The Struggle to Find a Home in the Affordable Care Act and a Place in History

This article first appeared at Pharmaceutical Compliance Monitor on October 14, 2013.

The more sand that has escaped from the hourglass of our life, the clearer we should see through it.”  –Jean-Paul Sartre

When discussing the prospect of change to the structure of the American health care system, a little background is in order. Historically, the pharmaceutical industry has yielded to certain cyclical patterns that emerge when a new drug or treatment is introduced to the marketplace or new regulations come into effect, resulting in an initial surge followed in time by greater restraints imposed from both the federal and state level. Since its inception in 2010, the Affordable Care Act has in many ways preempted these cycles as it seeks to provide a nearly universal health care blanket by constructing a new foundation made of regulatory building blocks aimed at shifting emphasis from a cost based to a performance driven philosophy that it believes will reduce fraud and waste, thereby lowering costs across the board.  Within its folds exist a number of pharmaceutical specific studies and programs designed to more accurately police the industry as the federal government attempts to curtail spending. With the emergence of the ACA, today’s pharmaceutical companies find themselves in an all too familiar situation, overlooking a vast new horizon of potentiality while beset by a host of new rules, where the prospect of greater market opportunity grapples with the restrictions that accompany increased regulation.

With cost savings as not only its driving force, but also the effective public barometer gauging the plan’s success or failure, the ACA has taken an aggressive stance toward what the Federal Government views as wasteful spending.  With this in mind, the best course of action for those in the field of pharmaceuticals would be to learn from history and not fall victim to the mistakes of the past by underestimating the effects of well-enforced regulations. This is especially true under the changes set forth by the ACA in its bid to restructure reimbursements and prevent misuse of information. Bundled within the core tenets of the ACA is the newly enacted Physician Payment Sunshine Act, which, despite its benign moniker, wields an impressive set of muscles as it seeks to promote transparency in the dealings between physicians and group purchasing organizations, as well as the pharmaceutical, medical device and biologic industries. By September, 2014, CMS plans to track all information pertinent to the relationships between physicians and those in related fields through a public database available on its website. In doing so, this marks a significant development in the Federal Government’s commitment to policing the health care industry and hints at the resolve behind the fledgling ACA’s long-term goals vis-à-vis the pharmaceutical industry.

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