Brandon W. Shirley

Brandon W. Shirley has a diverse knowledge of Federal and State regulations. He has extensive experience with State and Federal Medicaid laws, regulations, policies, waiver programs, audits, and administrative appeals having previously served in top-level legal positions with the State of Indiana. His practice extends to Medicaid managed care policies, audits, and disputes. He assists clients investigating and appealing government overpayment determinations or other Medicare or Medicaid sanctions. He assists clients with internal investigations of noncompliance issues involving Medicare and Medicaid billing. He has additional experience with Medicare and Medicaid pharmacy issues, including 340B drug pricing, telehealth and telemedicine, State and Federal site surveys, Department of Health and licensure issues, and Federally Qualified Health Centers.

Mr. Shirley specializes in Medicare and Medicaid fraud and abuse laws, including establishing arrangements that comply with the Anti-Kickback Statute and Stark Law. He has assisted clients facing qui-tam lawsuits, government sanctions, or with government investigations or self-reporting noncompliance. He has extensive experience assisting clients with implementing policies for and complying with Corporate Integrity Agreements.

Professional Associations

• Member, Indiana Pharmacy Association

Seminars & Presentations

• Presenter, "Navigating the Uncertainty: The Future of 340B in a Shifting Landscape," Indiana Rural Health Association Annual Conference, June 10, 2025
• Presenter, "The 340B Drug Pricing Playbook," Krieg DeVault Podcast Series, May 1, 2025
• Co-Presenter, "Emerging Issues in Compliance and Risk Management," Indiana Society of Medical Assistants Workshop, November 16, 2024
• Co-Presenter, "Rural Health Care: Payor Issues and Reimbursement", Indiana Rural Health Association Annual Rural Health Conference, June 11, 2024
• Presenter, "OIG's Compliance Guidance", Meritas Law Firms Worldwide Health Care Committee's Open Mic, 2024 
• Presenter, "Office of Inspector General (OIG) Compliance Guidance", Indiana Rural Health Association Spring Summit, March 5, 2024
• Co-Presenter, “End of the Public Health Emergency: A Federal and State Regulatory Overview for Physicians”, Indiana State Medical Association, May 25, 2023
• Co-Presenter, "Understanding Regulations to Guide Effective Strategy", Indiana Rural Health Association Spring Rural Summit, April 11, 2023
• Presenter, "2023 Congressional Outlook", Healthcare Financial Management Association, February 16, 2023
• Presenter, "Medicare Overpayment Proposed Rule", Indiana Statewide Rural Hospital Network CFO Roundtable, February 9, 2023
• Presenter, "CMS's Proposed Government Overpayment Rule Is Sure to Make You Sleep Less", Krieg DeVault Podcast Series, February 8, 2023
• Co-Presenter, "Indiana Abortion Law Post Dobbs and Senate Enrolled Act 1 - What Physicians Need to Know", Indiana State Medical Association, September 14, 2022
• Presenter, "Indiana Licensing Q&A", American Massage Therapy Association ," September 12, 2022
• Co-Presenter, "New Options: Rural Emergency Hospitals and Critical Access Hospitals", Indiana Rural Health Association," September 8, 2022
• Presenter, "No Surprises Act", Meritas Law Firms Worldwide Health Care Practice Group, August 11, 2022
• Co-Presenter, "Take the Surprise Out of Surprise Billing Laws - Part 3/Dispute Processes and Procedures",  Indiana Medical Group Management Association, July 20, 2022
• Co-Presenter, "Take the Surprise Out of Surprise Billing Laws - Part 2/Good Faith Estimates", Indiana Medical Group Management Association, June 8, 2022
• Co-Presenter, "Take the Surprise Out of Surprise Billing Laws - Part 1/Surprise/Balance Billing", Indiana Medical Group Management Association, June 2, 2022
• Presenter, "Key Considerations for Pharmacy Compliance: An Overview of Recent State and Federal Cases", Indiana Pharmacists Association, March 4, 2022 
• Presenter, "Surprise Billing: Patient Protection Etched into Law Webinar, Indiana State Medical Association", December 17, 2021
• Presenter, "Into the Unknown: A look Into the Uncertain Future of New Surprise Billing Laws", Krieg DeVault Podcast Series, August 21, 2021
• Co-Presenter, "Take the Surprise Out of Surprise Billing Laws", Indiana Medical Group Management Association, 2021
• Co-Presenter, "No Surprises - Understanding and Complying with New Medical Price Transparency Laws," IndyBar Association, 2021
• Co-Presenter, "Indiana Surprise Medical Billing: What You Need to Know About HB 1004," Indiana Primary Health care Association, 2020
• Co-Presenter, "Don't Be Surprised By Surprise Billing: What You Need to Know About HB 1004," Krieg DeVault, 2020
• Co-Presenter, Telemedicine: The New Frontier During COVID-19, Indiana State Medical Association 2020

Publications

• Author, "Clearing the Path to Care: OIG Continues to Approve Modest Patient Incentives to Accessing Health Care Services," April 22, 2025
• Co-Author, "OIG Signals Potential Approval of Prescription Drug Assistance Programs," February 12, 2025
• Contributor, "Pharma Industry Ramps Up Legal Fight of State Drug Discount Laws", Bloomberg Law, August 7, 2024
• Co-Author, "Federal Court of Appeals Lifts Stay of Indiana’s Prohibition on Gender Transition Services to Minors", March 19, 2024
• Co-Author, "CMS's New Federal Prior Authorization Rule: An Eventual Step In the Right Direction", February 13, 2024
• Author, "Indiana Unlikely to Deliver 340B a Reprieve from 340B Restrictions", February 13, 2024
• Co-Author, "The OIG’s New Unified Compliance Resource Tool: You’ve Been “Voluntold” to Comply", November 29, 2023
• Co-Author, "A Time to Change", October 3, 2023
• Co-Author, "SURPRISE! Federal Alternative Dispute Resolution Grinds to a Halt", August 16, 2023 
• Co-Author, "Don’t Let the End of the Public Health Emergency Create a Compliance Problem", May 19, 2023
• Co-Author, "CMS Runs Out of Patience: Hospital Price Transparency Rules to Face Stricter Enforcement", May 9, 2023
• Co-Author, "CMS’s Proposed Government Overpayment Rule Sure to Make You Sleep Less", January 18, 2023
• Co-Author, "Are You Compliant with Indiana’s Annual Hospital Public Forum Requirement?", January 6, 2023
• Co-Author, "It’s Time to Come to Terms with New Surprise Billing Laws", February 1, 2022
• Co-Author, "Had Enough Compliance Challenges? Don’t Forget About the Stark Law’s Group Practice Compensation Changes Effective January 1, 2022", January 6, 2022
• Co-Author, "The Long, Winding Road of Indiana’s Electronic Prescribing Mandate", December 27, 2021
• Co-Author, "Should Co-Located Hospitals Hate Those Blurred Lines?" November 30, 2021
• Co-Author, "CMS Takes Another “Shot” at COVID Vaccination Transparency in Nursing Facilities", September 22, 2021
• Co-Author, "Hurry Up and Wait: Feds Delay Enforcement of Medical Billing Transparency Requirements", September 7, 2021
• Co-Author, "Don't Let Expiration of Emergency COVID Waivers Leave You With Unlicensed Members of the Care Team", August 11, 2021
• Author, "Don’t Be Caught by Surprise! Prepare for New Medical Surprise Billing Laws Effective January 1, 2022", July 15, 2021
• Co-Author, "Between a Rock and a Hard Place – 340B Covered Entities Sidelined as Battle Over Drug Pricing Continues", April 20, 2021
• Co-Author, "Why Are You Really Here? Government Increasingly Skeptical of Paid Physician Speaking Engagements", March 12, 2021
• Co-Author, "Will Legislatures Put Telehealth on Hold in 2021?" January 14, 2021
• Co-Author, "Don't Lose Focus on Your Compliance with Important COVID-19 Requirements," November 16, 2020
• Co-Author, "Indiana Improves Telemedicine Reimbursement During COVID Emergency," October 19, 2020
• Co-Author, "Check Before You Repay: CMS Contractors' Overpayment Extrapolation Methods Questioned," September 2, 2020
• Co-Author, "Don't Be Surprised by Indiana's New Surprise Billing Requirements Effective July 1, 2020," July 14, 2020
• Co-Author, "Protect Yourself from Anti-Kickback Statute Liability When Donating PPE," May 18, 2020
• Co-Author, "CMS Publishes New Medicare Changes to Address the COVID-19 Pandemic," May 3, 2020
• Co-Author, "CMS Announces Recommendations for Reopening Facilities to Provide Non-Emergent Health Care," April 19, 2020
• Co-Author, "Governor Holcomb Issues Additional Licensure Waivers to Increase Health Providers Available to Address COVID-19," April 9, 2020
• Co-Author, "Governor Holcomb Waives More Indiana Health Care Laws in Executive Order 20-13 to Address COVID-19," March 30, 2020
• Co-Author, "CMS Expands and Makes Advance Medicare Payments More Available to Address Cash Flow Affected by COVID-19," March 29, 2020
• Co-Author, "Indiana Medicaid Covers Telemedicine Services in COVID-19 Response," March 19, 2020
• Co-Author, "OCR Temporarily Lessens HIPAA Requirements for Telecommunications in Wake of COVID-19," March 17, 2020
• Co-Author, "CMS and OIG Temporarily Clear Regulatory Obstacles to Expand Telehealth Coverage to Address COVID-19," March 17, 2020

Education

• J.D., Dean's List, Indiana University Robert H. McKinney School of Law, Indianapolis, Indiana, 2010
  
  • Vice President, J. Ruben Clark Law Society
  • Participant, Trial Practice Course
  • Participant Staton Intramural Moot Court Competition
• B.A. in English, magna cum laude, University of Utah, Salt Lake City, Utah, 2007

Bar & Court Admissions

• Indiana, 2010
• U.S. District Court for the Northern District of Indiana
• U.S. District Court Southern District of Indiana

Practices

• Health Care Litigation
• Pharmacy Law
• Long-Term Care Providers
• Health Care Reimbursement
• In-House Counsel Services
• Telehealth and Telemedicine
• Medicaid Strategy and Health Policy
• Hospitals and Health Systems
• Professional Licensing
• Licensure, Accreditation, and Certification
• Stark Act Compliance

Industries

• Health Care