The heavily regulated and rapidly changing healthcare industry has created a broad range of legal issues for institutional providers, group practices, individual providers, and business entities.  The wealth of experience of our Healthcare group, chaired by William McDonald, positions us at the forefront of the healthcare industry and helps guide our clients through the complex regulations.  Our healthcare clients benefit from the multidimensional resources of the firm’s corporate, employment, real estate, litigation, and financial service capabilities, which enhance the scope of the health law services we provide.

Healthcare Practice Transactions
As the healthcare industry shifts to more value-based payment models, providers must consolidate and collaborate in new ways.  Our Long Island healthcare attorneys are highly experienced in the myriad transactions and challenges that accompany this changing environment.  We represent doctor practices acquiring or being acquired by medical groups or moving hospital systems as well as practices merging or affiliating.  We also advise clients in the creation or retention of management service organizations (MSOs) that provide management, administrative, and other support services.  Our team is well versed in the critical issues surrounding such engagements, including anti-kickback, corporate practice of medicine, and Stark compliance.  We also assist clients in all aspects of establishing medical practices, including startup, corporate governance, and compliance issues.

Healthcare Professionals
We represent licensed healthcare professionals in all types of investigations and proceedings that could jeopardize their professional licenses or their participation in Medicare, Medicaid, or private insurance plans. We offer experienced representation before the Office of Professional Medical Conduct (OPMC) and the Office of Professions, as well as in administrative proceedings where the HHS Office of Inspector General or the New York State Office of the Medicaid Inspector General may seek to exclude providers from participation.  We also defend physicians and residents in clinical privileges actions and hearings.

As an added benefit, our attorneys are experienced in representing licensed medical professionals facing criminal prosecution.  Unlike many criminal defense attorneys, we have the advantage of our firm’s vast healthcare experience, and understand that an otherwise acceptable disposition of a case could have dire effects on a licensed professional’s ability to earn a living after the criminal case is over.  We work to protect our clients’ professional licenses, hospital and clinic privileges, participating provider insurance contracts, and eligibility for Medicare and Medicaid programs.  To that end, we regularly litigate and negotiate with the New York State Office of Professional Medical Conduct, the New York State Office of Professions, the New York State Office of the Medicaid Inspector General, and the Office of the Inspector General for the Department of Health and Human Services.

Life Sciences
Our team has advised trial management organizations while conducting clinical trials for contract research organizations.  Principal investigators and sub-investigators have also turned to us for advice before signing on to projects.

Our lawyers also stand ready to advise clients while dealing with the Food and Drug Administration during the premarket approval process for drug and medical device approval.  If the FDA sends a warning letter, we can advise our clients, facilitate compliance, and defend against enforcement actions if necessary.

Managed Care Litigation
No field has changed more, and continues to change, than managed care.  Since the passage of the Affordable Care Act (ACA), insurance companies have dramatically increased the rate of auditing healthcare providers, while at the same time they have sought to terminate providers from their networks to lower their costs. We are experienced in fighting for healthcare providers against insurance company tactics that seek to “recover” alleged overpayments during audits that use flawed methodology, and we have helped healthcare providers navigate the appeals process to preserve participating provider status with insurers.

Many insurance companies have utilized the Civil Racketeer Influenced and Corrupt Organizations Act (RICO) to recover large sums from healthcare providers and to obtain declaratory judgments to prevent having to pay future claims.  Our lawyers include former prosecutors who have prosecuted criminals under RICO and bring that experience to benefit clients needing aggressive defense against civil RICO claims.

Medicare RACs and the Office of the Medicaid Inspector General
Medicare Recovery Audit Contractors (RACs), Zone Program Integrity Contractors (ZPICs), and New York State’s Office of the Medicaid Inspector General (OMIG) are ruthless entities with a clear mandate to recover money from healthcare providers.  We have successfully defended healthcare providers against these audits and won reversals of audit findings in administrative hearings.

Fraud, Abuse, and Compliance
Our healthcare group has guided clients through the complex web of statutes and regulations that encompass the Stark Law, the federal anti-kickback statute, and the Health Insurance Portability and Accountability Act (HIPAA), and their application to situations involving hospital privileges, employment relationships, expansion of physician practices, and reimbursement disputes.  Running afoul of regulations can have dire consequences for providers, and our attorneys advise clients, including physicians, dentists, chiropractors, RNs, LPNs, NPs, LCSWs, pharmacists, and home health agencies, in compliance issues with the goal being to not only prevent violating applicable laws, but also to draft appropriate compliance policies.

HIPAA and Privacy Compliance
We have significant experience working with healthcare businesses and medical practices to ensure compliance with federal and state privacy laws, including HIPAA and HITECH (the Health Information Technology for Economic and Clinical Health Act).  Our clients benefit from our vast experience in navigating the ever-changing landscape of privacy rules.  Our specialized technology and healthcare experience provides a unique opportunity for us to assist clients with building and instituting privacy compliance programs.  In addition to creating new privacy policies and procedures, we have the capabilities to test and improve existing processes to increase efficiency and minimize legal exposure to breaches of protected health information (PHI) or any related issues.

Our experience in representing clients before administrative and governmental agencies allows us to effectively represent healthcare businesses before the federal Department of Health and Human Services (HHS) for violations of federal privacy laws.  We are adept at vigorously defending PHI breach claims and negotiating fair and reasonable settlements with HHS and other governmental agencies that oversee privacy compliance.

False Claims Act
Our team has a broad investigatory background and significant complex litigation experience, enabling us to successfully represent clients facing False Claims Act lawsuits and investigations in the healthcare realm. Our multidisciplinary team includes healthcare and municipal practitioners as well as former prosecutors and government attorneys.

McDonald’s Healthcare Blog