Tuesday, May 2, 2017

Middle District of Florida Employs Unique Provisions for False Claims Act Settlements with Compounding Pharmacies

During the last three years, the U.S. Attorney for the Middle District of Florida ("the District") settled a number of False Claims Act investigations relating to "compounding pharmacies" that sold and marketed compounded pain cream medications that were reimbursed by Tricare. See here and here. The allegations against these pharmacies and their owners were very similar: compounding pharmacy paid kickbacks of one kind or another to marketers and/or physicians to generate prescriptions for compounded pain cream medications that were, in turn, filled by the same pharmacy who profited handsomely due to Tricare's very high rate of reimbursement. The District announced in October 2016 that it had "recovered almost $70 million" from these FCA settlements.

The FCA settlements for WELLHealth, Topical Specialists, and North Beaches compound pharmacies included settlement provisions that are rarely, if ever, seen. In these settlements, the District agreed to accept payment over five years of "50% of net profits" from each of these pharmacies. Normally, the Government only permits an FCA defendant three years to pay its settlement obligations. Additionally, I have never seen an FCA settlement where the Government agreed to accept a defendant's pledge of future net profits to pay off an FCA settlement obligation.

For example, the District's FCA settlement agreement with WELLHealth pharmacy of Jacksonville also provided:
  • No admission of liability;
  • Payment of approximately $1.9 million at the time of settlement;
  • Payment of proceeds from the liquidation by WELLHealth's shareholders of their interest in another pharmacy; 
  • Payment of proceeds from a future sale of a property owned by a third party after paying off the initial investment of the investors who purchased the property;
  • Payment of net proceeds from the future sale of a second property; 
  • Payment of 50% of the pharmacy's net profits over the next five years; and 
  • In the event the defendant defaults on the settlement, the Government has options (1) to enter a consent judgment in the amount of $28 million, which includes treble damages; and (2) to exclude the pharmacy and its current or former owners, officers or directors during the covered conduct period from participating in all federal health care programs.
To obtain this ability to pay settlement, WELLHealth not only had to provide financials so that the Government could evaluate its ability to pay but also had to swear to and warrant the accuracy of its financial statements. Additionally, WELLHealth promised to provide yearly balance sheets for the business, so the Government could evaluate the pharmacy's net profit calculation.

From the perspective of FCA defendants, such ability to pay settlements as these are a combination of good news and bad news. Good news because such settlements permit longer repayment periods, the ability to sell properties in the future, and the ability to apply a portion of future profits to pay off settlement obligations. Bad news because the financial obligations and the disastrous exposure from a consent judgment resulting from a default extend years into the future. Notwithstanding the mixed message, such settlements show that the Government is sometimes willing to go outside its comfort zone of "this is the way we always do it" in order to secure an FCA settlement.

A. Brian Albritton
May 2, 2017

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