Healthcare

The attorneys at Fitzpatrick Lentz & Bubba understand the complexities inherent in negotiating and effectuating business transactions unique to the healthcare industry. Our attorneys regularly structure healthcare transactions to ensure compliance with applicable laws and regulations, while bringing a pragmatic approach to the business and financial realities impacting those transactions.

Our Services Areas:

• Agreements with managed care networks and third-party payers
• Asset or stock purchase and sale transactions
• Employment/independent contractor
• Expert and medical device consulting agreements
• Formation, dissolution and reorganization of medical and dental practices, home health care agencies and pharmacies
• Fraud and abuse compliance including Stark Law and Anti-Kickback Statute
• Hospital/physician relationships
• Intellectual property
• Joint ventures
• Management and professional services agreements
• Office of Inspector General (OIG) exclusions
• Practice mergers, acquisitions and joint ventures
• Recruitment, retention and employment arrangements
• Real estate, land use, acquisition, and development
• Restrictive covenant negotiation

Notable representations:

• Represented physicians in the formation, licensing and operation of an ambulatory surgical center, including drafting of ownership documents to comply with federal fraud and abuse laws
• Represented a diagnostic imaging facility in the creation of a pre-authorization call center
• Served as general counsel for the manufacturer of specialized building materials unique to the healthcare industry and was involved in the negotiation and enforcement of various service contracts worldwide for use by referring physicians following a favorable federal interpretation of fraud and abuse law
• Prepared and implemented comprehensive fraud and abuse compliance plans for an independent diagnostic testing facility
• Secured a physician buy out from deadlocked professional corporation and subsequently negotiated a relationship with competing medical system
• Negotiated a multi-million dollar pharmaceutical provider contract on behalf of regional health system
• Effectuated the formation and operation of an independent sleep lab facility, including the negotiation of agreements with participating physicians regarding reimbursement, the medical director position and professional interpretation services
• Counseled numerous healthcare entities in establishing and/or revising patient privacy policies to ensure HIPAA compliance
• Represented small and large physician practices in the sale of their assets to health systems, including ongoing employment relationships
• Represented a community hospital in the acquisition and improvement of adjacent medical office space, including first-of-its-kind financing through a special taxing zone

Our healthcare attorneys understand the unique needs of our medical staff and physician clients and have the knowledge and experience to meet ever-changing accreditation, regulatory and statutory requirements. To support our clients’ varying medical relationships, we frequently develop bylaws, peer review protected processes, and fair hearing and appellate review procedures. We also regularly assist physicians with navigating the corrective action, fair hearing and appellate review processes to ensure compliance with bylaws, regulatory and statutory requirements.

Our Services Areas:

• Corrective action processes
• Fair hearing and appellate review procedures
• Formation of professional companies and restricted LLCs
• Health Care Quality Improvement Act (HCQIA) compliance
• Hospital accreditation (e.g., The Joint Commission, Healthcare Facilities Accreditation Program [HFAP], etc.)
• Internal investigations
• Joint ventures
• Medical staff and allied health professional (AHP) credentialing
• Medical staff bylaws
• National Practitioner Data Bank (NPDB) reporting standards
• Pennsylvania Peer Review Protection Act (PRPA)
• Physician employment agreements
• Quality improvement
• Rules, regulations and other organizational policies and procedures

Notable Representations:

• Represented hospitals and physicians in numerous internal fair hearings and appellate review processes
• Served as hearing officers in hospital internal fair hearings and appellate reviews
• Advised physicians and hospitals regarding disciplinary responses to physicians’ violations of specialty board examination rules
• Addressed various issues of incorporating ambulatory surgical center into area medical staff, as well as its bylaws and related governing documents
• Negotiated amicable distribution of medical staff membership dues following an acquisition of local hospital
• Counseled hospitals on CMS Conditions for Participation (CoP) regarding unified medical staff
• Developed tailored organizational and operational bylaws and policies for hospitals and health systems
• Advised hospitals regarding disciplinary responses to clinical competency concerns
• Counseled physicians and hospitals on possible violations of hospital policies and procedures
• Developed and implemented tailored, focused and ongoing professional practice evaluation policies (FPPE/OPPE)

Our healthcare attorneys provide highly skilled legal assistance to physicians, medical staff, hospitals, practices and others in the medical field to help them resolve disputes and complex professional problems.

Our attorneys regularly appear in state and federal court throughout Pennsylvania, New Jersey and beyond. We have represented clients before various state agencies, including the Department of Environment Protection (DEP), Department of Health (DOH) and Department of Public Welfare (DPW). We collaborate with members of our employment, intellectual property, litigation and real estate practices to provide comprehensive representation. In addition, our department chair, Joseph A. Bubba, regularly serves as a mediator/arbitrator for the American Health Law Association’s  Alternative Dispute Resolution Service, as well as for the American Arbitration Association. In short, FLB has the breadth of experience and depth of knowledge to provide real-world counsel and represent healthcare providers and provider organizations at trial, on appeal and in administrative and regulatory disputes.

Our Services Areas:

• Administrative proceedings
• Alternative Dispute Resolution
• Bankruptcy
• Civil
• Commercial disputes
• Discrimination and harassment claims
• Employment/employee relations
• Expert witness discovery
• Medical staff disputes
• Post-trial and appellate practice
• Professional liability oversight counsel
• Professional licensure inquiries and disputes
• Restrictive covenants
• Shareholder and ownership disputes
• Trade secret disputes
• Workers’ compensation defense

Notable Representations:

• Successfully obtained summary judgment for a health system against a physician regarding an appeal of the fair hearing process
• Secured dismissal of all claims in U.S. Bankruptcy Court for fraudulent transfer
• Secured relief from a restrictive covenant in a physician-practice dispute
• Obtained municipal approval for development of medical office building involving an historic structure
• Secured municipal zoning approval as appellate counsel for physician-owned hospital
• Counseled imaging facility investigated by Pennsylvania Department of Environmental Protection
• Regularly serve as mediators and arbitrators in healthcare law matters

Fitzpatrick Lentz & Bubba is well-equipped to advise healthcare-related clients on the intricate and ever-changing regulatory climate that impacts their licensure and operations. This includes counseling them on compliance with state and federal regulations, including those promulgated by the Pennsylvania Department of Health (DOH), as well as compliance with federal laws including the Stark Law, Anti-Kickback Statute, and the Patient Protection and Affordable Care Act.

Our Services Areas:

• Accreditation standards (e.g., The Joint Commission, Healthcare Facilities Accreditation Program, Accreditation Association for Ambulatory Health Care, and National Committee for Quality Assurance)
• Employment, recruitment and retention arrangements
• Electronic medical records (EMR)
• Federal and state statutory and regulatory law, including the Health Care Quality Improvement Act, CMS, HIPAA, state compliance audits
• HIPAA and patient privacy
• Licensure (physician, facility and pharmacy)
• Medicare, Medicaid and other third-party payor contracting, compliance and reimbursement
• Stark, Anti-Kickback and other fraud and abuse laws
• Zoning, land development
• Medical Marijuana Act and compliance

Notable Representations:

• Advised physician-owned ambulatory surgery center regarding physician’s failure to comply with policies relating to an Anti-Kickback statute exception
• Counseled physician practices regarding HIPAA and medical record retention policies under Omnibus Rule
• Obtained governmental approvals for the development of multiple medical office buildings and hospital campus
• Obtained professional licensure for Pennsylvania corporate entity operating a pharmacy in the Lehigh Valley
• Advised physicians and hospitals regarding possible disciplinary responses to physicians’ violations of specialty board examination rules
• Addressed various issues of incorporating ambulatory surgical center into medical staff
• Negotiated corrective action plan with Department of Environmental Protection for Radiology facility under government investigation
• Represented medical practice in the negotiation of a recruitment agreement in compliance with Federal Anti-Kickback Law
• Assisted group with a private offering for a medical marijuana organization, including compliance with pertinent regulations

Fitzpatrick Lentz & Bubba has the broad array of experience in providing legal counsel to personal care homes, assisted living facilities and home health agencies through all stages of their development, from zoning and construction to licensing and ongoing operations. Our healthcare, employment, real estate and corporate law attorneys regularly collaborate to meet the varied needs of our clients in this industry.

Our Service Areas:

• Facility development and licensure
• Administrative law and regulatory compliance
• Human Resources
• Reimbursement and collection issues
• Arbitration agreements
• Physician and other healthcare provider relationships, as well as other vendor relationships

Notable Representations:

• Represented regional provider in the development of an assisted living facility and memory care facility, including municipal issues such as compliance with outdated building codes inconsistent with industry practices
• Represented developer and operator of personal care homes in acquisition, development and licensure of a new facility, including financing
• Represented personal care homes with Patient Protection and Affordable Care Act compliance
• Counseled facilities in drafting and implementing medical records policies needed for conversion to electronic medical records and HIPAA compliance
• Obtained administrative approvals for construction of new assisted living facility
• Negotiated professional services agreements between personal care homes and medical directors

Our healthcare attorneys counsel our clients on a wide-range of matters to improve patient safety and satisfaction and meet regulatory requirement while avoiding costly litigation. We are well-versed in medical malpractice defense, having handled all aspects of litigation from pleadings to trial. We offer oversight counsel services in select medical malpractice matters. We also offer services to licensed individuals before disciplinary boards.

Our Services Areas:

• Licensure
• Patient satisfaction and safety
• Practice of defensive medicine
• Expert discovery

Notable Representations: 

• Negotiated consent agreement on behalf of physicians and nurses approved by State Board
• Medicine and State Board of Nursing
• Developed procedure-specific informed consent for licensed facility
• Represent expert-physicians served with Cooper v. Schoffstall discovery
• Advised clients on Professional Health Monitoring Programs (PHMP), the Voluntary Recovery Program (VRP) and the Disciplinary Monitoring Unit (DMU), of the Bureau of Professional and Occupational Affairs (BPOA)
• Advise physician and physician practices on handling of difficult patients
• Counsel client on Privacy Rule, Notice of Privacy Practices and HIPAA compliant authorizations
• Recommend practice and procedure regarding electronic communication between providers and patients
• Develop physician evaluation program (FPPE/OPPE) for large surgical practice
• Advise physician on documentation practices and use of electronic medical records (EMR)