Beyond Fines, Corporate Integrity Agreements Compound Compliance Costs


Healthcare organizations accused of violating a federal law often find themselves in the settlement agreement process with the Department of Health and Human Services’ Office of the Inspector General (OIG), leading the company to comply with rigorous terms of a corporate integrity agreement (CIA).   Those involved in particularly egregious or consistent violations of federal law governing the manufacturing and marketing of pharmaceuticals may even be obligated to enter into a deferred prosecution agreement with the U.S. Department of Justice (DOJ).
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The New Relationship Dilemma: Evaluating Physician Payment Transparency Regulations


The struggle is real. As an executive in health care, I understand the impact regulation has on our business.  No doubt, physicians and pharmaceutical companies feel it as well: especially given some very significant changes that have transpired over the past 20 months. The Physician Financial Transparency Reports, or Sunshine Act, requires increased reporting of financial relationships between health care providers and pharmaceutical manufacturers and sheds light on potential conflicts of interest. Ultimately, the Act surmises, patients would have a better opportunity to learn about potential conflicts and consider those in the context of their prescribed treatment. But like others, well-intentioned legislations, I sometimes wonder how the Act is working.
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In the Age of Overwhelming Opinions, Who Is Your KOL and How Do You Assess Their Risks and Benefits in the Evolving Health Care Environment


As with most disciplines, including scientific and medical fields, clinical teams, marketing and business minds seek out a spokesperson — or Key Opinion Leader (KOL) — who will help launch a new product and with whom patients can identify. This was evident in the late 90s, which observed a new therapeutic class that entered the post-menopausal osteoporosis scene, bisphosphonates, mainly Fosamax, Actonel and Boniva. For example, Actonel from Procter & Gamble (P&G), the second drug to market bisphosphonate, had a once-a-day and then once-a-week therapy. A few years later, Actonel faced stiff competition from the launch of the once-a-month Boniva. P&G could not complete with the message of Sally Field, a well-known actress who became the face of for aging women and a key spokesperson for Boniva. Patients told their doctors they wanted what Sally was taking to protect their bones. With this as a backdrop, one can begin to see how a strong voice for an idea, product or trend can be important within the scientific and medical fields.
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Being Ethical: How Hard Can It Really Be?


As a child growing up, we are all taught right from wrong, good from bad, lawful from unlawful. Yet, our prisons are full of people that made the wrong decision. However, being ethical is not always about right and wrong; it is often about understanding the framework in which we make decisions. “The good of the many is more important than the good of the one” is a statement espoused by those who support utilitarianism – and was often used by Spock on the television series Star Trek. But there are other principles of ethics that oppose such a framework. So, if there are several guiding principles to drive ethical behaviors, how hard can it be to be ethical?
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The Implications of Corporate Integrity Agreements: What Providers Should Expect


For corporate health care providers involved in a civil health care fraud investigation, entering into a corporate integrity agreement (CIA) with the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) is often a necessary condition to resolving the matter.  If there is a parallel criminal investigation, CIAs are usually, although not necessarily, included as part of any global resolution.
 
Under the terms of the CIA, HHS will require the corporate provider to accept a number of detailed, compliance-related obligations.  In exchange, the corporate provider is given the opportunity to avoid being barred from participating in Medicare, Medicaid, or other Federal health care programs – a financially devastating outcome for any entity.
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Lean, Taut SOPs: Five Steps to Trim the Bloat

Picture this: On the first day at your new job, your supervisor slaps a copy of the great 2,783-page classic Les Misérables on your desk. “You have thirty days to read this,” she says. “Don’t let any other deliverables slip. And, by the way, there will be a quiz on each chapter.”
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