Healthcare

The ever-changing regulatory landscape requires a commanding knowledge of relevant laws and regulations, as well as innovative approaches to issue resolution. Gibbons attorneys counsel clients on such regulatory and licensing matters as: Medicare, Medicaid, and third party reimbursement, appeals, and disputes; Stark Law and Anti-Kickback Statute compliance; health information technology provisions of the American Recovery and Reinvestment Act; Joint Commission and Community Health Accreditation Program (CHAP) accreditation; accountable care organization and physician practice development; integrated delivery systems and managed care contracting; state and federal licensing; institutional review board and clinical trial compliance; credentialing; patient advocacy, pastoral care, and end-of-life decision-making; hospital ethics committee counseling; qui tam (whistle-blower) action defense; and unrelated business income matters. We are experienced in creation and compliance matters in connection with organized delivery systems (certified and licensed) and in securing provider enrollment in governmental programs such as Medicare and Medicaid. As discussed elsewhere, we also represent healthcare providers and systems on all regulatory aspects of mergers, affiliations, and divestitures, along with numerous complex related issues.

Gibbons attorneys have represented numerous clients in connection with the Health Insurance Portability and Accountability Act (HIPAA) and other healthcare privacy and security laws, such as New Jersey state laws governing the confidential treatment of individually identifiable health information. This representation has included: (i) drafting and updating HIPAA compliance manuals, particularly to bring those manuals into compliance with the Health Information Technology for Economic and Clinical Health (HITECH) Act and the HIPAA Breach Notification Rule; (ii) analyzing transactions to determine the impact on them of HIPAA, the HITECH Act, and the Breach Notification Rule; (iii) advising clients on healthcare privacy related issues; and (iv) analyzing and drafting business associate agreements.

The Gibbons Healthcare Team represents all types of healthcare-related entities and organizations with respect to mergers, affiliations (for example, between hospitals or between hospitals and medical schools), acquisitions, joint ventures, management agreements, divestitures, spin-offs, licensing transactions, strategic alliances and collaborations, and other corporate arrangements. We provide counsel regarding corporate structuring, restructuring, and reorganizations, including accountable care organization start-up and development and managed care plan development and representation.

Our Trenton-based attorneys regularly analyze existing law governing the approval process for new healthcare facilities and represent clients before the appropriate agencies and departments. We possess longstanding relationships among senior decision-makers at the Departments of Health and Senior Services and Human Services and regularly shepherd regulatory matters from the initial meetings and analyses through final approvals or licensures.

We are also familiar with the particular issues facing nonprofit healthcare organizations, healthcare providers, trade associations, foundations, and related charitable organizations in connection with corporate transactions, interaction with other entities, unrelated business income, private inurement, lobbying, reporting, restrictions on activities, and other aspects of formation and operations, such as 1023 filings for recognition of federal tax exemption. We provide additional legal and tax advice on business issues that include employee benefits; health, disability, and other insurances; benefit and compensation plans; real estate; and tax matters, including recent changes to and compliance with IRS 990 filings.

The Gibbons Healthcare Team handles the full range of contractual matters when serving as clients’ outside general counsel, including review of vendor contracts and physician contracting arrangements. We represent healthcare providers in connection with provider network contract negotiations with health insurers, health maintenance organizations (HMOs), self-funded employee benefits plans, and preferred provider organizations (PPOs). We are experienced in managed care contracting with independent practice associations (IPAs), physician-hospital organizations (PHOs), HMOs, management services organizations (MSOs), and other entities, as well as counseling and negotiation on behalf of providers regarding innovative joint ventures, accountable care organizations, and integrated delivery systems.

Outside general counsel services encompass many additional areas, such as: counseling on transactions, purchases, sales, mergers, financings, affiliation agreements, practice structures, partnership, joint ventures, and acquisitions; federal and state licensing; all manner of disputes; management arrangements; ERISA advice; antitrust issues; Medicare and Medicaid reimbursement issues; hospice and wellness programs; patient referral issues; advance directives; health insurance coverage disputes; patient and other privacy and confidentiality requirements, as well as Conditions of Participation compliance; and major medical equipment acquisitions and financings.

Our outside counsel services also can include employment and labor matters, employee assistance, and employee benefits; environmental matters, including medical waste disposal and issues arising in connection with real estate development and construction matters; intellectual property matters, including trade and service marks and client branding; interaction with law enforcement and regulatory authorities; and healthcare information technology and electronic discovery. Our broader corporate services to healthcare entities include handling healthcare bankruptcies, preferences, and distressed restructurings.

Attorneys on the Gibbons Healthcare Team have a national reputation with regard to healthcare fraud and abuse issues, with years of experience in criminal, civil, and administrative matters arising from federal and state healthcare fraud investigations, including government investigations, internal investigations, corporate compliance, and complex civil litigation. We participate in investigations around the country while retaining a Mid-Atlantic regional focus. Gibbons has a proven track record of vigorously defending clients against investigations and actions initiated by whistle-blowers or the government alleging fraud and abuse regarding Stark, Codey, False Claims, anti-kickback laws, Medicare and Medicaid reimbursement, and the Food, Drug and Cosmetic Act, whether such actions are conducted by the Department of Justice, United States Attorneys’ Offices, Department of Health and Human Services Office of Inspector General, the FBI, or other federal and state agencies.

Gibbons is also frequently engaged to conduct internal investigations, and we work proactively with clients to avoid investigations by assisting in the implementation of effective compliance programs and the design and execution of related compliance training. For example, we counsel hospitals, physicians, and device and drug manufacturers regarding sales and marketing compliance issues relating to interactions with healthcare professionals and off-label promotion. Gibbons attorneys also review and analyze transactions and business models to ensure compliance with various laws addressing fraud and abuse in the healthcare industry.

The state and federal governments’ continued focus on healthcare policy is creating an ever more complex statutory and regulatory environment. The Gibbons Government & Regulatory Affairs Group is uniquely qualified to represent healthcare entities and human services providers, serving to raise their profiles in the State House and on Capitol Hill, advance priority initiatives, and analyze the impact ongoing legislative changes have on our clients. We also develop, then implement, lobbying strategies to address their concerns. Healthcare is the most prominent aspect of our Trenton-based practice, making up nearly half of all matters our government affairs team handles. We review, analyze, and monitor hundreds of bills per legislative session for each of our healthcare clients, evaluating those of particular operational or financial significance and creating lobbying strategies to achieve our clients’ objectives. We often testify on bills before the Assembly Health and Senior Services Committee; the Assembly Financial Institutions and Insurance Committee; the Senate Health, Human Services and Senior Citizens Committee; and the Assembly and Senate Budget Committees. We possess strong relationships with senior staff in the Governor’s Office and with the Commissioners of Health and Senior Services and Human Services. At the federal level, we have a strong lobbying presence on Capitol Hill, where we represent several healthcare entities on federal legislative and regulatory matters.

Gibbons has handled a challenging and diverse group of issues confronting health carriers in New Jersey, including:

• Major revisions to the claim payment, prompt payment, and internal and external appeal processes on claim adjudications considered by the Legislature, including the “Claims Payment Act,”;  “Healthcare Carrier Accountability Act,”;  “Health and Dental Claims Authorization, Processing and Payment Act,”; “Healthcare Claims Payment Responsibility Act,”;  and “Health Claims Authorization, Processing and Payment Act.”
• The “Health Information Electronic Data Interchange Act,”; “Healthcare Quality Act,”; “Genetic Privacy Act,”; establishment of medical savings accounts; licensing of organized delivery systems; establishment and expansion of FamilyCare and KidCare programs and amendments to same; establishment of small employer health purchasing alliances; and right to joint negotiations by physicians and dentists with.
• Various bills concerning medical errors and medical malpractice insurance, including the “New Jersey Healthcare Access and Patient Protection Act”; “New Jersey Medical Access and Responsibility and Patients First Act”; “New Jersey Medical Care Access and Responsibility and Patient First Act”; and “Healthcare Professional Responsibility and Reporting Enhancement Act.”

Gibbons attorneys represent hospitals and hospital systems regarding all types of reimbursement matters, including governmental programs such as Medicare and Medicaid; commercial carriers; governmental funding under the New Jersey Hospital Care Payment Assistance program (“Charity Care”); Hospital Relief Subsidy Fund; and commercial and Medicaid managed care. We also address major health information technology acquisition and support arrangements and counsel clients regarding electronic medical records (EMR) utilization and the meaningful use of EMR and related technology contracting for hardware, software, professional IT services, and maintenance support. We handle matters involving facilities operations and management, building construction, and facility safety and security.

Our attorneys also represent hospitals and hospital systems in a myriad of vendor contracting arrangements, such as bio-med maintenance services providers, patient accounts collections arrangements, employment agreements, architectural agreements, construction contracts, waste management agreements, and medical device supply agreements, among others.

In addition, the Gibbons Healthcare Team represents hospitals and hospital systems regarding group purchasing arrangements and exclusive hospital-based physician group contracting arrangements (Emergency, Intensivist, Hospitalist, Radiology, Pathology). We counsel and negotiate regarding the full range of hospital supplies and services contracting, hospital group purchasing organization (GPO) arrangements, and major medical equipment and lease financing arrangements.

Our attorneys also handle health facility governance matters, such as medical staff bylaw revisions to meet changes in Joint Commission Standards. Our representation of hospital systems additionally covers employment and labor matters, employee assistance, and employee benefits; issues arising in connection with real estate development and construction, as well as real estate transactions; and fraud and abuse matters, including civil, criminal, and administrative matters arising from federal and state healthcare fraud investigations.

Our attorneys have broad experience representing physician practice groups and networks, including negotiation and general counseling regarding physician network participation agreements with health insurers, HMOs, self-funded employee benefits plans, and PPOs. We are experienced in managed care contracting with IPAs, PHOs, HMOs, MSOs, and other entities; the development of Medical Malpractice Liability Purchasing Alliances by physician specialty associations; representation of single- and multi-specialty physician practices in connection with partnership agreements and practice merger and acquisition matters; and leasing, billing, and administrative services agreements regarding space and equipment, including major medical equipment acquisitions and financing arrangements with global equipment manufacturers and national healthcare finance companies.

The Team also represents individual physicians regarding employment agreements, partnership agreements, practice formation, employer-employee matters, and services agreements for billing, collection, and general administrative services. Gibbons additionally negotiates leasing agreements regarding space and equipment, including major medical equipment acquisitions and financing arrangements with global equipment manufacturers and national healthcare finance companies. We counsel clients and negotiate on their behalf regarding comprehensive practice management services, corporate practice of medicine matters, and concierge and flat-fee medical practice models.

Gibbons attorneys have represented numerous clients in connection with HIPAA and other healthcare privacy and security laws. We also handle fraud and abuse matters, including civil, criminal, and administrative matters arising from federal and state healthcare fraud investigations.

Gibbons acts as outside general and special counsel to home health and hospice agencies, as well as federally qualified health centers, in connection with state and federal licensing and regulatory compliance, providing assistance in obtaining and updating applicable licenses to expand geographic territories or scope of services, and updating and implementing compliance plans. We field various day-to-day issues, including negotiation of contracts, such as supply agreements and provider agreements; employment and labor issues; corporate governance issues; and issues that may arise and implicate HIPAA and other laws, including matters involving medical or other emergencies. The Gibbons Healthcare Team represents home health and hospice agencies in connection with various corporate transactions, such as collaborative arrangements with other providers, acquisition of other providers, and joint venture arrangements to provide home care services. We also handle government affairs for these clients, participating in state legislative and regulatory processes on issues important to them.

Gibbons attorneys are experienced in various reimbursement and commercial insurance areas. The Gibbons Healthcare Team counsels provider clients regarding enrollment in Medicare, Medicaid, and private insurance. Additionally, Gibbons attorneys represent providers in disputes over Medicare reimbursement. We also handle appeals before the Provider Reimbursement Review Board regarding Medicare payment and challenging Medicaid payment rates, as well as other disputes with governmental payors. Our attorneys have represented hospital systems and individual providers in their disputes with local health insurance companies, managed care companies, HMOs, PPOs, and others, including disputes regarding reimbursement, credentialing, overpayment, and medical necessity determinations.

The Gibbons Healthcare Team represents healthcare facilities in connection with such state and federal reimbursement programs as Charity Care and Hospital Relief Subsidy Fund disbursements and appeals. We represent healthcare facilities before the New Jersey Department of Health and Senior Services and the New Jersey Department of Human Services – Division of Medical Assistance and Health Services.

We have defended hospitals, physicians, and physical therapists against Recovery Audit Contractor (RAC) and Zone Program Integrity Contractor (ZPIC) audit responses and similar demands for recoupment in connection with Medicare and Medicaid. We have also handled demands for recoupment from commercial carriers involving disputes over medical necessity, medical record documentation, and other allegations affecting provider reimbursement. Gibbons has represented large, multi-specialty physician groups in connection with innovative Accountable Care Organization (ACO) reimbursement arrangements. Our attorneys have negotiated large payor contracts with hospitals and physician practices involving most major commercial payors conducting business in the state of New Jersey.