Drug Pricing and 340B Program
Powers Pyles Sutter & Verville has represented safety net providers and pharmacies participating in the 340B drug pricing program since the program’s inception in 1992.
The firm’s drug pricing and 340B Program practice is led by William von Oehsen, one of the primary architects of the 340B program who fought for the inclusion of safety net hospitals as covered entities eligible to access lower cost drugs. William von Oehsen and others within the practice continue to advocate for the interests of safety net hospitals, federally qualified health centers, Ryan White HIV/AIDS clinics, their pharmacies, and others.
The firm represents a diverse group of clients on 340B matters, ranging from safety net hospitals to federally-funded clinics to retail pharmacies and pharmacy-related vendors. The firm serves as counsel to the 340B Health, formerly known as the Safety Net Hospitals for Pharmaceutical Access, which William von Oehsen founded. Our hospital clients include disproportionate share hospitals, children’s hospitals, cancer hospitals, and rural hospitals. Our clinic clients include federally qualified health centers and FQHC look-alikes, Ryan White clinics, hemophilia treatment centers, family planning clinics, etc. Our pharmacy-related clients include independent and chain pharmacies, contract pharmacy administrators, pharmaceutical distributors, and related vendors.
We also provide cutting-edge guidance on the Medicaid Drug Rebate Program, Medicare Part D, and other federal drug payment and acquisition mechanisms. State and local governments look to Powers when developing programs to help individuals, especially seniors and low-income patients, access affordable drugs. Accordingly, Powers’ drug pricing client base includes a growing number of states and local government agencies that are seeking to lower drug costs for government-funded populations, such as Medicaid recipients, Medicaid expansion populations, prisoners, mental health, and other long-term care patients, and government employees. Powers is also at the forefront of developing prescription drug value-based purchasing solutions for Medicaid agencies.
The firm brings decades of experience advocating for safety net providers and their allies. We testify and advocate before state legislatures, state and federal executive branch officials and Congress. Another area of collaboration with states and local government agencies relates to numerous ongoing investigations into potential violations by industry of federal and state drug discount laws and efforts to recover overpayments from industry. We also form and lead coalitions specific to the 340B program where our team uses our legal, policy, and advocacy skills to advance our clients’ interests on Capitol Hill and within the agencies.
Finally, as a result of the firm's extensive expertise in the drug pricing area, it has found itself serving a growing number of pharmacies, both freestanding and institutional, in various legal and regulatory matters. Our pharmacy-related projects have involved analysis of federal laws such as Robinson-Patman and the Non-Profit Institutions Act, food and drug law, DEA registration, the Prescription Drug Marketing Act, Medicare/Medicaid coverage and reimbursement of pharmaceutical care and federal fraud and abuse laws such as Stark and anti-kickback. At the state level, we have advised clients on the practice of pharmacy, mail-order regulation, wholesaler registration, and related state licensure laws. We also assist our pharmacy clients with their transactional and litigation needs.
Download PDF