Washington, D.C.

Health Care

The health-care industry is dynamic and highly regulated. In health-care matters we advise a diverse cross-section of health-care providers, practice-management companies, device manufacturers, private-equity firms, and lenders. We counsel health-care entities, and those who work with them, on a broad range of health-care matters. These include compliance with fraud-and-abuse laws, Medicare payment rules, telemedicine, HIPAA and other privacy laws, and health-care data-breach response. We advise clients in health-care transactions, including acquisitions, joint ventures, contractual arrangements, and credit facilities.

Regulatory Compliance

We represent clients in matters that involve compliance with federal and state fraud-and-abuse laws, including the Anti-Kickback statute, the Stark law, and the False Claims Act. We structure and restructure health-care entities and joint ventures to comply with fraud-and-abuse laws. We also advise health-care providers in payment and claim disputes with commercial and government health plans.

We also have experience helping clients obtain advisory opinions from the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS).

Health-care laws and regulations are complicated and highly technical, filled with traps for the unwary. Penalties for violations are severe. We help clients navigate these laws to stay in compliance or become in compliance.

Whether you need quick advice to avoid a single potentially improper payment, or in-depth investigation into the reguatory requriements of a complex business relationship, we can help you stay on the right side of a complicated, sometimes byzantine regulatory scheme.

HIPAA

We represent health-care providers, and "business associates" that provide services to to them, in compliance with the privacy and security provisions of HIPAA—the Health Insurance Portability and Accountability Act.

We guide responses to data breaches and other improper disclosures of protected health information (PHI), advising clients on the necessity, nature, and scope of legally required notifications. We also assist clients with all other aspects of data breaches, from pre-breach assessments to post-breach investigations and litigation.

Civil Investigations

We represent clients in civil investigations of health-care entities and management companies in response to government investigations regarding allegations of violation of fraud-and-abuse statutes. We conduct internal investigations and guide clients in settlements with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS), and we negotiate settlement agreements and corporate integrity agreements. We also represent health-care providers in payment disputes with Medicare and commercial payors regarding reimbursement disputes.

Corporate Health Care Transactions

Our attorneys have represented clients in a wide range of corporate transactions. We have advised management companies, private equity firms, hospitals, and physicians in the formation, sale, and acquisition of management companies, physician practice-management companies, physician practices, physician joint ventures, ambulatory surgical centers, health imaging providers, radiation-therapy centers, and urgent-care centers. We have also advised physicians in the sale of their practices to hospitals and management companies, management companies and hospitals in the acquisition of physician practices, and bankers regarding credit facilities.

Compliance Training

We advise clients in the development, implementation, and maintenance of health-care regulatory and HIPAA compliance plans, working with company executives to tailor compliance programs to fit each company's specific needs.

We conduct training in regulatory compliance matters for executives and employees, both to educate them regarding legal requirements and to ensure they understand their obligations under the company's compliance program—including how to recognize and combat fraud and abuse in company arrangements.

We also provide HIPAA compliance training to health-care providers and commercial entities that provide services to health-care providers, known as business associates.

Clients

We provide guidance to a wide variety of health-care entities, including health-care management companies, hospitals and health systems, physician and dental-practice-management companies, large physician practices, lithotripsy providers, diagnostic-imaging companies, ambulatory surgery centers, endoscopy centers, vision service providers, ambulance companies, pharmacy networks, institutional pharmacies, pharmaceutical companies, disease management companies, assisted living facilities, substance-abuse treatment providers, skilled-nursing facilities, medical-device manufacturers, and home-health agencies. We also advise private equity firms, banks, and other lenders.

Common Health Care Matters

  • Structuring of physician joint ventures to comply with the federal anti-kickback statute and the Stark law
  • Drafting of Operating Agreements for health-care entities and physician joint ventures
  • Creation and implementation of fraud-and-abuse compliance programs
  • Creation and implementation of HIPAA compliance programs
  • Advising purchasers, investors, and lenders on target companies' compliance with health-care laws
  • Drafting and negotiating contracts for the provision of health-care services
  • Drafting appeals to Medicare and commercial payors regarding retroactive claims denial
  • Drafting and negotiation of purchase agreements
  • Reviewing and drafting of health-care representations, warranties, and covenants in purchase agreements and credit agreements
  • Advising concerning compliance with fraud-and-abuse laws regarding contracting with physicians or health-care entities
  • Negotiating settlements and corporate-integrity agreements with the Office of the Inspector General of the Department of Health and Human Services (OIG)
  • Advising on compliance with corporate integrity agreements
  • Drafting reports to OIG required by a corporate integrity agreement
  • Conducting internal investigations
  • Advising clients in making voluntary disclosures to the OIG
  • Drafting and negotiating applications for procurement of advisory opinions from the OIG
  • Advising on data breaches regarding improper disclosure of PHI