Clinical Diagnostic Laboratories and Genetic Testing
As an important component of our respected Life Sciences practice, we represent clinical diagnostic laboratories, genetic and genomic testing companies and other personalized medicine companies involved in the development and provision of advanced diagnostic testing products and services within the realms of cancer, prenatal testing, genetic disease testing, gene sequencing and personalized medicine and wellness.
We also advise many of the world’s leading pharmaceutical, biotechnology and medical device companies, as well as health IT companies, health and wellness companies, professional associations and research institutions on scientific and business initiatives related to the practice and advancement of genomic medicine.
We represent large, well-established laboratories, as well as those in the newest segment of the industry—specialty clinical diagnostic laboratories that focus on esoteric testing in personalized medicine, prenatal and cancer diagnostics and predictive genetic testing. We also advise companies with pharmacogenetic products, as well as genetic testing companies that map and sequence the human genome and provide personalized DNA-sequence data for a variety or health, wellness and other purposes.
CLIA and State Laboratory Licensure Laws
Our lawyers assist clients with the application for certification at each level of Clinical Laboratory Improvement Amendments (CLIA) and applicable state licensure, as well as with the application of rules related to qualification of CLIA testing personnel, proficiency testing and other specialty testing quality standards pertaining to clinical laboratories. We also assist clients with understanding licensure and other rules related to direct-to-consumer testing.
FDA and In Vitro Diagnostic Tests
Our lawyers have extensive experience with FDA laws and policies concerning in vitro diagnostic (IVD) tests, which are essential for clinical laboratory services. Tests used by clinical laboratories range from those that are simple, low-risk and lightly regulated to those requiring pre-market approval by FDA. These tests include IVDs manufactured by traditional test manufacturers and tests developed by laboratories (Laboratory Developed Tests or LDTs) and may be offered only through a physician or directly to consumers. Each of these factors affects the level of FDA oversight. We are familiar with the wide range of clinical laboratory products and experienced in providing compliance advice for each.
We also counsel clients with respect to the FDA’s evolving policies for “research use only” (RUO) and “investigational use only” (IUO) products and recommend strategic approaches to dealing with the uncertain regulatory environment.
Our team also has experience in the area of pharmacogenetics. We counsel device and pharmaceutical manufacturers on the FDA’s evolving policies for genetically-targeted drugs and on the “companion” diagnostics needed for their safe and effective use.
Medicare, Medicaid and Other Healthcare Program Coverage
Our lawyers have particular knowledge of the complex coverage, coding and payment rules related to reimbursement under the Clinical Laboratory Fee Schedule, as well as the Physician Fee Schedule for tests involving a professional component. We have worked with clients and trade associations to guide government decision-makers as they develop reimbursement policies for both existing and novel products and services, including, for example, the new billing codes for molecular pathology testing and next-generation sequencing. Our lawyers also possess an in-depth understanding of the Palmetto GBA Laboratory and Molecular Diagnostic Services Program (the MolDx Program), which develops coverage policy and impacts clinical diagnostic laboratories on a nationwide basis. Our team also works extensively with anti-markup, disclosure and other coverage and payment rules related to clinical and anatomical pathology testing under federal and state law.
Mergers and Acquisitions, Initial Public Offerings and Private Financings
Our healthcare and FDA lawyers work with the firm’s robust corporate practice to assist clients on both sides of transactions involving the purchase, sale and financing of clinical diagnostic laboratories and other diagnostic companies. We conduct due diligence, structure transactions and draft transaction documents to appropriately protect the interests of our clients. We also advise on the impact of transaction structures under the complex Medicare and Medicaid change-of-ownership rules. With our broad base of experience in the laboratory area, we are well-equipped to identify, evaluate and quantify regulatory risks, and address such risks in transaction documents, and in some cases, in public filings, prior to entering a transaction or making an investment in the clinical laboratory and diagnostics industry.
Enforcement and Litigation
Our firm represents healthcare clients, including clinical laboratories and diagnostics companies, in federal and state criminal, civil and administrative investigations and related qui tam actions. We also conduct internal investigations of compliance, reimbursement and other regulatory matters for clinical laboratories, particularly for newer laboratories with fledgling compliance programs and complicated Medicare, Medicaid and private third-party payor billing requirements. We have had substantial success in persuading prosecutors not to prosecute criminal matters or intervene in civil matters. Yet our experience also includes negotiating resolutions and settlements, and advising clients on issues arising from mandatory and voluntary disclosure rules.
OIG Compliance Programs and Policies
Our lawyers have helped clients establish and implement their compliance programs since the inception of such programs for clinical laboratories by the United States Department of Health and Human Services Office of Inspector General (OIG) in 1998. We draft compliance programs and policies, conduct training for board members, executive management, physicians and technicians, and sales and marketing staff, and assist with investigations, audits and interactions with government regulators. We are particularly knowledgeable in assisting with the complex issues facing clients whose businesses function as a hybrid of clinical diagnostic laboratory, medical device or pharmaceutical company, and physician practice.
Anti-Kickback Statute, Stark Law and False Claims Act
We counsel clients in all aspects of fraud and abuse, including in the special risk areas applicable to clinical diagnostic laboratories and genetic testing companies revolving around sales and marketing activities, and relationships with physicians and patients. Our lawyers work closely with clients to structure transactions and other financial relationships appropriately, establish and advise on billing and reimbursement policies, and guide business operations consistent with federal and state false claims acts, self-referral and anti-kickback limitations, and state corporate practice of medicine and fee-splitting laws. We also consult with government administrative agency and legislative officials to keep our clients current on the latest enforcement developments and trends.
HIPAA, HITECH Act, EHR and Other Health IT Issues
With medical and genetic privacy as major concerns, we advise clients on issues arising under the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH), the European Union Data Protection Directive and state laws governing privacy of personal medical information. Our lawyers advise clients on how to maximize the opportunities presented by new methods of health information delivery while avoiding regulatory problems and significant penalties in this increasingly robust enforcement environment, which includes ongoing audits by the U.S. Department of Health and Human Services Office for Civil Rights (OCR). We have experience addressing the specific needs of laboratories using Laboratory Information Systems (LIS) and laboratories communicating with physicians and customers (including patients) via web portals and similar online tools. Increasingly we are addressing complex legal, policy and ethical questions raised by genetic and genomic “Big Data” and by the new programs and policies resulting from President Obama’s Precision Medicine Initiative and Cancer “Moon Shot.”
We advise clients on healthcare, FDA, privacy and other regulatory issues arising from clinical investigations involving genetic and genomic testing, laboratory-developed tests and other new laboratory and medical technology. Our reimbursement practice is also well-equipped to provide advice on Medicare Secondary Payor (MSP) issues and related MSP “Section 111” reporting requirements that apply to sponsors of clinical research.