Health Care - Regulatory and Transactional

Practice Contacts

Peggy E. Kozal
Partner

Justin M. Puleo
Senior Counsel

Regulatory Practice Overview 

Overview - Subject Matter Expertise 

The attorneys in the Health Care Regulatory and Transactional Sub Practice Group (in addition to the transactional items described in the following section) routinely counsel health care providers to identify and resolve regulatory compliance issues in order to maintain business operations.  They are deeply knowledgeable in the following areas:

  • Stark Law 
  • Anti-Kickback Statute
  • Corporate Practice of Medicine 
  • False Claims Act
  • Overpayments, Reimbursements, and Self-Disclosure 
  • Transactions 
  • Licensure
  • Third Party Payor Agreements
  • Antitrust
  • Health Insurance Portability and Accountability Act
  • Medicare Conditions of Participation
  • Certificate of Need
  • Joint Commission Requirements 
  • Office of Inspector General Investigations 
  • Affordable Care Act
  • State and Federal privacy laws, including HIPAA, HITECH and 42 CFR Part 2

Types of Matters

Practice attorneys regularly represent health care providers in the following types of matters:

  • Regulatory issues
  • Appropriate structuring of joint ventures and transactions 
  • Overpayment disputes
  • Fraud and abuse investigations
  • Provider suspensions
  • Contract terminations
  • Preliminary internal investigations 
  • Medicare and Medicaid self-disclosures
  • Administrative litigation
  • Pre-dispute compliance counseling
  • Prepayment review counseling and litigation

Existing Clients and Locations 

Practice attorneys represent a broad spectrum of health care professionals and entities, including hospitals, health systems, management service organizations, long-term care facilities, assisted living facilities, home health agencies, hospices, federally qualified health centers, rural health centers, behavioral health facilities, physician practices, medical spas, ambulatory surgery centers, imaging facilities, physicians, and other health care providers.

Among other locations, our team has represented health care providers in Alabama, California, Colorado, Florida, Georgia, Hawaii, Indiana, Nevada, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, South Carolina, Texas, Virginia, West Virginia, and Wyoming.

Representative Experience 

Practice attorneys have extensive experience advising a variety of health care providers on regulatory and compliance issues at both the state and federal level. We routinely assist health care clients navigate licensure, certification, reimbursement, and compliance requirements for Medicare, Medicaid, and other federally funded health care programs.

Our representative experience includes, but is not limited to, the following matters: 

  • Regulatory compliance pursuant to transactions, including Stark Law, Anti-Kickback Statute, Corporate Practice of Medicine, and other considerations
  • Licensure and certification
  • Disciplinary matters before state licensing boards
  • Challenging adverse survey findings
  • Defending providers in Medicare and Medicaid hearings and Appeals before the Provider Reimbursement Review Board, Medicare Office of Hearings and Appeals, and state administrative agencies
  • Negotiating with and litigating against Medicare fiscal intermediaries regarding Medicare overpayments
  • False Claims Act litigation
  • Health Insurance Portability and Accountability Act compliance and privacy practice counsel 
  • Compliance plans and policies and employee training programs
  • Government investigations, responses, and settlement negotiations
  • Avoiding violations of fraud and abuse laws and regulations
  • Managing and appealing disputes with payors regarding reimbursement, including Medicare and Medicaid overpayment appeals and self-reporting obligations
  • Litigation of provider termination decisions, overturning flawed audits and prepayment review processes, resulting in reinstatement of the providers in the Medicaid and Medicare program
  • Medical staff and governance issues, including medical staff bylaws, rules and regulations, and policies and procedures, as well as guiding providers during the peer review and credentialing processes
  • Health care operational issues, including evaluation and development of risk assessment procedures, operational contract management and patient care issues, and evaluating corporate policies for compliance with federal and state law
  • Compliance advice regarding licensing, certification, and accreditation with state and federal agencies
  • Licensing board representation on acceptable scope of practice issues

Transactional Practice Overview

In addition to providing regulatory counsel as described above, the attorneys in the Health Care Regulatory and Transactional Sub Practice Group regularly represent clients in a broad spectrum of transactional projects.  The Practice routinely engages in the following types of transactions, often with an eye towards thriving in an era of health reform:  

  • Mergers and acquisitions
  • Physician contracts
  • Regulatory compliance
  • Joint ventures
  • Managed care contracts
  • Third Party Administrator contracts 
  • Government payor contracts
  • Antitrust 
  • Tax planning
  • Loan refinancing 

Types of Matters and Clients

Practice attorneys provide a wide range of services to transactions that must take into account considerations that are unique to the health care field, including Stark Law, the Anti-kickback statute, corporate practice of medicine, privacy, reimbursement, antitrust, tax, and a myriad of local, state and federal regulations.

Our experience includes transactions involving nursing homes, hospitals, physician groups, management service organizations, health plans, third party administrators, ancillary service providers, assisted-living facilities, pharmacies and pharmacy benefit management companies, ambulatory surgery centers, independent diagnostic testing facilities, provider networks, and medical device manufacturers.

We advise on enterprise structure and governance; mergers, acquisitions, divestitures and affiliation arrangements; business and corporate reorganizations; and services and practice management joint ventures. Our experience in deal structures, term negotiation, and due diligence includes several types of business transactions in the nonprofit and for-profit healthcare arena.

Representative Experience 

Practice attorneys have extensive experience advising a variety of health care transactions, including, but not limited to the following:

  • Stock purchases, Asset purchases, and nonprofit Changes of Control 
  • Corporate reorganizations 
  • Health system acquisition of wholly owned subsidiaries
  • Distressed entity purchases 
  • Negotiations with government agencies
  • Mergers and acquisitions
  • Joint ventures between physicians and other entities such as health systems and management service organizations 
  • Partnership agreements for physician groups
  • Purchases and sales of physician practices, including but not limited to cardiology, imaging, and surgical 
  • Business transactions involving licensing, e-commerce, and privacy issues, including issues unique to telemedicine
  • Emergency Department provider contracting agreements and relationships
  • Third Party Administrator contract negotiation 
 

G&R Fast Facts

  • 5 Attorneys
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