Overview
Attorney Connie Wilkinson concentrates her practice on pricing and reimbursement policy, commercial pricing, federal health care and health benefits program issues, and contracting strategies—including health care fraud and abuse considerations—for the pharmaceutical, medical devices and products, and biotechnology industries.
Based in the Washington, DC, office, she also serves as a member of the firm’s Board of Directors.
Connie regularly advises direct and indirect providers in the health care industry regarding pharmaceutical pricing and program compliance under Medicare Parts B and D, the Medicaid Drug Rebate Program, the 340B Drug Discount Program, the Veterans Health Care Act/Federal Supply Schedule Program, and the DoD TRICARE program. She conducts due diligence and internal reviews, performs and responds to fraud and abuse investigations, prepares and negotiates voluntary disclosures and restatements, and assists in implementing Corporate Integrity Agreements, including providing counsel regarding reviews conducted by Independent Review Organizations. Additionally, Connie develops and reviews corporate compliance programs for federal contractors and for direct and indirect providers of health care services, including manufacturers of drugs, devices, and biologicals.
Some of Connie's recent engagements include the following:
- Assisting a pharmaceutical manufacturer in developing a full suite of government program compliance and price reporting policies
- Drafting and negotiating commercial supply, distribution, and pricing agreements for pharmaceuticals and biologicals
- Structuring and performing risk assessments of value-based contracting arrangements in the context of the current legal and policy landscape
- Developing and delivering training modules on legal and regulatory requirements for federal government contractors
Connie is a former Co-Chair of the ABA Public Contracts Section Health Care Contracting Committee. She has authored numerous articles on the procurement, pricing, and reimbursement of pharmaceuticals, medical devices, and supplies, and she lectures frequently on these topics.
Read less
Focus Areas
Services
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Digital Health
- Drug and Medical Device Coding, Coverage, and Payment
- Drug Pricing Policy & Reporting
- Fraud and Abuse Compliance Counseling and Defense
- Government and Commercial Coding, Coverage, and Payment
- Government Contracts and Procurement
- Health Care
- Health Care and Life Sciences Investigations and Enforcement
- Health Policy and Legislation
- Life Sciences
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
- Value-Based Purchasing and Accountable Care
Industries
Trending Issues
Experience
Credentials
Education
- The George Washington University (J.D., 1984)
- National Law Center
- Catholic University of America (B.A., magna cum laude, 1980)
Bar Admissions
- District of Columbia
Court Admissions
- U.S. Court of Federal Claims
- U.S. Courts of Appeals, All Circuit
Professional & Community Involvement
- American Health Lawyers Association
Media
Events
Past Events
Insights
Insights
- BlogsCMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin ...13 minute read
- BlogsLast Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future10 minute read
- Publications
In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute
9 minute read - Media CoverageConnie Wilkinson Quoted in “Stelara Biosimilar Tests Market Impact of Drug Price Program”3 minute read
- PublicationsCMS Seeks Stakeholder Feedback About Medicare Transaction Facilitator Services for the Medicare Drug Price Negotiation ...4 minute read
- BlogsCMS Names Its First Ten Negotiated Part D Drugs: Inflation Reduction Act Updates11 minute read
- PublicationsState Regulation of Pharmacy Benefit Managers: Tenth Circuit Holds That ERISA and Medicare Part D Preempt Key Parts of ...25 minute read
- PublicationsCMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates7 minute read
- PublicationsManufacturers Must Request Small Biotech Exception by July 3: Inflation Reduction Act Updates4 minute read
- PublicationsCMS Seeks Comment on Initial Guidance for the Part D Manufacturer Discount Program: Inflation Reduction Act Updates ...2 minute read
- BlogsMore Federal Action in the Pharmaceutical Sector as PBM Bill Advances in the Senate12 minute read
- PublicationsCMS Issues an Information Collection Request for the Drug Price Negotiation Process: Inflation Reduction Act Updates ...3 minute read
- PublicationsCMS’s Initial Guidance on Medicare Drug Price Negotiation Program Suggests Familiar Pharmacy Chargeback Process ...12 minute read
- PublicationsCMS Issues an Information Collection Request on Negotiation Data Elements: Inflation Reduction Act Updates3 minute read
- PublicationsCMS Issues New Guidance on Medicare Drug Price Negotiation Program: Inflation Reduction Act Updates2 minute read
- PublicationsCMS Releases Its List of 27 Part B Rebatable Drugs for Q2 of 2023: Inflation Reduction Act Updates3 minute read
- BlogsComments to CMS Guidance on the Medicare Prescription Drug Inflation Rebate Program Due March 11, 202310 minute read
- PublicationsCMS Launches First Federal Regulatory Action to Implement Medicare Drug Price Negotiation Program6 minute read
- PublicationsMore Changes in Store for Pharmaceutical Supply Chain Following Passage of Inflation Reduction Act18 minute read
- PublicationsFTC’s PBM Study Signals Broader Federal Scrutiny of the Prescription Drug Sector23 minute read
- PublicationsCMS Finalizes Changes to Pharmacy DIR in Part D Starting with Contract Year 202414 minute read
- BlogsPresident Biden Revokes Trump Administration’s Workplace Diversity Training Restrictions2 minute read
- PublicationsFinalized HHS Drug Formulary Rebate Rule Faces Uncertain Future Under Biden Administration and Current Legal Challenge ...20 minute read
- BlogsNAACP Lays Down First Challenge to Executive Order 13950 Prohibiting Inclusion of “Divisive” Concepts in Workplace ...3 minute read
- PublicationsExecutive Order Prohibits Inclusion of "Divisive" Concepts in Workplace Training11 minute read
- PublicationsPresident Trump Signs Executive Orders on Drug Pricing and Domestic Supply Chain Reform22 minute read
- PublicationsChapter 6, "Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices ...2 minute read
- PublicationsHHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration ...19 minute read
- PublicationsCMS Releases Medicare Advantage and Part D Drug Pricing Proposed Rule for Contract Year 202028 minute read
- BlogsHRSA Establishes January 1, 2019 Effective Date for 340B Ceiling Price and Civil Monetary Penalty Rule3 minute read
- BlogsCMS Seeks to Revamp Medicare Part B Drug Reimbursement through Proposed International Pricing Index (IPI) Model ...3 minute read
- BlogsCMS Finalizes Policy and Technical Changes to the Medicare Advantage and Part D Programs for CY 20195 minute read
- BlogsWhite House 2019 Budget and White Paper Shape Ambitious Policy to Reduce Drug Prices8 minute read
- PublicationsComment Deadline Approaches for CMS's Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2 ...21 minute read
- PublicationsComment Deadline Approaches for CMS's Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 - Part 1 ...15 minute read
- PublicationsComment Deadline Approaches for CMS's Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 3: Part D ...13 minute read
- BlogsCMS Final Rule Will Reduce Medicare Part B Drug Payments by Nearly 30% for 340B Hospitals5 minute read
- Media CoverageConstance Wilkinson Quoted in "Top Four Approaches to Reduce Pharmaceutical Costs"2 minute read
- Media CoverageConstance Wilkinson Quoted in "Long-Awaited AMP Rule Heralds Shift to Acquisition Cost-Based Reimbursement"2 minute read
- PublicationsCMS Issues Final Rule on Covered Outpatient Drugs38 minute read
- PublicationsOpportunities in Connected Health: Improving Patient Care, Reducing Provider Cost, and Enabling New Business Models ...2 minute read
- BlogsU.S. District Court Vacates HRSA's Interpretative Rule on Orphan Drugs9 minute read
- BlogsHRSA Issues Proposed "Omnibus Guidance"11 minute read
- PublicationsHouse Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation ...1 minute read
- BlogsHouse Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation ...4 minute read
- PublicationsConstance Wilkinson, Alan Arville Comment on Specialty Drug Cost Upswing2 minute read
- PublicationsLegal Risks of Co-Payment Assistance Programs2 minute read
- PublicationsVeterans Choice Program Expanded in Interim Final Rule by the Department of Veterans Affairs12 minute read
- BlogsHRSA Withdraws 340B "Mega-Reg;" Plans to Issue Guidance in 20156 minute read
- PublicationsOPM Issues Ebola Guidance to FEHBP Carriers1 minute read