Alex M. Hendler
Regulatory Attorney (primarily federal)
I have more than ten years of experience developing straightforward and pragmatic solutions to complex regulatory and policy problems. My experience includes drafting administrative law judge decisions, conducting detailed health care fraud and abuse legal analysis, and advising clients on interpreting and complying with complex regulatory and policy systems such as US food and drug labeling and United Nations Clean Development Mechanism project design and execution.
Jun 2008 - Present
• Design, create, and deploy web-based software to help users better understand and comply with complex legal and policy regimes, with a particular focus on United States (US) federal health care fraud and abuse laws.
◦ Developed a patent-pending software system to efficiently display, navigate, and analyze hierarchically-organized textual materials such as statutes and regulations.
• Provide legal advice, leadership, guidance, and training on compliance, policy, and technical matters. Examples:
◦ Represented a client before the Office of Medicare Hearings and Appeals (OMHA) to reduce by approximately 30% a six-figure overpayment identified in a post-payment audit.
◦ Advised a client on US federal Anti-Kickback Statute issues related to an innovative health care services payment model.
◦ Led a feasibility study for a proposed $100+ million solar power project in East Africa, including: developing 30-year exchange rate, inflation, and tariff risk projections; evaluating customs clearance processes, freight forwarding options, security, and technical issues.
◦ Developed a business plan and financial model to enable a client to win a $1 million matching grant in a competition to fund renewable energy projects in East Africa.
◦ Advised clients on executing United Nations (UN) Clean Development Mechanism (CDM) electricity generation projects in East Africa, including conducting technical and financial due diligence and working with third-party auditors to guide clients toward compliance with UN policies.
◦ Led development of an environmental management system and training program for a commercial airline to work towards ISO 14001 environmental management certification.
◦ Led multiple energy efficiency audits detailing specific risk- and cost-ranked operational procedure and equipment modifications to realize substantial reductions in energy-related operating expenses and carbon emissions for industrial, commercial, and residential clients in Tanzania.
Powell Goldstein, LLP
Apr 2007 - Jun 2008
• Advised clients on Medicare provider and supplier enrollment, reimbursement, and regulatory compliance; US food and drug labeling. Examples:
◦ Advised a Fortune Global 100 company on how to most efficiently bring to market a potential new product line considering relevant Medicare reimbursement requirements and US Food and Drug Administration (FDA) labeling and marketing requirements.
◦ Advised a client on modifying a multi-million dollar discount agreement between client and a drug manufacturer to ensure compliance with the federal Anti-Kickback Statute.
◦ Developed a risk-ranked range of strategies to not incur fines of up to $10,000 per item for a client wishing to sell organic food that was not labeled in strict compliance with federal organic labeling requirements.
◦ Advised a third-party administrator for private health insurers on how its clients could recoup incorrect primary payments for care provided to Medicare beneficiaries.
◦ Advised a national DMEPOS/PEN-related association on developing a Medicare reimbursement manual for its members.
◦ Collaborated with a senior litigator and former federal prosecutor to conduct an internal investigation for a specialized Medicaid managed care organization (MCO) investigating alleged professional misconduct of MCO network providers.
Office of Medicare Hearings and Appeals
Jul 2005 - Apr 2007
(OMHA) Office of the Secretary, US Department of Health and Human Services. (Headquarters, 2006-2007; Mid-Atlantic Field Office, 2005-2006)
• Drafted OMHA-wide policies and pre-rulemaking analysis under Titles II, XI, and XVIII of the Social Security Act and related rules, regulations, and policies.
• Drafted approximately 100 administrative law judge (ALJ) decisions on complex Medicare claim appeals.
• Regularly advised ALJs and senior attorneys on research and legal analysis techniques specific to OMHA’s mission.
• Developed and implemented relational databases to improve efficiency of adjudicating high-volume appeals.
• Regularly provided formal and informal feedback to Medicare Appeals System (MAS) database developers on proposed or recent technical changes to MAS.
• Received three cash performance awards in 2006 before being promoted from OMHA field office to OMHA headquarters.
Maryland Department of Business and Economic Developement
Nov 2003 - Jun 2005
• Drafted legislative proposals for the 2005 session of the Maryland General Assembly and presented those proposals to the Secretary of the Department.
• Represented the Department at meetings of the Maryland Technology Development Corporation ("TEDCO") to recommend distribution of grants and forgivable loans to encourage the development of innovative technologies in the State.
• Collaborated with a biophysicist and a pharmacologist/physiologist to develop a confidential briefing paper for the Secretary addressing the political, scientific, and legal implications of pending or proposed federal and State legislation regarding funding for human embryonic stem cell research.
Office of Science and Technology Policy
May 2002 - Aug 2002
Executive Office of the President (a.k.a. "The White House").
• Analyzed congressional hearings and science and technology aspects of legislation, in particular, comparing legislation creating the Department of Homeland Security (H.R. 5005 and S. 2452); briefed OSTP legislative staff on matters of potential interest or concern in light of the Administration’s priorities.
• With OSTP’s Chief of Staff and a senior technical advisor, in preparation for a congressional hearing closed to the public, briefed congressional committee staff on technical challenges of screening for radiological materials at border entry points.
Office of the Attorney General for the State of Maryland
Law Clerk, Civil Litigation Division
Jun 2001 - Aug 2001
• Wrote multiple legal memoranda for the Deputy Attorney General, Solicitor General, and an Assistant Attorney General in the Civil Litigation Division, analyzing issues such as interstate comity in the context of sovereign tort immunity and federal retaliatory discharge claims made by a State employee.
• Drafted a memorandum to support the Solicitor General’s work in Virginia v. Maryland, 540 U.S. 56 (2003).
Biotechnology Industry Organization
Government Relations Assistant
Jun 1999 - Jun 2000
• Supported senior government relations staff by preparing or analyzing congressional testimony, arranging meetings with congressional staff; analyzed hearings, legislation, proposed regulations; coordinated industry response to proposed federal guidelines regarding the intellectual property aspects of the research use of biological materials under the Bayh-Dole Act (35 U.S.C. §§ 200–212). (http://l4w.us/35usc200)
• Prepared BIO’s president’s periodic presentations to the organization’s Board of Directors.
• Briefed congressional staff to support passage of patent reform legislation (Pub. L. 106-113). (http://l4w.us/PubL106-113)