KAT (KATHERINE) MAKIELSKI is an associate in the Healthcare group. In her practice, Kat focuses on healthcare regulatory and compliance matters for pharmaceutical and medical device manufacturers, healthcare providers and other organizations in the healthcare industry.
Kat primarily advises on healthcare fraud and abuse risk under the federal Anti-Kickback Statute, federal False Claims Act and other applicable federal and state laws; Medicare and Medicaid program rules, including coverage and reimbursement strategy; and the federal Sunshine Act (Open Payments) and state transparency and reporting laws. In addition, Kat has experience advising on HIPAA and similar state health privacy laws, as well as government price reporting requirements. Examples of Kat’s recent engagements include assessing existing and proposed patient support programs (such as commercial copay assistance, reimbursement support, and charitable and commercial free drug programs) for compliance with applicable healthcare laws and recommending changes and safeguards as appropriate to reduce risk; counseling on various details related to patient support implementation, including vendor contracting, communications strategy and interactions with patient advocacy groups; advising on Medicare reimbursement methodology under the End-Stage Renal Disease (ESRD) prospective payment system and the ESRD Quality Incentive Program; reviewing and drafting compliance policies and procedures; preparing HCPCS Level II code modification requests; conducting internal reviews and legal analysis related to potential overpayments; analyzing the potential impact of proposed regulations and policies and advocating for clients in the rulemaking process; and liaising with regulators on behalf of clients.
Kat received her J.D., magna cum laude, with a health law concentration with honors from Case Western Reserve University School of Law. Kat is a member of the Order of the Coif and served as Editor in Chief of the Case Western Reserve Law Review. While in law school, Kat also served as an extern for the Honorable Chief Judge Solomon Oliver, Jr. in the Northern District of Ohio.
Kat received her B.A. in Biology from Washington University in St. Louis in 2006. Before law school, Kat began her career at a large medical education agency, where she worked with various functions in the pharmaceutical industry and helped develop novel corporate collaborations with patient advocacy groups.
Admissions & Certifications
- Case Western Reserve University School of Law, J.D., 2014 (magna cum laude, Order of the Coif)
- Washington University, B.A., 2006