Helping health care companies navigate regulatory hurdles 

Simone Colgan Dunlap advises on regulatory compliance, related risk management and corporate/contracting matters for a variety of clients, including drug and device manufacturers, pharmacy benefits managers (PBM), third-party administrators (TPA), health care insurers, discount medical plan organizations (including prescription discount card administrators), pharmacies, specialty pharmacies, home health agencies, hospitals, physician organizations, physicians, pharmacists and nurses. She advises on a full range of issues, including:

• Health care agreements
• Health care regulatory compliance
• Health privacy
• Structuring and drafting agreements for novel health care products and services

Simone understands the business needs of health care companies and the constantly shifting regulatory environment in which they operate. She is national chair of the firm's Health & Life Sciences industry team.

Bar Admissions

• Arizona

Education

• University of Michigan Law School (J.D., cum laude, 2008)
  • University of Michigan Journal of International Law, Business Development Editor

• Whitman College (B.A., with honors, 2002)

• "Big Data, Big Risk: Strategies to Mitigate Risks Associated with Data Monetization"
• "COVID-19 and Increased Cyber Risk"
• "COVID-19 and the risks of an expanded remote workforce"
• "Discounts, & Rewards & Loyalty Programs, Oh My"
• "Double, Double Toil and Trouble: Avoiding Regulatory Pitfalls Related to Thy Hubs Interactions"
• "Double, Double Toil, and Trouble: Avoiding Regulatory Pitfalls Related to Thy Hubs Interactions"
• "Examining the Law on Health Information and COVID-19 for Businesses"
• "Federal District Court in Eleventh Circuit Holds that Failure to Allege Actual Submission of a Specific False Claim is Fatal to an Off-Label Use Marketing Qui Tam Suit"
• "Health Care Reform: A Look Back and A Way Forward"
• "Health Law"
• "Hot Button Issues on PBMs’ Radars"
• "How COVID-19 increases cyber risk and tips to protect yourself"
• "Legal Issues in Specialty Pharmacy"
• "NASP presentation: Lunch with a Lawyer: Privacy Please! Recent developments in federal and state privacy laws that impact specialty pharmacy"
• "Paying for Performance: Understanding Key Issues in Risk Sharing Agreements"
• "Pharmacy 101"
• "Pharmacy Law—Examination and Board Review: Arizona Chapter"
• "Privacy (and Security) Please! Hot Topics in Pharmacy"
• "Special report: How COVID-19 could reshape telemedicine sector in Arizona, US"
• "Specialty Pharmacy and the Law"
• "Specialty Pharmacy"
• "State Health Care Fraud Law: An AHLA 50-State Survey with Summaries and Links"
• "Summary of Fraud and Abuse Statutes and Regulations, Rhode Island"
• "Telemedicine: The Role of Technology and Changing Laws in the Delivery of Cancer Care"
• "The Acceleration of Technology"
• "The Cost of Coupons: Implications of Recent OIG Guidance on Pharmaceutical Manufacturer Copayment Coupons"
• "The Dating Game: Navigating Relationships with Pharmaceutical Manufacturers"
• Alabama Board of Pharmacy Imposing 3:1 Technician to Pharmacist Ratio on Non-Resident Pharmacies
• Arkansas' PBM Law Upheld By Supreme Court
• Beware of Individuals Impersonating the Arizona State Board of Pharmacy (or other Regulators)
• California Board of Pharmacy Changes
• California Passes Two Drug Pricing Transparency Laws
• CMS Proposed Rule to Delay Effective Date of Amended Regulatory Definitions under the Medicaid Drug Rebate Program
• Fraud in the Time of Corona: Beware of Individual Impersonating OCR Investigator
• Massachusetts Drug Discount Provision Set to Expire January 1, 2020
• Massachusetts Law Permitting Pharmacies and Pharmaceutical Manufacturers to Offer Drug Discounts to Consumers Extended to January 1, 2026
• Massachusetts Passes Emergency Opioid Legislation
• Massachusetts’ Court Creates a New Duty for Pharmacies to Notify Prescribers of Prior Authorization Requirements
• New Limitations on Chain Pharmacy Quotas in California
• New York State Department of Financial Services Reporting Requirements for Pharmacy Benefit Managers
• Ohio Board of Pharmacy Formalizes a Pathway for Approval of Innovative Pharmacy Arrangements
• Planning for Preparedness and Response: COVID-19 Response for the Health and Life Sciences Industry
• Privacy and Cybersecurity Considerations and Opportunities Related to COVID-19
• Rhode Island Pharmacist Drug Administration Expansion
• Rhode Island: Summary of Fraud and Abuse Statutes and Regulations
• Safeway Prevails on Motion for Summary Judgment in Whistleblower Pharmacy Usual and Customary Pricing Case
• The OIG Green Lights Brand Manufacturer's Discount Drug Program
• Trade Group Sues State of California to Block S.B. 17 Drug Pricing Bill
• Winter Blues Client Alert Series: Privacy Concerns in the Collection and Use of Biometric Data
• ​What’s So Special About Specialty Pharmacy? What Hospitals and Health Systems Need to Know About Specialty Pharmacy Integration
• “Circling Back” After the New Year: Recent Updates in Data Privacy & Security

Seminar

• 2015 Pharmacy Law Symposium
• 2018 Pharmacy Law Symposium
• 2021 Pharmacy Law Symposium
• American Society for Pharmacy Law (ASPL) 2020 Virtual Fall Meeting
• Hot Button Issues on PBMs’ Radars
• NASP 2019 Annual Meeting & Expo 4th Annual Specialty Pharmacy Law Conference
• NASP 2020 Annual Meeting & Expo Virtual Experience and 5th Annual Specialty Pharmacy Law Conference
• NCPDP Annual Conference
• Privacy (and Security) Please! Hot Topics in Pharmacy
• State of the Law in Specialty Pharmacy
• State Pharmacy Licensure & Compliance
• Telemedicine: The Role of Technology and Changing Laws in the Delivery of Cancer Care
• Under Pressure: A Musical Journey to Understanding the Legal Framework Necessary to Leverage Big Data – 2022 ACC Annual Meeting