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The heavy hand

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The country continues to vest the federal government with more and more power over all aspects of health care. In 2009, the American Recovery and Reinvestment Act (ARRA) funded more than $1 billion over two years for comparative effectiveness research. Last year, the Patient Protection and Affordable Care Act (PPACA) extended the ARRA-enabled effort by amending Title XI of the Social Security Act to add a new “Part D” dedicated to even more comparative effectiveness research.

Proponents initially described this work in rather benign terms. They saw it as a way to help establish best protocols and practices. Opponents saw it as the first step in creating “death panels.” Proponents countered that it was just research. Opponents pointed to another government entity created in PPACA: the Patient Centered Outcomes Research Institute (PCORI). PCORI is charged with more than just identifying and distributing information; its mission is the prioritization and execution of the results of comparative effectiveness research.

It does sound like a one-two punch, doesn’t it? Is government aligning its components to exert an even heavier hand? The news from the Department of Health and Human Services (HHS) earlier this week is especially troubling. Pharmaceutical company Forest Labs decided to enter a plea agreement in action stemming from one of a number of government lawsuits challenging commonly used marketing practices. Remember, Forest Labs never admitted guilt — the company just settled what would have been a costly and protracted court case. This is done all the time.

Forest Labs’ 83-year-old CEO, Howard Solomon, was not charged and was unaware of any misconduct, and the government did not allege that in its complaint. Nevertheless, at some time after the agreement was reached, HHS sent Solomon a letter informing him that it would no longer do business with Forest Labs. HHS used a seldom-cited provision in the Social Security Act that allows officials to keep executives of health companies from working with the government when the firms are guilty of criminal misconduct.

If Solomon steps down as the firm’s CEO, the government will continue to do business with Forest Labs. HHS says it is only trying to hold CEOs accountable. Forest says it sounds like blackmail. You decide.