Khaled J. Klele | McCarter & English, LLP

Healthcare providers turn to Kay Klele for strategic advice and counsel on complex regulatory issues, strategic growth, and high-stakes disputes.

Khaled “Kay” Klele is a dedicated and knowledgeable healthcare attorney. He represents numerous clients in the healthcare industry, including group practices, ambulatory surgery centers, urgent care centers, telemedicine providers, laboratories, medispas, infusion centers, healthcare service firms, home health agencies, imaging centers, addiction centers, senior living facilities, management service organizations (MSOs), pharmacies, hospitals, and rural clinics, among others. Kay is well-versed in healthcare litigation, regulatory compliance matters, and transactional matters, providing comprehensive legal support to his clients. To better assist his clients, Kay keeps track of statutory and regulatory changes to both state and federal laws, and routinely writes and speaks on healthcare issues. His in-depth knowledge and experience in healthcare law make him a valuable asset to his clients.

As an experienced litigator, and with extensive knowledge of regulatory issues, Kay represents healthcare clients in a wide range of disputes including payor audits, healthcare reimbursement issues, including ERISA, and claims involving the federal False Claims Act and its state equivalents. He also represents his clients in contract disputes, partnership disputes, facility construction disputes, non-compete actions, as well as other general litigation matters. Additionally, Kay represents individual physicians and other healthcare professionals before their respective boards for investigations and disciplinary actions, as well as in other licensing matters.

Kay also counsels his clients on compliance and operational issues. He provides guidance, among other things, on a variety of licensure issues, the corporate practice of medicine, marketing plans, Stark and Anti-Kickback laws, state self-referral and anti-kickback laws, DEA and controlled substances and prescription issues, HIPAA, fair market value issues, fee-splitting laws, telemedicine, Medicare/Medicaid, federal and state transparency laws, and licensing and certification renewals and transfers.

He is frequently called upon by his clients, including MSOs, to analyze and create compliant business structures or arrangements. He advises MSOs on compliance issues throughout their operations from the MSO’s creation, scaling, and then the ultimate sale of all or part of the MSO.

In his transactional practice, Kay is actively involved in practice and facility mergers and acquisitions, practice consolidation, and private equity healthcare transactions. He assists in the sale and purchase of practices, in creating multi-specialty groups, and drafting provider agreements, independent contracts, and HIPAA Agreements.

Assists clients in creating group purchasing organizations (GPOs), negotiating contracts with members and suppliers. Also helps GPOs navigate the complex regulatory framework applicable to group purchasing organizations including rebates, discounts, and fraud and abuse laws.

Represented a fertility practice in the purchase of another fertility practice that had multiple locations in different states. In addition to drafting the transactional documents necessary to close the transaction, coordinated with multiple agencies in different states to assist the client with transferring and/or obtaining the numerous federal and state laboratory licenses that are customarily held by fertility practices at the various locations involved.

Representing several clients in forming management services organizations, addressing regulatory and compliance issues in their business structures and daily operational needs, and scaling businesses through acquisitions.

Represented various healthcare providers in matters brought by insurance carriers alleging violations of the New Jersey Insurance Fraud Prevention Act.

Represented a behavioral health provider in an Insurance Fraud Prevention Act matter brought by a national insurance carrier, and subsequently represented the provider in an investigation brought by the Attorney General of New Jersey.

Represented healthcare providers and a medical software company in litigation involving the False Claims Act.

Represented a medical practice in opening locations within independently owned pharmacies. In addition to handling the transactional documents, coordinated with the Board of Pharmacy to receive approval of these transactions and to identify the location within the pharmacy where the practice could see patients.

Represented a New Jersey public school district in dissolving a temporary restraining order that prevented the district from switching its prescription benefit provider. The switch was opposed by one of the teacher’s unions, and the fund that oversaw the prescription benefits was evenly deadlocked between school district and union trustees. After persuading the Court to dissolve the restraining order, successfully argued that the fund, which was created approximately 40 years ago, was ultra vires and had to be dissolved. Once the Court held that the Fund was ultra vires, the parties settled and the fund was dissolved.

Represented a national healthcare service firm in the partial sale of its business to a private equity firm. Assisted with drafting and revising the transactional documents to address regulatory compliance issues, including New Jersey’s statute imposing notice requirements in connection with a change in control of certain healthcare entities, N.J.S.A. 34:11-4.15. Additionally, handled the license transfer applications for all of the states in which the client operated.

Represented a medical practice in an action against a medical billing company for failing to properly bill. In a matter of first impression, the New Jersey Superior Court agreed that a medical billing company owes a fiduciary duty to the medical practice in handling the medical practice’s medical records, and could breach that duty by failing to return the medical records back to the practice in a timely matter after the arrangement terminates.

Representing a client purchasing pharmacies in the tristate area. Assisting in deal negotiation related to inventory and prescription medication issues, drafting transactional documents, and addressing any ancillary documentation.

Represented a New Jersey hospital in a matter seeking to enforce various restrictive covenants against two of its former executives. After winning several discovery motions, the parties settled on terms favorable to the client, including an extension of the former employees’ non-competes.

Represented a client in its licensure applications for outpatient and inpatient behavioral and mental health facilities. Worked with the client on documentation for the licensure applications and coordinated with the New Jersey Department of Health to address any application deficiencies and later during the physical plant inspection.

Defended over twenty different skilled nursing facilities throughout New York and New Jersey in litigation matters involving regulatory violations and standard of care issues. Assisted the clients in addressing and remedying any alleged regulatory violations.

Represented a healthcare client in establishing an overseas call center, including drafting the appropriate documentation and addressing various regulatory issues.

Represented a multinational pharmaceutical company and a number of its aﬃliates in non-compete matters. Obtained restraints against former employees and competitors, including notably against a former employee—despite not having a non-compete agreement—after conducting a forensic review of his computer and discovering the employee transferred confidential information to his personal email days before he resigned.

Assisted a multi-national fertility practice in identifying billing transparency laws in the various states in which they operated and guided the client in addressing those transparency laws by drafting various forms and policies to use in their operations.

Represented a multi-room licensed surgery center in a class action lawsuit against several payors for failing to properly reimburse out-of-network claims.

Negotiated provider agreements and addressed credentialing issues for one of the first urgent care centers to become credentialed by a major health insurer payor as an urgent care center.

Represent physicians and other healthcare professionals before their respective boards for investigations, fair hearings, and disciplinary actions, as well as other licensing matters. Routinely petition various boards to obtain their perspectives on regulatory interpretation and approval.

Assisted a client in petitioning the Board of Dentistry to consider a dental assistant as a “closely allied healthcare professional” so that they could form a corporate partnership with a licensed dentist.

Represented a medical malpractice carrier during the COVID-19 pandemic to identify and monitor the changes to telemedicine and telehealth statutes and regulations at the federal level and in the State of New Jersey.

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