Pharmacy Healthcare Lawyer
Pharmacies in Florida are some of the most heavily regulated businesses in the United States. Besides various federal and state regulations and licensing, they also have significant legal liabilities and other industry specific rules. In addition to this, there are the standard business related legal concerns that need to be addressed. If not handled properly, all of these regulations and issues can be suffocating for a pharmacy and cause undue business hardship.
It is strongly recommended for those interested in starting, owning or operating a pharmacy in the State of Florida to consult with an attorney specializing in healthcare and pharmacy law. Our team of expert lawyers have decades of experience working with pharmacists as well as owners, managers and operators of retail pharmacies. If you are in need of legal advice or assistance for your pharmacy, please do not hesitate to contact us today to get started.
Establishing a Pharmacy
One of the most complicated and difficult processes involved with the retail pharmaceutical industry is the establishment of a new pharmacy. Besides the legal aspects of setting up any business, there are many pharmacy specific requirements and certifications needed in order to establish a pharmacy. Most of these are through the federal government, however the State of Florida also has certain regulations that must be followed.
One of the first things that must be done is obtaining permits from the State of Florida. Before any permits are issued, the state will conduct an inspection of the pharmacy to ensure it is in compliance with state and federal rules. After the state permit has been obtained, the pharmacy can file for DEA registration and CMS enrollment. Once this has been completed, retail business operations can commence.
Working with an attorney during the startup phase of a pharmacy is critical to ensuring not only its compliance with a plethora of legal requirements but also to ensure its long term business success. Our expert attorneys work with a variety of different types of pharmacies from independent and single location operations to large scale chain pharmacies with multiple locations.
Operation and Compliance
While the startup of a pharmacy is the most complex and challenging legal aspect of the business, operating and managing a pharmacy can involve many legal issues. One of the largest issues faced by pharmacies is regulatory compliance violations and license suspensions or revocations. These can occur due to improper employee training, or as a result of honest mistakes or misunderstandings.
Many of these issues can be avoided with proper training and guidance from attorneys specializing in healthcare and pharmacy law. While training and policy manuals are required during the inspection phase when a pharmacy is being established, they also are exceptionally useful afterwards for recurring training. This continuing education helps to ensure ongoing compliance with state, DEA, HIPAA and CMS regulations. Our attorneys can help to craft these policy and procedural manuals, as well as offer assistance in the design of ongoing educational courses.
Investigations and Disciplinary Actions
Unfortunately, there are times when a pharmacy may be facing licensure disciplinary actions by the state, BOP or DEA. These are serious situations and it is vital that they are handled appropriately to minimize their damage to the business. In addition to this, these agencies also conduct investigations and audits, which open a pharmacy up to possible litigation and disciplinary action.
Outside of agencies directly involved in the regulation of pharmacies, there are other parties that can be involved in the investigation and auditing of pharmacies. Conducted by Medicare, Medicaid and other third party payor auditors, these audits and investigations can cause issues surrounding deficiencies and over payment demands. These issues should not be overlooked as they can cause pharmacies a considerable amount in fines, fees and lost revenue from payment mismanagement.
Because of the serious impact that investigations, audits and disciplinary actions can have on a pharmacy, it is strongly recommended to work with an attorney specializing in pharmacy law. In many cases, having this legal assistance is the difference between continued future successful operations and struggling or being unable to stay open. Our pharmacy lawyers have years of experience working with pharmacies and regulatory agencies to achieve an amicable outcome for all parties involved and ensure continued operations.