Drug and Medical Device Coding, Coverage, and Payment

Overview

For innovators, providers, and investors, setting the right strategy for securing coding, coverage, and reimbursement for new drugs, medical devices, and services is a complex task that involves a deep knowledge of multiple government agencies, health plans, providers, and other related stakeholders.

Our coding, coverage, and payment experience spans these distinct elements, as well as the application of the detailed laws, regulations, rules, and policies that govern how those decisions are made. Clients turn to us to develop integrated strategies to help them effectively and efficiently navigate issues involving the introduction of new technologies.

Epstein Becker Green’s team represents clients in connection with Medicare, Medicaid, and commercial plan coverage and reimbursement matters. This includes negotiating Medicare national and local coverage determinations and challenging adverse determinations in administrative hearings and litigation. In addition, we have applied for codes across the spectrum of code sets, including CPT and HCPCS codes.

Clients also rely on us to prepare strategic assessments tailored to the specific coverage, coding, and reimbursement environment that affects a new innovation and to assist in anticipating any challenges that may arise.

Meeting Client Challenges

In some cases, a new drug, medical device, or service fits comfortably within the existing coverage, coding, and reimbursement framework. However, when a drug, medical device, or service faces coverage, coding, or reimbursement hurdles, Epstein Becker Green has earned a reputation for effectively handling those challenges. We help our clients identify potential obstacles and evaluate the options for success. If the strategy requires a change in existing policies or rules, we are advocates for our client before health plans, government agencies, and other regulatory bodies to seek the necessary approvals or authorizations.

A Broader Perspective

Our team represents providers, payors, medical device manufacturers, and investors across virtually every type of entity in health care and life sciences. This broader perspective affords our lawyers a more comprehensive view of the industry landscape and our clients’ place within it. Our ability to understand the concerns and motivations of those on the other side of the table, regardless of the issue or its complexity, works to a client’s advantage.

Additionally, our lawyers approach each challenge as a mix of legal and business issues based on our deep understanding of the field. We work closely with a client’s general counsel and collaborate with the client’s entire business development team and scientific and technical staff who contribute to innovations. We can also draw upon the wide range of skills among Epstein Becker Green attorneys and our consultants in the EBG Advisors network.

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Focus Areas

Services

Life Sciences

Industries

Experience

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Advised genomics companies in obtaining coverage and reimbursement for precision medicine diagnostics.
Obtained, on behalf of wound care manufacturers and medical device manufacturers, Medicare National Coverage Determinations.
Advised a medical device manufacturer in obtaining Medicare New Technology Add-on Payments.
Represented medical device manufacturers and biologics companies in Centers for Medicare & Medicaid Services (CMS) rulemaking.
Advised multiple companies on clinical trial design to include data demanded by health plans.
Served as counsel of record for an oncology diagnostics company in multiple hearings and litigation challenging adverse medical necessity determinations.
Successfully litigated a challenge to Medicare coverage determinations for a combination drug.
Guided medical device and durable medical equipment clients in obtaining unique HCPCS billing codes for innovative products.
Represented a cancer diagnostics company and behavioral health companies in all phases of their U.S. market entry.
Served as counsel to multiple providers challenging Medicare and Medicaid facility cost report audits.
Advised a drug manufacturer on issues relating to reimbursement for ophthalmic drugs under Medicare Part B.
Provided strategic and legal advice to a global biotechnology company on a range of Medicare Part D issues, including exceptions and appeals processes, beneficiary protection provisions, formulary design, and annual CMS Call Letter guidance.