March 27, 2012 ·
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Industry Insights from Kristen Smithwick
Albeit a bit late, the U. S. Centers for Medicare and Medicaid Services (CMS) issued a proposed rule on the Patient Protection & Affordable Care Act’s Physician Payments Sunshine Provision (also known as the “Sunshine Act”) to implement it as law.
CMS invited comments on the proposed rule through mid-February 2012, and a recent webcast, sponsored by PharmaLive’s Pharmalot, featured key facts and summaries of comments on the proposed rule. Working for a provider of research and consulting to the biopharmaceutical, medical device, and diagnostics industries on relationships with physicians and other health care providers, I enjoyed the opportunity to join the webcast, led by experts from Buchanan Ingersoll & Rooney, P.C., and am eager to share some of my key takeaways.
As mentioned in previous Thought Leader Select Blog posts, the Sunshine Act, as with many laws and regulations, is full of unintended consequences – some positive and some negative. Lance K. Stell, medical ethics teacher at Davidson College and Carolinas Medical Center, reports in his USA Today op-ed piece that the “Sunshine Act will cost far more than the $224 million estimated for just the first year of compliance” and that “the biggest cost will be the valuable, socially useful physician-industry collaborations that simply won’t occur.” Of course, the idea of ... read more »
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AdvaMed BIO biopharmaceutical biotechnology Buchanan Ignersoll & Rooney CMS Davidson College Carolinas Medical Center diagnostics HCP payments health care providers Kristen Smithwick Lance Stell medical device medical ethics OTC manufacturer Patient Protection and Affordable Care Act pharmaceutical PharmaLive Pharmalot PhRMA Physician Payments Sunshine Provision physicians Sunshine Act Thought Leader Select Thought Leader Select Blog US Centers for Medicare and Medicaid Services veterinarians veterinary schools
December 6, 2011 ·
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Industry Insights from Paul Meade, M. Sc, MPH
For every transaction over ten dollars paid to a physician by a pharmaceutical manufacturer, the Physician Payments Sunshine Provision demands disclosure to a database that will be made public in 2013.
Notwithstanding the absurdity of collecting such an enormous amount of information, someone will undoubtedly spend a lot of time sifting through this data to create lists of “worst offenders.” These lists will be publically promulgated with the sole purpose of bestowing shame on these so-called “offenders.”
Of course, these lists may be perceived as tantamount to publishing a list of child molesters moving into a new neighborhood, or those people charged with driving under the influence of alcohol over the weekend listed in the Monday newspaper. Some of the most brilliant and renowned physicians in this country will be brought to shame for consulting with some manufacturers.
So, how bad can it get? Well, let’s imagine the following scenario, which I refer to as Grinding to a Halt. Leaders in the medical community who are respected for their research and experience may become so concerned about being publically exposed for consulting with various manufacturers that they may decide to cease all interactions going forward.
There will be no more advising pharmaceutical companies about the unmet medical needs for new molecules discovered in their research laboratories. There ... read more »
TAGS: academic medical centers capitation centers of excellence clinical studies CME continuing medical education drug compounds drug manufacturers healthcare reform medical community medical conferences pharmaceuticals Physician Payments Sunshine Provision physicians research laboratories Sunshine Act
October 14, 2011 ·
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Industry Insights from Paul Meade, M. Sc, MPH
The Sunshine Act is on the horizon, and all we know for certain is that things will be different. Will the changes be good, bad, or ugly for healthcare and the biopharmaceutical industry? Well, a bit of all three. But it is a bit like the Y2K scare, or the coming of the end of the world in December 2012 predicted by the Mayans—people in healthcare and biopharma are on alert, and no one really knows for certain how this will all play out.
Let’s start with the good, since there will be greater transparency in the interactions between manufacturers and physicians. The intended outcomes will be greater standards of remuneration for services rendered by healthcare professionals to various manufacturers, some defined threshold limit of activities (type and quantity) deemed permissible by institutions for their affiliated physicians, and a greater sense of awareness of the interactions between healthcare professionals and manufacturers, presumably by a concerned public.
With regard to the first outcome, it is hoped that some kind of industry standard for Fair Market Value will be established for the activities physicians are often engaged in when dealing with manufacturers. It will likely serve to “level the playing field,” so some manufacturers will not pay excessively for a given activity, such as consultative services. As ... read more »
TAGS: academic institutions biopharmaceutical industry centers of excellence clinical studies fair market value healthcare healthcare innovation innovation in medicine key opinion leaders media witch hunt medical community medical ethics medical experts Paul Meade pharmaceutical companies pharmaceutical manufacturers Physician Payment Sunshine Provision physicians public scrutiny of pharmaceutical industry public trust remuneration scientific advisory boards scientific community scientific conferences Sunshine Act Thought Leader Select thought leaders transparency US healthcare legislation US healthcare regulations Y2K
April 27, 2011 ·
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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 »
TAGS: $10 American Association of Family Physicians biotechnology Census Bureu compensation consulting cost drug government government database healthcare information JAMA Journal of American Medical ASsociation manage manufacturer medical device medical institution monitoring Paul Meade pay pharmaceutical company physician report reporting sales representative Sunshine Act Sunshine Provision thougth leader WHO World Health Organization
February 28, 2011 ·
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Regulatory Guidance from Aprel Buonpane
The main components of the new US healthcare reform legislation will continue to be subjects for debate in the coming months and years, but tucked in among all of the changes for Medicare beneficiaries, coverage for pre-existing conditions, and the effects on small business owners lies a provision that most laypeople would not even notice. This provision, however, has the attention of US drug and device manufacturers and cannot be ignored.
The Physician Payment Sunshine Provision, also known as the Sunshine Act, requires that these companies publicly report gifts and payments made to physicians and other entities such as teaching hospitals. The intention of the provision is to address the public’s perception that biopharmaceutical companies use payments to influence a physician’s prescription-writing habits and to improve transparency as to what actually does exchange hands, in the form of services and remuneration for those services, and why. Drug and device manufacturers must begin capturing this data in January 2012 and must make their first report on these activities to the Department of Health and Human Services by March 2013. This provision has far-reaching implications for how the medical meetings and event industry will conduct its business in service of the healthcare community for years to come.
The new law requires that every dollar spent on physicians and health care ... read more »
TAGS: Aprel Buopane biopharmaceutical companies Department of Health drug and device manufacturers fines gifts HCP health care providers healthcare community healthcare reform Human Services increasing regulation influence payments Physician Payment Sunshine Provision physicians publically report Sunshine Act teaching hospitals thought leaders TMP Meeting Services transparency US legislation worldwide phenomenon
February 22, 2011 ·
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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 »
TAGS: biopharmaceutical industry capitation system compensation consultative services fees full disclosure health issues healthcare manufacturer industry insights key oopinion leaders KOL limits managed care organizations medical experts medical treatment options new insight patient advocacy gorups Paul Meade physicians product development remuneration specialists Sunshine Act thought leaders transparency Unique skills well-balanced
December 10, 2010 ·
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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 »
TAGS: compensation drug companies ethics healthcare healthcare bill healthcare reform medical professionals pharma pharma-medical relationship pharmaceutical companies pharmaceutical industry pharmacists physicians prescriptions Sunshine Act thought leader
November 4, 2010 ·
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Neil Mellor, business development consultant at Thought Leader Select, and Paul Meade, the company’s president and founder, attended SMi’s KOL: Knowledge Leader Partnerships conference on September 29 and 30 in London. Neil sat down with the Thought Leader Select Blog to discuss his takeaways from the conference.
TLS Blog: Neil, how was the conference in London?
Neil Mellor: I found it quite interesting, and so did Paul—since we’ve grown the company over the last five years to include multiple European and global thought leader assessments, we thought it made sense to get a real sense of the industry’s thinking about what we do on the European continent.
TLS Blog: What were some of the main points of discussion?
Neil Mellor: Right now, there’s a pretty hot debate going on about the roles that health care professionals play in the development and launch of new medicines. This conference even included a robust discussion on what to call them—it seems the European marketplace is evolving away from the term “key opinion leader,” with companies choosing instead to rely on what they call “external experts,” “opinion leaders,” or “thought leaders.” It made us feel even better about the name of our company, that’s for sure!
TLS Blog: Would you say that there’s a migration going on in the perception of the HCPs ... read more »
TAGS: allied health professionals biopharmaceutical biotech British Medical Journal clinical practice Dr. Fiona Godlee external experts FDA HCP health care professionals key opinion leader Knowledge Leader Partnerships Conference London medical experts Neil Mellor new medicines nurse practitioners opinion leaders patient Paul Meade pharma pharmacists physician assistants public health publishing registered nurses research SMi Sunshine Act therapeutic area thought leader assessments Thought Leader Select thought leaders
