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 resolving complex regulatory questions, and in contract negotiations. Her clients include life sciences companies, disease management providers, group purchasing organizations, hospitals, surgery centers, dialysis providers and nephrologists, durable medical equipment (DME) companies, physicians and physician practices.
In the patient privacy and digital health space, 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, employee training, 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 OCR investigations. Kimberly has significant experience addressing the interplay between HIPAA and clinical research, and regularly counsels clients regarding patient consent issues, data de-identification and the maintenance of patient registries.
For nearly thirty years, Kimberly has assisted nephrologists, dialysis providers and industry trade associations with regulatory, reimbursement and corporate matters, including joint ventures, medical director agreements, coverage and payment disputes, and Stark and Anti-Kickback Statute compliance. Kimberly has assisted various nephrology practices in the negotiation and implementation of value-based care arrangements, including in connection with the CKCC program and commercial contracting.
Represented a specialty hospital provider in the development and implementation of an enterprise-wide HIPAA compliance program, including performing employee training.
Represented a global sales and marketing firm in the development of two comprehensive sets of HIPAA privacy and security policies and procedures, one for its health plan and the other for its core business.
Represented a revenue cycle management (RCM) firm in the preparation and negotiation of business associate agreements (BAAs) and the development of HIPAA training modules for employees.
Represented a publicly traded telecommunications company in the development and implementation of a HIPAA compliance program to support its healthcare vertical.
Represented various physician practices, surgery centers, dialysis facilities and other providers in the establishment of HIPAA compliance programs.
Developed and assisted with the implementation of corporate compliance programs for various publicly traded and privately held medical device manufacturers and suppliers, including orthopedic implant manufacturers, a support surfaces manufacturer and various DME manufacturers and suppliers.
Developed and assisted with the implementation of corporate compliance programs for nephrology practices, dialysis providers, and surgery centers.
Represented a large academic medical center in an overpayment refund dispute with the Medicare program regarding outlier payments made to its dialysis facilities over a period of several years, ultimately achieving a multimillion-dollar reduction in the provider’s refund obligation through the Medicare administrative appeals process.
Assisted a chain neurodiagnostic monitoring provider in complying with Medicare and Medicaid coverage requirements and in appealing related overpayment refund demands.
Represented an ESRD laboratory in successfully reversing payment denials for separately billable laboratory tests.
Represented a range of healthcare providers and suppliers, including hospitals, ambulatory surgery centers, dialysis providers, laboratories, other chain providers, and physician practices in challenging overpayment refund demands from Medicare, Medicaid and commercial payors.
Advised scores of healthcare providers and suppliers regarding billing and coding issues and related False Claims Act implications.
Represented a manufacturer of a blood flow monitoring device for hemodialysis in seeking a new HCPCS code from CMS.
Represented a pharmaceutical manufacturer in a commercial dispute with a competitor regarding coding for its product and resolved the dispute by obtaining a new HCPCS code from CMS.
Represented a nonprofit research and education foundation in the development and implementation of a new funding model to facilitate industry support for graduate medical education, continuing medical education (CME) and research.
Represented an osteopathic medical school, dental school and various allied health programs in establishing policies and procedures governing industry support for university-sponsored CME programs.
Member, American Health Lawyers Association
Tutor, Chicago Lights Partners in Education Tutoring Program
Mentor, University of Michigan Club of Chicago Alumni Mentoring Program