Acute Care Hospitals and Health Systems

Acute care providers operate in one of the most highly regulated economic sectors, and are subject to continual legislative and regulatory changes. Goodwin helps hospitals and health systems, academic medical centers, specialty hospitals, doctors, physician groups and other acute care providers on commercial transactions and M&A, and with navigating the challenges and opportunities presented by this shifting legal and regulatory landscape.

We advise acute care providers on the regulatory risk and compliance issues they face, help facilitate strategic transactions to better serve patients, and defend clients facing government investigations or civil litigation. Our team also has significant experience advising nonprofit hospitals and health systems on the unique issues they face, including participation in joint ventures with for-profit entities and other business arrangements.

Our work for acute care providers covers both traditional areas of hospital/healthcare law and regulation, and emerging issues such as the continuing revolution of digital health and other technology changes.

Areas we handle include:

• Mergers and acquisitions (physicians, hospitals and other healthcare-related organizations and companies), including antitrust compliance, tax and related issues
• Regulatory risk and compliance monitoring, including Stark, Anti-Kickback Statute, and Medicare/Medicaid fraud and abuse
• Organizational structuring, including Accountable Care Organizations and other clinical integration models
• Physician/hospital relations
• Digital Health (privacy, security, meaningful use, breach, mobile, telehealth)
• Labor and employment services
• Tax and nonprofit issues
• Loan structuring
• Antitrust
• Foundation and restricted assets

Transactions

We assist our acute care clients with mergers and acquisitions, joint ventures and partnering arrangements, restructurings and reorganizations, dispositions and carve-outs, and venture capital and other transactions. We also advise clients on a wide range of agreements with vendors, suppliers, purchasing groups, payors (including Medicare and Medicaid), PBMs, PDPs, wholesalers and residents. We are experienced in advising acute care clients on the regulatory compliance issues attendant to transactions, including fraud and abuse issues, safe harbor regulations, and regulatory issues impacting relationships with other participants in the continuum care chain.

Frequently, transactions involve such disparate legal areas as healthcare, tax, antitrust, environmental, real estate, labor and employee benefits. Our transactional lawyers regularly team with lawyers in these and other practice areas to resolve client problems. We have significant experience counseling nonprofit hospitals and other providers on a wide range of issues, including compliance with requirements of the Internal Revenue Service and the Community Health Care Assets Protection Act, as well as other state attorney general requirements and Orphans’ Court procedures.

Regulatory and Compliance

We represent acute care clients in dealing with regulatory issues affecting commercial healthcare transactions as well as those impacting their operations. These issues generally fall under federal fraud and abuse laws (including the federal Anti-Kickback Statute and safe harbors), Stark, civil monetary penalties law, the False Claims Act, healthcare fraud statutes, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and Medicare Parts A, B and D, and state regulatory requirements concerning operations, facility management, local code requirements and patient issues.

Government Investigations and Litigation

Acute care providers and health systems increasingly are targeted by the DOJ, HHS OIG, individual U.S. Attorney’s Offices, and state attorneys general, all seeking to enforce a wide range of fraud and abuse laws, such as the False Claims Act, the Anti-Kickback Statute, Medicare and Medicaid regulations, healthcare fraud and other criminal statutes. We represent these and other provider clients facing investigation or prosecution by federal and state authorities seeking to enforce these laws. Goodwin also handles a wide range of civil litigation matters for healthcare clients, including antitrust, class action, medical malpractice, securities/shareholder, and ERISA/employment matters.