Judith A. Waltz is a partner with Foley & Lardner LLP. She is former co-chair of the Life Sciences Industry Team, and former vice chair of the Health Care Industry Team. She is also a member of the Government Enforcement, Compliance & White Collar Defense Practice.
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.
She also provides ongoing compliance counseling and Medicare and Medicaid payment advice to clients, which include 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. For product manufacturers, she has addressed issues on coverage, reimbursement, "Sunshine Act" reporting, off-label promotion, pricing, and marketing practices. She has handled many internal investigations, and numerous self-disclosures to government agencies for overpayments resulting from billing issues, provider enrollment deficiencies, and the employment of excluded individuals. She is experienced in Medicare and Medi-Cal provider enrollment appeals, and Medicare billing number deactivations and other enforcement actions.
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. 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. In 2012, she was recognized by the Legal 500 for her work in life sciences. 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 - 12). According to Chambers USA (2011), Ms. Waltz's thorough knowledge of Medicare and Medicaid regulations makes her "a wonderful choice for compliance work." Clients applaud her exceptional client service and ability to become "a partner in problem solving."
Ms. Waltz is admitted to practice before the Ninth Circuit and all Federal District Courts for California. She 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 was admitted to the California Bar in 1982.
Ms. Waltz is a past chair of the Women's Network Steering Committee at Foley. She is a member of the American Health Lawyers Association (serving as a vice chair for the Regulatory, Accreditation, and Payment Practice Group), the American Bar Association's Health Law Section, the California Society for Healthcare Attorneys, the Healthcare Businesswomens' Association, the Health Care Compliance Association, and HIMSS.
· "Florida District Court Adopts Magistrate Judge's Recommendation Reversing and Remanding ALJ's/MAC's Medicare Overpayment Determination," American Health Lawyers Association Practice Group Alert (August 2012)
· "CMS Issues FY 2013 Update for IPF PPS," American Health Lawyers Association Practice Group Alert (August 2012)
· "CMS to Begin Recovery Audit Prepayment Review on August 27," American Health Lawyers Association Practice Group Alert (August 2012) (co-authored)
· "Proposed Overpayment Regulations Issued for 60-day Refund Rule," Compliance Today (May 2012) (co-authored with Lawrence Vernaglia and Nathaniel Lacktman)
· "CMS Issues Proposed Overpayment Refund Regulations for the 60-Day Rule," Legal News: Health Care (February 2012) (co-authored)
· "Top Ten Health Law Stories of 2011," Association of Corporate Counsel Web site (November 2011) (co-authored)
· "CMS Issues Final Rule Requiring States to Develop Medicaid Recovery Audit Contractor Programs," Legal News: Health Care (September 2011) (co-authored)
· "HHS Puts Stamp on Personalized Medicine," Genetic Engineering & Biotechnology (July 2011) (co-authored)
· "The HEAT Is On, Chicago: Practical Tips To Prepare," Health Law360 (May 2011) (co-authored)
· "Government Takes Another Step in Holding Corporate Executives Accountable in the Absence of Personal Wrongdoing," Legal News: Litigation (May 2011) (co-authored)
· "Sen. Grassley Introduces the Strengthening Program Integrity and Accountability in Health Care Act of 2011," Legal News: Health Care (March 2011)
· "Whistleblowers Take On Off-Label Marketing," Genetic Engineering & Biotechnology News (December 2010) (co-authored)
· "Executive Summary on CMS Proposed Rule on PPACA Enrollment Requirements," American Health Lawyers Association (October 2010) (co-authored)
· "U.S. Focuses Enforcement on Manufacturers," Medical Device and Diagnostic Industry (August 2010)
· "CMS Releases Final Rule for End-Stage Renal Disease Prospective Payment System (Effective January 2011)," American Health Lawyers Association (August 2010)
· "The Genomics and Personalized Medicine Act of 2010," Health Law360 (August 2010) (co-authored)
· "Reading Tea Leaves: An Update on Personalized Medicine: Innovation, Threats, and Opportunities," Bloomberg's Intellectual Property Law Report (July 2010) (co-authored)
· "Personalized Medicine: Innovation, Threats and Opportunities," Bloomberg's Intellectual Property Law Report (July 2010) (co-authored)
· "Walking the Line: When Providers "Go Wrong" Under Corporate Integrity Agreements," Compliance Today (June 2009) (co-authored)
· "CMS Makes Medicare Part D Data Available For the FDA Sentinel Initiative, External Research, and Other Outside Uses," The Health Lawyer, Volume 21, Number 3 (February 2009) (co-authored)
· "Bad Advice from Health Care Consultants May Lead to False Claims Act Liability for Both Consultants and Clients," ABA's The Health Lawyer, Volume 16, Issue 3 (March 2004) (co-authored)
· "Am I My Company's Alter Ego? Theories of Alternative Liability for Debts to the Medicare Program," Foley & Lardner LLP (March 2003) (co-authored)
· "CMS Report Analyzes Factors Affecting the Marketing of Prescription Drugs," Drug Benefit Trends (March 2003)
· "Payment Suspensions and Withholds," AHLA publication entitled The RAP Sheet, Volume 5, Issue 2 (Summer 2002) (co-authored)
· "Injunctive Relief in Health Care Insolvencies," California Bankruptcy Journal, 24, No. 3 (1998) (co-authored)
Key Recent Presentations:
· "Case Study: Staying Ahead of the Curve: Cost-Effective and Compliant Reporting Strategies Learned from CIA Reporting," American Conference Institute's 4th Annual Forum on Physician Payment Disclosure & Aggregate Spend (October 2012)
· "Enrollment/Payment Suspension as Enforcement Tools," American Health Lawyers Association Fraud and Compliance Forum (September 2012)
· "Regulatory and Legal Risks: A Comprehensive Overview," ExL Pharma 11th MSL Best Practices Summit (September 2012)
· "Avoiding Anti-Kickback Challenges Related to Pricing and Contracting," American Conference Institute's 9th National Drug Pricing Boot Camp (May 2012)
· "Negotiating False Claims Act Settlements and Corporate Integrity Agreements," Health Care Compliance Association's 16th Annual Compliance Institute (May 2012)
· "The RAP Practice Group's Year in Review," American Health Lawyers Association (AHLA) Institute on Medicare and Medicaid Payment Issues (March 2012)
· "False Claims Act Enforcement on the Rise," Stafford Webinar (February 2012)
· "Kay Involvement of Medical Communications Within CIAs," Q1 Productions Conference (January 2012)
· "Fundamentals of Medicare/Medicaid," American Bar Association Health Law Section Webinar (November 2011)
· "Case Study: Examining the Accelerated Reporting System Enacted Under a Corporate Integrity Agreement," American Conference Institute's 3rd Annual Forum on Physician Payments Disclosure & Aggregate Spend (October 2011)
· "Enrollment/Payment Suspensions," AHLA/HCCA Fraud & Compliance Forum (September 2011)
· "Government Options for Collecting Medicare Overpayments," AHLA Annual Meeting (June 2011)
· "Understanding How Pricing Issues Tie Into Government Compliance and Enforcement Efforts," ACI's Rx Drug Pricing Boot Camp (June 2011)
· "Voluntary Disclosure and Overpayment and False Claims Act Liability," Health Care Compliance Association's 15th Annual Compliance Institute (April 2011)
· "The RAP Practice Group's Year in Review" and "Medicare Overpayment Demands and Collection," AHLA's Medicare and Medicaid Institute (March 2011 and March 2012)
· "False Claims Act Compliance After the PPACA: Minimizing Liability Exposure From Healthcare Reform's Expanded Fraud and Abuse Provisions," Stafford Webinar (March 2011)
· "Regulation and Dissemination of Off-Label Information," FDA Boot Camp (August 2010)
· "Regulation, Accreditation, and Payment Voluntary Refunds of Overpayments Now Mandatory: New Deadlines, Definitions, and Difficulties for Providers, Suppliers, and Plans Resulting from Healthcare Reform Legislation," AHLA Annual Meeting & In-House Counsel Program's Practice Group Luncheon (June 2010)
· "Voluntary Disclosure and Reverse False Claims," False Claims Act and Qui Tam Litigation Conference (April 2010)
· "Medi-Cal Enforcement: New Federal and Continued State Focus," Annual Meeting and Spring Seminar of the California Society for Healthcare Attorneys (April 2010)
· "Hospital Strategies for Managing Vendor Gifts and Relationships," Corporate Research Group Webinar (March 2010)
· "The HEAT Is on: Prepare Now for Enhanced Government Enforcement Efforts," Foley & Lardner LLP Health Care Friday Focus Web Conference Series (January 2010)