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Health Care and FDA: 340B Program and Pharmacy

Our health care and FDA practice brings a comprehensive understanding of pharmacy supply chain, operations, and reimbursement that is leveraged alongside years of experience representing multiple players in the pharmaceutical manufacturing, distribution, and dispensing process. We apply in-depth knowledge of unique pharmacy issues to the overall organization and deliver practical pharmacy operational, reimbursement, and compliance advice. 

By taking a holistic approach and examining areas such as our clients’ business structures, current compliance policies, wholesaler and limited distribution purchasing arrangements, and pharmacy benefit manager (PBM) contracting, we identify areas of risk and opportunities to help clients strengthen their operations and financial performance.

In the 340B Program context, we apply our knowledge of unique 340B Program issues to the overall organization and deliver strategic 340B Program advice. By taking a holistic approach and examining areas such as our clients’ current 340B compliance policies, contract pharmacy arrangements, physician practice arrangements and other ambulatory practice locations, cost report filings, and wholesaler arrangements, we identify areas of risk and opportunities for improvement and help clients strengthen their operations. Our extensive knowledge of industry best practices, combined with our experience working with federal and state agencies, gives clients unique insight into agency policies and enforcement priorities to help providers anticipate and mitigate risk while ensuring they are getting the full benefit of the 340B Program.

Our capabilities include:

Compliance

We help clients address day-to-day compliance issues while taking a leading role in resolving matters with state boards of pharmacy and state-controlled substances agencies, the Drug Enforcement Administration, the Food and Drug Administration, and other state and federal agencies involved with compounding, home infusion therapy providers, and nuclear pharmacies. Our lawyers’ intimate knowledge of the complex regulatory regimes that impact pharmacies and their breadth of experience in resolving compliance matters allows them to deliver timely strategic advice to clients regarding policies and enforcement trends and adjust their internal policies and procedures accordingly.

We also represent pharmacies in billing compliance, enrollment, and credentialing matters related to Medicare, Medicaid, Tricare, Part D, and commercial payor plans, as well as in regard to governmental and commercial reimbursement audits. We bring years of experience in this area and an aggressive approach to defending pharmacies working in a complex billing environment.

Specific to the 340B Program, our lawyers serve as special ongoing 340B Program compliance counsel for many clients. In addition to assisting on routine matters, we also take a lead role during Office of Pharmacy Affairs audits, manufacturer enquiries or audits, and resolution of internal reviews and potential self-disclosures of material noncompliance with 340B Program standards.

Reimbursement and Billing Compliance

Reimbursement for 340B Program acquired drugs is the subject of significant changes in recent years. We work with covered entities to assess and respond to 340B Program reimbursement cuts under the Outpatient Prospective Payment System, state Medicaid managed care organization reimbursement changes and billing requirements, and commercial payor reimbursement cuts and modifier requirements. Compliance with these changes implicate both duplicate discount compliance and traditional billing compliance. We have extensive experience working to respond to reimbursement changes and addressing compliance issues that may arise as a result of the failure to meet these evolving billing requirements.

Pharmacy Contracting and Disputes

Wholesaler contracting for routine pharmaceutical purchasing, obtaining access to limited distribution drugs, and navigating the complex path to obtaining and maintaining in-network reimbursement through PBMs and third-party payors is essential to successful pharmacy operations. Our lawyers bring years of experience negotiating key contracts with leading industry players in the pharmacy space. In addition, we have extensive experience negotiating contract pharmacy arrangements for pharmacies involved in the 340B Program. Finally, an experienced payor litigation group provides pharmacy-specific insight to clients who need to rely on any willing pharmacy laws and other means to seek and maintain in-network enrollment and reimbursement or defend pharmacies facing commercial audits and unreasonable direct and indirect remuneration fee recoupments and offsets.

Transactions and Complex Reorganizations

We also help those acquiring and divesting pharmacies through transactions and financing vehicles. In addition to core deal negotiations, we work with pharmacies to obtain, maintain, and transfer pharmacy licenses and Medicare, Medicaid, and 340B Program enrollments. Likewise, we work with clients to assign key operational and reimbursement contracts during the course of reorganizations and acquisitions. Our lawyers’ knowledge of clients’ business structures, reimbursement, Medicare and Medicaid enrollment, and the 340B Program gives us the ability to manage these complex transactions and seamlessly execute business plans without impacting pharmacy operations and reimbursement.

We help providers maintain the 340B Program during the course of reorganizations and acquisitions. Our knowledge of hospital and other 340B-eligible entities’ business structures, reimbursement, Medicare enrollment, certification, and provider-based rules, and the 340B Program gives our lawyers the ability to manage these complex transactions and seamlessly execute business plans without impacting 340B Program eligibility.

Given our breadth of transactional, regulatory, enrollment, and 340B Program experience, we assist clients with the full transaction lifecycle, from conception to closing and beyond.

340B Program Enrollment

340B Program enrollment and annual recertification review has become a key tool in ensuring 340B Program compliance. Even the best-intentioned health care providers must carefully review the accuracy of their enrollment filings on a continuous basis to ensure that key eligibility criteria and contracts—such as qualifying contracts with state and local government and contract pharmacy agreements—are in place. Enrollment issues can also have significant implications under the 340B Program, with missed deadlines potentially leading to months of ineligibility for hospital-affiliated “child sites” and other challenges. We also regularly work with cost report consulting firms to determine compliant means to maintain and sustain 340B Program eligibility.

Public Policy

We draw upon the experience of our public policy and law practice to help clients anticipate and respond to legislators and regulators in regard to potential changes to the 340B Program. A number of publications, including Chambers USA, Legal 500, and The National Law Journal, have ranked our public policy and law group as one of the premier policy practices in the United States. Working in tandem with the firm’s lawyers, our public policy lawyers develop creative solutions to complex business and compliance issues ranging from procedural 340B Program enrollment-related matters to substantive changes in policy through legislation and regulation.

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