Theresa counsels health care clients on a variety of transactional, regulatory, and fraud and abuse matters.
Theresa focuses much of her practice on counseling health plans, pharmacy benefit managers, pharmacies, device manufacturers, and distributors on regulatory and compliance matters. Her practice extends to counseling on drug pricing and reimbursement issues, Medicare Advantage and Medicare Part D compliance, and the regulatory requirements under the Affordable Care Act and state health insurance exchanges. Theresa has extensive experience drafting, negotiating, and structuring PBM agreements, retail, mail and specialty pharmacy agreements, GPO agreements, and pharmaceutical purchase, distribution, and rebate agreements. She also regularly counsels these clients on compliance with federal and state fraud and abuse laws, the PhRMA and AdvaMed Codes, state disclosure and gift ban laws, and state licensure laws.
Theresa also specializes in representing clients in connection with mergers and acquisitions, joint ventures, strategic affiliations, complex service agreements, provider contracts, network development programs, and general contracting. Theresa advises clients on the structuring and legal, practical, and fraud and abuse implications of these business arrangements and transactions. She has served as health regulatory counsel on managed care, PBM, pharmacy, laboratory, behavioral health, anesthesiology, DME, and practice management company transactions. Theresa also has deep experience assisting private equity firms in connection with their investment in the health care industry and the day-to-day regulatory compliance of their portfolio companies.
Other aspects of Theresa's practice include day-to-day counseling on matters related to the anti-kickback statute, the Stark law, and state statutes prohibiting kickbacks and self-referrals. Theresa regularly advises client on the structuring of business arrangements to comply with state regulatory restrictions such as corporate practice of medicine and fee-splitting prohibitions. Theresa is also an Editor of and a frequent contributor to Mintz Levin's Health Law blog,Health Law & Policy Matters.
• Fifty-One Mintz Levin Attorneys Featured in Chambers USA 2014 Guide, (05.23.2014)
• Mintz Levin Attorneys Theresa C. Carnegie and Thomas S. Crane to Present at AHLA Fraud and Compliance Forum, (09.26.2013)
• Quoted inDocs Lobby to Keep Stark Exemptions,MedPage Today (09.06.2013)
• Quoted inBill to Scrap Stark Law In-Office Ancillary Services Exception Fiercely Opposed,Inside Health Policy (08.16.2013)
• Quoted inWith Stark Law Loophole Under Fire, Docs Eye Bottom Line,Law360 (08.09.2013)
• Quoted inCMS Ratings Push Pressures Medicare Plans to Improve,Law360 (10.11.2012)
• Mintz Levin Elevates Six Attorneys to Members of the Firm, (04.28.2011)
Recognitions & Awards
• Chambers USA:District of Columbia (Up and Coming) - Healthcare (2014)
• Nightingale's Healthcare News: Outstanding Young Healthcare Lawyers (2005)
• Phi Beta Kappa
Co-author,CMS Proposes Major Changes to Medicare Part C and Part D,BNA's Medicare Report (03.07.2014)
• Co-author,CMS Proposes Major Rule Changes to Increase Payment Accuracy and Improve Program Integrity in Medicare Part C and Part D,BNA's Health Care Fraud Report (03.05.2014)
• Co-author,CMS Proposes Major Changes to Medicare Parts C and D,Health Law Advisory (01.21.2014)
• Co-author,New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services,Med Monthly Magazine (09.2013)
• Co-author,Caution: Risk Adjustment Hurdles Facing Plans and Providers Under the Affordable Care Act,BNA's Health Insurance Report (07.17.2013)
• Co-author,2014 Final Call Letter: CMS Raises Medicare Advantage Rates but Foreshadows Other Significant Program Changes,Health Law Advisory (04.16.2013)
• Co-author,Medicare Star Ratings-What Plan Sponsors Need to Know,BNA's Medicare Report (11.29.2012)
• Co-author,Fiscal Year 2013 Work Plan Highlights OIG's Medicare Parts C and D Priorities,Health Law Advisory (10.09.2012)
• Author,Legal Challenges, Risks of Rx Drug Adherence Programs,Law360 (07.09.2012)
• Co-author,Electronic Health Record Donations: Best Practices to Minimize Liability,G-2 Compliance Report (02.01.2011)
• Co-author,Vermont Passes Sweeping Regulation of Pharmaceutical Marketing Activities,Health Law Advisory (05.28.2009)
Speaker,What Do the Proposed Changes to Medicare Parts C and D Mean for Your Business?, Mintz Levin, Webinar (01.29.2014)
• Speaker,Fundamentals of PBM Compliance in the Health Reform Era, CBI, Chicago, IL (11.13.2013)
• Speaker,Fundamentals of Healthcare Valuation for Health Lawyers,Fraud and Compliance Forum, American Health Lawyers Associaton (AHLA), Baltimore, MD (09.30.2013)
• Speaker,Healthcare Transactions and Compliance with State and Federal Laws and Regulations, Strafford Publications, Webinar (12.20.2012)
• Moderator,The Future of Health Care: Opportunities for Reforming Our Current System, District of Columbia Bar, Washington, DC (04.16.2009)