Practice

Life Sciences Coverage & Payment

Navigating the coverage and reimbursement landscape for your new technology

Our team advises leaders of early stage and global 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 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, coding and coverage issues.

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.

Patient access and appropriate reimbursement depend on addressing four key elements. Each presents challenges for companies introducing new technology into the healthcare marketplace. Our lawyers and specialists work closely with our clients to address each aspect of the Medicare process:

  • Coverage: We work with companies and expert advisors to develop compelling clinical and economic rationales, to identify the key decision makers at CMS and Medicare contractors and to prepare the best presentation of the new technology.
  • Payment: We work with CMS and Congress to establish payment methodologies and rates that enhance patient access. Both CMS and the Medicare 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.
  • Coding: We help clients obtain and use appropriate permanent, temporary, and unlisted HCPCS, CPT and ICD-10 codes to describe new technology. Effective coding must be coordinated with coverage and payment strategies.
  • Billing: Our team helps identify billing issues that may arise at multiple sites of care, when legacy Medicare regulations may have unanticipated effects on new business models.

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.

Areas of Focus

Our team provides regulatory and legislative advice to leading life sciences companies across industry sectors, including:
  • Pharmaceutical and biotechnology
  • Medical device
  • Molecular diagnostics
  • Digital health
  • Laboratory technology
  • Venture capital and investment funds
  • Patient associations and advocacy groups

Experience

  • Helped CMS design and create one of the first data registries in its Coverage with Evidence Development (CED) program, by advising a coalition of leading academic medical centers and medical device manufacturers.
  • Advised numerous molecular diagnostic companies on current Medicare coverage, payment, and implementation of the Protecting Access to Medicare Act (PAMA) of 2014, including the establishment of the Advanced Diagnostic Laboratory Test (ADLT) payment category and approval of the first ADLTs.
  • Developed novel legal arguments and assembled compelling scientific evidence that secured a critical policy decision affecting the coding and payment for biotechnology products.
  • Successfully advocated for changes to CMS’ coding policy for biosimilar biological products and date of service billing policies for molecular diagnostic laboratory tests, including advocacy before HHS Office of General Counsel.
  • Developed legal arguments for a new medical technology that led to the creation of a new MS-DRG for an inpatient hospital payment.
  • Worked with the Center for Medicare and Medicaid Innovation (CMMI) on potential innovative payment and service delivery models, and methods to improve quality of care for federal health care beneficiaries.
  • Represented a manufacturer of therapeutic radiopharmaceutical products before CMS and Congress leading to the creation of a new payment methodology for therapeutic radiopharmaceuticals.
  • Represented an independent diagnostic treatment facility before CMS and a contractor to obtain more favorable reimbursement for their medical technology. We successfully overturned a CMS contractor’s decision to retroactively cut the company’s reimbursement rate.
  • Assisted biopharmaceutical companies and molecular diagnostic laboratories in developing price reporting policies to set Medicare rates.

Related Media

Our attorneys share their points of view on life sciences coverage and payment matters.