Drug and device manufacturers, health care providers, and suppliers need legal and policy guidance on a variety of issues that affect Medicare and Medicaid reimbursement. Is Medicare likely to cover the service? Are there local or national coverage determinations that apply? How should the product or service be coded? Are there other limitations, such as Correct Coding edits, that affect how the service will be billed? Is payment made on an individual basis or bundled into a larger service? Are there other compliance concerns, such as federal anti-kickback and Stark self-referral issues, that may apply? We help answer these and other complex questions.
As part of our work, we assist clients in developing comprehensive reimbursement strategies for new and established therapies, technologies, and services. We work closely with the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA), as well as with key committees and members of Congress, to help our clients achieve answers to their reimbursement and regulatory questions. We help companies obtain favorable coverage policies (i.e., local and national Medicare coverage and utilization decisions) and make the case for appropriate reimbursement. Because of our experienced team, we are able to develop a regulatory and legislative strategy that combines scientific data, legal analysis, and advocacy at all levels of government. We also help clients manage regulatory processes governing waivers and Medicaid managed-care programs, Medicaid drug rebate programs, and provider survey and certification requirements. When federal or state enforcement agencies become involved, we also work with attorneys in our health care litigation practice to assist clients in responding to these inquiries.
Our health care practice has the significant advantage of including former high-ranking officials from the federal government, authorities in health care regulatory compliance, and health policy professionals. This range in policy and legal talent enables us to hit the ground running when dealing with our clients’ diverse and complex reimbursement issues.