Healthcare

 

These concepts are at the core of Womble Carlyle’s Healthcare Industry Practice. We have represented healthcare providers, and vendors to those providers, for almost a century. As a result, we have experienced firsthand the evolution that has transformed healthcare into the largest, most complex and highly regulated industry in the United States. We have served on the front lines with clients, dealing with the constantly changing regulatory and business issues that are distinct to healthcare.

 

Our multidisciplinary team of more than 75 attorneys allows Womble Carlyle to provide healthcare industry clients with practical, comprehensive experience to better serve patients and achieve clinical, business, and professional goals. Womble Carlyle’s Healthcare Industry Team leaders assemble customized groups of attorneys with a variety of skills and experience to meet the specific needs of each client.

 

Womble Carlyle's Healthcare Industry Practice team provides clients with thoughtful advice, careful documentation, creative negotiation and vigorous advocacy in the following areas, common to many healthcare industry initiatives:

 

Early Stage Planning and Organization: Evaluation of provider network options, including clinical and financial integration issues; choice of entity; governance provisions; licensure requirements; identification of certificate of need, anti-kickback, self-referral and related regulatory issues.

 

Antitrust Considerations: Prospective and retrospective antitrust assessment of health care transactions, including mergers, acquisitions, joint ventures and other forms of competitive collaboration; state and federal antitrust inquiries and investigations; antitrust compliance counseling; managed care contracting solutions; clinical and financial integration of health care providers; economic credentialing issues; evaluation of competitor conduct under federal and state antitrust statutes.

Tax and Tax Exempt Considerations:  Federal and state income tax applicability; assessment of private inurement/public benefit issues and overall tax-exempt status options; sales and use tax impact; joint ventures between not-for-profit and for-profit entities.

Capitalization: All types of public and private debt and equity options, including bond financing and public/private offerings; availability of tax concessions and other public incentive programs.

Project Development: All types of property acquisitions – real, personal, intangible and intellectual; associated governmental approvals and construction agreements; landlord/tenant relationships (including those with self-referral and anti-kickback implications).

Intellectual Property Protection: All types of domestic and international patent, trademark and copyright protections; preparation of appropriate licensing agreements.

Third Party Reimbursement: Public and private reimbursement programs, together with free-standing vs. provider-based considerations, “incident to” considerations, bundled payments, applicability of self-referral exceptions and anti-kickback safe harbors; and financial incentives for the meaningful use of electronic health records

Contractual Relationships: Employee, independent contractor, and vendor relationships; determination of need for background checks; negotiation and documentation of contractual joint ventures, management agreements and medical staff bylaws; physician recruitment and compensation models.

 

Employee Relations: OSHA compliance and dispute resolution; wage/hour claims; ERISA defense against claims brought by plan participants or the Department of Labor; ADA compliance; and EEOC claims and subsequent litigation; layoffs and related WARN Act considerations; union organizing campaigns and collective bargaining negotiations; employee handbooks, drug testing programs, affirmative action plans, and employment policies.

Employee Benefits: All types of qualified and nonqualified employee benefits (health; disability; long term care; life insurance; and retirement).

Patient Rights/Patient Privacy: Health information privacy and security compliance, including HIPAA and HITECH compliance and privacy and security implications of health information technology; required documentation of privacy and security practices; informed consent; advance directives; patient rights (both state and federal).

Patient Safety, Electronic Health Records, Risk Management and Quality Improvement: Privilege and confidentiality protections; processes to ensure appropriate levels of risk retention; document retention policies; implementation of electronic health records

Accreditation/Operating Compliance: Accreditation and compliance standards; documentation of compliance; evaluation of competitive pricing proposals, monopolization claims and unfair trade practices.

Government Audits/Investigations: RAC and other agency audits and investigations; self-disclosure options; “whistle-blower” exposure; defense of white-collar crime allegations.

Products Liability/Professional Liability: Protocols to minimize exposures for failures of products or professional personnel in conjunction with available insurance and other indemnity provisions. Defends health care systems, hospitals, insurance companies and physician practices in medical malpractice and professional liability disputes, including those involving catastrophic injury and wrongful death claims. Also provide guidance with compliance issues that reduce the risk of product liability, medical malpractice and professional liability litigation.

Conflict Management/Litigation/Dispute Resolution: All types of conflict management tools, mediation protocols, arbitrations and litigated defense programs; practice break ups; medical staff peer review and corrective actions; patent infringement and enforcement. FirmLogic team supports litigation efforts by collecting medical records and physical evidence, performing medical research and analysis, and vetting medical experts.

Collaborations/Mergers/Acquisitions: Mature business collaborations, mergers, acquisitions, and affiliations; physician network development; federal and state antitrust clearance.