Calm, clear and collaborative health law advice

Brenda Maloney Shafer advises a wide variety of health care providers – including pharmacies, pharmacy benefit managers (PBM), drug wholesalers, hospitals, physician groups and long-term care facilities – on regulatory, compliance and transactional matters. A U.S. Army Nurse Corps officer before she became a lawyer, Brenda brings hands-on experience as a health care provider to the counsel she provides on:

• Regulatory compliance, with a focus on pharmacy, nursing, assisted living and long-term care
• 340B Drug Pricing Program compliance
• Licensing issues
• Physician group practice management

Nurturing collaborative professional relationships with regulators across the country and working closely with clients to understand their business needs and risk tolerance, Brenda works nimbly to guide clients toward the legal and business results they seek even in a rapidly changing health care technology and business environment. When the realities of health care delivery outpace the regulations governing them, she focuses on providing practical, operationally feasible recommendations to her clients. In addition to her J.D., Brenda holds a Master of Laws degree (LL.M.) in Health Law. She is also the national vice chair of the Health & Life Sciences Practice Group.

Bar Admissions

• Arizona
• Idaho
• Kentucky
• New Mexico
• North Carolina

Education

• Northwestern University, Kellogg School of Management, Certificate, Quarles & Brady Leadership Program (2022)

• Creighton University (BSN, 1993)

• Saint Louis University (LL.M., 2002)
  • Major: Health Law

• University of New Mexico (J.D., cum laude, 2001)

• "340B Drug Pricing Program"
• "A Knowledge Infusion: A Legal Overview of Infusion Pharmacy Services"
• "CVS Caremark Reverses Planned Payment Cuts to 340B Providers"
• "Hot Topics in Pharmacy Law"
• "The 340B Drug Pricing Program Year in Review: What's Smoke and What's Fire in a Changing Landscape"
• "To Be or Not to 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback"
• "We're 340Back! Review of Major Developments to the 340B Program"
• 340B Developments in 2024 – Litigation and Legislation
• 340B Litigation Updates and Other Program Developments
• 340B Program Changes on the Horizon? Start Planning Now for Potentially Seismic Impact of Upcoming Genesis Decision
• 340B Program Compliance in a Shifting Landscape: What Challenges Do Stakeholders Face?
• Amidst Ongoing Manufacturer Restrictions, 340B Covered Entities and Contract Pharmacies Get Creative
• Answers to Questions About USP's Notice of Intent to Revise New Compounding Standards
• Arizona Supreme Court Clarifies Deadline By Which Non-Hospital Health Care Providers Must Record Liens
• Arkansas Proposes Amendments to Restrict Corporate Ownership of Pharmacies
• AstraZeneca to Cut Off 340B Pricing for Contract Pharmacies on October 1
• Brenda Shafer, Michael French and Richard Davis Author Law360 Article on Questions Related to Section 340B Drug Pricing
• CMS Proposal to Make One-Time $9 Billion Lump Sum Payment to 340B-Covered Entity Hospitals
• CMS Publishes 340B Drug Acquisition Cost Survey: Respond by May 15, 2020
• Continuing Changes in the 340B Space: New Restrictions and Shifting Alliances
• District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling
• FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances
• Fifth Circuit Issues Mifepristone Decision: Case Likely to Move to Supreme Court
• GAO Report Suggests Increased Oversight of 340B Program
• HRSA Notice Provides Clarity on 340B Child Site Registration Requirements
• HRSA Unveils New 340B Flexibilities During COVID-19 Crisis
• Interesting 340B Takeaways from 2020 OPPS Proposed Rule
• Kentucky Board of Pharmacy Continues to Research and Review Proposed Non-Resident Pharmacy Permit Regulations
• Kentucky Board of Pharmacy Regulation Committee Proposes New Requirement of Licensure for All Out-of-State Pharmacists
• Kentucky Proposes First-in-Nation Non-Resident Pharmacist License—What’s Next?
• Kentucky Withdraws Controversial Non-Resident Pharmacist License Regulation
• Nevada Legislature Rejects Board of Pharmacy’s Licensing Requirement for Out-of-State Pharmacists
• New PBM State Laws Indicate a Shifting Battlefront over 340B Program Drug Pricing
• Notice to Covered Entities: Manufacturer Seeking 340B Claims Data
• Puerto Rico Implements Licensure Requirement for Non-Resident Wholesalers & Manufacturers
• Supreme Court Decision Maintains Status Quo for Disproportionate Share Percentage Calculation: What Does It Mean for the 340B Program?
• The Current State of 340B and What to Expect in 2023
• The End of a Wild Year for 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback
• The President’s 2020 Budget Keeps 340B Program in the Spotlight
• T​he 340B Program Mega Guidance: Muddying the Water for All Stakeholders
• UPDATE: U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling
• UPDATE: U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling
• USP Appeals Panel Grants Appeals to USP 795 and 797, Denies Appeal to USP 825
• USP Publishes Notice of Intent to Revise New Compounding Standards

Seminar

• 2015 Pharmacy Law Symposium
• 2018 American Society for Pharmacy Law Fall Meeting
• 2018 Pharmacy Law Symposium
• 2019 Pharmacy Law Symposium
• 2022 Pharmacy Law Symposium
• 2023 Pharmacy Law Symposium
• 2024 Pharmacy Law Symposium
• WESTMARC Healthcare Innovation Summit