Clinical and pathology laboratories are subject to a myriad of health care regulatory requirements and Medicare, Medicaid and third party payor rules. Additional regulations apply to laboratories owned by physicians, known as physician-owned laboratories or POLs, hospitals, and other health care providers and entities.
Laboratories require health care legal expertise pertaining to federal and state fraud and abuse laws, such as EKRA , the federal Anti-Kickback Statute and Stark, as well as laboratory-specific state and federal laws and payor rules. Benkoff Health Law has extensive experience in advising laboratories with respect to health care regulatory compliance including compliance with federal and state fraud and abuse laws, HIPAA and state privacy laws, Clinical Laboratory Improvement Amendments of 1988 (CLIA) certification, compliance and audits, state licensure and other laboratory laws, compliance with research requirements and other FDA regulations, and payor enrollment and out-of-network issues.
In addition, Benkoff Health Law regularly advises laboratories with respect to health care transactions and agreements and compliance with state and federal laws that impact those transactions and arrangements. In addition, we are experienced in providing health care corporate legal guidance to laboratories with respect to structuring new entities, restructuring existing entities, and advising as to appropriate methods for business combinations (e.g., mergers, sales, and acquisitions).
Laboratories must comply with applicable federal and state regulations and government and third party payor rules on an ongoing basis. Benkoff Health Law regularly advises laboratories with respect to federal and state fraud and abuse laws, such as EKRA , the federal Anti-Kickback Statute and Stark. These laws govern the relationships that laboratories have with physicians, other referral sources and their marketing personnel and contractors. Laboratories have historically been and continue to be the focus of fraud and abuse regulations and the laws in these areas are dynamic, which requires laboratories to reassess their compliance on an ongoing basis. Benkoff Health Law has expertise in advising laboratories with respect to the fraud and abuse laws that currently govern their arrangements.
In addition, Benkoff Health Law regularly assists laboratories in complying with HIPAA and state privacy laws and FDA regulations, including research and IRB related requirements that are applicable to laboratories. We also advise laboratories with regard to state licensure and CLIA requirements, including ongoing CLIA compliance and CLIA audits.
Laboratories are subject to unique Medicare, Medicaid and third party payor requirements. In addition, laboratories are sometimes out-of-network for various payors and must comply with payor requirements and fraud and abuse laws with respect to arrangements relating to their out-of-network status. Benkoff Health Law is experienced in recommending compliant solutions to payor issues facing laboratories.
Transactions and Agreements
Laboratories often require agreements for certain relationships including: employment and independent contractor agreements, sale and acquisition agreements, equipment and space leases and purchase agreements, management agreements, supply purchase agreements, and professional service agreements. We specialize in advising laboratories regarding arrangements involving other healthcare providers and entities, such as physicians, hospitals, skilled nursing facilities, and other health care facilities. Benkoff Health Law regularly drafts and negotiates a broad range of agreements for laboratories to ensure compliance with applicable health care regulations.
We also have expertise in drafting and revising corporate and organizational documents, such as corporate bylaws and company operating agreements, buy-sell agreements, and the like. The structure and terms pertaining to transactions and agreements in the health care industry are often impacted by health care regulations and third-party payor rules including federal and state fraud and abuse laws, such as EKRA, the federal Anti-Kickback Statute and Stark. At Benkoff Health Law, we focus on ensuring that agreements are tailored to laboratories’ business and legal needs and that our laboratory clients understand the terms of the agreements that they are entering into.
Laboratories must ensure that they structure their corporate arrangements in a manner that complies with health care regulatory laws. Benkoff Health Law is experienced in advising laboratories with respect structuring new laboratories as well as their ventures with other health care providers, such as hospitals and other health care entities, and with non-healthcare providers, such as private equity firms and management companies.
Laboratory investments and sales, acquisitions and mergers implicate many health care laws including, without limitation, licensure laws, CLIA, and fraud and abuse laws, such as EKRA, the federal Anti-Kickback Statute and Stark. Benkoff Health Law strives to offer laboratories realistic options for corporate structures that meet their business goals while complying with applicable health care regulations. We also regularly work with attorneys who specialize in tax, securities, merger and acquisition and corporate law to provide those attorneys with health care industry legal expertise and contractual assistance.
For more information about federal resources pertaining to clinical laboratories, please see CMS’s Clinical Labs Center page.
For more information about CLIA, please see CMS’s CLIA page.