Pharmacy

Specialty pharmacy growth transactions can offer tremendous value opportunity but require experienced legal advisors to evaluate how a platform operates and where its business model may be exposed. Shifts in purchasing structures and reimbursement changes can weaken expected returns, while restricted access to therapies may limit the platform’s reach. We help specialty pharmacies, investors, health systems, and strategic partners identify these issues early so they can protect value while supporting growth and scalability.

Our multidisciplinary team examines pharmacy service structures, purchasing and reimbursement models, and commercial relationships to test the assumptions behind an investment or growth strategy. We also advise hospitals and health systems on specialty pharmacy and 340B strategies that support patient access and institutional goals while strengthening their financial capabilities. For investors, that analysis can also help identify specialty pharmacy opportunities across an existing portfolio.

As platforms enter new markets or add services, we help build the infrastructure needed to scale, addressing licensure; staffing; audit readiness; contracting; and requirements involving the Drug Supply Chain Security Act, the US Drug Enforcement Administration (DEA), Risk Evaluation and Mitigation Strategies, and 340B. By connecting these considerations to the transaction and operating plan, we help clients anticipate obstacles, execute effectively, and protect long-term value.

Covered entities and the vendors that support them are making consequential 340B program decisions amid heightened scrutiny and continued uncertainty. Manufacturer and government claims data reporting requirements, along with rebate models and ongoing litigation, are reshaping longstanding 340B operational and optimization strategies. We help clients cut through that uncertainty, protect their 340B programs, and pursue opportunities that support the statutory intent of the 340B program – stretching scarce resources to provide more care to more patients.

We advise hospitals, health systems, academic medical centers, federally qualified health centers, and stakeholders across the 340B life cycle. Our team helps clients obtain and preserve eligibility, strengthen and defend existing programs, and evaluate new opportunities to responsibly grow 340B programs. We also have deep experience supporting our 340B clients through federal and state investigations and audits, including US Department of Justice and state attorney general matters.

Because 340B issues rarely stand alone, we bring together experience in federal and state fraud and abuse laws, billing, Medicare and Medicaid cost reporting and billing, state licensure, and other requirements that can affect compliance and strategy. This integrated approach helps clients protect program integrity while building durable and defensible models aligned with patient access and operational and financial goals.

Retail pharmacies are doing more than filling prescriptions. Pharmacists are taking on a bigger role in patient care, and investment and consolidation are pushing retailers into new states. To make the most of these opportunities, retailers and investors need business and care models that work within the rules governing pharmacy operations.

We help clients test their growth plans before they commit. We look at how licensing, ownership, change-of-ownership, and other regulatory requirements could affect a deal’s timing, execution, and economics. As a business grows across states and service lines, small compliance issues can quickly become big ones. We advise on dispensing policies and controlled-substance protocols, and we help clients respond to boards of pharmacy, the DEA, and other regulators.

As retailers add clinical and virtual care, we help them structure their relationships with providers, health plans, and pharmaceutical manufacturers. By addressing these issues early, we help retail pharmacy clients grow their footprint, build stronger partnerships, and find new sources of revenue.

Evolving US Food and Drug Administration (FDA) interpretation and enforcement of the 503A and 503B frameworks can quickly change the risk profile of a compounding operation. We help compounding pharmacies, healthcare providers, telehealth platforms, prescribers, marketers, and investors understand how changes in formulation, production, distribution, or growth may affect compliance, enterprise value, and the ability to scale.

Our team assesses operations against requirements for 503A pharmacies and 503B outsourcing facilities, including United States Pharmacopeia and current good manufacturing practice standards, FDA regulations, and guidance as they relate to “essentially copies” and anticipatory compounding, prescriber determinations, and combination formulations. We also review labeling, advertising, and promotional claims on drug containers, websites, and marketing collateral and advise on pharmacy services agreements and other commercial arrangements that shape how compounded products reach patients.

When drug shortages or demand for products such as compounded glucagon-like peptide-1 (GLP-1) medications create new opportunities, we help clients understand FDA parameters and enforcement trends before making investment or expansion decisions. Whether evaluating an acquisition or scaling operations, we develop practical compliance strategies that support informed investment and sustainable growth.

Digital pharmacy models are reshaping how patients access prescription therapies, but a seamless consumer experience can mask a complex legal structure. We help digital health companies, pharmacy operators, provider platforms, and investors align the clinical, operational, and commercial components of their models so they can scale with confidence.

Our team traces the patient journey from engagement through prescribing, including electronic prescribing and dispensing, identifying where state licensure, telehealth, controlled-substance, corporate practice, fee-splitting, and fraud and abuse requirements may affect execution. Our experience includes programs across the United States that combine virtual care, GLP-1 therapies, patient support, and compounded and branded medications within a single offering.

We also address the privacy, data-sharing, and technology considerations behind these platforms, including the growing use of artificial intelligence in pharmacy workflows. By bringing these issues together, we help clients anticipate regulatory friction, withstand scrutiny, and build digital pharmacy models positioned for sustained growth.

Infusion providers are navigating pressure from Medicare drug-price negotiation, site-of-care shifts and corresponding billing and operational complexities, a changing reimbursement landscape, and new drug acquisition models. We help investors and operators understand how these shifts affect where and how care is delivered, how drugs are acquired and reimbursed, transaction economics, and strategies for protecting patient access and service-line viability.

Across the Part B and Part D infusion ecosystem, we help clients understand how reimbursement, drug acquisition, licensing, and change-of-ownership requirements can affect deal value and execution. We also structure physician joint ventures; medical directorships; and other arrangements involving Stark Law, Anti-Kickback Statute, and related requirements to ensure ongoing compliance.

As businesses expand into ambulatory and home infusion, we help clients develop and implement the compliance infrastructure needed to support expansion, including with respect to licensure, revenue cycle management controls, controlled-substance compliance, and 340B considerations. Whether acquiring a platform or expanding an existing service line, we help clients anticipate risk, protect patient access, and build for sustainable growth.