Medical Alley Association Salutes Efforts to Align CMS & FDA on Breakthrough Technologies
GOLDEN VALLEY, MN – Shaye Mandle, President and CEO of the Medical Alley Association, applauds the introduction of HR 5009 in the U.S. House of Representatives as an opportunity to stimulate innovation and improve patient access to the newest therapies, stating:
“HR 5009 would make it possible for U.S. patients to have confidence in the ability to gain access to the newest and most effective therapies our innovators are creating. This legislation would require CMS to provide immediate transitional three-year coverage for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA.
“This critical window of three years will provide patients and innovators with a predictable model for access and reimbursement, while also providing CMS an opportunity to evaluate any additional data requirements for continued coverage.”
HR 5009 contains provisions that would also make improvements to the New Technology Add-on Payment (NTAP) program of CMS to further address and reduce existing disincentives to innovation and patient access.
Weekly recap – Senate targets released
Week No. 7 of the 2016 session gets underway today for a short 4 day week. The legislature will be on Passover break from Friday April 22nd thru Monday April 25th. The Senate DFL released their budget targets this week; a reflection of where they would like to focus their spending this year. The state has a projected surplus of $900 million and the Senate is proposing to spend about $789 million split between $489 on spending proposals and $300 million in tax cuts. Significant differences have arisen between both caucuses including funding for economic disparities, broadband expansion and transportation. The full set of targets can be found here: DFL Targets.
Patent-trolling protection bill passes the House
HF1586, sponsored by Rep. Joe Hoppe (R-Chaska), would allow an attorney general to bring civil action against someone who has made a “bad faith claim” against another for infringement on any potentially patented product. A penalty of up to $50,000 per violation could be imposed on any individual or business. Currently, 27 states have passed legislation to help prevent patent trolling. Passed 129-0 by the House Thursday, the so-called “Patent Trolling Bill” now goes to the Senate, where it is sponsored by Sen. Kari Dziedzic (DFL-Mpls). The Medical Alley Association has been involved with negotiations on this bill to ensure that our members are protected in asserting their legitimate patents.
The bill has the intent of targeting patent assertion entities — businesses that acquire patents with no intention of using the technology itself, but rather suing for alleged infringement. It would not limit any other rights or remedies available under existing laws related to patent infringement.
In Minnesota when patent trolling occurs, the “end user” (who purchased the product, or is using the technology) is caught in legal limbo. Current law prohibits someone from taking private action, and in certain circumstances prohibits existing laws from being enforced. There are no federal laws creating precedent.
House HHS Finance bill
The House Omnibus Health and Human Services finance bill includes a repeal of MNsure, the state’s health exchange. This move allows the House to add new spending on its other priorities in this category. The bill calls for more than $13.3 million in new spending for Fiscal Year 2017 and over $27.2 million in the 2018-19 biennium.
The bill was referred to the House Ways and Means Committee.
In contrast, Gov. Mark Dayton’s supplemental budget calls for increasing health and human services appropriations by $199 million for Fiscal Year 2017 and $656 million in the 2018-19 biennium. The Senate budget target released Wednesday seeks $43.3 million in new health and human services spending.
The following are select bills that have been incorporated in part or in whole into the omnibus health and human services finance bill:
Katie Clark Sieben announces plans to step down, pursue other opportunities
Incoming DEED Commissioner Shawntera Hardy promises commitment to building an economy that works for all Minnesotans, everywhere in Minnesota
ST. PAUL – Governor Mark Dayton yesterday appointed Shawntera Hardy to serve as Commissioner of the Minnesota Department of Employment and Economic Development (DEED). Ms. Hardy – who has pledged her strong commitment to building an economy that works for all Minnesotans, everywhere in Minnesota – will bring policy expertise, organizational management, and a wealth of public and private sector experience to the department. Commissioner Hardy will succeed Katie Clark Sieben, who yesterday announced she will step down effective Friday, April 22, to pursue other opportunities.
“Commissioner Clark Sieben’s devoted service to the people and businesses of Minnesota has improved our state’s economy. During her tenure, Minnesota was named ‘America’s Top State for Business’ by CNBC, and earned numerous accolades for job creation. I thank her for her excellent work, and wish her the best as she begins the next chapter of her career,” said Governor Dayton.
“Shawntera Hardy will be an outstanding Commissioner of Employment and Economic Development,” he said. “As a member of my senior leadership team, she has consistently demonstrated her exceptional ability to manage complex organizations and engage a wide variety of viewpoints in solving difficult problems. Ms. Hardy shares my commitment to eliminating economic disparities in our state, and building an economy that works for all Minnesotans, everywhere in Minnesota. I will strongly support her efforts to continue the progress that Commissioner Clark Sieben began.”
Since her appointment to serve as Deputy Chief of Staff in the Office of the Governor and Lt. Governor in March 2015, Ms. Hardy has worked on a wide range of policy and operational issues. As a member of the Governor’s senior leadership team, she has coordinated the Administration’s response to crises impacting the state, including floods, fires, and public health emergencies. Ms. Hardy has been instrumental in advancing the Administration’s policy initiatives, helping manage Minnesota’s state agencies, and expanding the state’s community outreach efforts. She has also helped lead the Governor’s efforts to diversify the ranks of state government, and expand economic opportunity for Minnesotans of color.
“Minnesota has a strong and growing economy, made possible by the many successful businesses and hard-working people who call Minnesota home,” said Commissioner Hardy. “Despite our nation-leading progress in business development and job creation, we have much more work to do to ensure all Minnesotans share in our state’s economic prosperity. I am honored by Governor Dayton’s appointment, and grateful for his confidence in me to lead this important agency. I look forward to working with the staff at DEED, employers, communities, and the hard-working people across our state to build an economy that works for all people, everywhere in Minnesota.”
Prior to her service in the Office of the Governor and Lt. Governor, Ms. Hardy worked in senior leadership positions at several Minnesota companies and nonprofits, and she owns and operates two small businesses. Ms. Hardy worked as a policy director at Fresh Energy, where she worked on environmental and transportation policy, and as manager of government relations for HealthPartners’ hospital division. Before joining HealthPartners, Hardy served as a city planner for the City of Saint Paul and as a legislative assistant in the Ohio House of Representatives. Additionally, Ms. Hardy is a co-founder and the director of strategic growth for Civic Eagle – a civic technology and data analytics company committed to developing tools that bridge civic engagement and social networking. She is also the founder of PolicyGrounds Consulting, LLC – a policy and planning strategy firm.
“Minnesota’s businesses, our workforce, and our communities will be well-served by the leadership of Commissioner Shawntera Hardy,” said Lt. Governor Tina Smith. “Commissioner Hardy’s life-long commitment to organizational change and her experience leading in both public and private sector organizations have prepared her well for this important position. Shawntera will continue to be a great asset to our Administration and Minnesota as Commissioner. I am proud to serve with her.”
Shawntera Hardy is involved in a number of community organizations. Ms. Hardy serves as: Board President of the YWCA of Saint Paul; Board member of the Wilder Foundation; co-founder of Power Moves MN; co-founder of two scholarships at The Ohio State University – the Fatima Kinshasa Memorial Fund and the Pioneer Scholars Award. Recently, Ms. Hardy was selected as a Minnesota Business Magazine 2016 (Real) Power 50 Finalist, as a Minneapolis/St. Paul Business Journal 2015 “Forty Under Forty” honoree, and as a participant in the 2015 Young American Leaders Program at Harvard Business School.
Born and raised in Youngstown, Ohio, Ms. Hardy holds a Bachelor of Science in Consumer Affairs from The Ohio State University, and a Master of Urban and Regional Planning from the State University of New York at Buffalo School of Architecture and Planning – which she attended as a U.S. Department of Housing and Urban Development (HUD) fellow.
Commissioner Clark Sieben Announces Plans to Step Down
Minnesota Department of Employment and Economic Development (DEED) Commissioner Katie Clark Sieben yesterday announced she will leave her post effective April 22, 2016. Clark Sieben will leave the administration to pursue other opportunities. She was appointed DEED Commissioner in October 2012 and previously served as the Executive Director of the Minnesota Trade Office.
“It has been one of the greatest privileges of my life to serve in this role. Governor Dayton and Lt. Governor Smith’s vision for Minnesota is – and always has been –to build a stronger Minnesota. I am beyond grateful for the trust they put in me to be a part of that effort, and to help lead us to where we are today,” said Commissioner Katie Clark Sieben. “I am incredibly proud of the work we have done over the past five years to build a better Minnesota for people, communities, and businesses all across our state. I know that DEED will continue that progress under Commissioner’s Hardy’s leadership. As we head into the fourth quarter of the Dayton Administration, the time has come for me to begin a new challenge and I look forward to this next journey.”
As DEED Commissioner, Katie Clark Sieben steered the revitalization of Economic Development funding at the department, securing $30 million in ongoing funding for the Minnesota Investment Fund and $25 million in ongoing funding for the new Minnesota Job Creation Fund. During her time at DEED these initiatives have helped 143 businesses expand or locate in Minnesota, creating an estimated 11,100 new jobs and leveraging $1.8 billion in private investment. Under her tenure in 2015, Minnesota was chosen for the first time by CNBC as “America’s Top State for Business.”
“Through her work as Commissioner of the Department of Employment and Economic Development, Commissioner Katie Clark Sieben has earned the trust and respect of Minnesota’s employers,” said Lt. Governor Smith. “Katie has made a lasting positive impact on Minnesota’s economy. We are deeply grateful for her service in this Administration.”
Under Commissioner Clark Sieben’s leadership, DEED saw the creation of the Office of Broadband Development and managed the expansion of the Minnesota Trade Office to three new markets in Brazil, Germany, and the Republic of Korea. She was instrumental in securing a new Minnesota Workforce Center in North Minneapolis and developing the state’s new $12 million Pathways to Prosperity program to provide individuals with barriers to employment training, education, and a career pathway to a good job and family sustaining wages. Additionally, Commissioner Clark Sieben was instrumental in creating Governor Dayton and Lt. Governor Smith’s $100 million budget proposal being considered this session to expand economic opportunity for people of color in Minnesota.
Clark Sieben was a recipient of the 2012 MSP Business Journal’s ‘Forty Under Forty’ Award, the MSP Business Journal ’13 People to Watch in 2013′, the Minnesota Business Magazine ‘Real Power 50, and Harvard Business School ‘Young America Leaders Program’. She serves on the University Of Minnesota’s Carlson School of Management’s Global Advisory and Office for Technology Commercialization Advisory Boards.
Medical Alley Association VP of Government Relations, Genevieve Plumadore, visited Washington DC last week for meetings with Minnesota’s federal delegation. Genevieve traveled in conjunction with the annual BIO Fly-in and was able to meet with members on key legislation affecting innovation on a national level. One highlight was sitting down with Rep. Erik Paulsen to talk about projects he is working in regards to FDA and CMS reform.
Key policy priorities included:
– Full repeal of the medical device tax: MAA thanks those members of the delegation that voted for suspension of the medical device tax, a move that has already seen a reinvestment of millions of dollars in research & development in the state.
– Senate Innovation Initiative/Development, Discovery, Delivery Reforms: Patent-centric approaches to drug and device development are essential to a strong innovation ecosystem. Changes to the FDA regulatory landscape that have more incentives will help those processes keep up with advances in scientific discovery.
– Target abuses of the US Patent System while protecting innovation: MAA supports a measured, thoughtful approach to patent litigation reform that attacks the “patent trolls” and does not inadvertently capture the legitimate patent protection practices of our members.
– Support full appropriations for NIH, Project BioShield SRF & CARB initiatives: NIH spurs key discovery in an era of genomic health and personalized medicine; MAA was pushing for a budget of at least $34.5B to restore funding to pre-recession levels.
Congressman Rick Nolan co-creator of the Lung Cancer Caucus
The Lung Cancer caucus serves as a clearinghouse of information to aid Members of Congress in their understating of issues surrounding those living with, and those that are at risk for, lung cancer. Lung cancer is the leading cause of death in men and women across every ethnic group and those who serve in the military. The Lung Cancer Caucus helps to educate and inform Members on issues specifically related to eliminating the stigma, reducing mortality, improving survivorship, furthering research and ensuring equitable access to preventative screening, treatments, diagnostics and testing. Nolan spearheaded the effort to create this caucus after his youngest daughter was diagnosed with stage 4 non-smoking lung cancer.
Below is a list of co-chairs and current members:
For hearings of interest, learn more at the Minnesota State Legislature Combined Calendar.