The Sunshine Act: Who Pays for It Anyway?

April 27, 2011 · Leave a comment

Industry Insights from Paul Meade, M.Sc., MPH

By now, just about everyone involved in healthcare has heard about the Sunshine Provision (also known as the Sunshine Act). Starting January 1, 2012, any U.S. drug or device manufacturer that provides compensation to a physician or medical institution for any kind of services rendered will have to report it to the government.
The reporting benchmark is any amount over $10 for any single event. This means that if a sales representative for a pharmaceutical company buys a sandwich for a physician’s lunch and it costs $9.95, it doesn’t have to be reported, but if the physician adds a bottle of water to the sandwich, bringing the total to $11.95, it will need to be reported. Is it really to report sandwiches? Of course not, but it will! It’s really for some of the “big ticket” items, like compensation for conducting clinical studies, consulting on the development of new products, speaking at small meetings to colleagues that are sponsored by a company, etc.
So who pays for collecting, capturing, analyzing, and reporting all this information, and what will all of this monitoring activity cost? Let’s start by determining the number of active physicians in the United States. Well, there’s a problem right off the bat! According to the World Health Organization (WHO), there are ... read more »

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Should Doctors Be Paid By Drug Companies?

March 30, 2011 · 1 comment

Industry Insights from Paul Meade, M.Sc., MPH

Should doctors be paid by drug companies? Well, I guess that depends on the reason for the payment. If a physician, known for her expertise in a given area, is asked by a pharmaceutical company to determine if a newly discovered drug compound would meet a medical need in healthcare, then the answer is clearly yes. Likewise, if a patient consults with an orthopedic specialist on whether to undergo a surgical procedure to repair a damaged cartilage, that consultation is paid for by the person’s health insurance.

In any profession based on an individual’s expertise—think lawyers, management consultants–a person’s informed opinion usually commands some form of payment.  Also, the level of expertise generally dictates the level of compensation. So why is it that when a physician gives advice to a patient, or even a group of patients during a patient advocacy lecture, we all feel compensation is fair and just, but when that same person provides his or her expertise to a pharmaceutical company seeking to make a decision on whether to continue the development of a new drug, many people cry foul? Should pharmaceutical companies be forbidden to seek out and pay for the expertise and knowledge of physicians?

In order for a new medicine to become available to the general population, regulatory authorities demand ... read more »

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The Sunshine Act and Working with Thought Leaders

February 22, 2011 · Leave a comment

Industry Insights from Paul Meade, M.Sc. MPH

With the Sunshine Act getting closer to implementation, every company that works with thought leaders is preparing for full disclosure and transparency in the way they work and compensate these physicians and other medical experts. So the big question at hand is this–just how many thought leaders should a healthcare manufacturer work with going forward? Some say just a few and others say many. What’s the right answer here?

If we take the argument that working with just a select few is better, one could surmise that it is best to cement a working relationship with a few key thought leaders rather than get to know a “cast of hundreds.” This way, companies may gain a better understanding of the respective key opinion leaders’ interests, preferences, beliefs, and skills. Companies can more effectively create a set of activities that most appropriately matches the skills and experiences of each physician and work with the strengths of each physician to bring new insights into new medical treatment options.

But the one factor working against the “less is more” option is the fact that many academic medical institutions are placing limits on how much remuneration a thought leader can accept from the industry in a given year. Whereas, not too long ago, managed care organizations were placing providers ... read more »

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KOL Engagement and Enforcement in Canada, Relative to the United States

December 16, 2010 · 2 comments

In the Field with Neil: Observations from Neil Mellor, Business Development Consultant

“When the US sneezes,” as they say, “Canada catches a cold.” This cliché could not be more apt for the Canada pharmaceutical executive when it comes to managing relationships with key opinion leaders (KOLs). Canada is still a long way off from having similar regulatory activity to the US, with regard to governing interaction with healthcare professionals, but Canadians should pay attention to what is happening south of the border.

The Office of the Inspector General (OIG) is a well-known entity to any US pharmaceutical sales representative, product manager, sales or marketing executive. The OIG is a division of the US Department of Health and Human Services and has strict powers governing how the US pharmaceutical industry engages with KOLs and promotes pharmaceutical products. According to The OIG’s website (http://oig.hhs.gov/), “The OIG’s duties are carried out through a nationwide network of audits, investigations, inspections and other mission-related functions performed by OIG components.” The OIG has sweeping powers to investigate, prosecute and fine, if necessary, or even invoke jail terms. Since 2000, over $11.7 billion in legal settlements have been collected by the OIG from pharma companies promoting off-label usage of their products or violating the agency’s expectations of how the industry should interact with KOLs.

Canada ... read more »

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The Future of Thought Leaders in Healthcare

December 10, 2010 · Leave a comment

Industry Insights from Paul Meade, M.Sc, MPH

For decades, the pharmaceutical industry has had a good working relationship with the medical profession. Of course, pharmaceutical companies have always been dependent on physicians writing prescriptions for their products, and for pharmacists filling these prescriptions, so ultimately the patients could return to health. This has been a true symbiotic relationship where pharmaceutical companies needed doctors to prescribe their drugs, and physicians had effective medicines to offer their patients.

Occasionally, there were a few bad apples on both sides of the equation that overstepped the boundaries of this relationship, but for the most part, it worked well. So what happened? Why the Sunshine Act? And why the apparent “witch-hunt” to expose every Thought Leader that engages with someone from a pharmaceutical company? Is it time for a course correction? Don’t we have bigger problems to deal with in the financial and economic arenas than to worry about how much money a Thought Leader made from conducting clinical studies or speaking at a conference on behalf of a pharmaceutical company?

Where did it all go wrong? How do we fix it? And what does the future hold for this pharma-medical relationship? Healthcare costs have been steadily rising in most countries across the globe. And while there have been increases in these costs, almost no other country has ... read more »

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