Compounding Pharmacy Defense
Over the last several years, federal health care fraud prosecutions have skyrocketed. Most recently, the government has focused intensely on physicians and other health care professionals who have written a high-volume of prescriptions for compounded topical pain and scar creams between 2013 and mid-2015. Specifically, the government is closely scrutinizing whether physicians had financial incentives from compounding pharmacies, or from affiliated marketing companies, to write these high dollar value prescriptions.
Prosecution Method and Theories
The government has several prosecution theories, and the following circumstances are likely to trigger government scrutiny:
- Based on the same “data mining “ techniques, the government focuses on physicians, physician assistants, podiatrists and chiropractors who prescribed a high volume of pain cream and scar cream prescriptions between 2013 and mid-2015. The government’s interest is piqued even further if there was a sudden and precipitous increase in the physician’s prescribing patterns, especially if the physician never previously prescribed compounded medications.
- Using “data mining,” the government also focuses upon physicians and other medical professionals who prescribe compounded pain and scar creams for out-of-state patients, leading investigators to assume that there was no lawful physician-patient relationship. This fact pattern often arises in cases where compounding pharmacies used “telemedicine” doctors and “call center” marketers.
- The government has also focused intense scrutiny on prescribing physicians who receive any compensation whatsoever from compounding pharmacies, whether in the form of Medical Director fees, research fees, speaking fees, or payments to designated family members, friends or associates.
- When doctors receive “research fees”, the government closely examines whether there was any legitimate, bona fide research by examining: whether (i) there was a detailed research protocol, (ii) the research was approved by appropriate government bodies, (iii) the research data was collected and collated in a timely fashion, (iv) the research results were analyzed by a statistician, and subsequently peer reviewed or published, (v) the participating research physicians were paid a set amount per patient, regardless of the time involved, or whether they were paid a percentage of the prescribed drugs.
- In cases involving “medical director” payments to prescribing physicians, the government will consider, among other things, whether (i) the physician had a written contract, (ii) the contract lasted a year or more, (iii) the hourly rate was based on fair market value, (iv) the physician had legitimate job duties and was required to report hours on a periodic basis, and (v) the Medical Director payments varied based on the volume or value of the physicians’ compounded prescriptions.
The attorneys at Stumphauzer Foslid Sloman Ross & Kolaya have extensive experience in representing physicians and other health care professionals, and we understand the theories and techniques that the government utilizes to bring enforcement actions against them. We are also well-versed in the nuances of the Anti-Kickback Statute and Stark Law, and can help you formulate an effective and comprehensive defense if you received any form of compensation from a compounding pharmacy.
Under Investigation? You Need Help
If you are a physician and you have received a subpoena or Civil Investigative Demand, or if you have other reasons to believe you are under investigation, it is imperative that you hire a lawyer that thoroughly understands the operations of compounding pharmacies, and that has a wealth of experience defending federal health care fraud investigations.
Call us Today at (305) 614-1400
The attorneys at Stumphauzer Foslid Sloman Ross & Kolaya are uniquely qualified to represent you in these high-stakes government investigations where your freedom, livelihood and professional reputations are on the line.