The Affordable Care Act: What’s the Right Thing to Do?

July 3, 2012 · Leave a comment

Industry Insights from Paul Meade, M. Sc, MPH

The United States Supreme Court finally rendered its ruling on 2010’s Affordable Care Act (ACA), finding that its so-called mandate was indeed constitutional, inasmuch as the government is free to place a tax on U. S. citizens. While many thought that resting on the power of the federal government to control interstate commerce was the legal approach to move this law forward, the justices deemed that while the mandate was not a valid use of this power, the government can impose any tax it deems appropriate.

Unfortunately, all of this amounts to jockeying by our duly-elected officials in Washington, as they play election-year political football with subject matter that is of critical importance to the citizens of this country. The nine justices are even getting into the election game by suggesting that the government’s insistence upon everyone being covered by some form of health insurance can be implemented by imposing a tax on those that refuse to abide by the law. This ruling, especially in the manner that Chief Justice John Roberts articulated his concurrence with the majority opinion, easily permits the Act to be used as a target in the coming election by having either party debate the issue of a tax. Almost everyone is missing the point of this and other reforms ... read more »

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Understanding the Sunshine Act—Part Two

April 10, 2012 · Leave a comment

Industry Insights from Kristen Smithwick

Last week proved to be another interesting week for the developing Sunshine Act. Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) sent a pivotal memo to Acting CMS Administrator Marilyn Tavenner. The senators urged the agency to publish a final rule no later than June 2012 and to respond to several questions related to implementation.

Senators Grassley and Kohl want the agency to begin gathering transparency data this year, and they’re not willing to give CMS any wiggle room for delays. To meet the senators’ timeline, CMS will need to address comments and recommendations from numerous interested parties, especially the Pharmaceutical Research and Manufacturers of America (PhRMA), the Advanced Medical Technology Association (AdvaMed), and the Biotechnology Industry Organization (BIO). We covered a number of areas questioned in Part 1 of this blog. In this post, we’ll mention just a few additional areas of concern.

Definition of Applicable Manufacturer and Separate vs. Consolidated Reporting – Questions and concerns abound when it comes to defining applicable manufacturers, especially as the definition impacts requirements for separate vs. consolidated reporting for entities with common ownership. The challenge for CMS will be to ensure the definitions of applicable manufacturers and common ownership are broad enough to meet the public’s demand for transparency, while being specific enough to protect the ... read more »

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Happy Holidays from Thought Leader Select

December 22, 2011 · 1 comment

Clients and Friends,

After another successful year, we wish you a holiday season filled with joy and fun times with family and friends.

The month of December causes many to reflect on the successes and challenges they have experienced throughout the year, and we’re no different. In any business, you win some and you lose some, but we find ourselves very thankful for all of the new friends we’ve made this year and the times we’ve shared with old friends, too.

Our work remains more fulfilling than ever, even with the constant ratcheting of regulation and legislation in the industry we serve.  This increasing scrutiny demands that we bring our “A game,” keeping our clients ethical and compliant in all that they do with thought leaders and centers of excellence.

We hope all of you, as you take time to reflect this year, have as many reasons to be thankful as we do. We are grateful for your business, your friendships, and your continued faith in us.

Happy Holidays from all of us at Thought Leader Select.

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The Sunshine Act–How Bad Can It Get?

December 6, 2011 · Leave a comment

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 »

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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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How Will Healthcare Reform Impact Your Next Investigator or Advisory Board Meeting?

February 28, 2011 · Leave a comment

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 »

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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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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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Rising Health Insurance – How to Win and Lose at the Same Time!

September 9, 2010 · Leave a comment

Industry Insights from Paul Meade, M. Sc, MPH

The front page of the Wall Street Journal announced yesterday that several health insurance companies are raising the premiums on their plans, which are likely to impact small businesses and individual policyholders. The reason cited for this unusually high hike in premiums is recent healthcare reform. The net result of all this it that the taxpayer pays for the added costs of healthcare reform, and the taxpayer pays for increased premiums that the insurance companies add as a result of healthcare reform.

This is like having car insurance, having an accident, and then watching your premiums quadruple for three years before returning to what they originally were before the accident. Guess who just paid for the accident? So why do we have insurance to protect us against an accident when ultimately we end up paying for the accident anyway?

Health insurance, like any insurance, is a risk game. Not for the insurance company, but for the consumer. If the insurance company lost enough money from insuring people, they would go out of business. So the game is simply this: take in more money than you pay out. If you pay out more than you expected in a given year, raise the premiums. If you pay out less than you thought you would, pocket the profits. ... read more »

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Personalized Medicine Shaping Pharma's Future

May 25, 2010 · 1 comment

Industry Insights from Paul Meade, M. Sc, MPH

I have spent the last 30 years directly or indirectly involved with the pharmaceutical industry. I worked for two international pharmaceutical companies and have advised many other pharmaceutical and biotechnology companies over the past few years. So I undoubtedly have a biased view in favor of this industry and its aims to promote health while making a reasonable profit for its research efforts.

While I can appreciate all the activities undertaken by pharmaceutical companies to develop medicines to improve the health of people throughout the world, I can also understand why many people have a jaded view of these companies. The perception that pharmaceutical companies take advantage of sick people and make them pay high prices for medicines to make them better is one that prevails among many societies. Yet, through the invention of antibiotics to control infectious diseases, and vaccines to prevent many childhood diseases, and many other products for a variety of diseases, the pharmaceutical industry has made significant improvements to healthcare. In addition to the high cost of medicines, few people realize that the total cost of pharmaceutical products as a portion of the total healthcare spending in the United States is less than 10%. Yet, many people believe that medicines are far too expensive.

Pharmaceutical companies, for the most part, ... read more »

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