Practices: Compliance

Health care providers must grapple with significant regulatory and compliance issues unique to provider operations. Whether you’re a major provider organization or a solo physician, you need legal counsel on compliance that combines detailed healthcare knowledge with practical business experience. The members of our healthcare team fully understand the complex web of federal and state regulations that affect every aspect of provider operations, and are well-positioned to give you effective guidance that is customized to your business operations and planning. Senior administrators, in-house counsel, chief compliance officers and boards of directors all rely confidently on the compliance counsel that they receive from us.

Fiduciary Responsibility

As corporate counsel to many not-for-profit and for-profit provider organizations, we have gained the insight and discretion necessary to advise boards of directors and trustees on even the most sensitive compliance issues. You can call on us to review, develop and implement ethics and compliance programs to prevent or detect violations of laws and regulations, including private inurement and self-referral statutes, reimbursement fraud and abuse, credentialing and staff relations concerns, protected health information privacy requirements, and much more. Even in such specialized areas - such as the work of the board’s Medical Executive Committee or the establishment of a non-profit foundation to fund community healthcare programs with assets not directly involved in the sale of a non-profit provider organization - board members get complete information and comprehensive guidance on fulfilling their fiduciary responsibility.

An important part of the fiduciary guidance board members need is an understanding of the specialized requirements of health regulatory enforcement agencies. Our lawyers constantly interact with senior personnel from the Centers for Medicare & Medicaid Services, the Joint Commission on Accreditation of Healthcare Organizations, the Office of the Inspector General, and such state agencies as the Department of Taxation and the Health Facilities Planning Board in Illinois.

Proactive Help

Board members have special compliance needs, but all medical staff personnel have compliance responsibilities as well. Compliance audits and training are the best ways to ensure that they are met, and Ungaretti & Harris lawyers will work with you to get the job done, helping your administrators develop and implement a sound compliance strategy that identifies potential problems before they become concerns. We ask the right questions about your current compliance policies, in order to find areas that may be out of date or need improvement. The goal is to help you eliminate the problems and avoid the risk, and the key to that is developing policies that meet all legal requirements and minimize your likelihood of regulatory complaints and litigation. We review and revise such existing policies and procedures, and provide training to help your supervisors effectively implement such policies.

Fraud and Abuse

Any healthcare provider could face allegations of fraud and abuse under federal and state laws prohibiting kickbacks and regulating physician self-referral, as well as Medicare and Medicaid billing and reimbursement rules. Increasingly, such allegations expose health care providers and provider organizations to the possibility of monetary penalties and even criminal prosecution. You need informed guidance on how to structure internal investigations and litigation defenses to meet the government’s tactics head on. Because members of our firm have been senior enforcement officials in both the United States Attorney’s and Illinois Attorney General’s offices, we know how to structure internal investigations and litigation defenses that meet the government’s tactics head-on. Our extensive relationships with former FBI, DEA and IRS agents enable us to put superb investigative resources at your service. If you face a False Claims Act investigation by the HHS Office of the Inspector General, you can turn to us knowing that we have successfully represented providers like you in investigations, administrative proceedings and trials.

Reimbursement Compliance

Beyond issues of fraud and abuse, reimbursement concerns often center on the everyday business activities of healthcare providers. We will help your staff proactively identify reimbursement problems in your organization and work to reduce the risk involved with filing false claims, incorrectly bundling and unbundling claims for service, and billing for “unnecessary” services, working with reimbursement consultants under attorney-client privilege. You’ll get a full analysis of existing and proposed coding, billing, collection, consulting and reassignment arrangements.

Joint Ventures

Joint venture affiliations between provider organizations and physicians can be an integral part of a cost-effective healthcare, but all participants need help with structuring the venture to ensure that it meets all antitrust and other regulatory requirements. Because a joint venture is in effect a “virtual merger,” you will benefit from our ability to ensure that you comply with all antitrust requirements and related fraud and abuse enforcement and regulation. That includes counseling on state certificate of need reviews and federal scrutiny to guard against price-fixing and anticompetitive practices. You’ll get advice on the proper structuring of group purchasing arrangements, counsel on exclusive dealing and tying arrangements, guidance on pricing, and answers to questions on division of markets.

Private Inurement and Private Benefit

Your provider organization may use financial incentives to help recruit specialty practice physicians or to secure the senior administrative expertise that you need. However, nonprofit healthcare organizations cannot allow any part of their net income to “inure” to the benefit of a private individual – or risk losing their 501(c)(3) tax-exempt status. We can give you sound guidance in structuring physician recruitment packages in order to avoid private inurement or impermissible private benefit sanctions. Our lawyers also give your tax-exempt organization the guidance you need to avoid “excess benefit” transactions with executives and other insiders, which can cause the IRS to impose intermediate sanctions against both your organization and individual officers and directors.

Tax Exemption

For tax-exempt entities entering business transactions with taxable entities, we maintain compliance with 501(c)(3) exempt classification requirements through appropriate revision of charters and bylaws and establishment of new corporate structures or leasing arrangements to handle unrelated business income tax issues. In Illinois and many other states, taxing authorities are aggressively seeking to use a merger or acquisition as an opportunity to reassess property and sales tax exemption. Our relationships with senior administrators at the Illinois Department of Taxation and tax authorities in other states can often help us ensure continuity of your tax-exempt status. If taxing authorities do impose assessments on your post-acquisition organization, we can pursue Certificate of Error filings to get your exemption reinstated, and can also take the matter before the Department of Taxation’s Board of Review.

HIPAA

Hospitals, nursing homes, insurers and their service providers all have ongoing responsibility not only to comply with the patient information privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA), but also to evaluate the effectiveness of their compliance efforts. Whether you’re an administrator with general HIPAA responsibilities or a Chief Privacy Officer charged with full compliance oversight, Ungaretti & Harris will partner with you to ensure that your privacy procedures are comprehensive and effective. That includes analysis and proposed remedial action on everything from written policies and procedures, to data security practices involving password protection, computer terminal access and data encryption.

EMTALA

One of any hospital’s most specialized and controversy-charged compliance requirements involves the Emergency Medical Treatment and Active Labor Act (EMTALA). Known as the “patient anti-dumping law,” it is designed to ensure public access to emergency healthcare services regardless of ability to pay. In reality, it creates a record-keeping and decision-making nightmare for many hospitals, which must respond to federal Medicare/Medicaid regulators and state enforcement agencies when there are allegations of inappropriate patient transfer – and be prepared to defend their own interests if they are inappropriately sent patients by another provider organization. Ungaretti & Harris has special experience with these complex problems, including representation at either the professional review or administrative authority levels if you face investigation.

Insightful Guidance

Today's headlines make the risk clear: the healthcare industry’s legal and regulatory structure is so complex that any organization may potentially be in violation of the law. A supervisor’s judgment in interpreting a regulation, or an executive's decision in structuring a transaction can involve subsequent allegation of illegal or criminal activity, no matter how spotless your organization's reputation. And once an allegation is made, your survival may be at stake. With Ungarteti & Harris as your compliance counsel, you get insightful compliance guidance and confidential internal investigation skill that keep you where you want to be – on the right side of the law.