Frier Levitt has vast experience representing all types of pharmacies throughout the country including specialty pharmacies, such as fertility pharmacies. Part of the firm’s fabric is having clinician attorneys that specifically understand the clinical nature of fertility pharmacies and how those unique clinical issues impact various statutes and contracts. Many fertility pharmacies focus exclusively on providing infertility treatment to patients which generally involves complex medication therapy regimens, dispensing medications that require special storage and handling, specialized knowledge of fertility treatments, continuous patient education, and careful monitoring for safety and/or efficacy by a healthcare professional such as a pharmacist or nurse. In representing various fertility pharmacies, Frier Levitt has gained an in-depth understanding of the various legal issues and challenges that fertility pharmacies face.
Understanding the Complexities and Opportunities for Fertility Pharmacies and Related Entities
As a law firm that focuses in areas of healthcare and life science, many of our attorneys come from a variety of backgrounds and experience, including some of whom are pharmacists. As such, our attorneys collaborate to provide our clients with the best legal guidance taking into consideration various PBM, regulatory, transactional and litigation concerns to prepare our clients to operate in a compliant manner, respond to regulatory issues, and engage in litigation avoidance.
Frier Levitt understands that fertility pharmaceuticals involve a tremendous amount of complexity and can encompass a number of factors and affect various groups, including patients, payers, manufacturers, and the fertility pharmacy itself. Additionally, the costs associated infertility treatment and associated medications can be exceptionally high and many patients without insurance coverage for infertility treatment often decide whether to seek treatment based on their ability to pay.
The world of specialty fertility pharmacy is simultaneously expensive and filled with complex distribution channels. Manufacturers are producing infertility drugs often require limited distribution networks. Additionally, fertility pharmacies and related parties often face further challenges from Pharmacy Benefits Managers (“PBM”) who do not always cover these medications and if they do provide coverage, there may be lengthy prior authorization processes requiring extensive paper work and clinical information for review before approving a drug which may ultimately exclude coverage despite valid clinical indication. Many specialty fertility pharmacy providers work diligently to gain access to limited distribution medications and service patients to the best of their ability. To address this challenge, many fertility HUB services have formed to simplify the complexity and perform as an intermediary between involved parties. Fertility pharmacies must carefully analyze and structure these agreements to comply with applicable healthcare and life sciences regulations, as well as PBM requirements. Further, several fertility pharmacies may self-identify as a specialty pharmacy but nevertheless participate in a retail pharmacy networks with their PBMs, and for such reasons, fertility pharmacies must be aware of their network status and the terms and conditions that accompany any network. That said, Frier Levitt has extensive knowledge surrounding the relationship of fertility pharmacies, clinics, biopharmaceutical companies, and other entities who are integral players providing these complex services which includes finance programs and other arrangements.
How Frier Levitt Helps Fertility Pharmacies, Fertility Manufacturers and Related Entities
Frier Levitt represents a number of different providers and stakeholders in various legal matters throughout the country including in PBM dispute, regulatory, transactional, and litigation matters. Frier Levitt has legal expertise in may related areas including challenging issues arising from unwarranted PBM scrutiny including audits and investigations, access to restricted PBM and payor networks, prior authorization issues reimbursement issues, change of ownership, state pharmacy licensing issues, PBM and regulatory compliance with State Boards of Pharmacy rules and regulations, structuring arrangements and relationships between wholesalers/manufacturers and pharmacies to maximize profitability, participation in HUB arrangements, prescriber relations and physician marketing, off-label dispensing and REMS compliance, drug sourcing and inventory maintenance practices, structuring central fill and shared-services arrangements, pharmacy transactions and related real estate, anti-kickback compliance and patient savings program, mail order practices, combatting prescription leakage and PBM prescription “trolling”— matters which can prove to be even more difficult in this highly complex space.
How Frier Levitt Can Help
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.