Kimberly focuses her practice on the provision of corporate, regulatory and compliance counseling to healthcare and life sciences companies. The cornerstone of her practice is providing guidance to clients regarding HIPAA and the HITECH Act, the Medicare and Medicaid fraud and abuse laws, the Stark Law, Medicare coverage and reimbursement rules, and state healthcare laws and regulations. She regularly assists providers in the development and implementation of corporate compliance programs, in responding to government investigations and in contract negotiations. Her clients include life sciences companies, disease management providers, group purchasing organizations, retail and specialty pharmacies, hospitals, dialysis providers, durable medical equipment companies, physicians and physician practices.
Kimberly represents a range of clients in matters arising under HIPAA and its implementing regulations as well as state data privacy and data breach laws. Her experience includes the development and implementation of HIPAA compliance programs, the preparation and negotiation of business associate agreements, the provision of assistance with breach assessment and reporting, and the representation of clients in response to government investigations. Kimberly has significant experience addressing the interplay between HIPAA and clinical research, and regularly counsels clients regarding consent issues, data deidentification and the maintenance of patient registries.
Kimberly routinely represents clients in criminal and civil investigations based upon alleged violations of the Medicare and Medicaid program rules. She has represented providers in survey and certification proceedings, qui tam litigation based upon alleged violations of the Medicare billing rules, and in prepayment and post-payment audits by government contractors and commercial payors.
Kimberly was instrumental in the development of a new and innovative funding model which allows life sciences companies to support medical research, graduate medical education and CME without running afoul of federal and state anti-fraud laws. The model has been utilized by life sciences companies to support research and education in various medical specialties, including orthopaedics, neurosurgery and spine care.
Kimberly is a regular speaker at corporate seminars, webinars and industry conferences. For the past eight years, she has served as the Chairperson of McGuireWoods Annual Pharmaceutical and Medical Device Conference.
She also writes frequently on various health law topics, as represented by the following recent articles: "HIPAA and HITECH Proposed Regulations Released," "HHS Issues Regulations Regarding Notification of Breaches of Unsecured Protected Health Information" and "Federal Stimulus Bill Significantly Expands the Scope of HIPAA’s Privacy and Security Requirements."
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