Pharmaceuticals and Medical Devices. Our lawyers are well versed in reimbursement and regulation of pharmaceuticals, biotechnology products and medical devices. We work extensively with the relevant federal agencies on behalf of manufacturers and their customers. Areas of particular focus include:
- pricing and price reporting,
- reimbursement coding, product sales and vendor service contracting,
- Medicare (Parts B and D) and Medicaid reimbursement,
- product distribution, discounting and rebating,
- GPO and PBM administrative fees and rebates,
- free goods, samples and educational and research grants,
- “advisory committees” and similar personal services relationships,
- gifts and business courtesies and joint ventures of various types, and
- tracking of marketing expenditures for federal and state reporting.
Diagnostic Clinical Laboratories and Genetic Testing. Our lawyers are particularly adept at advising diagnostic clinical laboratories on the legal issues and challenges facing the industry. We represent large laboratories with long-term experience in the business, as well as the newest segment of the industry: specialty diagnostic clinical laboratories that focus on esoteric testing, and often in the cancer diagnostic, genetic disease or other DNA-based testing realm. Our experience includes:
- CLIA and state laboratory laws and related quality assurance issues,
- Medicare, Medicaid and other federal and state healthcare program coverage, billing and reimbursement issues,
- OIG-compliant compliance programs and policies, including development and implementation of compliance plans, compliance training, and investigations of compliance matters,
- Anti-Kickback Statute, Stark Law and False Claims Act review and advice,
- Laboratory-developed tests, including reimbursement and FDA-related issues,
- FDA regulation, and
- HIPAA, HITECH Act, EHR and other health IT issues specific to laboratories.
Corporate Compliance Programs. Our lawyers work with clients to establish and implement effective corporate compliance programs. We have prepared, reviewed and/or updated corporate compliance programs, overseen internal audits, conducted training, and drafted policies and procedures. We frequently assist clients with integration projects, providing strategies and processes to integrate newly acquired entities into a client’s compliance culture. This includes providing targeted integration assistance with respect to acquisitions of entities outside the client’s core healthcare line of business. We also support our healthcare enforcement group in investigations, and, when necessary, assist with voluntary disclosures and government negotiations related to issues uncovered via operation of client compliance programs.
Licensing and Certification Issues. Sidley lawyers work with a variety of state and federal agencies, accreditation organizations, and professional associations, on licensing and certification issues for our clients, including certificate of need issues, JCAHO accreditation, and CLIA certification. We also assist clients with enrollment in the Medicare and State Medicaid programs under the newly revised, considerably more stringent, enrollment and re-enrollment requirements of federal healthcare programs. This includes compliance with these enrollment and re-enrollment rules in the context of a change of ownership of a healthcare entity.
Clinical Trials. Sidley lawyers advise on FDA and other regulatory issues that arise in clinical investigations of new drugs and medical devices (including biological products regulated as drugs and medical devices). We assess relatively routine questions such as whether an investigational new drug exemption (IND) or investigational device exemption (IDE) is required and evaluate how the FDA’s commercialization rules apply to standard-of-care products used in trials. We also provide guidance in more complex situations such as high-stakes issues arising in FDA inspections of clinical investigations at academic medical centers and the special considerations presented by investigations of novel technologies such as pancreatic islet cells. One of the distinguishing factors of our clinical trials practice is the extent to which our healthcare lawyers coordinate with their FDA colleagues. We work to make sure that the myriad regulatory issues presented by the investigational administration of new medical technologies are thoroughly and efficiently addressed. In addition, our reimbursement practice is 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.
