Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice (Non-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.

Shruti C. Barker is an attorney in Covington’s Washington, DC office, where she is a member of the Health Care Practice Group. Shruti has experience on a range of health care compliance and Medicare and Medicaid reimbursement issues. She provides advice to pharmaceutical, biotech, and medical device companies related to fraud and abuse, interactions with health care professionals, and transparency reporting rules. Shruti regularly works on matters related to the Anti-Kickback Statute, the Sunshine Act, and the False Claims Act.

Beth Braiterman 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. She advises pharmaceutical, biotechnology, medical device, and food companies on a variety of regulatory and compliance issues.

Elizabeth Brim is an attorney in Covington’s Washington, DC office, where she is a member of the Health Care and Data Privacy and Cybersecurity Practice Groups. Elizabeth advises clients on a broad range of regulatory and compliance issues, including fraud and abuse, health information privacy and compliance with HIPAA, market access, pricing and reimbursement activities, and other related areas.

Tara Carrier is an attorney in Covington’s Washington, DC office, where she is a member of the Health Care and White Collar Defense and Investigations Practice Groups. Tara advises clients on a variety of health care compliance matters, including fraud and abuse, health information privacy and compliance with HIPAA, promotion and advertising, market access, pricing and reimbursement activities, and other related areas. She routinely advises on regulatory compliance and enforcement risk, commercial transactions, and administrative and legislative policy opportunities. Tara also has experience counseling clients on investigations and compliance matters, including implementing and operating under HHS OIG Corporate Integrity Agreements. In addition to serving as an author on this treatise, Tara is an author of the U.S. chapter of a global treatise on drug pricing and reimbursement. 

Andrew B. Do is an attorney in Covington’s Washington, DC office, where he is a member of the Food, Drug, and Device Practice Group. Andrew draws on his scientific training, years at the Food and Drug Administration (FDA), and experience on political campaigns to provide strategic advice to clients on a broad range of regulatory compliance and policy issues. He works at the intersection of law, policy, and politics. Andrew has assisted companies, trade associations, and private equity clients on a myriad of matters, including compliance with FDA regulations, assessing regulatory and consumer litigation risks, responding to FDA enforcement actions and Congressional inquiries, analyzing proposed bills and legislative priorities on Capitol Hill, and conducting due diligences of FDA regulated companies for acquisition. Before joining Covington, Andrew was an ORISE Research Fellow with the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, where he conducted research on food allergens, gluten, and pathogens to support the agency’s regulation and enforcement concerning food products. His research and work have been published in numerous scientific peer-review journals.

Matthew F. Dunn is an attorney in Covington’s Washington, DC office. Matt’s practice focuses on white collar defense and litigation, with a particular emphasis on representing health care companies. He has extensive experience representing companies in federal and state criminal and civil investigations by the Department of Justice and other enforcement agencies. His complementary litigation practice focuses on defending companies in government-facing litigation, such as cases arising under the False Claims Act and state consumer fraud laws, and follow-on litigation arising from government investigations. Prior to becoming an attorney, Matt was a captain in the United States Air Force.

Daniel Grant is an attorney in the Covington’s Washington, DC office, where he is a member of the Litigation and White Collar Defense and Investigations Practice Groups. He has experience representing companies and individuals in federal and state criminal and civil investigations by the U.S. Department of Justice, the Securities and Exchange Commission, and other enforcement agencies. Dan’s complimentary litigation practice focuses on defending companies in government-facing litigation, including cases arising under the False Claims Act. Prior to joining the firm, Dan served as a political appointee at the U.S. Department of Homeland Security (DHS), where he worked in the Office of the Secretary and the Office of the General Counsel.

Alexander B. Hastings is an attorney in Covington’s Washington, DC office, where he advises large and small businesses across a broad range of government contracting issues. Alex specializes in advising government contractors in the defense (including those with classified and unclassified portfolios) and life sciences industry through complex government contracts M&A deals. He also regularly provides regulatory counseling to businesses who are selling to the U.S. Government or performing development activities with U.S. Government funding. He has significant experience leading regulatory transaction teams on both the buy- and sell-sides involving due diligence reviews of government contractors, negotiating transaction documents, and assisting with integration matters. Alex also maintains an active regulatory counseling practice, advising government contractors on proposal, performance, and compliance matters. In this role, he has significant experience advising companies on intellectual property, small business, conflicts of interest and supply chain matters when contracting with the U.S. Government. Alex also advises companies pursuing and performing under agreements beyond standard procurement contracts such as grants, cooperative agreements, CRADAs, and other transaction authority agreements. Additionally, Alex advises companies concerning best practices in information management, including record retention, mobile devices, and messaging platform issues.

Claire C. Jacob is an attorney in Covington’s Washington, DC office. Claire’s practice focuses on counseling clients through investigations by federal and state enforcement authorities and conducting complex and sensitive internal investigations on a broad range of issues, with particular experience representing life sciences and health care industry clients. Prior to joining the firm, Claire clerked on the U.S. Court of Appeals for the Sixth Circuit.

Mingham Ji is an attorney in Covington’s Washington, DC office, where she advises biopharmaceutical companies, health care and data analytics organizations, and trade associations on FDA regulatory and policy matters. In her work with these clients, Mingham regularly: advises on a broad range of substantive FDA regulatory issues, including the use of real-world evidence for regulatory decision-making, drug safety and pharmacovigilance requirements, and supply chain requirements for prescription drugs; works with companies and trade associations at all stages of the legislative process, including the development of legislative solutions and analyzing proposed legislation; advises companies on appeals of FDA decisions, including formal dispute resolution proceedings and requests for reconsideration; develops comments to FDA for industry trade associations and individual companies on FDA regulatory topics; and counsels companies on the Freedom of Information Act and the protection of trade secrets and confidential commercial information submitted to FDA.

Sanchi Khare is an attorney in Covington’s Washington, DC office, where she is a member of the Health Care Practice Group. She counsels clients on regulatory issues under federal health care programs.

Caitlin Koury is an attorney in Covington’s Washington, DC office and a member of the firm’s Health Care and Food, Drug, and Device Practice Groups. Prior to joining Covington, Caitlin advised biopharmaceutical companies on health policy and reimbursement strategy as a director for a government affairs firm focused on life sciences.

Michael S. Labson is an attorney in Covington’s Washington, DC office, where he has been a trusted advisor to pharmaceutical and biotechnology clients for more than 25 years. He draws on his wide range of regulatory expertise to provide strategic and compliance advice and to address FDA and other health care law issues in litigation, investigations, and transactions. Mike provides creative and practical solutions to biopharmaceutical clients large and small across critical regulatory areas. He actively advises on: clinical trial programs, including study subject recruitment, informed consent, good clinical practice conduct issues, and expanded access; regulatory approval strategies, including FDA expedited approval programs, FDA advisory committee preparation, and drug/device and drug/diagnostic approvals; FDA dispute resolution; orphan drug, pediatric, and Hatch-Waxman exclusivity, and generic drug and biosimilar product approval standards; product promotion, payer, and scientific exchange communications; company post-approval activities, including REMS, pharmacovigilance, required post-marketing studies, and NDA and BLA changes; Rx-toOTC drug switches and OTC drug claims; and DEA requirements for controlled substances. He is on the Board of the Children’s Law Center and previously served as the Vice Chair of the Children’s Dental Health Project. Mike has also been an Adjunct Professor of Law at the American University Washington College of Law and is a Fellow of the American Bar Foundation.

Kassandra Maldonado is an attorney in Covington’s Washington, DC office, where she represents civilian and defense contractors in a broad array of litigation matters and regulatory issues. She litigates government contracts disputes and general civil cases in the U.S. Courts of Appeals, U.S. District Courts, U.S. Court of Federal Claims, the Government Accountability Office, and U.S. government agencies. Her advisory practice spans a number of subject areas, including intellectual property rights and participation in federal health care programs such as 340B. 

Krysten Rosen Moller is an attorney in Covington’s Washington, DC office, where her practice focuses on representing clients in internal investigations, government investigations, and follow-on civil litigation, with an emphasis on serving clients in the life sciences and health care industries. Krysten assists companies with complex internal and government investigations covering a broad range of issues, including fraud and abuse, advertising and promotion, and bribery and corruption. She has particular experience conducting targeted and efficient internal investigations and representing pharmaceutical and medical device companies against investigations from the Department of Justice or other government regulators. Krysten’s complementary litigation practice focuses on defending life sciences and health care companies in related litigation, including cases arising under the False Claims Act and other follow-on litigation arising from government investigations. Krysten also counsels clients on compliance matters. She regularly represents companies negotiating HHS OIG Corporate Integrity Agreements (CIAs) and advises companies on implementing and operating
under CIAs. She has also conducted False Claims Act risk assessments and advised on other fraud and abuse issues.  

Raymond Ngu is a former Covington attorney in the firm’s Washington, DC office, where he was a member of the Health Care and Public Policy Practice Groups. In his practice, he advised clients on a range of regulatory, compliance,
and policy matters.  

Jennifer L. Plitsch is an attorney in Covington’s Washington, DC office, where she is the chair of Covington’s Government Contracts Practice Group. Jen works with clients on a broad range of issues arising from both defense and
civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues. She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under nontraditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements. For more than 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics, and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including: the Department of Veterans Affairs (VA); the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH); the Centers for Disease Control (CDC); the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and the U.S. Agency for International Development (USAID). Jen regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program. Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures. She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.

Molly Ramsden is an attorney in Covington’s Washington, DC office, where her practice focuses on the design, implementation, and ongoing compliance of employee benefits and executive compensation arrangements. Molly assists employers of all sizes and industries with navigating the complexities of ERISA, the Internal Revenue Code, and all other federal, state, and local laws that impact employee benefits and executive compensation. In particular, Molly frequently advises clients regarding: health and welfare plans; tax-qualified retirement plans (defined benefit pension plans, 401(k)s, 403(b)s, etc.); equity compensation; nonqualified deferred compensation (top hat plans); and various other employment and/or benefits related matters.

Kendra L. Roberson is a former Covington attorney in the firm’s Washington, DC office, with extensive employee benefits law experience. Kendra utilizes nearly two decades of experience to design and implement health and welfare
plans, retirement plans, executive compensation agreements and equity compensation plans. Kendra has deep knowledge of health and welfare plan compliance issues and provides creative solutions to implementing increasing regulations affecting those plans. Kendra has represented public companies, tax-exempt organizations universities and governments in these areas. She has experience representing clients before the Internal Revenue Service, Department of Labor, and the Pension Benefit Guaranty Corporation. 

Tiffany P. Rodriguez is an attorney in Covington’s Washington, DC office, where she is a member of the Food, Drug, and Device and Health Care Practice Groups. She regularly advises pharmaceutical, biotechnology, medical device, and food companies on a variety of regulatory and compliance issues. 

Sarah M. Schuler is an attorney in Covington’s Washington, DC office, where she is a member of the Government Contracts Practice Group. Sarah advises clients on a broad range of government contracting issues. 

Chelsea Segal is an attorney in Covington’s Washington, DC office, where is a member of the Food, Drug, and Device and Health Care Practice Groups. Chelsea regularly advises clients on a broad range of regulatory and compliance issues. 

Olivia Vega is an attorney in Covington’s Washington, DC office, where she is a member of the Health Care and Data Privacy and Cybersecurity Practice Groups. Olivia provides strategic advice to global companies on a broad range of privacy, health care, and technology issues, including in technology transactions, mergers and acquisitions, and regulatory compliance. Within her practice, Olivia counsels clients on navigating the complex web of federal and state privacy and data security laws and regulations, including on topics such as HIPAA, California’s Confidentiality of Medical Information Act, and the California Consumer Privacy Act. 

Allison Whelan is a former Covington attorney in the firm’s Washington, DC office, where she was a member of the Food, Drug, and Device and Health Care Practice Groups. In her practice, Allison advised clients on a range of drug regulatory and compliance matters.