As you navigate the complex world of pharmacy operations, it is crucial to stay abreast of the regulatory landscape. A failure to do so can come with harsh consequences. In a recent example, Texas authorities accused two pharmacy owners of healthcare fraud. The prosecution claimed the pharmacy owners worked with physicians to provide medically unnecessary compound creams. The prosecution presented evidence of illegal kickbacks and bribes. Upon review, a federal jury agreed with the prosecution and convicted the men of various crimes including healthcare fraud and money laundering. Sentencing will occur at a later date, but they each face decades imprisonment.
Pharmacy owners can mitigate the risk of similar allegations of wrongdoing by becoming familiar with applicable regulations including those at the federal, state, and local levels.
Federal Oversight: DEA, CMS, and More
At the federal level, your pharmacy needs a DEA registration to handle controlled substances. This is your golden ticket to legally distribute medications that can potentially be abused. Keep this registration current.
Next, Centers for Medicare & Medicaid Services (CMS) enrollment. If you are serving patients on Medicare or Medicaid, enrollment is a must. It better ensures your pharmacy gets reimbursed for those prescriptions that keep your community healthy.
Texas state permits: License to operate
In the heart of the Lone Star State, the Texas State Board of Pharmacy is the gatekeeper. They issue the permits that let you operate legally. This includes a bevy of specific permits, from your pharmacy license itself to additional authorizations for services like compounding.
Mitigating Legal Risks
When it comes to the Stark Law, the Anti-Kickback Statute, and the Eliminating Kickbacks in Recovery Act (EKRA), the name of the game is compliance. These laws aim to prevent unethical practices like referral incentives.
To protect your pharmacy:
- Establish clear compliance programs.
- Train your staff thoroughly on what constitutes a violation.
- Regularly audit your practices and make changes as needed to ensure compliance.
Staying on top of these regulations is no small feat, but it is essential for running a successful pharmacy in Texas. Keep your DEA registration and CMS enrollment in check, secure your state permits, and adhere to local laws. A failure to comply can come with more than a steep financial penalty, it can come with allegations of criminal wrongdoing as discussed in the case above. The case serves as a reminder for pharmacy owners to always be vigilant against legal risks and foster a culture of compliance. With careful attention to these guidelines, you can focus on what you do best — caring for your community’s health.
Attorney John Rivas is responsible for this communication.