Healthcare Transactions, Regulation & Compliance

For nearly forty years, Dughi, Hewit & Domalewski, P.C. has provided high-quality legal services to hospitals, physicians and other healthcare providers.  Building on its reputation as one of New Jersey’s premier medical malpractice defense firms, the firm broadened its practice areas over a decade ago to provide a wider range of services to its healthcare clients on transactional, regulatory, compliance and reimbursement matters.

The attorneys at Dughi, Hewit & Domalewski, P.C. represent or have represented a broad range of industry stakeholders, including health systems; life sciences companies; ambulatory surgery centers; academic medical centers; integrated delivery networks; long-term care, home health and hospice providers; physician groups and imaging centers, among many others, delivering sophisticated transactional, regulatory and compliance counsel.

Our Healthcare Transactional & Regulatory Practice group is comprised of attorneys with deep experience in the healthcare industry, including a former General Counsel of a life sciences company and Associate General Counsel of a regional health system.

Our team’s diverse background provides a multifaceted perspective, enabling us to anticipate critical legal and performance hurdles and recommend novel solutions to achieve business goals while reducing risk.

At Dughi, Hewit & Domalewski, we are acutely aware that the current uncertainty in the healthcare industry, coupled with an ever-evolving reimbursement environment, is dramatically altering the strategies and budgets of industry legal departments.  We firmly believe that it is the responsibility of outside counsel to adapt to these changing times and to offer solutions that will enable clients to reduce their legal budgets without compromising the quality of the legal services upon which they rely.

Examples of our representation include:

Joint Ventures, M&A, Physician Contracting

  • Healthcare Entity Joint Ventures, Mergers, Acquisitions and Affiliations
  • Physician Alignment Transactions (including Employment, Professional Services, Physician Recruitment, Management Services, Space Lease, Asset Purchase, Equipment Lease, Employee Lease and Time-Share Agreements)

Vendors, Procurement, Supply Chain

  • Vendor Contracts, Supply Chain & Procurement (with a focus on pay-for-performance criteria)
  • Software as a Service Agreements & Health Information Technology
  • Equipment Service & Maintenance Agreements
  • Group Purchase Organization Contracting

Pharmaceuticals, Biologics, Medical Devices

  • Specialty Pharmacy Workflow and Outsourcing
  • Specialty Pharmacy Data Programs and Hub Services Arrangements
  • Market Access
  • Prescription Fulfillment
  • Patient Assistance Programs and Co-Payment Coupons
  • Drug Distribution & Purchasing Contracts
  • Pharmacy Dispensing Software
  • PhRMA and AdvaMed Code Compliance
  • 340B Drug Program Management and Compliance

Reimbursement, Payor Relations

  • Governmental and Commercial Payor Reimbursement Criteria
  • Payment Disputes
  • Managed Care Contracts
  • Telehealth
  • Readmissions Reduction Programs
  • Delivery System Reform Incentive Payment Programs

Licensure & Credentialing

  • State Licensure & Certificates of Need
  • Accreditation Bodies
  • Professional Review Actions & Credentialing
  • Institutional and Medical Executive Committee Bylaws

Regulatory Compliance, Fraud & Abuse

  • Compliance with Federal and State Insurance Fraud, False Claims, Anti-Kickback and Self-Referral Laws, including Conducting Internal Compliance Investigations
  • Reporting and Returning of Federal Healthcare Program Overpayments & Self-Disclosure Protocols
  • Medicare and Medicaid Exclusion, Revocation and Sanctions
  • Compliance with Conditions of Participation and Payment
  • Qui Tam Litigation
  • Home Health and Hospice Compliance
  • CMS Quality Payment Program (including Merit Based Incentive Payments System (MIPS) and Alternative Payment Models (APM))

Privacy & Security

  • Risk Assessments
  • Policies and Procedures
  • Breach Investigation and Notification (HIPAA/HITECH, 42 CFR Part 2, FTC & State Law)
  • PHI Deidentification
  • Electronic Medical Records, Meaningful Use (now the Advancing Care Information component of CMS’ Quality Payment Program)
  • Business Associate and Business Associate Subcontractor Agreements

Academic & Research

  • Resident Rotation Agreements
  • Clinical Research/Trial Agreements

Tax-Exempt Organizations

  • Compliance with IRS Management Service Contracts Safe Harbor for Qualified Tax-Exempt Bonds
  • Intermediate Sanctions