Health Care

Overview

Today’s health care environment is defined by dramatic change, extraordinary competition and rising regulatory complexity. In this dynamic marketplace, the efficient delivery of expert legal services is a necessity. Arent Fox combines lawyers from several practice areas to provide coordinated representation in all aspects of health care law.

Reimbursement and Coverage

The successful launch and sale of a health care product or service depends largely on the availability of adequate Medicare, Medicaid and third-party payer coverage and reimbursement. Whether a product or service is a state-of the-art emerging technology or considered an established standard of care, Arent Fox experts have the experience to develop and implement local and national strategies to champion new reimbursement and to address existing coverage and payment inequities. The health care practice includes former legal and policy advisors to the Medicare and Medicaid programs, health care professionals, a former C.E.O. of a specialty pharmacy distribution company and in-house science consultants with expertise in organic chemistry, physics and the biologic sciences.

A governmental or commercial payer’s decision to cover a service or product is influenced by circumstances that develop long before the service or product becomes available to patients and the health care community. We work with clients to ensure that clinical trials are designed to collect data critical to address the safety and efficacy standards for FDA approval as well as the medical necessity standards of payers. We also assist clients determining the most advantageous regulatory approval strategy to position a product for third-party reimbursement.

Fraud and Abuse Counseling

Arent Fox counsels clients on how to avoid violations of the federal and state laws that regulate the conduct of health care providers. These include anti-kickback statutes, self-referral laws, fee split laws, corporate practice of medicine doctrines and certificate of need and licensing requirements. We also have experts on laws and regulations applicable under the Medicare program, including the reassignment rule and restrictions on billing for certain purchased services.

We provide fraud and abuse counseling to every segment of the health care marketplace, including physicians and physician practice management companies, hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, clinical laboratories, diagnostic centers, home health agencies, health maintenance organizations and medical device and drug manufacturers.

Compliance

Prompted by government enforcement actions and a series of program compliance guidelines issued by the Health and Human Services Office of Inspector General (OIG), health care companies over the past decade have come to view internal compliance programs as their first line of defense in preventing misconduct.

Arent Fox assists health care companies in navigating the complex, ever-changing world of government regulation and enforcement. Our compliance-related legal services include:

• Compliance Program Development. Assisting with the development and implementation of compliance programs for all types of health care providers, as well as for pharmaceutical and medical device manufacturers. Our expertise ranges from working with the client to formalize and document existing compliance activities, to designing entire compliance programs specifically tailored to the client’s structure and corporate culture.
• Compliance Training. Providing ethics and compliance training and developing interactive Web-based training programs used by some of the nation’s largest health care companies.
• Internal Investigations and Legal Audits. Conducting internal investigations of alleged misconduct and perform legal audits as part of clients’ ongoing compliance efforts.
• Voluntary Disclosures. Advising clients on legal responsibilities in redressing Medicare or Medicaid overpayments, billing errors and misconduct.
• Investigation Defense. Responding to government investigations of health care fraud allegations and defend health care companies in civil, criminal and administrative enforcement actions.
• Corporate Integrity Agreements. Negotiating Corporate Integrity Agreements, or CIAs, with the OIG that have included groundbreaking provisions aimed at ensuring efficient and effective government oversight of clients’ operations.

Regulatory Due Diligence

Arent Fox has developed a specialized practice in regulatory due diligence for merger, acquisition and financing transactions. For acquiring companies, venture capital firms, lenders and underwriters, we put our regulatory knowledge and extensive investigative experience to work in assessing target companies in a health care context.

We look at issues such as licensure, certification, coverage and reimbursement, billing and coding, marketing and financial relationships with physicians (anti-kickback and Stark law compliance) to evaluate a target’s compliance with applicable laws, rules and regulations. We identify and assess a target’s regulatory risks and communicate them to clients.

False Claims Defense

Arent Fox counsels clients who are under investigation by the Department of Justice, US attorneys offices, the FBI and the OIG. We also work closely with lawyers in various state Medicaid Fraud Control Units. These investigations can involve allegations of billing fraud, kickbacks, violations of the Stark self-referral law, wrongdoing during clinical research and violations of the Prescription Drug Marketing Act.

We have represented companies in three of the major industry investigations over the last 15 years: the clinical laboratory industry, the dialysis industry and the perenteral nutrition industry. In the clinical laboratory industry, we represented National Health Laboratories, which settled for a record-breaking amount of $111 million in 1992. In the dialysis industry, we represented National Medical Care, which settled for a record-breaking amount of $486 million in 2000. We now represent a major supplier in the perenteral nutrition industry, where the first case to settle was Abbott Laboratories, which settled for $660 million in 2003.

Joint Ventures

Arent Fox advises providers on the structuring of joint venture arrangements to comply with the requirements of federal and state fraud and abuse laws, including the Medicare/Medicaid Anti-Kickback Statute and the Stark law. We work with physicians in establishing joint venture relationships with other entities, including hospitals, suppliers of services and other physician groups. We advise local and national hospital clients on the legal requirements to establish joint ventures with other providers and suppliers in a variety of states. We develop joint venture documents for physician groups, hospitals, dialysis companies, ambulatory surgery centers, diagnostic imaging companies, long-term care therapy companies and lithotripsy providers.

HIPAA/Health Privacy Advice

Arent Fox helps health care providers, ranging from small physician practices to major publicly traded companies, develop appropriately scaled approaches to health privacy. We have written chapters on privacy compliance in management handbooks targeted to specific segments of the health care industry and lectured extensively at industry conferences and workshops. We present executive briefings and seminars to acquaint top management with the burdens and responsibilities that providers, health care clearinghouses and health plans face under the Privacy Standards issued to implement the Administrative Simplification title of the Health Insurance Portability and Accountability Act (HIPAA).

We counsel pharmaceutical and medical device manufacturers dealing with privacy issues that arise during clinical trials. We assist manufacturers design marketing programs that met their promotional objectives without violating state or federal privacy laws. We develop training programs to sensitize field sales forces to the privacy issues confronting their customers, and we help manufacturers deal effectively with the privacy procedures adopted by their health care customers.

Telemedicine and E-Health

Telemedicine—the exchange of medical information from one site to another using electronic communications—offers consumers and providers enormous opportunities for expanded access. As with any burgeoning technological innovation, providers and entrepreneurs face an array of legal and policy issues. Some recent telemedicine activities include:

• Representing nationwide providers of telenursing services on licensing and contract issues.
• Advising Internet-based health information providers on contract drafting, advertising review and fraud and abuse.
• Representing a major university in establishing international telemedicine ventures.

Arent Fox’s experts in telemedicine speak at conferences sponsored by the American Telemedicine Association, the Center for Telemedicine Law, the American Health Lawyers Association and others.

Arent Fox helped pioneer the field of e-health—a term that encompasses Internet medicine and virtually everything related to computers and medicine. We advise many of the nation's leading e-health companies on legal and regulatory issues unique to e-health enterprises.