Find an Attorney

Practices » Regulatory Compliance

Many members of our health care team were regulators in their former lives.  Consequently, we have an insider’s perspective into understanding how a regulator makes decisions and how to navigate through a challenging regulatory situation.

Our clients seek our help with a range of compliance related issues. These include:

  • Compliance audits
  • Policy drafting
  • Defense against enforcement actions
  • Seeking regulatory opinions, including office of Inspector General and Attorney General Opinions
  • How to identify and appropriately refund overpayments

It is our goal to help our clients reduce risk through proactive compliance strategies whenever possible.

Antitrust

When consolidations lead to questions of antitrust violations, our attorneys are able to help you decipher the rules and determine the best course of action.

Corporate Practice of Medicine / Dentistry / Pharmacy

Some states, including Texas, prohibit the corporate practice of medicine, dentistry, and/or pharmacy.  In other words, they do not allow corporations, such as hospitals, to employ physicians to provide patient services. But like all health care laws, there are exceptions.  Our attorneys stay abreast of these laws and structure arrangements to minimize corporate practice of medicine risks.

Fraud and Abuse

Fraud allegations can cause amazing distress to those involved and can ruin a reputation.  Because of recent changes to the False Claims Act, even innocent mistakes can lead to allegations of serious criminal violations.  Our attorneys have negotiated settlements on behalf of clients under investigation by virtually every federal and many state regulatory agencies, including the U.S. Attorney’s Office, the federal Office of Inspector General, the Texas Office of Inspector General, and the Attorney General offices.   

Maintaining complete compliance, especially within a fast evolving regulatory environment, is extremely difficult.  Consequently, many of our clients ask us to continuously monitor regulator changes and advise them when new policies are needed. Some recent areas of focus have been: 

  • False Claims – We have represented providers in investigations, administrative proceedings, and civil and criminal trials involving fraud and abuse allegations, whether brought by government or qui tam actions.
  • Stark – The complexities of the physician self-referral law and its interpretations continue to evolve as do the direct and indirect physician compensation arrangements triggering the law.  Our attorneys have an in-depth understanding of Stark, its enforcement, and how to address alleged violations.  
  • Anti-Kickback – The federal anti-kickback law and its safe harbors are intended to prevent the influence of money on provider and patient decisions.  And all states have adopted similar anti-kickback laws, though their scopes vary.  Our attorneys help clients analyze arrangements for potential violations of the anti-kickback law and defend arrangements facing allegations that they have violated in a federal or state anti-kickback law.      
  • RAC, MIC, ZPIC Audits – As of June 24, 2009, the Centers for Medicare and Medicaid Services (CMS) started to phase in its Recovery Audit Contractors (RACs) review process.  Aside from RAC audits, Medicaid Integrity Contractor Audits (MICs) and Zone Program Integrity Contractor Audits (ZPICs) are also occurring.  Our attorneys offer internal assessment reviews to determine if you are in compliance with applicable rules and provide assistance with responding to demand letters and filing appeals.

HIPAA and HITECH

The Health Insurance Portability and Accountability Act (HIPAA) and The Health Information Technology for Economic and Clinical Health (HITECH) Act are designed to protect privacy and increase medical record portability. Because of recent changes, both laws now have significant penalties for non-compliance. 

Our attorneys assist provider organizations with their ongoing responsibility not only to comply with the patient information privacy requirements of HIPAA and disclosure requirements of HITECH but also to evaluate the effectiveness of their compliance efforts.  Our assistance includes audits, analysis, and proposed remedial actions on everything from written policies and procedures for privacy protection, to data security practices involving computer hardware and software.