Drug Pricing

The US pharmaceutical market is unique in that pricing is regulated, either directly or indirectly, under a complex array of federal and state laws designed to make prescription drugs more affordable to government programs and providers, as well as to seniors and other vulnerable populations. As prescription drug prices continue to climb at double digit inflation rates, the demand for expertise in these laws has also grown. It is not surprising, therefore, that drug pricing has become one of the most active practice areas in the firm. Indeed, Powers Pyles Sutter & Verville commands one of the preeminent drug pricing practices in the nation.

The firm serves as general counsel to the Safety Net Hospitals for Pharmaceutical Access (SNHPA), formerly known as the Public Hospital Pharmacy Coalition (PHPC), which was launched more than ten years ago to help high-Medicaid public and non-profit hospitals take advantage of a federal law - section 340B of the Public Health Service Act - that requires pharmaceutical manufacturers to give drug discounts on covered outpatient drugs as a condition of the Medicaid program covering and paying for those drugs. As membership for SNHPA has grown to more than 400 hospitals, expertise on 340B matters and related drug pricing laws has deepened such that the firm has become a national leader in this area. Our attorneys were instrumental in forming the 340B Coalition, a coalition of approximately seventeen national organizations whose members collectively comprise all the entities that are eligible to participate in the 340B program. The 340B Coalition hosts two annual conferences for safety net providers, industry, wholesalers and policymakers, that, as a result of their popularity and broad attendance, now serve as major forums in which national drug pricing policy issues are addressed. The firm is responsible for organizing these annual events and delivering regular presentations on recent developments - regulatory, legislative and judicial.

The 340B program is one of five federal drug discount programs and, because one cannot truly understand federal regulation of drug pricing without an understanding of how these programs interrelate, the firm has expertise in each of these federal areas. They include the Medicaid drug rebate program, the Medicare prescription drug benefit, the federal supply schedule and the federal ceiling price program. States have also been active in helping individuals, especially seniors and low-income patients, access affordable drugs, and many of these efforts build upon the federal programs. Accordingly, PPSV's drug pricing client base includes a growing number of states that are seeking to lower drug costs for state-funded populations, such as Medicaid recipients, Medicaid expansion populations, prisoners, mental health and other long term care patients, and state employees. We regularly testify before state legislatures, executive branch officials and Congress. Another area of collaboration with states relates to numerous ongoing investigations into potential violations by industry of federal and state drug discount laws and efforts to recover overpayments from industry.

Finally, as a result of the firms' extensive expertise in the FDA and drug pricing areas, 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, 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.