Our pharmacy lawyers represent pharmacy owners and managers (e.g. pharmacists in charge, prescription department managers, and consultant pharmacists), with issues related to the ownership and operation of pharmacies. Our clients include pharmacists, community, specialty and compounding pharmacies, durable medical equipment suppliers and home medical equipment providers.
We assist pharmacy owners with:
Whether you are opening your first pharmacy or have experience in pharmacy ownership, our pharmacy lawyers can help you navigate and manage the legal aspects of pharmacy ownership. Pharmacy is a highly regulated industry, and our pharmacy attorneys aim to assist pharmacy owners with various issues, from business formation to defense of disciplinary issues. Business formation of a pharmacy often begins with preparation and/or negotiation of shareholder, ownership and franchise agreements. Inevitably, business disputes arise between owners and a well-prepared agreement can save time and money in the future. Similarly, appropriate business structuring can limit exposure, and better protect the business. Our pharmacy lawyers assist pharmacy owners with business formation and structuring, as well as preparation and filing of all necessary business documents.
Our pharmacy lawyers also assist with drafting and review of employment contracts. We consider potential state and federal anti-kickback and Stark laws when drafting employment contracts between owners and managing pharmacists, and can help draft contracts that meet safe-harbor provisions. We also assist with the review and negotiation of managed care organization contracts.
Our pharmacy lawyers also assist with procedural and compliance issues. We can help owners obtain the required state permits, DEA registration, and CMS enrollment. Prior to obtaining a permit, the state will conduct a pharmacy inspection. Our pharmacy lawyers work with owners and pharmacy staff to ensure compliance prior to the inspection and help address any deficiencies that may present. Once the pharmacy has the proper state permit, we can help obtain a DEA registration, and assist with enrollment with CMS and third-party payors.
We also offer start-up pharmacies is assistance with preparing policy and procedure manuals. These manuals are not only required during the initial pharmacy inspection, but they are valuable in helping ensure future compliance with State, DEA, HIPAA, and CMS regulations. Our pharmacy lawyers also assist existing pharmacies with review and updating of policies and procedure manuals to ensure compliance with current regulations.
While buying an existing pharmacy may sound like an easier task than establishing a new pharmacy, it requires different considerations and presents additional legal issues. Our lawyers assist pharmacy owners during all stages of pharmacy purchasing. One of the first things to consider, apart from financial considerations, is whether the pharmacy has had prior legal or disciplinary actions or is currently under investigation, action or audit. While these issues need not prevent the purchase, they should be reviewed by an attorney. Some current and future actions will not affect the new owner; however, some actions may. Also, fully understanding how these actions may affect the business, may be useful in negotiations.
Negotiations can be particularly difficult when the parties do not have equal power or resources. This is often the case of pharmacy sales to big box stores. Our attorneys are trained negotiators. We strive to not only take the stress out of the negotiation but to help clients get the best deal. Once a deal is reached, we ensure that all elements of the sale are included in the agreement. Given the serious repercussions of the False Claims Act and Anti-kickback laws, it is important to ensure that certain representations and warranties are contained in the purchase agreement and the failure to include these provisions can lead an innocent purchaser down a road involving civil fines and criminal penalties.
Once the sale is finalized, new owners will need to negotiate employment contracts with either existing or new staff. Employment contracts should take into consideration stark and anti-kickback laws and safe harbor provisions. In the case of existing employment contracts or informal arrangements with sales agents, contractors, and providers, new owners should ensure that the practices of these individuals do not violate kickback laws.
Purchasers’ will also need to file a change of ownership applications with the appropriate agencies to ensure that any interruption of business activity is prevented or minimized. The owner will need to conduct an inventory, properly handle records, and ensure that certain information regarding the sale is timely reported to the State and DEA. Our pharmacy attorneys can assist new owners in making sure they timely fulfill their legal responsibilities when purchasing a pharmacy.
For pharmacy owners selling a pharmacy, the negotiation stage is often the most stressful, especially if selling a pharmacy to a big corporation. Large corporations often have pharmacy acquisition teams that can make small pharmacy owners feel powerless during the sales process. Whether selling to a big corporation or small pharmacy owner, our attorneys assist with sales negotiations to help owners obtain a deal that they are satisfied with. Once a deal is made, our attorneys can draft or review sales documents and ensure that the terms of the agreement are contained in the sales contract and that no additional terms are added without the owner’s understanding of those terms. Additionally. our attorneys can help ensure that owners meet all state and DEA regulations regarding change of ownership, such as inventory and transfer of controlled substances, surrender of permits and registration, transfer of records, reporting of sale, etc.
Expanding an existing pharmacy or adding a new pharmacy location is an exciting achievement for pharmacy owners. We recognize the amount of planning, hard work, risk, and the tough decisions it takes to grow a pharmacy and our pharmacy law attorneys want to help pharmacy owners protect their growing investment.
Our attorneys can assist pharmacy owners during the planning stage by determining the best business structure for the corporation, given the new location. The best structure is one that considers the owner’s desired level of risk, liability, tax responsibilities, level of administration, etc., and future goals of the corporation. Our due diligence process ensures that the proper transactional structure is employed to either avoid an interruption of cash flow or prevent previous licensing issues to haunt the new business entity.
Our pharmacy attorneys also assist in obtaining the proper permits, licenses, and registrations for new locations.
Whether you are closing or transferring ownership of a pharmacy, the state and DEA have various laws and regulations requiring surrender of permits and issued supplies, written notice of certain terms of the sale and/or closure, transfer of certain records, notice to the public, proper transfer or destruction of controlled substances, etc. Closure of a pharmacy is no small task and should not be undertaken alone given the serious repercussions of failing to follow the proper procedures. Our pharmacy law attorneys are here to assist pharmacy owners during this hectic time to ensure that they meet all state and federal regulations regarding the closure of a pharmacy and that such requirements are completed timely. Sadly, many administrative actions against pharmacies are for failure to report closure or transfer of ownership. Given that many pharmacy owners hold professional licenses, or go on to operate new pharmacies, licensed businesses or rely on CMS enrollment, it is important that they comply with all closure regulations to protect their future business and/or licensing interest.
We assist pharmacists and pharmacy owners with prior disciplinary and/or criminal histories, obtain proper permits, licenses and CMS enrollment. While prior disciplinary and criminal histories can make pharmacy applications a little more difficult, these prior issues do not necessarily mean an application will be denied. Certain convictions related to fraud, violations of the Controlled Substances Act (CSA), and ability to practice pharmacy are grounds for the state Board of Pharmacy and CMS to deny an application; however, most other convictions and disciplinary actions are subject to the Board’s discretion. Our pharmacy law attorneys can assist applicants with prior criminal or disciplinary actions to prepare their applications so that it discloses all necessary information in the best possible light while taking care to limit the information that is not necessary and may prevent licensure. It is important to note that failure to disclose required information can lead to suspension of a license, and even criminal charges.
Our pharmacy attorneys also assist pharmacists accused of failure to report certain information regarding prior disciplinary and criminal convictions.