Experience

Karuna Therapeutics

• United States
• Biotechnology
• 100 - 200 Employee

• Senior Director, Market Access and Commercial Operations Counsel

  • Sep 2023 - Present



Apellis Pharmaceuticals

• United States
• Biotechnology Research
• 500 - 600 Employee

• Senior Director, US Market Access Counsel

  • Dec 2022 - Sep 2023



Jazz Pharmaceuticals

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Corporate Counsel, U.S. Market Access

  • Apr 2021 - Dec 2022

  • Conducted legal analysis of government price reporting methodologies, policies and reasonable assumptions of manufacturer acquired by Jazz; adjusted and harmonized government price reporting approaches of the two companies with a focus on governance and mitigating legal risk. • Supervised performance of government price reporting audit by third party auditing firm; collaborated with auditing firm and business lead to finalize audit report and implement recommendations. • Broke down complexities to present straightforward guidance on business implications of consequential statutory and regulatory developments, including elimination of the AMP cap, OIG’s Part D Rebate Rule, and CMS regulatory actions affecting government price reporting requirements for value-based purchase arrangements, “line extensions,” authorized generics and patient assistance programs subjected to co-pay accumulators and maximizers. • Counseled line of business regarding resolution of high value rebate disputes with payers; developed negotiation strategies resulting in advantageous settlement outcomes despite restrictive contractual dispute procedures. • Represented Legal department at Contract Review Committee meetings, providing guidance on structuring of compliant pricing and access strategies with a focus on GPO rebate arrangements for buy-and-bill products. • Counseled line of business concerning government price reporting implications of increased consolidation between pharmacy benefit managers and specialty pharmacies; advised market access team regarding negotiation of specialty pharmacy discount offers to avoid adverse government price reporting consequences. • Provided guidance to line of business concerning resolution of commercial rebate audit and exclusion disputes with pharmacy benefit managers, Medicaid rebate payment disputes with states, and challenges arising under the New York Medicaid Drug Cap law. Show less



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Corporate Counsel - Market Access, Government Pricing & Supply Chain

  • Mar 2020 - Apr 2021

  • Directed Legal department efforts supporting launch of innovative solution to mitigate 340B contract pharmacy abuses and devised external messaging regarding same; advised business concerning industry and legal developments relating to the 340B Discount Drug Program, including contract pharmacy data collection and limitation strategies of other manufacturers, and actions of covered entities, advocacy groups, HRSA/HHS, the Administration and Congress.• Partnered with line of business to develop and implement innovative rebate agreements, discount programs, patient support programs, educational programs, and a variety of affordability initiatives with PBMs, GPOs, LTCs, pharmacies, wholesalers and specialty distributors.• Devised successful negotiation strategies resulting in double-digit million-dollar recoveries of improperly invoiced 340B utilization and other excluded claims by various large payers.• Developed reasonable assumptions governing calculation and reporting of AMP, BP, ASP, 340B Ceiling Price, and overpayment refund obligations under the Health Resources & Services Administration’s 340B Civil Monetary Penalty Final Rule.• Advised government pricing team concerning the identification of bundles in payer rebate agreements and development of methodology for unbundling temporal discounts.• Represented Novo Nordisk on various PhRMA legal committees; collaborated with public affairs team to draft comment letters to government agencies concerning Notices of Proposed Rulemaking. • Provided critical legal support in development of authorized generic affiliate, including structuring of organization; negotiation and drafting of payer agreements; application for participation in Veterans Affairs, Department of Defense, 340B, Medicaid Drug Rebate, and Medicare Part D programs; development of pricing protocols; registration to do business in Puerto Rico; and negotiation and drafting of essential distribution and vendor agreements. Show less

• Senior Attorney

  • Mar 2019 - Mar 2020



Dughi, Hewit & Domalewski P.C.

• Cranford, New Jersey

• Of Counsel, Life Sciences & Healthcare

  • Dec 2017 - Mar 2019

  Pharmaceuticals, Biologics, Medical Devices • Rebate Agreements; Price Reporting and Transparency; Specialty Pharmacy Arrangements; Data Programs and Hub Services; Market Access; Patient Assistance Programs and Co-Payment Coupons; Drug Distribution & Purchasing Contracts; Pharmacy Dispensing Software; PhRMA and AdvaMed Code Compliance 340B Drug Program (Recipient of 340B Advanced Operations Certification) Reimbursement, Payor Relations • Managed Care Contracting; Governmental and Commercial Payor Reimbursement Criteria; Payment Disputes; Telehealth; Readmissions; Delivery System Reform Incentive Payment Programs Physician Alignment, Joint Ventures, M&A • Physician Alignment Transactions ; Stark and Anti-Kickback-compliant Physician Incentive Programs; Joint Venture Arrangements; Healthcare Entity Mergers, Acquisitions and Affiliations Vendors, Procurement, Supply Chain • Vendor Contracts, Supply Chain & Procurement; Software as a Service Agreements & Health Information Technology; Equipment Service & Maintenance Agreement; Group Purchasing Organization Contracting Licensure & Credentialing Regulatory Compliance, Fraud & Abuse • Insurance Fraud, False Claims, Anti-Kickback and Self-Referral Law Compliance, including Conducting Internal Compliance Investigations; Reporting and Returning of Overpayments; Self-Disclosure Protocols; Medicare and Medicaid Exclusion, Revocation and Sanctions; Home Health and Hospice Compliance; CMS Quality Payment Program (including MIPS and APMs) Privacy & Security • Risk Assessments; Policies and Procedures; Breach Investigation and Notification (HIPAA/HITECH, 42 CFR Part 2, FTC & State Law); PHI Deidentification; EMR, Meaningful Use (now the Advancing Care Information component of CMS’ Quality Payment Program); Business Associate and Business Associate Subcontractor Agreements Academic & Research Agreements Tax-Exempt Organizations • Compliance with IRS Management Service Contracts Safe Harbor for Qualified Tax-Exempt Bonds Show less



Asembia

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Vice President, General Counsel

  • Jan 2017 - Jun 2017

  Vice President and General Counsel for privately-held family of companies that include a GPO, a specialty pharmaceutical hub services and health information technology organization, a pharmaceutical distributor, a specialty pharmacy consulting company and a licensed non-dispensing pharmacy. • Advised Board concerning laws and regulations that govern entities across the spectrum of the health industry, including pharmacies, physicians, pharmaceutical manufacturers, commercial insurers, GPOs, governmental payors and distributors, among others. • Counseled management regarding the efficient and compliant delivery of pharmaceutical market access and prescription fulfillment solutions, including insurance adjudication, prescription triage, clinical counseling, patient assistance program and co-payment card guidance, refill reminders, data programs and a software platform capable of transmitting real-time dispensing information. • Reviewed, drafted and managed the company’s contracts and RFPs which included client contracts, vendor contracts, contracts pertaining to the sale and purchase of software and pharmaceuticals, business associate agreements, leases and many more. • Participated as a senior member of management, working directly with the corporate executive team to understand strategic initiatives and business needs, providing legal and business counsel, and establishing and influencing appropriate ethical standards. • Provided guidance and assistance to Compliance Officer with respect to information privacy risk assessments and the performance of related ongoing compliance monitoring activities in coordination with the compliance and operational assessment functions. Show less



McCarter & English, LLP

• United States
• Law Practice
• 700 & Above Employee

• Special Counsel

  • Mar 2015 - Jan 2017

  • Secondment as Associate General Counsel with multi-hospital regional health system. Responsibilities included: counsel client concerning compliance with State and Federal regulations and physician credentialing; negotiate and draft professional service, physician recruitment, resident rotation and vendor agreements; provide legal advice to various hospital boards and committees. • Performed intensive regulatory and compliance due diligence investigation and drafted associated representations, warranties and conditions of closing in connection with 4 hospital system mergers, including merger between two leading New Jersey health systems creating a $5 billion system, the State’s largest. • Drafted contribution, operating and management agreements in connection with various joint ventures between hospital systems and physician practices. • Provided counsel regarding compliance with Health Resources & Services Administration guidance and management of 340B drug programs. • Conducted negotiations and structured professional services, employment and management agreements to consummate acquisitions of physician practices by hospital systems. • Served as counsel for regional health system‘s Medical Executive Committee; advised committee regarding amendments to bylaws, professional review actions and compliance with Joint Commission standards. • Drafted opinion letters concerning compliance of physician-hospital alignment transactions with state and federal anti-kickback and self-referral laws. • Provided regulatory counsel to hospital systems and physicians concerning the implications of government payor and state and federal licensing rules and regulations on their businesses. • Advised institutions and providers regarding healthcare coding, coverage and reimbursement, including analyzing CPT and HCPCS issues. • Compiled HIPAA Security and Privacy Rule compliance manuals for Covered Entities and Business Associates. Show less



Brach Eichler LLC

• United States
• Law Practice
• 100 - 200 Employee

• Health Law Attorney

  • Apr 2014 - Feb 2015

  • Advised physician and hospital clients regarding compliance with State and Federal self-referral and anti-kickback laws and regulations. • Drafted employment agreements governing employment of physicians by group practices and hospitals. • Counseled physician pharmaceutical dispensing software vendor regarding implications of self-referral, anti-kickback, and drug compounding regulations on operations. • Successfully represented providers and suppliers in appeals of Federal healthcare program exclusions, revocations, and sanctions imposed by the Centers for Medicare and Medicaid Services and the Office of Inspector General, obtaining dismissal of sanctions and reduced penalties. • Counseled teaching hospital regarding implications of Stark Law Academic Medical Centers exception and alternatives following merger with community hospital. • Defended practitioners in proceedings before State licensure Boards. • Litigated professional review actions on behalf of hospitals. • Defended healthcare providers against State insurance fraud and RICO claims. • Represented healthcare entities in reimbursement actions under ERISA and various State law theories. Show less



Drinker Biddle & Reath LLP

• United States
• Legal Services
• 400 - 500 Employee

• Associate

  • Sep 2007 - Mar 2014

  • National trial counsel for global pharmaceutical organization. Responsibilities included: interviewing sales representatives, supervising comprehensive discovery efforts, and preparing fact witnesses for trial in multi-jurisdiction litigation involving allegations of “misbranding,” “off-label promotion,” and other conduct in violation of the Anti-Kickback Statute, False Claims Act, Food, Drug, and Cosmetic Act and PhRMA code; providing regulatory advice concerning compliance of promotional activities with governing law and PhRMA code. • Represented regional healthcare system in qui tam litigation and obtained dismissal of complaint alleging False Claims Act violations for improper Medicare billing practices pertaining to level of care determinations and retaliatory discharge. • Conducted internal investigation of healthcare system pertaining to potential Stark Law and Anti-Kickback issues. • Counseled healthcare providers concerning level of care determinations, Medicare reimbursement issues, utilization review, and auditing matters. • Advised client regarding CMS ruling permitting re-submission of improper Medicare Part A inpatient claims as Part B outpatient claims. • Drafted memoranda concerning compliance with revised Inpatient Prospective Payment System 2-midnight benchmark and certification standards. • Counseled clients regarding Medicare Administrative Contractor and Recovery Audit Contractor claim denials. • Produced presentation concerning Stark Law compliance implications of Tuomey verdict. Show less



Boston College Law School

• Newton, MA

• Research Assistant to Intellectual Property Professor Joseph Liu

  • Jun 2005 - Aug 2005

  Conducted extensive legal research for intellectual property textbook and law review article regarding trademark and copyright law. Conducted extensive legal research for intellectual property textbook and law review article regarding trademark and copyright law.



Dughi & Hewit, P.C.

• Cranford, NJ

• Law Clerk

  • Jun 2004 - Aug 2004



Vermont Chamber of Commerce

• Berlin, VT

• Government Affairs Liaison & Lobbyist

  • Nov 2003 - Apr 2004

  Represented Chamber and testified before legislative and special committees at Vermont State House. Alerted members of potential impact of pending legislation and facilitated direct contact between Chamber members and lawmakers. Authored articles for Chamber’s member newsletter. Represented Chamber and testified before legislative and special committees at Vermont State House. Alerted members of potential impact of pending legislation and facilitated direct contact between Chamber members and lawmakers. Authored articles for Chamber’s member newsletter.



The Honorable James M. Jeffords, United States Senate

• Burlington, VT

• Intern

  • Sep 2002 - Dec 2002

  Researched potential impacts of legislation on Vermont residents and conducted constituent outreach. Drafted correspondence responding to residents' concerns and advocating Senator Jeffords's policy positions. Researched potential impacts of legislation on Vermont residents and conducted constituent outreach. Drafted correspondence responding to residents' concerns and advocating Senator Jeffords's policy positions.