Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice (AHLA Members)

Rujul H. Desai is an attorney in Covington's Washington, DC office, where he is a member of the Health Care and Digital Health Practice Groups. He advises life science clients on novel contracting, compliance, and policy issues related to pricing, market access, and reimbursement for medical products. He brings decades of experience advising on the complex system of federal and state laws governing the healthcare industry. Rujul regularly advises drug, biologic, device, and diagnostic manufacturers on legal risk assessments involving new product launches, government and commercial pricing, PBM and payer formulary access, value-based contracting, GPO and supplier arrangements, patient access and hub services, affordability programs, e-prescribing, telehealth, digital health, and the use of health economic data and modeling.

Stefanie A. Doebler is an attorney in Covington's Washington, DC office, where she is the co-chair of the Health Care Practice Group and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, transparency requirements, state law compliance and reporting regulations, interactions with health care professionals, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Stefanie also advises on the development and implementation of health care compliance programs.

Kristen C. Gurley is an attorney in Covington's Washington, DC office, where she is a member of the Health Care and Food, Drug, and Device Practice Groups. Kristie's practice focuses on market access issues for drug, device, and diagnostic companies, including with respect to pricing, reimbursement, contracting, patient support services, and engagement with payers and other entities. At the federal level, Kristie advises on compliance with the Anti-Kickback Statute and related fraud and abuse laws, federal health care program coverage and reimbursement, price reporting requirements, and advertising and promotion considerations. Kristie also advises on state pricing and market access laws, including drug price transparency reporting. While Kristie's practice is primarily focused on market access strategy and compliance counseling, she also advises on commercial transactions, litigation strategy, and policy advocacy.

Anna Durand Kraus is an attorney in Covington's Washington, DC office, where she is the co-chair of the Health Care Practice Group. Anna advises clients on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (HHS) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security.