Exposing device/physician financial relationships!

For doctors and med firms, a new eraof disclosure

•                Article by: JIM SPENCER , Star Tribune Updated: July 28, 2013 - 11:53 AM

FiDA highlight added

New federal law will expose ties to medical device, drug companies.

WASHINGTON – The nation’s medical device makers and drug companies will begin collecting this week what is expected to become a massive stockpile of data on their financial relationships with doctors, researchers and teaching hospitals.

A new federal disclosure law mandates that an array of pharmaceutical and medical manufacturers report payments to physicians, hospitals and other health care businesses that are more than $100 a year. Payments can include travel expenses, entertainment, consulting fees and research support.

The new rules emerged after six years of legislative and regulatory battles to address growing concerns that health companies were gaining inappropriate influence over research, education and clinical decisions. The provisions were eventually folded into the Affordable Care Act in 2010.

“Patients should have the right to know if their physician is getting paid by a certain drug company or has a financial interest in something that they are prescribing,” said Sen. Amy Klobuchar, D-Minn., who co-sponsored the 2007 bill to require disclosures.

Executives within Minnesota’s multibillion-dollar medical technology sector, as well as other health-related companies, say they hope the data will dispel worries that their financial ties with doctors and researchers lead to unethical behavior or unsafe patient outcomes.

“We need to restore public confidence in why a company like [ours] would be interacting with doctors,” said Tom Schumacher, vice president of ethics and compliance at Medtronic Inc.

Those ties lead to innovation and better care, said Chris White, the general counsel for the Advanced Medical Technology Association (AdvaMed). “The public needs to understand the value of these relationships,” he said.

A recent case that highlighted worries over doctor payments involved Fridley-based Medtronic, one of the world’s largest device makers.

The U.S. Senate Finance Committee alleged in October that Medtronic heavily influenced the content of medical-journal reports about its spinal fusion product, Infuse. The committee questioned whether doctors who supervised the studies understated Infuse’s risk and overstated its benefits while receiving $210 million in royalties and consulting fees from Medtronic over a 15-year period.

Medtronic has denied that it improperly influenced peer-reviewed reports or sought to minimize potential harm.

Sen. Chuck Grassley, an Iowa Republican who was the principal sponsor of the original bill, said Americans need a way to assess whether there’s an unethical relationship between a doctor advocating a product and the company that makes it.

“[Infuse] is an example of what this is aimed at, but it isn’t just aimed at Medtronic,” said Grassley, adding that his staff has found many other instances.

Dr. Eugene Carragee, a Stanford University surgeon and editor of the Spine Journal, was among those who revealed the links between Medtronic and the Infuse scholarship. “If your main mission is taking care of patients, you have an obligation not to be so financially vested in the outcome of the ­equipment you’re using,” ­Carragee said.

The new law doesn’t outlaw payments or business deals between companies and doctors or teaching hospitals, but it makes those transactions easily accessible to all Americans.

Starting Thursday, drug and medical companies must track transactions with doctors, teaching hospitals and some other health-related businesses. The first round of data must be submitted to federal regulators by the end of the year and will be made public by next September.

The new law comes with fines of up to $1.15 million for companies that fail to disclose. It also requires senior managers to sign off on the data, making them personally accountable to the Centers for Medicare & Medicaid Services, the agency compiling the information.

The federal disclosure law is much broader than a Minnesota one that since 1993 has banned certain gifts and required drug companies to reveal certain payments to doctors. The federal rules require disclosure of various forms of compensation to doctors or their immediate family members, including consulting fees, speaking fees, gifts, charitable contributions, royalty or license fees, stock options or other investment incentives. This includes payments of more than $10 or payments under $10 that together top $100 in a year.

“Virtually every interaction with a covered recipient has to be kept and analyzed,” said AdvaMed’s White.

Medtronic has spent more than a year and an estimated $10 million preparing to track interactions with an estimated 60,000 physicians.

Medtronic had to integrate and make adjustments to computer systems to make sure they capture information consistently. In particular, it meant identifying doctors who might have done business with different departments or company locations.

Schumacher said some doctors have told the firm they are uncomfortable with the change, saying “it’s not worth the stigma of having their income posted on a website.”

A greater concern may be that doctors don’t realize those dealings with will now be tracked.

The American Medical Association has a website devoted to the change and the AMA president posted tips in a blog.

Schumacher believes that may not have been enough. “I’m not sure the physician community knows this is coming,” he said.

At Advanced Circulatory, a 25-person company in Roseville, CEO Mike Black had to create a system for gathering payments and other valuable transfers to doctors or their immediate families. That includes more than software: It means making sure salespeople get information they never had to gather before.

Black estimates that the adjustments will cost his firm $20,000 a year to implement.

He already has heard from doctors who don’t want to participate in his company’s symposiums because they are afraid the free lunch might land them in a government database. Black worries that the new law will cause doctors “to shy away from perfectly legitimate educational opportunities” about his products, which are used to increase blood circulation.

Black has his doubts that many Americans will make use of this new trove of information. “I don’t believe the average consumer is going to take the time to go look at a database for a particular device or a

particular company,” he said.

Grassley counters that even if individuals don’t, the media will. Concern about negative publicity will discourage doctors from giving biased information, the senator said.

Doctors may not like it, Carragee acknowledged, but the law should help ensure that “research done with industry financing will have to be vetted.”

That’s “how science is supposed to work,” Carragee added.

Jim Spencer • 202-383-6123

gemie1

Jul. 28, 13

12:27 PM

Excellent! The patient has a right to know the relationship between a doctor and the manufactures of drugs and medical devices. A patient or a consumer has the right to know that their doctor does not have a conflict of interest when prescribing medical care.

3

0

explanthis

Aug. 1, 13

1:05 PM

The legislation is commendable if data is accurately compiled and shared with patients. The resistance to transparency is understandable, given the easy access that pharma and medical device industry operatives had to doctors for so many years. The conflicted doctors that miss this cozy relationship are not the doctors I wish to support with my trust and tax dollars. Thank you, Jim Spencer and StarTribune for reporting on this important story.

Proprietary Demands and Threats by Mayo Clinic CEO

Mayo CEO on Minnesota expansion: 'We'll have to rethink ... thebest use of our money'

•                Article by: KEVIN DIAZ , Star Tribune Updated: April 9, 2013 - 11:16 PM

He warned legislators on eve of hearing on $500M tax proposal.

WASHINGTON – In blunt words aimed squarely at the Minnesota Legislature, the president and CEO of the Mayo Clinic warned Tuesday that the hallowed medical institution has “49 states” eager to have Mayo’s planned multibillion-dollar expansion if the state is unwilling to pitch in.

“We’re never going to leave Minnesota, and we don’t want to leave Minnesota,” Dr. John Noseworthy said in an interview at the National Press Club, where the CEO made a pitch for federal investment in health care and medical research. “But we’ve got to decide where we’re going to put the next $3 billion.”

That money would be part of a $5 billion, 20-year expansion in Rochester dubbed “Destination Medical Center,” which would require a half-billion dollars from state officials for infrastructure improvements.

“If they say yes, that’s great, we want to stay in Minnesota,” Noseworthy said. But, he cautioned, “If they say no, or you’re going to have to go for a bonding bill every year for the next 30 years, we’ll have to rethink about whether that’s the best use of our money.”

Noseworthy, a neurologist, said Mayo is not threatening to leave Rochester, where the renowned clinic was established 149 years ago.

But in a clear message to the Legislature, where the clinic’s proposal is encountering significant sticker shock, Noseworthy pointed out that “there are 49 states that would like us to invest in them. That’s the truth.”

Noseworthy’s comments came on the eve of a House tax committee hearing, where skeptical legislators have split Mayo’s $500 million plan into separate tax and bonding provisions, a development that has concerned backers.

Mayo, the state’s largest private employer, says the taxpayer funding is needed for infrastructure improvements to keep up with the clinic’s expansion plans in Rochester.

Noseworthy said the clinic plans to pour $3.5 billion of its own money into the project and $2 billion from other potential private investors, fostering the city’s growth as an international destination, creating 40,000 jobs and expanding its tax base.

None of the proposed state money would be earmarked for the clinic, he said. “We just hope they’ll help us build some sidewalks and sewers,” he said.

Noseworthy also flexed some lobbying muscle in Washington, where he met with members of Congress on Tuesday to promote funding for medical research, quality care and payment reform under Medicare. Lagging federal provider rates have cost the clinic $128 million, he said, on top of another $47 million in the first year of the sequester budget cuts.

“This is a big deal,” he told the National Press Club audience. “It’s a very serious thing for all of us.”

The sold-out event, which included U.S. Sen. Amy Klobuchar, D-Minn., is an indicator of the Mayo Clinic’s influence in promoting a Minnesota model that drives down costs by emphasizing quality of care and collaboration among medical providers.

But the health care giant faces a tougher audience in St. Paul, where legislators are raising questions about the amount of the requested taxpayer assistance to a city of little more than 100,000 residents, about a third of them in the health care industry.

Noseworthy said the clinic is responding to legislators’ concerns.

“Yes, we’re listening to that input, and we’re trying to see how are we going to get the right answer,” he said. “It’s being reviewed, amended, revised and rethought as we go through.”

Some legislators have suggested that Rochester could pony up more for the stadium-size price tag by raising local sales tax rates.

But Noseworthy said the town doesn’t have the tax base to support the infrastructure improvements that could justify Mayo’s further expansion.

“I don’t know whether it will happen,” he said. “I hope it happens. We’ve told the state we want to grow, and we want to grow in Minnesota.”

In the meantime, other states beckon for a piece of the Mayo mystique.

“Medicine is a growth industry,” Noseworthy said. “We need to decide where to invest for that growth.”

Kevin Diaz • kdiaz@startribune.com

In a recent year Mayo Clinic made $7billion  though it is a 'non-profit' institution and it  paid its' CEO more than $1m.  It is so lawyered up that there has been only one conviction of a doctor in two decades.  Is it possible that these demands are being made by an institution that disguises it's mission as community-focused to derive maximum profit?  How can this be healthy for the majority of Minnesotans?   comment

Astroturf Lobby Group? Where is the Patient Engagement?

Greetings,

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration would like to make you aware of an upcoming event. Next Monday the independent non-profit Medical Device Innovation Consortium (MDIC) will be announcing a new public-private partnership between the MDIC, FDA, other government agencies, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues.  Additional information on the MDIC can be found at http://www.deviceconsortium.org/

As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.

Please join us if you can,

Michelle McMurry-Heath

Associate Director for Science, Acting Chief Scientist

Office of the Center Director

Center for Devices and Radiological Health

U.S. Food and Drug Administration

---------------------------------------------------------

You are invited to attend the Senate MedTech Caucus briefing:

Monday, December 3rd, 10:30 am – 12:00 pm

Room 106, Dirksen Senate Office Building

Announcing: “Medical Device Innovation Consortium”

Featuring: FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).

The MDIC is a Public-Private Partnership (PPP) whose mission is to improve health through the application of shared knowledge in medical device regulatory science.  It is the first-ever PPP created to focus exclusively on advancing medical device regulatory science.

The MDIC will create a collaborative environment where nationwide representatives from industry, non-profits, and FDA can work together to keep pace with the needs of patients in the United States.

Speakers will include:

Senator Amy Klobuchar

Senator Al Franken

FDA Commissioner, Margaret Hamburg, M.D.

FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.

Immucor, Inc., CEO, William Hawkins

LifeScience Alley CEO, Dale Wahlstrom

http://www.deviceconsortium.org

The Medical Device Innovation Consortium is a public private partnership whose mission is to improve health through the application of shared knowledge in regulatory science.

Focused on the Medical Device Industry

The MDIC is the only public private partnership focused exclusively on the strategic needs of the medical device industry. The MDIC is designed to create a collaborative environment where the private sector can partner with the FDA’s Center for Devices and Radiological Health to solve technical issues that affect the industry.

Focused on Regulatory Science

Regulatory science refers to the development and evaluation of new tools, methods, standards and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.

Focused on Improving Health

The MDIC has been formed to add value at the intersecting needs of the medical device industry, the FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the U.S.

Founding Members

FDA

Medtronic

Life Science Alley

About Us

The MDIC is the first ever Public Private Partnership (PPP) created with the sole objective of advancing medical device regulatory science. The intent is to be a national 501c(3) organization that operates in partnership with the FDA.

•                The PPP relationship was formalized with the signing of a Memorandum of Understanding between LifeScience Alley, Inc., a Minnesota trade association, and the FDA on December 7, 2011. In August 2012, Articles of Incorporation were filed to formally establish the MDIC.

•                Membership and participation in the MDIC will be open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or who have expertise in regulatory science.

Governance Structure

The MDIC will be governed by a Board of Directors that will oversee the MDIC’s subcommittees and assist in identifying sources of funding. Subcommittees will represent industry sectors or technology areas (eg. Modeling, interoperability, orthopedics, neurological devices).

•                Each subcommittee will be responsible for establishing working groups chartered with identifying key issues affecting their industry segment.

•                The working groups will bring forward project plans for prioritization and funding allocation.

What We Do

Strategies

The MDIC will pursue several strategies in support of its mission:

1.            Create a forum for collaboration and dialogue, working within a flexible governance structure to encourage broad participation from the different industry stakeholders including FDA.

2.            Make strategic investments in regulatory science, utilizing working groups to identify and prioritize key issues and to request, evaluate, and implement project proposals that support the MDIC’s mission.

3.            Provide tools to drive cost effective innovation, emphasizing education and the development of new methods and approaches with well documented data and details to enable implementation.

Value

The activities and output from the MDIC will:

•                Ensure innovative technology is readily available to U.S. patients

•                Make the medical device regulatory process more expeditious, transparent and effective

•                Reduce the risk and expense of clinical research

•                Reduce the time and cost of medical device development

Projects

The MDIC will accept project proposals specifically focused on advancing medical device regulatory science.

After the initial meeting of the MDIC Board of Directors (early in CY13), the first sector subcommittees will be commissioned.

•                The subcommittees will organize working groups to develop rigorous project plans for prioritized topics.

•                Detailed project plans will be used to solicit project specific funding from companies who will benefit from their outcome and foundations interested in supporting the initiative.

The advantages of conducting research within the MDIC include:

•                Involvement of the FDA at all stages of the work thereby building awareness of and support for specific product development tools and approaches.

•                The ability to share best practices across industry and academia.

•                Exposure to a range of perspectives representing multiple constituents which can ensure more robust project development and data interpretation.

•                A mechanism for sharing the expense of research in the regulatory science, non-competitive domain.

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Join

The core operations of the MDIC are funded through contributions from members.

•                Pricing for annual membership is determined based upon the operating expenses for the MDIC.

•                The goal is to keep the membership low enough to encourage broad, cross-industry participation while still meeting the operational needs of the organization.

•                It is anticipated that as the membership base is increased, there is the potential that the dues per member will decrease.

Membership will be offered at several levels based on organization type and, if applicable, annual revenue. Project specific funding will be obtained from companies and foundations as a result of working group development of rigorous project plans.

•                $150,000 contribution annually: Companies with annual revenue >$10 B

•                $100,000 contribution annually: Companies with annual revenue between $5–10 B

•                $50,000 contribution annually: Companies with annual revenue between $1–4.9 B

•                $10,000 contribution annually: Companies with annual revenue <$1 B

•                $5,000 contribution annually: Nonprofit Sector

Benefits of Membership

The MDIC will provide its members with:

•                A mechanism through which to influence the future of the medical device industry by virtue of direct, collaborative discussions and projects with FDA.

•                A process for identifying, documenting, prioritizing and removing issues affecting the industry.

•                Processes, policies, support staff and pooled project funding to enable efficient regulatory science research in areas of strategic importance to the industry.

•                Educational forums in which to learn about the evolving regulatory science process, new tools, standards and test methods.

•                Searchable databases and links to relevant reports and methods.

•                Regular updates on the status of the MDIC’s activities and opportunities for involvement.

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Contact Us

To receive further information and to discuss next steps and membership details, please contact:

Maura Donovan, Ph.D.
Interim Executive Director, MDIC
763-505-4515
maura.donovan@medtronic.com

or

Dale Wahlstrom
CEO of LifeScience Alley
952-542-3077
dwahlstrom@biobusinessalliance.org

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Press

Minnesota Device-Makers Join Forces with FDA to Advance Regulatory Science

Regulatory Intelligence | Posted: 8 December 2011

Minnesota-based medical device lobbying group, LifeScience Alley, signed a memorandum of understanding with the US Food and Drug Administration (FDA), making official a year-long partnership to continue developing best practices in regulatory science. Center for Devices & Radiological health chief Dr. Jeffrey Shuren signed the memorandum, formalizing more than a year of joint effort toward developing regulatory science — a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices. If the pilot version of the program works in Minnesota, it may serve as a national model for device safety and clearance. (Mass Device)

Join the discussion on Regulatory Exchange

http://www.massbio.org/news/181-sen_brown_co-chairs_medical_technology_caucus/news_detail

Sen. Brown co-chairs Medical Technology Caucus

April 4, 2011

WASHINGTON, DC— U.S. Senators Scott Brown (R-MA) and Amy Klobuchar (D-MN) announced today that they will serve as co-chairs for the new Senate Medical Technology Caucus in the 112^th Congress. The caucus aims to increase awareness about issues facing the medical technology sector, an industry that creates life-saving and life-enhancing innovations that improve patient care.

“In Massachusetts, we have more than 200 medical device companies and hundreds of bio and pharma companies, all of which provide good-paying jobs to thousands of citizens,” Brown said. “It is critical that we provide a business environment for them to innovate, grow and thrive. I’m pleased to be the Republican chair of this bipartisan caucus, and look forward to working with my colleagues on both sides of the aisle to give our medical device and technology companies the tools and resources they need to continue their important work.”

“These businesses not only spark medical breakthroughs, they save lives,” Klobuchar said. “Every day in every state small medical technology companies are driving the innovation agenda we need to compete in a global economy. I will continue to work to make sure that Minnesota remains a leader in health care innovation by developing innovative products while maintaining patient safety.”

The United States is the world’s only net exporter of medical devices, with a $5.4-billion annual trade surplus. Minnesota is home to 400 medical device practices that support over 50,000 jobs in the state. The industry provides good-paying jobs to more than 400,000 Americans, with total direct and indirect employment exceeding two million.

Klobuchar has led the effort to cut red tape that threatens innovation in this industry. After a December report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar and Brown pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and plans to hold a hearing to examine the medical device approval process and to examine ways to improve export options.