Government spending accounts for nearly one-half of the nation’s healthcare expenditures, and Medicare policy decisions have widespread impact on private sector medical coverage and payment. Rising health care spending is driving the transformation toward evidence-based medicine that rewards value and improved health outcomes. Medicare and commercial payers are now placing a greater emphasis on new payment models such as bundled payment models and accountable care organizations (ACOs). In order to commercialize new technologies, companies must develop clinical evidence to support timely, widespread coverage and payment decisions. Equally important, business leaders must consider how new payment models can rapidly change provider incentives.

What We Do

Foley Hoag has deep expertise in working with public and private payers on innovative products and therapies. Our strategy combines convincing legal arguments with a rich understanding of the clinical evidence necessary for widespread adoption and utilization of new products. Foley Hoag’s Medicare Coverage & Payment practice advises companies on a broad range of health policy matters with a particular expertise on Medicare coverage, coding and payment determinations. The group focuses both on health care legislative initiatives as well as legal and regulatory matters before the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS). In close collaboration with our clients, we regularly work with senior agency officials, congressional staff, patient advocates, and health care policy experts to seek agency interpretations, clarify regulatory guidance, and address novel payment and coverage issues.

Our services focus on strategic advice to help companies position new technologies in the evolving – and often challenging – reimbursement landscape. Based on decades of experience with CMS, Congress, Medicare contractors, 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 products and services, including drugs, biologics, medical devices and durable medical equipment, molecular diagnostics and laboratory technology. One of our greatest strengths lies in our ability to leverage learning across multiple healthcare policy areas and technology domains and use this expertise to achieve the specific business goals of our clients.

As part of our comprehensive approach to problem-solving, Foley Hoag provides our clients with guidance on health policy legislation and Congressional oversight. Congress in recent years has enacted numerous changes to Medicare payment rules for medical technology that can impact new product launches. Many new products present novel reimbursement challenges not anticipated by current regulatory frameworks and in need of legislative modification.

Coverage, Payment, Coding and Billing Determination

Patient access and appropriate reimbursement depend on addressing four major elements: coverage, payment, coding, and billing. Each presents potential risks for companies introducing new technology into the healthcare marketplace. The Foley Hoag Medicare Coverage & Payment team works closely with our clients to address each aspect of the Medicare process:

  • Building a strong clinical case for coverage, particularly in medical environments characterized by competition or small patient populations. We work with companies to develop the most compelling clinical story, to identify the best audience at CMS and the contractors, and to prepare the best presentation of new technology, often involving expert physicians in the process
  • Working with payers to establish payment rates that enhance patient access. Both CMS and the contractors play important roles in setting rates, and the most effective strategies often involve coordination of many stakeholders, including innovator companies, physicians, and patient groups 
  • Obtaining and using appropriate permanent, temporary, and unlisted HCPCS and CPT codes to describe new technology. Effective coding must be coordinated with coverage and payment strategies 
  • Identifying billing issues that may arise at multiple sites of care, when legacy Medicare regulations may have unanticipated effects on new business models

Affordable Care Act

Foley Hoag works closely with our clients on implementation of the Patient Protection and Affordable Care Act (ACA) of 2010. We combine a legal and policy strategy for our clients as we approach the regulatory agencies that are implementing the law.

In particular we have worked with the Center for Medicare and Medicaid Innovation (CMMI) on new payment and care delivery models.

Our Team

Foley Hoag is a law firm based in Boston and Washington with 275 attorneys and policy specialists, with a significant focus on the life sciences and medical technologies fields. The Life Sciences Government Strategies Group has 15 individuals with many years of experience working on health policy legislative and regulatory matters in the Congress, the Executive Branch, and in federal agencies. Our attorneys and health policy specialists have served in senior strategic decision-making roles at both the Department-wide and local Medicare levels.

Our attorneys and policy specialists draw upon a wealth of experience to identify the most effective strategy for solving the problem at hand. One of the unique challenges of health policy is coordinating regulatory developments at CMS and HHS with legislative proposals in Congress. Our lawyers provide a comprehensive range of legal and legislative services, including preparing draft legislation and congressional testimony, analyzing pending legislation and proposed rules, and working with congressional staff to track and influence complex legislation. We regularly update clients on legislative developments and present to senior management on long term payment trends and political developments that may impact the health care sector.