Specialty providers and suppliers encounter unique business challenges and legal issues, distinguishing them from their counterparts along the continuum of care.
Our firm has significant experience representing diagnostic labs, pharmacies, and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) companies in connection with their transactional, regulatory, and litigation needs.
We regularly counsel lab and companion diagnostic clients on complex regulatory issues, including relationships with referral sources, billing compliance and reimbursement, Medicare and Medicaid enrollment, and Clinical Laboratory Improvement Amendments, as well as on overpayment audits and appeals. We have successfully conducted lab internal investigations and resolved significant refunds with Medicare Administrative Contractors. We have assisted with civil and criminal investigations by federal and state governmental agencies. Similarly, we have provided Foreign Corrupt Practice Act guidance and assistance on other international compliance matters.
Along with our health care lawyers, our corporate and securities team has substantial experience in the acquisition of independent labs and pathology practices. Given our deep understanding of laboratory business operations, we are particularly adept in identifying risks and offering solutions as a part of the acquisition due diligence process. We are likewise experienced in the structuring of complex outsourcing and management arrangements between health systems and diagnostic laboratory companies.
We have particular knowledge in domestic and international contract management for laboratories. Standardization, specialization, and leveraging commonality, where possible, are the principal mechanisms driving efficiencies for our clients. Our contract management services include, among other things, the development of template contracts and playbooks, and sophisticated information technology-driven solutions for tracking contract status, including adverse party execution, and dependable turnaround times for standard and rush contracts. Generally, these services are requested by lab clients whose contract volume is large, whose contracts are subject to standardization, or whose contracts in certain areas are complex but whose business demands require swift response beyond the resources of in-house counsel.
Our lawyers bring years of experience in assisting leading industry players in the pharmacy space. As a part of our health care and FDA practice, our lawyers are knowledgeable in all aspects of the purchasing of, dispensing of, and payment for prescription drugs and medical devices. We help retail, specialty, and mail-order pharmacies—whether independent or associated with an institutional provider—on a host of legal issues.
We assist with licensure and DEA certification, as well as on complying with state drug substitution and mail order pharmacy requirements. Our lawyers represent pharmacy clients on responding to inquiries, audits, and investigations by licensing authorities, prescription benefits managers (PBMs), and other payors. We help 340B covered entities acquire drugs at reduced prices through participation in the federal 340B Drug Pricing Program and handle both 340B Program compliance and optimization. We also are regularly called upon to advise on 340B Program contract pharmacy arrangements.
Our lawyers’ knowledge of our pharmacy clients’ business structures, reimbursement, Medicare and Medicaid enrollment, PBM credentialing and contracting, and limited distribution drug and 340B Program purchasing programs gives us the ability to manage these complex transactions and seamlessly execute on business plans without impact to pharmacy operations and reimbursement.
Our capabilities extend to such operational issues such as with the development of provider network contracting with prescription benefits managers and Medicare Prescription Drug Plans, developing policies and procedures to ensure compliance with Medicare Part D regulations, and establishing a compliant electronic prescription system.
Additionally, our robust payor litigation group brings pharmacy-specific insight to clients who need to rely on any willing pharmacy laws and other means to seek and maintain in-network enrollment and reimbursement or defend pharmacies facing commercial audits and direct and indirect remuneration fee recoupments and offsets.
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
Our practice in the DMEPOS sector includes the full range of legal services, from transactional, to regulatory, to litigation. Given the depth and breadth of our practice in this area, we believe our firm occupies a unique position in this subspecialty health care market. Our lawyers have handled numerous mergers and acquisitions of DMEPOS suppliers, including navigating regulatory issues surrounding Medicare and Medicaid changes in ownership requirements and DMEPOS competitive bidding implications.
Our DMEPOS investigations and litigation experience includes matters involving the Department of Justice, the Department of Health and Human Services, state enforcement actions, and commercial payor disputes. We have substantial experience in defending clients against federal False Claims Act actions, including the recent national enforcement initiative, Operation Brace Yourself. Similarly we have defended clients in qui tam lawsuits and state investigations.
Our experience includes:
- Successfully challenging the use of statistical sampling and extrapolation in the Medicare appeals process to reduce multimillion dollar overpayment by 95 percent.
- Representing clients in response to Health and Human Services Office of Inspector General/Office of Audit Services audits.
- Successfully representing a national DMEPOS client in response to a Medicare payment suspension, resulting in the termination of the payment suspension and resolving all allegations with no final overpayment determination.
- Representing a coalition of ventilator suppliers in efforts to have Centers for Medicare and Medicaid Services implement a more robust coverage criteria.
- Representing multiple DMEPOS clients in response to, and resolution of, Notices of Termination of Competitive Bidding Contracts.