Healthcare Regulatory, Compliance & Operations

We help clients manage

• Assessing regulatory changes affecting operations
• Striking balances among cost, quality and efficiencies
• Establishing cohesive workplace environments
• Coordinating billing and coding requirements in different settings

Interdisciplinary team includes experienced healthcare professionals

• Attorneys with prior experience as hospital general counsel and compliance counsel
• Team members with healthcare experience as nurses, medical assistants, and coders
• Former hospital administrators
• Outside healthcare consultants

Our attorneys combine real-world experience with innovative legal strategy and a depth and breadth of regulatory knowledge to drive practical, real-time decision making.

Our clients span the healthcare industry

• Ambulatory Surgery Centers
• Home Health Agencies
• Hospitals and Health Systems
• Individual Physicians and Physician Practices
• Long-term care facilities including nursing homes, CCRCs, and assisted living facilities
• Medical Device Companies
• Retail and Specialty Pharmacies

Assess regulatory, compliance, and operational concerns and practically address identified challenges  

With real world industry experience and broad industry knowledge, Nelson Mullins offers healthcare providers practical advice coupled with innovative legal strategy to navigate the complexities of dynamic healthcare environment to move their business forward serving the healthcare needs of our communities.

Our healthcare regulatory, compliance, and operations services allow you to

• Coordinate Billing and Coding Audits, Reimbursement Denials and Overpayment Analyses
• Develop compliance programs for numerous platforms
• Provide a cohesive workplace environment − with appropriate employee relations and benefits
• Establish internal programs for contract review
• Implement Medical Staff Bylaw review systems
• Make appropriate decisions regarding patient care issues – including relating to informed consent, DNRs, durable powers of attorney, use of restraints
• Navigate potential regulatory pitfalls − involving Stark, Anti-kickback Statute, corporate practice of medicine, fee-splitting, False Claims Act, Sunshine laws, CMPs, and state licensure
• Obtain 340B and GAO pricing

Following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.

Experience-General

• Represent neonatology group in contracting, HIPAA and fraud and abuse compliance matters
• Represent Virginia hospital system in drafting, review, compliance and counseling regarding medical staff bylaws and related disciplinary actions
• Represent hospital and physician clients in drafting and auditing fraud and abuse and HIPAA compliance programs
• Develop physician contract review and compliance program to assist hospitals in monitoring physician contracts with applicable laws
• Develop hospital medical staff bylaw review protocol to assist hospitals in updating, monitoring, and enforcing medical staff bylaws
• Represent hospitals in overseeing development clinical trial programs and negotiating agreements with sponsors and pharmaceutical companies
• Represent providers and suppliers with reimbursement recoupments and denials involving government and non-government payors
• Work with health systems and community hospitals to manage liability exposure in patient care decisions such as transfer, discharge and end-of-life decisions, through interpretation of insurance policies, regulations such as EMTALA, and hospital by-laws
• Structure physician employment and referral relationships compliant with state and federal laws such as Stark, anti-kickback and corporate practice of medicine doctrine including medical director agreements, professional service agreements and call coverage agreements
• Assist with the provider enrollment and change of ownership (CHOW) process including updates of existing provider applications and new provider applications and obtaining National Provider Identifiers (NPIs)

Hospital/Physician Peer Review

• Obtained summary judgment in federal and state court peer review cases and had these wins affirmed on appeal
• Defended peer review recommendations in hospital peer review hearings and appeals
• Provided hospitals and medical staff leadership with advice on peer review issues

Professional Board Licensing and Permitting

• Obtained nonresident licensing for pharmacies
• Obtained licensing exemptions, waivers, and other approvals that allowed the implementation of new healthcare delivery models
• Defended physicians, pharmacists, and nurses in professional licensing hearings

State and Federal Surveys

• Represented multiple hospitals in formulation and negotiations of corrective action plans and defense of EMTALA survey actions
• Represented multiple hospital and nursing home clients in defense of Medicare survey actions
• Represented nursing home clients in Medicare and Medicaid revocation actions