Defense of Physicians & Other Prescribers of Compounded Medications
Over the last decade, physicians and medical providers have faced increased government scrutiny, with prosecutors now using federal health care laws to challenge physicians’ medical judgments. Most recently, the government has focused intensely on physicians and other health care professionals that wrote a high-volume of prescriptions for compounded topical pain and scar creams during the period of 2013 through mid-2015. In these circumstances, the government closely scrutinizes whether the physician had any sort of financial incentive from the compounding pharmacy, or from an affiliated marketing company, to write these high dollar value prescriptions.
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 from 2013 through mid-2015. The government’s interest is piqued even further if there was a sudden and precipitous increase in the medical professional’s prescribing patterns, or if the physician never previously prescribed compounded drugs.
- Using “data mining,” the government also focuses upon physicians and other medical professionals who wrote compounded pain and scar prescriptions for out-of-state patients, leading to a potential inference 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.
- In cases where “research fees” were paid to prescribing physicians, the government closely examines whether there was any legitimate, bona fide research by examining: (i) was there a detailed research protocol, (ii) whether the research was approved by appropriate government bodies, (iii) whether the research data was collected and collated in a timely fashion, (iv) whether the research results were analyzed by a statistician, and subsequently peer reviewed or published, (v) whether 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 the physician had a written contract, whether the contract lasted a year or more, whether the hourly rate was based on fair market value, whether the physician had legitimate job duties and was required to report hours on a periodic basis, and whether the Medical Direct payments varied based on the volume or value of the physicians’ compounded prescriptions.
Speak to a Miami Healthcare Lawyer Right Away
The healthcare attorneys at Stumphauzer & Sloman 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. 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 Miami healthcare lawyer that thoroughly understands the operations of compounding pharmacies, and that has a wealth of experience defending federal health care fraud investigations. The attorneys at Stumphauzer & Sloman are uniquely qualified to represent you in these high-stakes government investigations where your freedom, livelihood and professional reputation on the line.