Pharmacy and Pharmaceutical Law
Overview
Krieg DeVault’s pharmacy law team is uniquely qualified to provide insightful, results-oriented solutions to the challenges facing pharmacy providers in this complex and highly regulated industry. Its members are nationally-recognized experts in pharmacy law, with experience in the issues that impact operations in the pharmaceutical space, including regulatory, transactional, professional negligence, litigation, and licensing matters.
Our pharmacy law team represents the entire spectrum of pharmacy types and stakeholders, including:
- Chain and independent retail pharmacies
- Hospital (inpatient/outpatient) pharmacies
- Hospital-owned retail pharmacies
- Internet and mail order pharmacies
- Specialty compounding pharmacies/manufacturers
- Central fill and remote processing pharmacies
- Telepharmacy operations
- Wholesale drug distributors
- Health care technology companies
- Individual pharmacists
Krieg DeVault’s pharmacy law team lends practical yet sophisticated experience to our pharmacy clients on a range of matters:
- Advising on COVID-19 issues, including the Public Readiness and Emergency Preparedness Act (PREP Act)
- Corporate integrity agreement implementation and compliance
- Representation before regulatory agencies, including state departments of health, Medicaid agencies, Centers for Medicare & Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and the U.S. Drug Enforcement Administration (DEA)
- 340B Drug Pricing Program participation and compliance
- Advising clients on restructuring, mergers, dispositions, and acquisitions of pharmacies
- Representing clients before state pharmacy and medical boards on licensing, compliance, and disciplinary matters
- Navigating state and federal pharmacy licensure and controlled substance registration requirements
- Developing regulatory compliance plans and auditing pharmacies to monitor ongoing compliance
- Assisting pharmacy providers with third-party claims and reimbursement issues
- Advising and supporting pharmacy providers with government audits
- Representing pharmacy providers with claim denials and reimbursement appeals
- Compliance with Medicaid and Medicare enrollment, billing, and provider participation requirements
- Governmental affairs representation of pharmaceutical companies, including lobbying, state procurement, and regulatory matters
- Working with clients to obtain regulatory approval with governmental agencies for new pharmacy processes
- Advising on third-party insurance coverage and eligibility requirements
- Advising physician groups and other providers on in-office pharmaceutical dispensing issues
Krieg DeVault’s pharmacy law team is uniquely qualified to provide insightful, results-oriented solutions to the challenges facing pharmacy providers in this complex and highly regulated industry. Its members are nationally-recognized experts in pharmacy law, with experience in the issues that impact operations in the pharmaceutical space, including regulatory, transactional, professional negligence, litigation, and licensing matters.
Our pharmacy law team represents the entire spectrum of pharmacy types and stakeholders, including:
- Chain and independent retail pharmacies
- Hospital (inpatient/outpatient) pharmacies
- Hospital-owned retail pharmacies
- Internet and mail order pharmacies
- Specialty compounding pharmacies/manufacturers
- Central fill and remote processing pharmacies
- Telepharmacy operations
- Wholesale drug distributors
- Health care technology companies
- Individual pharmacists
Krieg DeVault’s pharmacy law team lends practical yet sophisticated experience to our pharmacy clients on a range of matters:
- Advising on COVID-19 issues, including the Public Readiness and Emergency Preparedness Act (PREP Act)
- Corporate integrity agreement implementation and compliance
- Representation before regulatory agencies, including state departments of health, Medicaid agencies, Centers for Medicare & Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and the U.S. Drug Enforcement Administration (DEA)
- 340B Drug Pricing Program participation and compliance
- Advising clients on restructuring, mergers, dispositions, and acquisitions of pharmacies
- Representing clients before state pharmacy and medical boards on licensing, compliance, and disciplinary matters
- Navigating state and federal pharmacy licensure and controlled substance registration requirements
- Developing regulatory compliance plans and auditing pharmacies to monitor ongoing compliance
- Assisting pharmacy providers with third-party claims and reimbursement issues
- Advising and supporting pharmacy providers with government audits
- Representing pharmacy providers with claim denials and reimbursement appeals
- Compliance with Medicaid and Medicare enrollment, billing, and provider participation requirements
- Governmental affairs representation of pharmaceutical companies, including lobbying, state procurement, and regulatory matters
- Working with clients to obtain regulatory approval with governmental agencies for new pharmacy processes
- Advising on third-party insurance coverage and eligibility requirements
- Advising physician groups and other providers on in-office pharmaceutical dispensing issues
