News
CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process
16 January 2021
PartnerWashington, D.C.
Email beth.roberts@hoganlovells.com
Phone +1 202 637 8626
Fax +1 202 637 5910
LanguagesEnglish
Practice groupGlobal Regulatory
For the past two decades, Beth Roberts has helped life science companies optimize the value of their innovations. She helps clients navigate the complex coding, coverage, and reimbursement challenges faced by their new technologies.
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 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 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). When existing mechanisms do not work, Beth creates new solutions through policy initiatives or by amending the law.
Beth gains great satisfaction from her pro bono work and giving back to the community.
Healthcare (District of Columbia)
Chambers USA
Regulatory Attorney of the Year: Pricing & Reimbursement
LMG Life Sciences
Life Sciences Regulatory Star
LMG Life Sciences
Health Care
Washington, D.C. Super Lawyers
Mary Allen Memorial Award
Washington Baltimore Center for Psychoanalysis Inc.
Healthcare: Service Providers
Legal 500 US
Healthcare (District of Columbia), Recognised Practitioner
Chambers USA
The LaSalle D. Leffall Hidden Hero Award
C-Change
Outstanding Young Healthcare Lawyers of 2004
Nightingale's Healthcare News
Top Lawyer, Food and Drugs
Washingtonian
Education
J.D., The University of Texas School of Law, with honors, 1993
B.S., The Wharton School of the University of Pennsylvania, magna cum laude, 1988
Memberships
Board Member, California Life Sciences Association
Board Member, Washington Baltimore Center for Psychoanalysis
Member, American Health Lawyers Association
Member Health Law Section, District of Columbia Bar Association
Policy Board Member, Leukemia and Lymphoma Society
Bar admissions and qualifications
District of Columbia
Pennsylvania (inactive)
On behalf of associations and individual clients, drafted amendments to most of the major Medicare and Medicaid legislation over the past two decades.
Obtained drug and device pass-through payments, new technology APCs, and NTAPs for several new drugs, devices, and procedures.
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.
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16 January 2021
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