Clinical Adoption: It Takes a Village!
Business Model Panel Discussion – Health Care Providers
11:35 AM - 12:20 PM
Judy Waltz is a partner and business lawyer with Foley & Lardner LLP. Her practice focuses on government investigations, false claims act, corporate integrity agreements (CIAs), bankruptcy, and Medicare and Medicaid counseling. Ms. Waltz works with clients in various areas of the health care industry. She is former co-chair of the firm’s Life Sciences Industry Team, and former vice chair of the Health Care Industry Team. Ms. Waltz is also a member of the Government Enforcement, Compliance & White Collar Defense and Bankruptcy & Business Reorganizations Practices.
Ms. Waltz regularly advises clients who are the focus of government investigations and other enforcement actions, and has negotiated false claims act settlements with the U.S. Department of Justice as well as corporate integrity agreements (CIAs) with the Office of Inspector General. She then has worked closely with those clients to implement their CIAs, including ongoing advice in connection with IRO audits and reviews. At the state level, she has been involved with various Medi-Cal audits, payment suspensions, and investigations, including a matter involving allegations of inflated drug pricing by a major pharmaceutical company. In 2004, she represented Gambro Healthcare, Inc., an entity with more than 500 sites, in CIA negotiations with the OIG, and subsequently was featured in the September 2005 cover story of Counsel to Counsel magazine for this work.
Ms. Waltz also provides ongoing compliance counseling and Medicare and Medicaid payment advice to clients, which include hospices, large physician practices, county health systems, hospitals, durable medical equipment suppliers, clinical laboratories, dialysis companies, skilled nursing facilities, ambulance companies, pharmacies, managed care providers, and a variety of other health care entities. In 2013, she served as special Medicare counsel in the bankruptcy of San Diego Hospice, a large not-for-profit entity. Ms. Waltz has advised clients (including physician practices, hospice, and hospitals) undergoing ZPIC, RAC audits, other Medicare or Medicaid audits, and pre-pay reviews. She is experienced in Medicare and Medi-Cal provider enrollment appeals, and Medicare billing number deactivations and other enforcement actions.
Ms. Waltz was recognized by The Legal 500 for her work in life sciences in 2012, and for her work in the area of health care – service providers in 2015. She was named to the 2007 list of Outstanding Healthcare Fraud and Compliance Lawyers published by Nightingale’s Healthcare News. She was also ranked as one of the top health care attorneys in California by Chambers USA (2009 - 16) where she is described as "the gold standard for issues with CMS" (2015) and “a leader in fraud and abuse” and “a masterful negotiator” (2014).
Ms. Waltz received her B.A., J.D. and M.P.A. degrees from Indiana University, where she was an associate instructor in the School of Business and a teaching assistant in the School of Public and Environmental Affairs (SPEA). As an undergraduate, she served as vice president of the Indiana University Student Association, the student government organization for the Bloomington campus. Ms. Waltz currently serves on the Board of Visitors for Indiana University’s Maurer School of Law. She is admitted to practice before the Ninth Circuit and all Federal District Courts for California. She was admitted to the California Bar in 1982.
Prior to joining the firm in 1998, Ms. Waltz served as assistant regional counsel for the U.S. Department of Health and Human Services in San Francisco, primarily handling Medicare issues including survey and certification and various types of reimbursement disputes. In that position, she appeared frequently before the Ninth Circuit and other federal courts in matters primarily involving payment disputes (including PRRB appeals), bankruptcy issues, and Medicare Secondary Payer disputes. She held collateral appointments as a special assistant United States attorney for the Eastern and Northern districts of California.
Ms. Waltz is a frequent speaker and writer on health care and life science compliance issues, including overpayments, payment suspensions, corporate integrity agreements, off-label marketing, drug and device pricing, and potential issues of personal liability for owners of entities who are the focus of government scrutiny.