Legal Compliance For Retail, Compound, Specialty, And 340B Pharmacies

Legal and organizational structures may differ for each pharmacy type depending on services offered, drugs provided, pricing arrangements, physician-pharmacy relationships, and operational characteristics. Our team has many years of experience successfully guiding organizations through all stages of pharmacy start-up and management.

Managing Legal Issues Connected With Buying Or Selling Licensed Pharmacies Or Acquiring or Transferring Licenses

Buying and selling pharmacies or acquiring or transferring pharmacy licenses is carefully controlled by federal, state, and local regulations. While every transaction is unique, Haque Law works with each client to validate the terms of all contracts, examine the organization’s P&L and Federal Tax statements, confirm business transactions, and advise our clients on related legal matters. We excel in assisting clients who acquire or divest operating or dormant pharmacies, transfer or acquire new required licenses, or need an appropriate legal organizational structure (LLC, corporation, etc.)

Defending Pharmacies Against PBM Audits

A PBM audit (Payment Benefits Manager audit) can be both time consuming and costly. These audits test a pharmacy’s claims payment processes and pricing accuracy seeking reductions in costing and reimbursements. To preserve the integrity of a pharmacy’s pricing structure, any organization subject to an audit should have an ally in its corner to ensure audit procedures and outcomes are favorable. Our team has extensive experience defending pharmacies against aggressive and intrusive outside audits.  Get in touch, if you are facing a PBM audit.

Negotiating Contracts With Federal (Medicare and Medicaid) As Well As Non-Federal PBM Payers

The contract negotiated with federal (Medicare and Medicaid) and non-federal PBM payers establishes a pricing and reimbursement structure for your organization. These contracts include MAC pricing (Maximum Allowable Costs), which fixes your pricing and reimbursement schedules.  These arrangements can be a make or break component in your agreements and could dramatically impact your P&L. Our team is skilled in negotiating these and other agreements as well as challenging unfavorable MAC pricing plans.

Often large PBMs will attempt to intimidate or bully individual pharmacies into agreeing to contract concessions.  We will be there to represent and defend you against any inappropriate PBM’s ‘strong arm’ tactics. 

Laws Regulating And Controlling Physician- And Clinic-Owned Pharmacies Are Complicated and Organization-Specific

These arrangements require in-depth legal experience and knowledge, the kind of expertise available to you at Haque Law.   Regulatory compliance involving double disclosures, Stark and anti-kickback laws, and patient notices are components of properly establishing this type of pharmacy. Give Haque Law a call to discuss how we can educate you and your associates on the essential steps needed to ensure your organization satisfies all legal requirements. With the help of Haque Law, you can be confident of regulatory compliance while at the same time ensuring the delivery of the highest possible levels of patient care.

Private Equity Investments And Management Services Organization (MSO) Contract Creation And Review

While some states restrict physician investment in pharmacies, Texas allows such investment so long as the arrangement conforms to Texas Patient Non-Solicitation Law exceptions as enumerated in Texas Occupations Code Ann., Section 102.003. Haque Law is skilled in creating, reviewing, and revising physician pharmacy ownership and investment contracts to ensure compliance with all applicable Texas and Federal laws. We are available to evaluate any arrangement you may be considering and provide guidance concerning regulatory compliance.

Department of Labor’s Exclusion List 

Under certain circumstances, companies may be disbarred (placed on an exclusions list) from participating in various government contracts, subcontracts, or financial benefits programs, including participation in Medicare, Medicaid, or other plans.  These DOL actions can result in significant financial burdens and operational restrictions. Haque Law attorneys have worked with clients to assist in their removal from the Department of Labor’s exclusion list. We aim to help our clients manage the regulatory landscape to achieve positive outcomes.

White-Collar Criminal Defense and Government Investigations (OIG/FBI)

Haque Law attorneys are available to defend clients against any investigations or legal proceedings carried out by any regulatory or judicial authority. Cases we accept include accusations of organized crime, healthcare, and insurance fraud, embezzlement, racketeering, and other white-collar wrongdoings.

Pain Management Pharmacy Defense And DEA Related Concerns

Based on the circumstances, we strategically partner with carefully selected defense attorneys to assist clients accused of crimes related to illegally dispensing controlled substances.  Similarly, we may also join forces with appropriate defense attorneys to defend individuals and organizations accused of similar offenses connected with pain management clinics. Contact our office for consultation and guidance on how we can help.

Outsourcing Facilities (503B) Sterile And Non-Sterile Manufacturing And Wholesale Licensing

Entities wishing to do business as a compounder of sterile drugs must register with the FDA under section 503B of The Food Quality and Securities Act.  Non-sterile manufacturing includes compounding of items such as lotions, creams, and powders.  Although not necessarily FDA approved, these items must be manufactured using good, ethical manufacturing practices. Further, compounding facilities must be licensed under various categories, such as manufacturer, pharmacy wholesaler, importer/exporter, or re-packagers. Our team has worked with individuals and organizations to secure proper licensing for these and other types of production facilities