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.
- Representing major trade associations of clinical laboratories and pharmaceuticals on a variety of reimbursement and regulatory issues, resulting in more favorable decisions and policies for these clients.
- Represented a manufacturer of a device used in weight reduction surgery on a coverage issue at CMS. In connection with this matter, CMS issued a national coverage decision consistent with the client’s interests.
- Represented a wound care company on a coding issue at CMS. As a result, CMS issued a new separate code for the product.
- Advised a major health information technology vendor on issues related to changes in coding and meaningful use requirements.
- Prepared multiple comprehensive reimbursement due diligence reports for investment in new medical technologies and health care companies.
- Regularly advising pharmaceutical clients on issues relating to the Medicaid Drug Rebate Program, 340B, and Medicare Part D.
- Serving as counsel in group appeals for more than 200 hospitals in reimbursement disputes with Medicare.
- Advising major health care providers on the handling of Medicare, Medicaid, and VA overpayments, audits, and recoupment actions.
- Advising an international pharmaceutical manufacturer regarding its participation in the Medicaid Drug Rebate Program.
- Drafting comments for a number of trade associations and drug manufacturers regarding the implications of the AMP regulations.
- Advising several trade associations, including those representing physicians, imaging providers, laboratories, hospice providers, nursing homes, home health agencies, and pharmaceutical manufacturers, on Medicare reimbursement and payment issues.
- Assisting the developer of a new, innovative genetic laboratory test in developing its reimbursement and coding strategy to obtain Medicare payment.
- Providing assistance to a manufacturer of a medical device used in weight reduction surgery in obtaining payment and coverage for its product.
- Advising companies specializing in anatomic pathology services on billing requirements for their services and likely payment issues.
- Advising a manufacturer of a medical device in the preparation and submission of its request for a New Technology Ambulatory Patient Classification under the Hospital Outpatient Prospective Payment System.
- Advising a provider of long-term rehabilitation services on recent changes in Medicare reimbursement issues.