Choice of Entity, Entity Formation and Continued Compliance
In the current healthcare environment, innovation is more crucial than ever. Healthcare providers and other entrepreneurs are developing more efficient and better care models of delivery every day. As a healthcare attorney, one of Ms. Nicol’s roles is to look at innovative ideas and make assessments and determinations as to the feasibility and risk associated with these business ideas. Many considerations that need to be taken into account include the following:
- Fraud and abuse laws including the Stark Law, Anti-kickback Statute, False Claims Act and other relevant federal and state fraud and abuse laws
- Prohibitions regarding the Corporate Practice of Medicine and Fee-Splitting rules
- Licensing regulations (state and federal)
- Payor requirements
- HIPAA compliance and business associate relationships
- Liability issues
Because healthcare regulations place restrictions on who can own an healthcare entity as well as how it is organized and structured, it’s critical to involve an experienced healthcare attorney in the initial stages of an entities creation. Ms. Nicol has extensive experience in counseling clients regarding the many considerations that should be taken into account when determining the type of entity works best for a particular business’ needs. She also prepares and files the corporate documents with the appropriate authorities.
Once the healthcare business has been formed and filed with appropriate state and federal agencies, Ms. Nicol continues to assist her clients to protect the proprietary and confidential business methodologies and intellectual property. She does this by advising on the enforceability of non-competes, and by drafting and negotiating non-disclosure agreements, confidentiality agreements, and other appropriate agreements. Kathrine also assists her clients with other legal matters on an on-going basis and acts as outside general counsel to numerous healthcare entities nationwide.
Purchase and Sales Agreements and Due Dilligence
Healthcare can be a “risky business” regarding audit and regulatory liability. Purchasing or selling a healthcare business requires thorough due diligence regarding the compliance of the existing entity with regulatory requirements including:
- Medicare claims submission requirements
- HIPAA compliance
- Employment law practices such as compliance with the Fair Labor Standards Act, FMLA and COBRA.
It is also important for purchasers to understand what steps must be taken to transfer Medicare billing privileges or certificates of need. In addition, there are warranty and indemnification provisions that purchasers can use to provide greater protection. In many cases, Stark and other fraud and abuse laws may be applicable. Ms. Nicol advises clients on purchasing and selling healthcare businesses including but not limited to physician practices.