Healthcare is one of the most heavily regulated, complex, and scrutinized industries. Providers and contractors face enormous challenges navigating the ever-changing regulatory healthcare landscape, especially for small and midsized companies because they cannot afford legal at the cost of large law firms. In this exceptionally challenging field, Atlas Legal applies its knowledge and experience to assist clients in identifying, avoiding, and resolving regulatory compliance and enforcement issues over a broad cross-section of healthcare platforms, including medical, pharmaceutical, laboratory, dental, chiropractic, medical device, and mental health. The Atlas team also provides critical counsel to companies leading market innovation, such as telehealth, direct to consumer (DTC) products, value based reimbursement, and accountable care organizations (ACO). Regardless of size or level of sophistication, healthcare providers are generally held to many of the same standards as large urban medical centers. Atlas works with providers on both ends of the spectrum to manage the high-stakes risk of governmental scrutiny, such as fraud and abuse claims, government and whistleblower enforcement actions, significant civil and criminal liability, and potential exclusion from participation in federal payor programs.

Atlas Legal’s healthcare team also regularly advises healthcare providers in their day-to-day operations to provide the highest level of care, encourage innovation, and retain quality employees. Atlas Legal’s healthcare team is also equipped to handle the technological and data-driven demands of its clients without overcomplicating an already complex business environment. 

Healthcare

Atlas Legal’s healthcare expertise includes the following:

Advising providers on how to comply with all applicable state and federal laws governing referrals and provider compensation, including the federal Anti-Kickback Statute (AKS), Stark law, Eliminating Kickbacks in Recovery Act of 2018 (EKRA), False Claims Act, and state self-referral and reimbursement laws

Negotiating and drafting contracts to comply with AKS, Stark and EKRA regulations and safe harbor requirements, including bona fide employment agreements, personal services agreements, and management services agreements

Providing counsel on a wide range of health data security and privacy issues under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH), and the HIPAA Omnibus Final Rule, including counsel on privacy and security compliance and managing providers’ security incident response, including breach notification evaluation, remediation, and potential breach reporting.

Assisting clients in the development and marketing of direct-to-consumer products through all phases, including initial classification, premarket and FDA approval, authorization applications, and aftermarket compliance

Representing individual providers with state licencing requirements and governing board compliance, including assistance handling board complaints, investigations, and enforcement action

Counseling clients on federal and state requirements for telehealth and assisting providers in developing/marketing telehealth programs

Providing healthcare specific due diligence and business sale services, including review and drafting of privacy and security representations and warranties, HIPAA policies and procedures, business associate agreements, breach logs and reporting documents, and performing compliance and risk evaluations for buyers

Assisting clients with corporate and employment needs specific to the healthcare setting, such as corporate and ownership structures to avoid the corporate practice of medicine, review and drafting of vendor and contractor agreements to ensure compliance with federal and state law, and provide internal compliance training on topics like HIPAA security requirements, anti-kickback regulations, and reimbursement rules.