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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Paul Meade Accepts Invitation to Speak at AACE Annual Meeting

March 31, 2011 · 1 comment

March 31, 2011 (CHAPEL HILL, NC)—Paul Meade, the president and founder of Thought Leader Select, a Research Triangle, NC company focused on facilitating medical expert collaborations with the biopharmaceutical and other healthcare industries, has accepted an invitation to speak at the annual meeting of the American Association of Clinical Endocrinologists (AACE).

The 20th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists will take place from April 13-17 in San Diego, CA.  At the invitation of AACE President-Elect Dr. Yehuda Handelsman, Meade will speak during the annual Corporate AACE Partner (CAP) meeting, an opportunity for physicians and representatives from partnering companies, including biopharmaceutical and medical device firms, to learn about emerging topics in inter-industry collaborations in medicine.  

Meade’s speech, “Interactions in the Age of Transparency,” will outline a new path forward for even better industry collaborations with medical experts based on a foundation of ethics and transparency.  “I am honored to accept the invitation from Dr. Handelsman and the AACE,” stated Meade. “I have built my career on the basis of an unwavering commitment to ethics and transparency.  We have to remember that we’re all in this together—health care providers, researchers, and people from industry—to promote better health for everyone in this country.  If we always keep patients’ best interest in mind and work together is an open ... 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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When Should Politics Stand in the Way of Healthcare?

March 25, 2011 · Leave a comment

Paul Meade, M.Sc., MPH

Well, there’s an easy answer: NEVER! I could stop there and be content with “enough said,” but I would like to expand on my concerns for a minute. The Obama administration has made some noble attempts at healthcare reform, and they made some small gains despite the need for a “major” overhaul in healthcare delivery in the United States. By the time the bill was passed, many argued it had become too watered-down to pass the House and Senate. In the end, the victories were small in relative comparison to what was truly needed to get healthcare back on track in this country.

Now, this new healthcare law has become a political ping-pong ball for grandstanding antics among politicians in Washington. When did “We the People” become “Me the Politician?” Elected officials are supposed to represent their constituents, not their self-interests for their own political survival.

What would be in the best interests of the American people with regard to healthcare? Most Americans want access to affordable and effective healthcare. Much like the tagline seen at Target stores–“expect more; pay less”–that’s what we all want. Do we want to be constrained by our healthcare insurance to lifetime limits? Do we want to be denied coverage based on pre-existing conditions? Do we want to continue to pay more and more ... read more »

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Transparency and the Sunshine Provision – Is This a Good or Bad Thing?

March 17, 2011 · Leave a comment

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

The Physician Payment Sunshine Provision is a part of the Patient Protection and Affordable Care Act passed by the U. S. Congress in March of last year. The provision will go into effect on January 1, 2012. Many people in the healthcare industry are struggling to determine if this provision is a good thing or a bad one. Truth be told, it is a bit of both—good, in that it ensures complete transparency among health care providers and manufacturers of pharmaceuticals and medical devices, and bad, because it may expose the benefits some healthcare professionals gain from interacting with some manufacturers.

For years, healthcare professionals have been interacting with manufacturers in many ways; when providers offer their professional services, they expect and receive compensation for their time and knowledge, as would experts in any other industry. Every industry has its experts, and healthcare is no exception. There are healthcare experts in a variety of functional areas and in all therapeutic areas. These experts have medical information and knowledge that is valuable to healthcare manufacturers as they develop and commercialize their products and services. Acting as consultants to industry manufacturers, experts offer guidance in the development of new products, from determining unmet medical needs to suggestions on how to price new products.

Is it fair to compensate ... 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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The Ethics of Invention

December 29, 2010 · 1 comment

Industry Insights from Paul Meade, M. Sc, MPH

In a December 20, 2010 article, the Wall Street Journal addressed the royalties paid to back surgeons by a medical device manufacturer. The article highlights a group of five senior spine surgeons that received over $7 million from Medtronics in royalties and consulting fees. The article also goes on to suggest that the number of procedures involving spinal fusions performed by these physicians may have exceeded those in the general population of Medicare patients. However, it was noted that these surgeons did not receive royalties from procedures performed in their hospital using devices from the manufacturer in question, since this would have been an ethical violation and a conflict of interest. So where’s the problem here?

The issue at hand may be defining fair and reasonable compensation. It could also be the level of influence these surgeons may have on other spine surgeons to use devices in which they have a royalty payment from the manufacturer. And lastly, it could be argued that these consulting and royalty payments could amount to surrogate “kickback” payments to use and influence the use of certain devices. All of these issues are fraught with ethical dilemmas and moral challenges.

If I am the inventor in new technology to enhance televisions, and I sell this technology to a ... read more »

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Thought Leader Select’s Noureddine Launches Non-Profit Aimed at Career Development for Medical Professionals

December 23, 2010 · Leave a comment

Press Release Out Today from the Offices of Thought Leader Select

December 23, 2010 (CHAPEL HILL, NC)—Dr. Maher “Max” Noureddine, a noted Parkinson’s disease researcher and chief scientific officer at North Carolina-based research firm Thought Leader Select, is leaving the company to launch the Institute for Advanced Career Development (IACD) on January 3, 2011.

The institute will offer an array of programs for medical professionals seeking to advance their academic careers in their respective medical fields.  Programs on offer will include a physician-centric curriculum called MedMentors, courses for nurses called RNMentors, and courses for pharmacists and veterinarians called PharMentors and VetMentors, respectively.

In addition to the programs centered on leadership in allied health professions, Dr. Noureddine will lead development courses for legal professionals interested in understanding the science of DNA-based evidence.  Dr. Noureddine is trained in human molecular genetics with years of laboratory research experience at top institutions such as UNC-Chapel Hill, Duke Medical Center, and The National Institutes of Health.

“I am excited to take all of my scientific training and combine it with my experience in working directly with leading academic medical specialists from across the globe,” stated Noureddine. “While I am sad to be leaving Thought Leader Select, I am doing so with the company’s complete endorsement—they really believe in what I’m doing to advance scientific careers for better healthcare delivery. ... read more »

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Accountable Care Organizations or Accountable Scare Organizations?

December 3, 2010 · Leave a comment

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

There has been a lot of talk lately of a new form of healthcare delivery known as “accountable care organizations” (ACOs). And while it may seem as yet another type of managed care organization, these ACOs are attempting to introduce the element of quality balanced with fiscal responsibility and cost containment. Undoubtedly, this is a noble attempt at bringing quality healthcare at an affordable level to patients within the United States. Actually, who could argue with affordable, quality healthcare based on sound outcomes research and cost-benefit analysis? So where is the scare?

Could the concept of an ACO be a variation on the theme of capitation that we saw in the 80s? The basic principle is for healthcare providers to deliver the optimal healthcare within a specified budget. So what’s the difference? Well, the old capitation model was based on responsible economic principles; deliver the best healthcare you can with the money you’ve got. The problem was that in order to meet the capitation hurdles, many providers simply under-delivered services, so a short-term gain often resulted in a long-term loss. Also, quality initiatives and health outcomes research was still in its infancy, so finding the optimal healthcare solution was often a hit-or-miss situation. But today, there are better quality measures based on outcomes research ... read more »

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Healthcare Reform: Where Do We Go From Here?

November 10, 2010 · Leave a comment

Industry Insights from Paul Meade, M. Sc, MPH

Now that the mid-term election results are in and the US House of Representatives has changed hands, does this mean that there will be a reversal of all the healthcare reform initiatives put into place by the Obama administration? This country is in dire need of healthcare reform, and someone has to have the courage to “step up to the plate.”

To be sure, the initiatives put into effect by the current administration can be considered a good start, but more is needed to fix the situation. Unemployment is not diminishing as quickly as the press would have you believe. And what happens when COBRA runs out for all these unemployed people in America? Insurance companies, in anticipation of higher “medical loss ratios” –such a lovely term–have decided to raise premiums just to hedge their bets. As a result, we are headed into the “perfect storm.”

So with a change in the House, will the new majority try to block these initial changes to healthcare set in motion by the Obama Administration? Healthcare reform is badly needed in America, for all Americans. This is the one time we need bipartisan political support to give Americans a sound healthcare delivery system that is affordable for all. Using healthcare as a political football is just the wrong ... read more »

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