Defense of Compounding Pharmacy Owners and Compounding Pharmacists
Compounding pharmacy owners and compounding pharmacists can expect intense government scrutiny, especially if the pharmacy distributed pain, scar and other compounded formulations that were reimbursed by Tricare via Express Scripts or CVS Caremark. The government has focused on several issues, including:
- Pharmacies and pharmacists that filled a high volume of compounded medications that contained identical, or nearly identical, chemical components, leading to an inference that the drugs were not truly custom-compounded to meet a patient’s unique needs, but instead were bulk manufactured.
- Pharmacists that failed to exercise reasonable diligence to confirm the existence of a doctor-patient relationship, especially in circumstances where pharmacy records reflected that the physician and patient lived in different states. The government often seeks to verify whether the pharmacist or technicians made “verification calls” to confirm that these patients had, in fact, spoken with a doctor and requested a topical pain or scar cream.
- Pharmacies that supplied physicians’ offices with pre-printed script pads, especially those reflecting controlled substances. The government’s scrutiny is further focused if the pre-printed formulations were frequently changed in a manner that increased the resulting reimbursement rate.
- Pharmacies that paid percentage-based commissions to individual marketers or marketing companies to promote their compounded products. The government’s view is that these commissions violate the Anti-Kickback Statute and do not fit within a statutory exception or safe harbor.
- Pharmacies that sponsored “research studies” for the compounded drugs, and who paid research fees to prescribing physicians. In these circumstances, the government closely examines whether the research study was “bona fide” by examining: (i) was there a detailed research protocol, (ii) 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.
- Pharmacies that hired and paid prescribing physicians to serve as Medical Directors. In these circumstances, the government closely examines whether the Medical Director relationship was bona fide. 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.
- Pharmacies and Pharmacists that automatically sent refills without contacting the patient. The government’s focus is further intensified if the pharmacy encouraged marketers to seek, and physicians to write, prescriptions reflecting “99” or “PRN” refills.
If you are a pharmacist or a pharmacy owner, and if you have received a subpoena, civil investigative demand or have other reasons to believe you are under investigation, it is imperative that you hire a Miami healthcare lawyer who thoroughly understands the operations of compounding pharmacies, and that has a wealth of experience defending federal health care fraud investigations.
Stumphauzer & Sloman: We Have a Miami Healthcare Lawyer Available to Help You
The lawyers at Stumphauzer & Sloman are uniquely qualified to represent you in these high-stakes government investigations where pharmacy owners and pharmacists have their freedom, livelihood and professional reputation on the line.