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Understanding Implications of Proposed Best Price Revisions for Manufacturer Assistance Programs

Start Date:10/13/2020

Start Time:1:00 PM EDT

Duration:60 minutes

Abstract:




In June of 2020, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that if finalized would revise how manufacturer coupons are accounted for in best price calculations. This discussion will focus on: 

1. Breaking down co-pay accumulator and maximizer scenarios that impact how a manufacturer offer may be subject to best price calculation

2. Operational approaches to delivering assistance programs within the parameters of the proposed rule

Manufacturer planning strategies to address multiple potential implementation and effective date scenarios for the proposed rule

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Speakers

Stacey Worthy

Partner

Sequel Health Law, PLLC

Stacey L. Worthy, J.D. is a partner at Sequel Health Law, PLLC and counsel to Aimed Alliance, a not-for-profit organization that works to protect and enhance the rights of health care consumers and practitioners. As counsel to Aimed Alliance, Ms. Worthy provides unique legal insight through research and analysis of laws, regulations, and legislation; assists with advocacy initiatives; offers policy analysis and drafting; and supports coalition-building efforts of allied organizations focused on advancing common goals. She has engaged in educational and outreach activities with employers, including on the topic of employee protections under the Americans with Disabilities Act and the Family Medical Leave Act for individuals with migraine disease. Her other clients include not-for-profit patient advocacy groups, health policy organizations, and other members of the health care industry. Ms. Worthy has authored several scholarly articles, including “Employers Beware: Understanding the Risks of Copay Accumulator Programs.” Prior to joining Sequel Health Law, PLLC, Ms. Worthy was a partner at DCBA Law & Policy and worked for the Pew Charitable Trusts. She also interned for the United States Department of Justice, Disability Rights Section; Porter Wright Morris & Arthur, LLP; and the American Bar Association, Criminal Justice Section. She earned her Juris Doctorate degree from the George Mason School of Law, and graduated magna cum laude from Boston’s Suffolk University.

William A. Sarraille

Partner

Sidley Austin

Bill Sarraille is a senior member of the Healthcare practice group and a nationally-recognized lawyer in healthcare law. Bill concentrates on a variety of healthcare matters, including Medicare and Medicaid reimbursement, coverage and coding, pharmaceutical price reporting, issues related to the marketing and promotion of pharmaceuticals and medical devices, internal investigations, clinical research issues, Stark and Anti-Kickback Law analyses, Medicare and Medicaid audits, healthcare acquisitions and due diligence, compliance program audits, managed care matters, healthcare contracts, administrative litigation, legislative matters, privacy and security, coverage for new devices and services, the Foreign Corrupt Practices Act, international compliance and healthcare contracting, the representation of witnesses and companies before Congressional Committees, and the defense of healthcare criminal and False Claims Act matters. Bill has defended clients in some of the largest healthcare fraud investigations brought by the U.S. Government. Bill’s clients have included pharmaceutical companies, biotechnology companies, device and equipment manufacturers, diagnostics manufacturers, academic medical centers, hospitals, health systems, faculty practice plans, durable medical equipment suppliers, healthcare consulting firms, ambulatory surgical centers, physician practice management companies, managed service organizations, managed care organizations, large physician group practices, imaging centers, financial institutions, contract research organizations, and leading healthcare trade associations and professional societies. Bill is consistently recognized as a leading healthcare lawyer in Chambers USA and LMG Life Sciences. He was named an LMG Life Sciences star in 2013–2015 and 2019, and has been recognized every year since 2013 in Chambers USA as a leading lawyer both in D.C. and nationwide. Chambers notes that sources describe Bill as a “terrific regulatory healthcare lawyer” with a “wide range of experience” and noted he is “an excellent reimbursement lawyer.” The directory has also described him as “an intellectual heavyweight. He is hugely professional on every issue.” It also listed Bill as “a very good communicator and a trusted adviser.” Recognized in the 2016 edition of Who’s Who Legal: Life Sciences, they noted “he superbly handles all the regulatory issues encountered by his clients.” Bill has been recognized in the 2006–2019 editions of Best Lawyers in America and in Washingtonian magazine’s 2013 list of Washington’s Best Lawyers as one of the region’s “best legal minds” in the area of healthcare law. He was listed by Nightingale’s Healthcare News as one of 10 “Outstanding Practice Lawyers for 2006.” He is the co-author of several books on healthcare. Bill served on the Regulatory Relief Committee for the American Hospital Association and served on the Compliance Advisory Committee for the Healthcare Financial Management Association as its Chairman. He served as a law clerk to the Honorable Harry L. Hupp in the U.S. District Court for the Central District of California in Los Angeles following his graduation from Harvard Law School in 1989.

Carl Schmid

Executive Director

HIV + Hepatitis Policy Institute

Carl Schmid has been a national policy and advocacy leader in the HIV community for over 20 years. He spent 16 years with The AIDS Institute, where he served as its Deputy Executive Director and led the Institute’s HIV and viral hepatitis federal policy work before the executive agencies and the Congress. In December 2019, he left The AIDS Institute to form the HIV + Hepatitis Policy Institute, which promotes quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions. Mr. Schmid helps lead the HIV and hepatitis communities’ advocacy efforts in Washington, D.C., to ensure domestic HIV and hepatitis programs, including the Ending the HIV Epidemic initiative, the Ryan White Program, CDC HIV and hepatitis prevention programs, and NIH AIDS Research, are based on sound public policy and fully funded. He has expertise in healthcare financing systems, including Medicaid and Medicare, and leads efforts to ensure that the Affordable Care Act meets the needs of people living with or at risk of HIV and hepatitis. As part of HIV + Hep’s work in advocating for people with HIV and hepatitis, Mr. Schmid works extensively with other patient and disease groups on collective efforts to ensure that patients, particularly those with chronic conditions, have access to quality and affordable healthcare, including prescription medications. In December 2018, he was appointed Co-Chair of the Presidential Advisory Council on HIV/AIDS (PACHA). He previously served as a member of PACHA in 2007-09 and chaired its Domestic Subcommittee. Mr. Schmid served as a consumer representative to the National Association of Insurance Commissioners in 2018-19. In July 2019, he was appointed to the PEPFAR Scientific Advisory Board. In 2010, he was named by POZ magazine as one of the 100 most effective AIDS fighters and by Whitman-Walker Health as one of the 25 individuals who have played prominent roles in the fight against HIV in D.C. In 2016, he was named the Champion of the Year by the ADAP Advocacy Association. Mr. Schmid earned a B.A. in Public Affairs and a M.B.A. in International Affairs from the George Washington University in Washington, D.C.

Peter Pitts

President and Co-Founder

Center for Medicine in the Public Interest

Peter Pitts is a Visiting Professor at Université de Paris Descartes Medical School and President of the Center for Medicine in the Public Interest. He is a former member of the United States Senior Executive Service and Associate Commissioner of the US Food & Drug Administration. Pitts is a member of the Council for International Organizations of Medical Sciences (CIOMS) Expert Working Group to help advance patient involvement in the development and safe use of medicines. (CIOMS is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.) He is the lead author of many professional peer reviewed publications including the Lancet, Therapeutic Innovation and Regulatory Science, and Nature Biotechnology. He is an Associate Editor of Therapeutic Innovation & Regulatory Science (the official DIA journal), a member of the External Advisory Board, IMS Institute for Healthcare Informatics in Asia, Executive Advisory Board, the Galien Foundation, Editorial Advisory Board, Food and Drug Policy Forum, Advisory Board, Journal of Commercial Biotechnology and a member of the Editorial Advisory Board of The Patient Magazine. Pitts lives in New York City. Specific areas of global policy expertise include FDA policy and process, healthcare technology assessment and reimbursement issues, real world evidence, social media, off label-communications, pharmacovigilance, patient-focused drug development, abuse-deterrent opioids, biosimilar development, Rx-to-OTC switching, risk management plans, GMP policies, pharmacy education programs, drug safety, Critical Path, personalized medicine, clinical trial transparency, IP protection, FDA reform, drug importation, counterfeiting, genetically modified food issues, food safety and security, recalls, nutritional labeling. His comments and commentaries on health care policy issues regularly appear in The New York Times, The Los Angeles Times, The Washington Post, The Wall Street Journal, The Financial Times, Health Affairs, Time, Newsweek, The Boston Globe, The Washington Times, The Chicago Tribune, The San Francisco Examiner, Investor’s Business Daily, The Baltimore Sun, The Economist, The Lancet, Nature Biotechnology, BioCentury, The Journal of Commercial Biotechnology, the BBC World Service, Fox News, CNBC, Bloomberg, The PBS NewsHour, NBC Dateline, Sky News, La Stampa. L’Opinion, The Daily Show with John Stewart, among others. He has given healthcare policy presentations throughout Europe, Canada, and the United States, as well as in Russia, China, Hong Kong, Taiwan, India, the Philippines, Malaysia, Saudi Arabia, Lebanon, Oman, Israel, Turkey, The United Arab Emirates, Kuwait, Qatar, Jordan, Kenya, South Africa, Egypt, Algeria, Ukraine, Thailand, Japan, Brazil, Mexico, Vietnam, Indonesia, Singapore, Panama, Costa Rica, Argentina, and Columbia. His new book is “Common Sense Healthcare for Common Sense Americans – and Presidential Candidates.” He is also the author of Become Strategic or Die, widely recognized as a cutting edge study of how leadership, in order to be successful over the long term, must be combined with strategic vision and ethical practice. He is the editor of Coincidence or Crisis, a discussion of global prescription medicine counterfeiting and Physician Disempowerment: A Transatlantic Malaise. A graduate of McGill University, he is married to Jane Mogel, and has two sons.

Jason Zemcik

Senior Director, Product Management

TrialCard

Jason Zemcik is the Product Director for TrialCard’s TC Synapse suite of compliance and risk management solutions, which encompasses co-pay program fraud monitoring and detection, co-pay accumulator mitigation strategies, and government exclusion and anti-kickback safeguards. Jason joined TrialCard in 2011 and has held roles in Program Management, Data Analytics, Marketing, and Operations. He holds a Project Management Professional (PMP) certification and is a member of the National Health Care Anti-Fraud Association. Prior to joining TrialCard, Jason served seven years as a United States Army officer, deploying to both Iraq and Afghanistan.  Jason is a graduate of the United States Military Academy at West Point where he earned a BS in Legal Studies with a minor in Systems Engineering.

Rick Fry

SVP, Commercial Solutions

TrialCard, Moderator

Rick Fry is responsible for leading TrialCard’s team of subject matter experts across all lines of products and services. In this role, Rick and his team provide strategic insight and consultation to TrialCard’s customers while partnering with a cross-functional team of product development, IT, analytics, marketing, and operations to deliver best-in-class patient support programs for TrialCard’s clients. Prior to this, Rick held roles leading TrialCard’s client services team and several operational departments responsible for claims processing, operations management, and production & fulfillment. Rick is an active participant in the National Council for Prescription Drug Programs (NCPDP) where he represents the interests of TrialCard and its customers.   Rick served for eight years in the United States Air Force as a Financial Management Officer. In this field, Rick led teams managing multimillion-dollar operational programs.   Rick holds a Bachelor of Science in Management from the United States Air Force Academy and a Master of Science in Cost Analysis from the Air Force Institute of Technology.
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