Counsel on Commercial Arrangements, Business Operations and Regulatory Matters

Regardless of size or structure, health care providers, payors, entrepreneurs and businesses must navigate a complex maze of Federal and state laws and regulations to remain economically competitive. Health care compliance continues to be an important part of the health care delivery system as the Federal government – and some state governments – are vigilant with enforcement activity. Maintaining compliance is critical to avoid significant financial exposure and public relations challenges – and potential litigation, criminal liability and/or administrative sanctions. Mergers and consolidations, patient and data privacy and security challenges, fraud and abuse enforcement, and reimbursement changes are ongoing issues in the health care delivery system. Successful parties in the health care delivery system will need to create and maintain legally compliant arrangements and relationships.

Saul Ewing Arnstein & Lehr’s health care industry clients confront these and many other issues on a daily basis and the firm’s attorneys are there to represent them and advise on corporate, transactional, regulatory, compliance, labor and employment, tax and employee benefits, energy and environmental, financing, litigation, and bankruptcy matters. Our attorneys regularly assist health care clients in developing and implementing sophisticated commercial arrangements relating to population health initiatives, relationships with managed care entities and third-party payors, mergers, acquisitions, sales, strategic engagements and affiliations, joint ventures, and new business formations. We understand the opportunities and challenges in the health care delivery system and routinely provide strategic planning advice on management and governance matters.

Typical issues for which our attorneys regularly provide legal advice include: HIPAA and state privacy laws; Federal and state fraud and abuse, anti-kickback and physician self-referral statutes and regulations; government investigations; corporate compliance; corporate practice of medicine and fee splitting; tax-exemption; antitrust; licensing, accreditation and survey-related matters; interactions with state and Federal regulators; and the Affordable Care Act.

Our firm is experienced in assisting clients with Certificate of Need applications and our attorneys have assisted academic medical centers, hospitals, long-term care facilities, ambulatory surgical centers and other facilities in obtaining state approval for new facilities, expansions and changes of ownership. 

The firm also has a well-established reputation in professional liability defense. We represent a number of insurance companies issuing professional liability insurance in the health care industry. In Illinois, for example, we represent the largest provider of professional liability insurance to physicians in the state. Additionally, we provide counseling and representation to a number of hospitals and provider networks that are self-insured.

Saul Ewing Arnstein & Lehr’s Health Care team has experience advising:

  • Academic medical centers and community hospitals
  • Ambulatory surgery centers
  • Ancillary health care providers (e.g., chiropractors, physical therapists, CRNAs and psychologists)
  • Dentists and dental practices
  • Federally qualified health centers
  • Health information exchange providers
  • Home health agencies
  • Insurers and third-party payors
  • Long-term care providers, nursing homes, skilled nursing facilities, assisted living facilities
  • Medical device companies
  • Physicians and physician practices
  • Trade associations and professional certifying bodies
  • Veterinarians

The activities of the firm’s health care lawyers include the following general subjects:

Compliance/Regulatory

  • Antitrust, unfair competition and trade regulation
  • Compliance plans and programs
  • Cybersecurity
  • Federal and state regulatory compliance
  • Fraud and abuse, including Stark, False Claims Act, and Anti-Kickback
  • HIPAA
  • Internal investigations
  • Medical marijuana

Litigation

  • Arbitration and mediation
  • Audits and investigations
  • Licensure actions
  • Litigation (complex professional, pharmaceutical drug, Title IX)
  • Medical malpractice defense

Corporate/Transactional

  • Certificate of Need
  • Credentialing
  • E-health, telemedicine and EHR issues
  • Employment and shareholder agreements
  • Employee benefits and executive compensation
  • Health care financing
  • Insurance and risk management
  • Integrated delivery systems
  • Joint ventures
  • Managed care contracting
  • Medicare/Medicaid reimbursement and appeal
  • Mergers and acquisitions
  • Physician-provider agreements
  • Practice formation and management
  • Professional services arrangements
  • Real estate
  • Strategic affiliations
  • Tax-exempt issues
Saul Ewing Arnstein & Lehr understands our company and recognizes our importance as a client. Even the small jobs are handled with a high level of service.

Experience

Saul Ewing Arnstein & Lehr attorneys have represented notable clients in these select matters:

  • Represented a Pennsylvania county in the sale of its nursing home and associated real estate. Responsible for the legal issues surrounding the sale of the assets including: real estate and environmental issues; financing; licensure transfer; and regulatory compliance.
  • Ongoing representation of a major university and affiliated health system for sophisticated health care information technology agreements.
  • Assisted a state medical society with the creation and implementation of a commercial accountable care organization with a large commercial insurance payor.
  • Counsel to four large academic medical centers with respect to their involvement in a large regional health information exchange.
  • Served as lead counsel in a class action effort against a well-known regional company relating to Medicare reimbursement benefiting some 300 ambulance providers in the 29-county Western Pennsylvania region.
  • Represented a multi-hospital health system in the formation and implementation of a completely new hospital. Advised the board of directors and the administration regarding the nonprofit corporate, charitable, tax and health care regulatory aspects of the creation of the new hospital.
  • Represented a 70-member, for-profit, multispecialty physician practice in its sale to a large, publicly traded health system. Handled the legal aspects of the transaction including negotiating and drafting the letter of intent, agreement of sale and the model employment agreement under which all the physicians would be employed following the sale.
  • Ongoing representation as external counsel to the leading U.S. provider of specialty home infusion services in the national expansion of its business operations, including counseling on licensure, certificate of need and regulatory compliance matters.
  • Negotiated and documented the acquisition of complex technology systems for electronic health records management; admission, discharge, and transfer (ADT); CPT coding, billing and reimbursement; electronic ICU facilities; radiation therapy and radiosurgery equipment; care management; patient flow management and bed tracking; medical records scanning and imaging; pharmacy and medication management; and patient and fetal monitoring.
  • Assisted a non-profit health network in the formation, structuring and implementation of a community-wide, hybrid health information exchange, including providing counsel on compliance with federal and state anti-kickback and physician self-referral statutes, privacy and security laws, including HIPAA, HITECH and protection of certain sensitive categories of information, and drafting required agreements and policies.
  • Serve as outside general counsel to a large northeastern urology practice. Regularly advise on contractual, personnel, third party affiliations, insurance, compliance, regulatory and labor matters.
  • Obtained “declination” from U.S. Attorney of both criminal and civil fraud charges against a health care practice alleged to have created fatal risk of infection by misusing medical devices during surgical procedures. Conducted an emergency internal assessment, counseled the practice on remedial and disciplinary steps, and helped the client self-disclose to the State Medical Licensing Board. Neither the State Medical Licensing Board nor the Department of Justice took action against the medical practice.
  • Assisted a large regional hospital system with its separation into two regional health systems including the separation of the systems’ combined debt.
  • Represented a major academic medical center in the purchase of an urban community hospital. Negotiated and drafted the letter of intent and the asset purchase agreement and obtained federal, state and local approvals; provided the antitrust analysis (and preparation of the HSR application); and created a new nonprofit corporate entity to acquire the assets of the community hospital; and obtained a determination that the new corporation was exempt under section 501(c)(3).
  • Engaged by a large multi-hospital health system in its acquisition of a community hospital in a neighboring state a few miles from one of its own Pennsylvania campuses. Handled issues related to the drafting, negotiating and implementation of the letter of intent, extensive due diligence (including CMS payment issues), and issues involving corporate governance, public finance, real estate, environmental compliance, charitable assets, corporate reorganization, antitrust (including preparation of its HSR application) and contract assignment. Prepared the definitive agreement, ancillary documents and corporate resolutions.
  • Counseled a Pennsylvania university regarding the advantages and disadvantages of continuing to maintain a legal and practical separation between the university and its college of medicine.
  • Assisted numerous hospitals in joint ventures involving physicians, including the development of ASCs, medical office buildings, wellness centers and various types of outpatient facilities.
  • Represented a large state university with its HIPAA/privacy compliance assessment and white paper.
  • Represented a university in university-wide HIPAA and privacy compliancy review. Assessed which health care components of the university were covered by HIPAA, and drafted and implemented policies and procedures.
 

Recognition

The group includes attorneys who have been named to the following lists:

  • Chambers USA

    Chambers and Partners uses a team of more than 140 researchers to rank lawyers on the basis of their legal knowledge and experience, their ability, their effectiveness and their client-service.

  • Super Lawyers

    Super Lawyers selects attorneys using a patented multiphase selection process, utilizing 12 indicators of peer recognition and professional achievement.

  • The College of Labor and Employment Lawyers

    The College of Labor and Employment Lawyers selects Fellows who have been in the field for at least 20 years and have proven to peers that they possess a high level of professional qualifications and character.

  • Benchmark Litigation - State Litigation Star

    Benchmark Litigation employs researchers who conduct interviews with litigators and their clients, examine recent casework handled by law firms and ask individual litigators to offer their professional opinions on peers.

  • American College of Trial Lawyers Fellow

    Fellowship in the American College of Trial Lawyers is extended only by invitation to trial lawyers whose professional careers have been marked by high standards of ethical conduct, professionalism, civility and collegiality.

  • The Best Lawyers in America list

    Inclusion in Best Lawyers is based entirely on peer review, employing a sophisticated, conscientious, rational, and transparent survey process designed to elicit meaningful and substantive evaluations of the quality of legal services.

Trade Groups & Associations
  • American Health Lawyers Association
  • Healthcare Information Management Systems Society
  • Pennsylvania Society of Health Care Attorneys
  • America’s Health Insurance Plans
  • Healthcare Financial Management Association

Contacts

Bruce D. Armon
Karilynn Bayus
Joe R. Ourth