Health & Life Sciences

Specialty Pharmacy

Quarles & Brady has been representing pharmacies for decades and understands that specialty pharmacy is unique. We provide real-world legal advice on issues ranging from REMS to accreditation, the Federal Anti-Kickback Statute (AKS) to adherence programs, licensing to 340B issues, and HUBs to data use agreements. Our team of specialty pharmacy attorneys includes a former pharmacy technician, a former nurse, and five attorneys who started their professional careers as pharmacists, one of whom was the owner of an independent pharmacy. We have cultivated meaningful relationships with regulators and are actively involved in industry organizations. In addition to specialty pharmacies, we also represent payors, prescribers, manufacturers, and pharmacists. The team's ability to combine multiple industry perspectives with legal experience enables us to provide exceptional strategic counsel and help clients achieve their long-term objectives.

Our list of “high touch” legal services includes:

Contract Drafting and Negotiation

  • Drafting and negotiation of pharmacy services agreements with manufacturers, other pharmacies, and payors.
  • Providing strategic advice on regulatory issues related to agreements.

Fraud and Abuse

  • Advising on compliance with federal and state laws including issues specific to rebates, coupons, PAP programs, AKS safe harbors, formularies, usual and customary price, and “switching programs.”
  • Providing assistance during investigations.

Corporate Transactions

  • Advising on strategic acquisition and divestiture transactions and related due diligence.
  • Advising on general corporate matters, including business planning and formation of business entities.

Licensing

  • Advising on license and reporting requirements for pharmacies, telepharmacies, pharmacist-administered vaccinations and screening tests, and pharmacy wellness centers, including clinics within pharmacies.
  • Responding to individual state board queries, representing clients in administrative proceedings and advising on reporting requirements before state health care licensing and regulatory entities.

Data Privacy and Security

  • Advising on HIPAA and state privacy laws issues, including determining whether there has been a privacy or security breach and the related reporting requirements, uses of de-identified data, the refill reminder exception, and contracting required of covered entities and business associates.
  • Providing guidance during investigations and inquiries from regulators.
  • Developing policies, procedures, and processes to mitigate risks and enhance compliance.

Billing and Coding Practices

  • Developing guidelines for avoiding unintentional mis-billing and over-utilization of pharmacy services and products.
  • Advising on appropriate billing of prescription medications, including auditing of pharmacies, developing internal audit procedures, corporate compliance guidelines and compliance education.
  • Assisting obtain reimbursement from governmental and third-party payors.

DEA

  • Advising on all aspects of compliance with the CSA and DEA regulations, including registration, recordkeeping, reporting, and proper handling of controlled substances and listed chemicals.
  • Developing Standard Operating Procedures involving controlled substances and listed chemicals.
  • Representing clients in administrative or other enforcement proceedings before the DEA.