Healthcare

HEALTHCARE

 

Strategic Transactions & Affiliations:

The Pretus Law Group counsels health systems, academic medical centers, hospitals, physicians, and healthcare entrepreneurs in planning, structuring, and executing on a variety of strategic affiliations, including corporate formations, change of ownership, mergers, acquisitions, divestitures, and joint ventures.

We advise and counsel clients through all phases of strategic transactions, including: assessing opportunities, due diligence, negotiation and contract preparation, closing, and integration.

 

Corporate Governance

The Pretus Law Group regularly advises its corporate clients on matters in connection with corporate governance, board responsibilities, and best practices.  Examples of our work include

  • Acting as general outside counsel to assist clients in developing internal controls and corporate protocols, such as conflict of interest policies and delegations of authority
  • Assisting clients in corporate reorganizations and rationalizations including restructuring of relevant governance documents
  • Counseling executives and boards and proposing changes to governance documents to address relationships with new affiliated entities, the roll-out of stock option plans, corporate policy changes, etc.

HIPAA Privacy & Security

Our firm has significant experience in advising on data privacy and security issues in a wide range of industries.  We work closely with our clients to minimize exposure and reduce risk through strategic advising, compliance counseling, and policy development.  We help our clients develop customer and employee policies, as well as procedures and training that fit their specific business in order to make their data security plan fully operational.  Should a data breach occur, we help clients with investigations that identify the cause of the breach, crafting an appropriate, coordinated response, and handle matters with regulatory agencies as needed.

We have substantial experience serving as privacy and information security counsel to all manner of healthcare entities including hospitals, health systems, clinics, and pharmacies. We also serve companies in a range of industries including information technology service providers, call centers manufacturing, and retail.

We counsel clients on compliance issues raised by the Health Insurance Portability and Accountability Act (HIPAA), Health Information Technology for Economic and Clinical Health Act (HITECH), Children’s Online Privacy Protection Act (COPPA), Telephone Consumer Protection Act (TCPA), CAN-SPAM Act, and Junk Fax Prevention Act, the General Online Data Protection Regulation (GDPR), as well as other federal, state and international privacy laws.

 

Compliance Counseling

Our firm works closely with our clients on diverse matters such as the investigation of complaints, assessment of physician relationships for compliance with Stark and Antikickback laws, evaluation of clinic development plans for compliance with CMS Conditions of Participation, and compliance with corporate integrity agreements.

We also help clients develop and implement what robust and effective compliance programs that meet OIG standards.  Examples of our work include:

  • Developed HIPAA compliance plans for a call center providing services to a health system
  • Conducted audits and due diligence reviews for a wide range of clients related to fraud and abuse, HIPAA, compliance with provider-based clinic requirements, and 340B Drug Pricing Program compliance.
  • Provided compliance advice to physicians, executives, and business development liaisons on fraud and abuse, anti-kickback statute, and Stark law compliance.
  • Assisted hospital in developing a compliant process for identifying and tracking device warranty credits to ensure that qualifying credits were appropriately refunded to Medicare.
  • Conducted audit of a major health system’s electronic medical records donation program for compliance with Stark law, and developed remediation plan to implement best practices.

 

Provider Alignment & Clinical Integration

We have experience serving physician and institutional clients in developing and negotiating a wide variety of alignment models, such as:

  • Practice & hospital acquisition including valuation, due diligence, preparation of all contracts, closing, and oversight of integration
  • Physician employment and professional service agreements
  • Developing and advising clinically integrated networks
  • Formation of service line joint ventures
  • Negotiation of co-management arrangements
  • Development and expansion of Management Service Organization (MSO) arrangements

 

Hospitals & Health Systems

The Pretus Law Group has extensive experience advising hospitals and integrated delivery systems on healthcare matters unique to larger institutions and regularly advises such clients (both for-profit and not-for-profit) in a wide variety of legal matters including

  • Reimbursement, Medicare conditions of participation, Provider-Based Status, 340(b) Drug Program, balance billing, Related Party Issues, and other matters.
  • Assessed clinic/hospital expansion plans for compliance with Conditions of Participation, DHH licensure requirements, and 340(b) child site eligibility
  • Advised hospital system leadership on expansion strategy to optimize development of provider-based clinics
  • Advised on various hospital transactions, including conducting regulatory due diligence, drafting documents, facilitating licensure and certification transfers and addressing compliance issues.
  • Counseled a large regional health system on the acquisition of an electronic medical records system.
  • Represented health system academic medical center in 3-party negotiation to establish an international accredited medical school.

 

Research & Clinical Trials

The attorneys at the Pretus Law Group have experience advising institutions, investigators, and academic medical centers engaged in every major stage of the clinical research process.  Our clients have included Principal Investigators (PIs), Institutional Review Boards (IRBs), and academic medical centers.

 

Health Information Technology

For more than ten years, the attorneys at the Pretus Law Group have worked with all types of businesses on strategic technology initiatives and transactions, as well as technology acquisition and commercialization. Our clients include academic medical centers, integrated health systems, physician, and entrepreneurs.

We help our clients develop and execute IT-based strategies to integrate hospitals and health systems with community providers. These strategies include the extension and integration of clinical, financial, and other software systems through joint ventures and strategic affiliation agreements.  As a result, our clients have achieved a meaningful return on the significant investments made in these systems and services, while advancing toward their growth and affiliation goals. Our services include advising on the pricing and business models, governance structures, contracting strategies, and document preparation.

We also advise healthcare vendors seeking to commercialize new software and professional solutions.  Our work includes counseling on deployment structures, pricing models, contracting strategies, and development of customer-facing contracts. We also represent clients in negotiations with all major technology vendors and service providers of multi-modal clinical and diagnostic technology.