Overview
Foley Hoag’s Life Sciences Coverage & Payment practice advises early stage to global leaders of drug, biological and medical device companies on a broad range of health policy matters impacting novel technologies with a particular expertise on Medicare coverage, coding and payment determinations. The group focuses on legal and regulatory matters before the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and, where relevant, the Health Resources and Services Agency (HRSA). We also closely follow health care legislative policy matters in Congress impacting the life sciences.
Attorneys in our Coverage & Payment practice provide strategic advice to help companies position new technologies in the evolving coverage and reimbursement landscape. Based on decades of experience with CMS, Congress, Medicare contractors, state Medicaid agencies, and the U.S. Food and Drug Administration (FDA), Foley Hoag has earned a reputation as a strong team of health policy experts who are focused on achieving our clients’ goals at the most appropriate decision-making level. Our extensive background informs our strategies to obtain appropriate coverage and payment for a wide range of life sciences technologies, including drugs, biologics, medical devices, molecular diagnostics, and durable medical equipment.
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We offer a comprehensive range of legal, regulatory and legislative services, including analyzing regulations, preparing draft legislation and Congressional testimony, analyzing pending legislation, and working with agency officials and Congressional staff to advocate on proposed regulations and complex legislation.
Coverage, Payment, Coding and Billing Determination
Foley Hoag's Coverage & Payment team works closely with our clients to address each aspect of the Medicare process: coverage, payment, coding and billing. These present potential risks for companies introducing new technology into the healthcare marketplace.
Our attorneys have considerable experience building a strong legal, regulatory and clinical case for coverage, particularly in medical environments characterized by competition or small patient populations. They also work with CMS and other payers to establish payment rates that enhance patient access; obtain appropriate codes to describe new technology; and identifying billing issues that may arise at multiple sites of care.
We also provide clients with guidance on health policy legislation and Congressional oversight. The Coverage & Payment team collectively has many years of experience working on health policy legislative and regulatory matters in the Congress and the Executive Branch. Our attorneys and health policy specialists have served in senior strategic decision-making roles at the Department level and as members of Congressional staff. As a result, we are able to bring unique perspectives to our clients and anticipate their individual needs.
Our team provides regulatory and legislative advice to a broad array of leading life sciences companies, including:
- Pharmaceutical and biotechnology
- Medical device
- Molecular diagnostics
- Venture capital and investment funds
- Patient associations and advocacy groups
