Pharmacists, Pharmacies, Dispensaries & Pharmacy Management Companies
The attorneys of Wachler & Associates have significant experience representing pharmacists, commercial pharmacies, physician-owned pharmacies and dispensaries, and pharmacy management companies in all healthcare regulatory matters. Our lawyers regularly represent physicians and physician groups in the development and operation of physician-owned pharmacies and physician dispensaries. We often counsel pharmacy management companies and physician groups in navigating the legal and regulatory challenges that impact healthcare providers in today’s complex regulatory environment.
Wachler & Associates represents pharmacists, commercial pharmacies, physician-owned pharmacies and dispensaries, and pharmacy management companies in matters that include:
- Development, acquisitions and sales of pharmacies
- Physician group practices and in-office ancillary service arrangements
- Stark law, Anti-Kickback Statute (AKS), and other federal Fraud & Abuse law compliance
- Compliance with state laws related to physician referrals, kickbacks, fee-splitting, the corporate practice of medicine doctrine, pharmacy and dispensing laws and other state laws impacting physician practices and their relationship with pharmacies
- Management company formation, contracting, and ongoing compliance matters
- Ownership structures, corporate governance, and employment and contractor agreements
- Pharmacy joint ventures
- Medicare Part D compliance and all Medicare reimbursement and assignment issues
- Pharmacy and pharmacy management company agreements and relationships with vendors, manufacturers, pharmaceutical companies, wholesalers, suppliers and group purchasing organizations (GPOs)
- Defense of Recovery Audit Contractor (RAC), Medicare, Medicaid & other third party payor audits and claim denials
- Pharmacy Benefit Managers (PBMs) audits, and other issues with third party administrators (TPAs) and other prescription drug programs.
- Compliance with Civil Monetary Penalty (CMP) and False Claims Act (FCA) laws
- Physician compensation arrangements
- Development of pharmacy compliance plans and governing documents
- Space, equipment and personnel lease arrangements and agreements
- Other billing & reimbursement issues
- Pharmacist licensure issues, including representation in matters with State Boards of Pharmacy and other federal and state government organizations
- Health care investigations and litigation
- Participation in and compliance with the 340B Drug Discount Program
- Health Insurance Portability and Accountability Act (HIPAA) compliance, including the implementation of privacy policies and Business Associate Agreements (BAAs)
- All other healthcare legal and regulatory compliance matters
Pharmacy Management Companies – Wachler & Associates attorneys regularly counsel pharmacy management companies across the nation with regard to their relationships with pharmacies, physician groups and the operation of physician dispensaries and physician-owned pharmacies. Our lawyers advise pharmacy management companies and their clients on permissible ownership structures, compensation and fee arrangements, compliance, required disclosures, and other state and federal laws. Our pharmacy and pharmacy management company compliance lawyers ensure that pharmacy management companies and physician-owned pharmacies comply with the federal Stark law, the Anti-Kickback Statute, CMP laws, and all state laws related to pharmacies, dispensaries, referrals, kickbacks, fee-splitting, and the corporate practice of medicine. Our representation includes drafting compliant management and lease agreements and governing documents and the implementation of compliance programs to monitor physician referral patterns and the pharmacy’s ongoing compliance with all legal and regulatory requirements.
Physician-Owned Pharmacies – Our health law attorneys assist physician groups in the creation and operation of physician-owned pharmacies. Similar to our work with pharmacy management companies, we ensure that physician group practices that seek to operate physician dispensaries or physician-owned pharmacies comply with all federal and state fraud & abuse laws, including the federal Stark law’s prohibition on physician self-referrals and the availability of the physician in-office ancillary services exception. We also counsel physician groups with regard to employment and contractor agreements, vendor contracts, space leases, equipment and personnel leases, corporate structure and organizational documents, compliance plans and programs, and other matters related to the operation of physician-owned pharmacies and dispensaries.
Pharmacy Audit Defense and other investigations – Our firm regularly represents clients in all types of Medicare, Medicaid and third party payor audits, including audits by pharmacy benefit managers and Medicare Part D contractors. We have counseled pharmacists and pharmacies in investigations related to medical necessity, referral relationships, licensure, and various types of pharmacy claims reviews.
For CMS’ Q&A for the Medicare Part D RAC Program, please click here.
For CMS’ “Pharmacist Center,” please click here.
For CMS’ Program Integrity, Pharmacy Education Toolkit, please click here.
For more information on the federal Stark law and Anti-Kickback Statute (AKS), please visit our Stark law and AKS page.
Wachler & Associates health law attorneys have written articles on a variety of issues relevant to pharmacies and pharmacy management companies. For a complete list of our health law articles, please click here.
Our attorneys also speak nationally to a variety of organizations on issues applicable to pharmacists, pharmacies, dispensaries and pharmacy management companies. For a complete list of Wachler & Associates’ health law speaking engagements, please click here.
If you or your healthcare entity seek additional information regarding our health law firm’s representation of pharmacists, pharmacies, pharmacy management companies, physician-owned pharmacies or dispensaries, and other pharmacy-related entities, or if you wish to schedule a consultation with one of our health law attorneys, please call us at (248) 544-0888 or send us an email. We look forward to discussing your healthcare legal and regulatory issues.