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’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
- Licensing, accreditation and survey-related matters
- Interactions with state and federal regulators
- 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 attorneys have handled these select health care matters in the representation of:
Hospitals/Academic Medical Centers
- A Michigan-based specialty hospital organization in the sale of its Pennsylvania facility that provides bariatric surgeries and trans-gender surgeries to a nonprofit health organization based in New Jersey. Given our firm’s knowledge and experience in the super-competitive health care delivery systems growing in the Philadelphia region, we encouraged the client to consider a sale of the facility to a local health care provider rather than shut it down. The client agreed, and proceeded to sell the property and related equipment. Since the property and the assets were owned by two distinct special purpose entities, the deal required two separate transactions for each of the purchase and sale of the property and the purchase and sale of the assets.
- Two Illinois hospitals in the successful challenge to a project to build a new nearby competing hospital. We convinced the court that the administrative agency responsible for the approval of permits to build hospitals completely disregarded the review criteria for minimum beds and that such a radical departure from the criteria required a meaningful explanation to stand. The court agreed with our position and concluded that the decision of the administrate agency to approve the new hospital was arbitrary and capricious; thereby reversing the grant of a permit.
- A large multi-hospital health system in its acquisition of three different hospital systems in recent years, including two simultaneous transactions. We handled all acquisition matters, including: drafting and negotiating the transaction documents; hospital resolutions; extensive due diligence; corporate governance; public finance; real estate; environmental compliance; charitable assets and court approvals; corporate reorganization; antitrust counseling; and contract assignment.
- A major university and affiliated health system regarding sophisticated health care information technology agreements.
- Four large academic medical centers with respect to their involvement in a large regional health information exchange.
- A Pennsylvania university in analyzing the advantages and disadvantages of continuing to maintain a legal and practical separation between the university and its college of medicine and in guiding the merger of these two entities.
- Numerous hospitals in joint ventures involving physicians, including the development of ASCs, medical office buildings, wellness centers and various types of outpatient facilities.
- A major academic medical center in the filing of a certificate of need application for Level 2 trauma center.
- A major Illinois hospital system in certificate of need approvals for an affiliation to create the 10th largest not-for-profit, integrated health care system in the United States, serving nearly three million patients each year with more than 27 hospitals and more than 500 sites of care, and employing more than 3,300 physicians and nearly 70,000 associates and caregivers.
Physicians and Physician-Related Issues
- A state medical society with the creation and implementation of a commercial accountable care organization with a large commercial insurance payor and a subsequent arrangement with a different payor for Medicaid beneficiaries.
- A medical practice in handling its ransomware attack, including engaging a forensic expert and analyzing HIPAA and state breach law obligations.
- A health care practice in obtaining "declination" from the U.S. Attorney of both criminal and civil fraud charges regarding allegations that the health care practice created a fatal risk of infection by misusing medical devices during surgical procedures. We 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.
- Hundreds of physicians and providers regarding contract issues and negotiations.
- Numerous physicians before the Illinois Department of Financial and Professional Regulation.
- Numerous physicians in connection with National Practitioner Databank Reporting issues.
- A Pennsylvania county in the sale of its nursing home and associated real estate. Our representation included the coordination of the sale of assets, including handling real estate and environmental issues; financing; licensure transfer; and regulatory compliance.
- A group purchasing organization comprised of five separate health systems on a variety of health care regulatory matters.
- A group of ambulance providers in a class action effort relating to Medicare reimbursement benefiting approximately 300 ambulance providers.
- 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.
- The seller of a dental practice in the $8.9 million sale of the practice to a dental management service organization.
- The seller of a renal dialysis center in the $7.8 million sale of the practice to a national dialysis center.
- A Colorado medical marijuana company in applications for Illinois medical marijuana dispensary licenses.
- A real estate investment trust regarding ongoing matters, including Stark and fraud and abuse guidance and lease arrangements with hospitals, medical practices and other health care providers.
- Health care providers in white collar criminal actions.
- A group purchasing organization on compliance with Stark and fraud abuse compliance.
- Health care providers on whose behalf we perform ongoing legislative lobbying as well as administrative matters.
- A national medical transcription company with a HIPAA compliance audit by the Office of Civil Rights.
- A health care data analytics company in the negotiation of an Illinois Medicaid managed care contract.