Healthcare Regulatory

Certificate of Need

Our lawyers also possess experience representing clients in certificate of need matters, including obtaining exemptions for the acquisition of health care facilities or technically innovative equipment, representing clients in contested certificate of need hearings, and obtaining certificates of need for the development of new health care facilities.

Compliance Counseling and Defense 

Our Health Law Practice has devoted considerable time and resources to helping health care service providers achieve and maintain compliance with the array of state and federal laws that regulate their operations. Our lawyers have experience interpreting the Medicare and Medicaid anti-kickback statutes, Stark Law, False Claims Act and other applicable laws and regulations. We structure transactions and review contracts, billing procedures, joint venture arrangements, leases and investments to help ensure that clients remain in compliance with the numerous laws and regulations affecting the health care industry.

In addition, our managed care experience enables us to help clients avoid new types of fraud and abuse targeted in managed care and insurance arrangements by federal and state authorities. We have acted as counsel and have conducted numerous legal risk audits to assist clients with their compliance efforts. We have also helped clients develop, implement and monitor comprehensive legal compliance programs for single and multiple hospital organizations.

We have experience defending health care providers in major fraud and abuse investigations under the Stark Law, anti-kickback statutes, False Claims Act and similar laws, several of which involved grand jury proceedings and qui tam actions. We have worked with Medicare carriers and intermediaries, U.S. Attorneys General and the Health and Human Services Office of Inspector General (OIG) to defend clients and negotiate settlements. We have been involved in internal corporate investigations of suspected misconduct, including Medicare fraud and abuse.

Our lawyers regularly advise clients regarding the numerous fraud and abuse questions that arise when health care entities wish to engage in transactions or form joint ventures. Our lawyers work with a variety of clients, including hospitals, health care systems and provider groups to assess, structure, modify and document compensation and ownership arrangements, recommend methods for ensuring compliance and vigorously defend clients facing allegations of misconduct.

Electronic Health Records and Information Systems

Health care providers face significant challenges under the Health Insurance Portability and Accountability Act (HIPAA) and more stringent state laws. Our lawyers work closely with administrators and medical staff to audit medical records and information systems to ensure compliance with HIPAA's complex regulations. We help clients develop, document and implement authorization procedures; information security systems; third-party administrator and outsourcing agreements; electronic medical records, claims, billing and reimbursement systems; use of "de-identified" information; and practice guidelines and clinical pathways on clinical information systems.

We work directly with insurers and third-party administrators to help them understand HIPAA's requirements concerning protected health information and apply the requirements of HIPAA into their larger information technology initiatives. We also work with employers, unions and other associations with self-insured plans to ensure that they are adhering to HIPAA's privacy and security rules. We counsel employers on the rules of hybrid entities, "ownership" of health care data, privacy and firewalls, and whistleblower protections and investigations.

Legislative Advocacy and Analysis

Our health law lawyers, along with our government relations professionals, have experience working with the legislative and executive branches of federal, state and local governments, which enables us to closely monitor and regularly report on any regulatory or licensing developments. Consequently, we are able to analyze the impact of legislative and regulatory proposals on clients' objectives and priorities.

Licensure 

Our Health Law Practice works closely with healthcare providers and other industry participants to ensure that their business operations are in full compliance with all applicable licensing regulations and requirements. We provide initial counseling and audit services and also help clients develop and implement programs that track and maintain licensing status. Our practice and experience allows us to counsel clients with regard to licensure, certificate of need and other regulatory schemes throughout the Southeastern United States.

Reimbursement

Health care providers face a complex, evolving system of rules and regulations governing Medicare coverage and reimbursement for services. This increasing level of regulatory scrutiny poses significant challenges to providers' ability to continue profitable operations. Our lawyers recognize the challenges that hospitals, clinics, physicians and specialty providers face, and work closely with clients to develop and implement legal strategies that increase their ability to achieve Medicare compliance while preserving Medicare revenues.

Our lawyers also assist clients with their interactions with central and regional offices of the Centers for Medicare and Medicaid Services (CMS) and Medicare intermediaries and carriers. We monitor federal regulations and CMS issuances to analyze areas of legal risk and emerging issues that may impact our clients. Because Medicare rules are constantly changing to reflect the current public opinion, political climate and state of the health care industry and medical research, our lawyers are dedicated to keeping ahead of the curve by working with clients, legislators and administrative bodies to identify issues, analyze proposed rules or modifications and influence Medicare policy in order to benefit our clients.

Hospitals, Skilled Nursing Facilities and Other Medicare Part A Providers

Our lawyers have experience addressing the countless Medicare coverage, billing, reimbursement and compliance issues confronting providers. We advise clients with respect to cost-reporting issues and provider-based status, graduate medical education rules, the "payment window" rule, coverage of diagnostic and therapeutic services rendered to hospital patients and the documentation requirements for these services. We also counsel hospitals on compliance with the conditions of participation and assist with responding to investigations, including those related to the Emergency Medical Treatment and Active Labor Act.

We have experience counseling clients on certification issues, reimbursement issues for specialty hospitals, change of ownership requirements, Medicare secondary payor rules, skilled nursing facilities, prospective payment issues and the election of hospice benefit and related certification issues. We routinely advise clients on the new outpatient prospective payment system and provider-based clinics (on-site or off-site), APCs, the prohibition against unbundling in the outpatient setting and pass-through payments.

Our lawyers also work with providers to determine the impact of new payment rules and develop methods and policies that accommodate new formulas and classifications systems while minimizing potential losses. We help clients take advantage of co-payment reduction opportunities, analyze costs of usage and services within payment classifications, recommend strategies to maximize applicable adjustments based on applicable wage and geographic assignments, work to ensure appropriate and accurate coding and billing operations and update our clients on complexities in the evolving regulations under Medicare.

Physicians and Other Medicare Part B Suppliers

Our lawyers work closely with physicians, clinics, independent diagnostic testing facilities and durable medical equipment suppliers on billing and reimbursement matters. We regularly address issues related to coverage of diagnostic services, supplier enrollment, physician reassignment and required documentation for coverage and billing (such as physician evaluation and management documentation requirements). We also advise our clients on the billing and reimbursement rules related to nonphysician practitioners and supervision requirements for diagnostic services. We assist providers with structuring delivery systems and the creation of new ventures under applicable regulations.

Tax-Exempt Organizations 

Our Health Law Practice has experience working with tax-exempt health care organizations on a variety of challenging issues. We have represented organizations before the IRS at all points in their life cycles, from the filing of initial exemption qualification applications and requests for private letter rulings for specific transactions to examinations of an organization by the IRS.

We have helped numerous clients develop creative strategies to comply with the restrictions on executive and physician compensation arrangements imposed on by the Internal Revenue Code. We have also helped clients minimize adverse tax consequences inherent with certain business transactions, such as the potential built-in capital gains tax liability involved with a stock sale and the tax treatment of non-competition and employment.