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Trump Administration Executive Order (EO) Tracker
Beth L. Roberts
Partner Global Regulatory
Languages
English
Beth counsels on Medicare and other health care issues and lobbies the U.S. Congress and regulatory agencies on her clients' behalf. Her clients include health care providers; pharmaceutical, biotechnology, and medical device manufacturers; investors; and professional and trade associations.
Beth is a creative problem solver who is passionate about improving patient access to care. She works strategically and collaboratively to solve bet-the-company issues in innovative ways. She helps turn reimbursement challenges and changes into business opportunities. She also explains complicated laws and regulations in a simple and straightforward way.
Beth guides clients from reimbursement strategy through implementation. She applies for new International Classification of Disease (ICD-10), Health Care Common Procedure Coding System (HCPCS), and Current Procedural Terminology (CPT®) codes. She helps clients obtain favorable coverage for their products through the Local Coverage Determination (LCD) and National Coverage Determination (NCD) processes and advises on the opportunities and pitfalls of the Transitional Coverage for Emerging Technologies (TCET) pathway, coverage with evidence development (CED), and parallel review. She also helps clients obtain appropriate payment, often through new technology add-on payments (NTAPs), drug and device pass-through payments, and new technology ambulatory payment classifications (APCs). Over and above, Beth advises on seizing opportunities through the Centers for Medicare and Medicaid Innovation (CMMI), including Accountable Care Organizations (ACOs) and the Oncology Care Model (OCM).
Beth gains great satisfaction from her pro bono work and giving back to the community.
On behalf of associations and individual clients, drafted amendments to most of the major Medicare and Medicaid legislation over the past three decades.
Obtained drug and device pass-through payments, new technology APCs, and NTAPs for several new drugs, devices, and procedures.
On behalf of a pharmaceutical manufacturer, collaborated with provider and patient groups to obtain favorable Medicare coverage and reimbursement for chimeric antigen receptor (CAR) T-cell therapy.
Obtained the first Category I CPT code, as well as favorable coverage and reimbursement, for the first FDA-approved autonomous artificial intelligence (AI) diagnostic for diabetic retinopathy.
Secured continued Medicare coverage for osseointegrated implants after CMS proposed to reclassify them as non-covered hearing aids.
Successfully lobbied for a provider association and a major trade association for statutory language for more favorable Medicare reimbursement.
Enabled an implantable device manufacturer to commercialize its core product by obtaining appropriate Medicare reimbursement for its category B device.
Helped secure a statutory mandate for Medicare coverage and adequate payment rates for a breakthrough new technology by a small medical device company.
Gained a retroactive reimbursement increase for a lifesaving therapy by working with a biotechnology company to articulate legal basis for its action.
Facilitated coverage and reimbursement for a client's new medical procedure by successfully obtaining a Category I CPT code.