False Claims Act Violations Lead to Industry-Wide Protections

This past week, the Centers for Medicare & Medicaid Services finally released the proposed rule that would require drug and device companies to report publically any gifts or payments given to doctors and medical professionals. The rule was written in response to the passage of the Physician Payments Sunshine provisions of the 2009 Affordable Healthcare Act. It appears that the government is trying to increase the transparency of the Medicare program so that they can have protections in place to safeguard against fraud or other illegal actions. The proposed regulations even state that “financial ties alone do not signify an inappropriate relation. However, transparency can shed light on the nature and extent of relationships, and may dissuade inappropriate conflicts of interests from developing.” It also may be in response to allegations over kickbacks to doctors and medical professionals in order to promote the products of several drug companies. This shows that after years of fighting fraud under the False Claims Act, whistleblowers can feel justified in their actions to expose illegal Medicare transactions.

In 2009, the same year that the Affordable Healthcare Act was passed, the drug company Pfizer Inc. settled a case with the Department of Justice over some of their off-label promotional practices. The settlement yielded over $2.3 billion in recovered funds, including payments to healthcare professionals in qui tam actions. One part of the settlement also included settling allegations related to the company’s payments to healthcare professionals involving Pfizer medicines. The corporate integrity agreement that Pfizer entered into as a result of the settlement created a system to monitor the company’s transactions and help change the promotional and product-related business functions to put them align them with what is legally acceptable. All of these actions appear to have been used as a precursor for the government in its proposed rules for the Sunshine Act.

The Sunshine Act is an important part of the government’s ability to safeguard its Medicare system and the social entitlement programs in general. This recent act shows that it sees the importance of whistleblowers and qui tam lawsuits to recovering government money and also to keep the private sector from engaging in any fraudulent activities. It is good to see that through this act, as well as the whistleblower provisions of the Dodd-Frank Wall Street Reform Act, the government is serious about protecting the consumer and making sure that all the information that may be needed for a decision is provided to the public.

See Also:
http://op.bna.com/hl.nsf/id/bbrk-8pjtfc/$File/SunshineRegsDec2011.pdf

http://www.policymed.com/2009/09/pfizer-23-billion-settlement-and-corporate-integrity-agreement.html

http://www.medpagetoday.com/Washington-Watch/Washington-Watch/30252

http://www.cohealthcom.org/category/sunshine-act-2/

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McEldrew Young (f/k/a Young Law Group, P.C.), Attorneys-at-Law, represents whistleblowers nationwide. For a free confidential consultation, please call Eric L. Young, Esquire at 1-800-590-4116 or contact one of our False Claims Act lawyers.