacturers Association says he’s hearing fewer concerns about FDA but reimbursement still needs fixing.
9:30 – Leahy says population management and value-based health care still have many unanswered questions.
10:50 – Ralph F. Hall, Professor of Practice – University of Minnesota Law School says the challenge is taking a 40-year-old system and making it worth with new technologies and stakeholders.
11:59 – Hall: How do we link up people, structure, culture, rule sets. If you think about our past and our structure historically reimbursement and FDA were separate worlds. Now they need to be linked in a way we haven’t figured out that the statutes don’t provide for, the structures don’t provide for and the people don’t know how to do.
14:00 –What is likely to happen on Capitol Hill over the next two years?
14:46 – Paulsen anticipated repeal of device tax, passaged of 21st Century Cures. “It’s a bright light coming through the tunnel that we can make some progress on.”
16:47 – As we’re defining value and the role of the patient, how do you see the role f the patient translating into the decision making process in an organization like Mayo or in the construct of innovators in the medtech industry? Are we going to end up in a world in a couple of years where we are actually selling to the consumer?
17:53 – Harrington say The era of defined contributions is something we always wanted. Now it’s required b-to-c marketing for providers. This also means narrower networks and fewer choices for consumers.
20:00 – Hall “Let’s be quiet honest. Different stakeholders have different value propositions. If I’m a patient I don’t care what it costs the insurance company, I’m selfish. Striking this balance, understanding ultimate decision making is the question for the decade and how that gets answer is going to define what innovation is valued and isn’t valued.” See more patients getting involved in the approving process, don’t see the same patient involvement in securing reimbursement. “That’s an interesting dichotomy that I hope people will start reviewing in some detail.
21:20 – Hall says he’s seeing a rise of “citizen research … doing own research, doing their own funding, creating their own intellectual property.”
22:00 – Leahy says patients are becoming empowered but even they may have different objectives.
23:24 – Harrington – When patients have more skin in the game financially they can develop a stronger voice too.
24:00 – Questions from the audience. Any change to the AMA control over codes?
24:45 – Paulsen says there’s been discussion about changing coding. Says physician groups continue to ask for delaying changes.
25:20 – Leahy – Getting a category 1 code is a more political process than anything up on Capitol Hill
26:20 – Harrington says this speaks to the need of Congressional oversight.
27:30 – Is there any anticipated change to patent regulation?
28:40 – Leahy says some bills have mandatory fee shifting. Suing entity – and investors – would be required to cover the legal bills if they’re unsuccessful.