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William H. von Oehsen
President and General Counsel
Phone: 202-872-6765
Fax: 202-785-1756
E-Mail: william.vonoehsen@ppsv.com
William von Oehsen, a principal in the law firm Powers, Pyles, Sutter and Verville P.C. (PPSV), has extensive experience in general health law, legislation and policy, especially in the areas of pharmaceutical pricing, materials management, and third party reimbursement, and food and drug law.
With respect to Mr. von Oehsen's pharmaceutical pricing practice, PPSV offers a wide range of services involving federal and state regulation of drug prices and reimbursement. The U.S. pharmaceutical market is unique in that pricing is regulated, either directly or indirectly, under a complex array of federal and state laws designed to make prescription drugs more affordable to government programs and providers, as well as to seniors and other vulnerable populations. As prescription drug prices continue to climb at double digit inflation rates, the demand for expertise in these laws has also grown. It is not surprising, therefore, that drug pricing has become one of Mr. von Oehsen's most active practice areas.
Mr. von Oehsen serves as president and general counsel to Safety Net Hospitals for Pharmaceutical Access (SNHPA) which was launched more than ten years ago to help high-Medicaid public and non-profit hospitals take advantage of a federal law - section 340B of the Public Health Service Act - that requires pharmaceutical manufacturers to give drug discounts on covered outpatient drugs as a condition of the Medicaid program covering and paying for those drugs. As membership for SNHPA has grown, expertise on 340B matters and related drug pricing laws has deepened such that Mr. von Oehsen has become a national leader in this area. He was instrumental in forming the 340B Coalition, a coalition of approximately a dozen national organizations whose members collectively comprise all the entities that are eligible to participate in the 340B program. The 340B Coalition hosts an annual conference for safety net providers, industry, wholesalers and policymakers, that, as a result of its popularity and broad attendance, now serves a major forum in which national drug pricing policy issues are addressed. SNHPA is responsible for organizing this annual event and delivering regular presentations on recent developments - regulatory, legislative and judicial.
The 340B program is one of four federal drug discount programs and, because one cannot truly understand federal regulation of drug pricing without an understanding of how these programs interrelate, Mr. von Oehsen has expertise in each of these federal areas. They include the Medicaid drug rebate program, the federal supply schedule and the federal ceiling price. States have also been active in helping individuals, especially seniors and low-income patients, access affordable drugs, and many of these efforts build upon the federal programs. Accordingly, Mr. von Oehsen's drug pricing client base includes a growing number of states that are seeking to lower drug costs for state-funded populations, such as Medicaid recipients, Medicaid expansion populations, prisoners, mental health and other long term care patients, and state employees. Mr. von Oehsen regularly testifies before state legislatures and executive branch officials. Another area of collaboration with states relates to numerous ongoing investigations into potential violations by industry of federal and state drug discount laws and efforts to recover overpayments form industry.
As a result of Mr. von Oehsen's expertise in the drug pricing and FDA areas, he has found himself serving a growing number of pharmacies, both freestanding and institutional, in various legal and regulatory matters. His pharmacy-related projects have involved analysis of federal laws such as Robinson-Patman and the Non-Profit Institutions Act, DEA registration, the Prescription Drug Market Act, Medicare/Medicaid coverage and reimbursement of pharmaceutical care and federal fraud and abuse laws such as Stark and anti-kickback. At the state level, he has state licensure laws. PPSV also assists pharmacy clients with their transactional and litigation needs.
In the food and drug area, Mr. von Oehsen guides companies through the FDA's premarket clearance process; assists companies with product development strategies; provides labeling, advertising, manufacturing and import/export advice; and handles other issues that arise during the progression from initial clinical testing through commercial distribution. He also works on the development and distribution of medical devices, biologics, food, food additives, dietary supplements, animal feeds, and cosmetics. He has also defended clients against FDA enforcement actions. Mr. von Oehsen has lectured and published articles on food and drug related issues.
In addition to his drug pricing and FDA practices, Mr. von Oehsen has considerable experience in advising clients on materials management, managed care, and general health law issues. He works with Medicare/Medicaid and other third-party payment programs, hospitals, HMOs, PPOs, physician groups, and other health care providers. He counsels clients on such issues as managed care, fraud and abuse, third-party reimbursement, mergers and acquisitions, state licensure of health professionals and providers, and confidentiality of records. He also has significant advocacy experience on health legislative issues, including in the areas of drug pricing, managed care, AIDS, long-term care, and Medicare/Medicaid. Mr. von Oehsen is co-author of a book concerning Medicare/Medicaid managed care and state health reform.
Mr. von Oehsen is a member of the District of Columbia Bar. He received his law degree from Georgetown University Law Center in 1988 and a masters from Harvard University in 1984. He earned his undergraduate degree from Princeton University in 1981. Mr. von Oehsen participates in a number of professional organizations including the Food and Drug Law Institute (where he was an Annual Scholar), the American Health Lawyers Association and the American Association of Health Plans. He was also a founding director of the Family AIDS Housing Foundation, now called Building Futures: Family AIDS Housing.
Concentrating in Health Legislation and Policy, Pharmaceutical Pricing, and Food and Drug law, Principal, Powers, Pyles, Sutter & Verville, P.C., Washington, D.C.
EDUCATION
- J.D., Georgetown University Law Center, 1988
- M.T.S., Harvard University, 1984
- A.B., Princeton University, 1981
BAR ADMITTANCE
- Admitted to the District of Columbia Bar, 1990
- Admitted to the Pennsylvania Bar, 1988
MEMBERSHIPS
- Food and Drug Law Institute
- American Health Lawyers Association
- American Association of Health Plans
- Founding Director, Family AIDS Housing Foundation, Inc.
- Annual Scholar, Food and Drug Law Institute, 1978-88
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Washington, DC 20005