During the past year, the 340B drug discount program has received unprecedented attention and experienced significant changes. More changes are expected as scrutiny of the program by Congress, regulators and the national media continues. The Health Resources and Services Administration (HRSA) has begun a second round of covered entity audits, with at least 30 already underway and more expected in 2013. While pharmaceutical manufacturer groups, private oncologists and other industry groups have been working more closely together to raise questions about the program and its intent, 340B providers and their allies have been urging the government to step up its oversight of how pharmaceutical manufacturers are complying with the program.
All of this attention means that 340B program stakeholders need to remain well-informed of the many new developments in this rapidly evolving program. In the year ahead, HRSA will continue and expand its program-wide recertification of covered entities' 340B eligibility and compliance. The agency is also expected to finalize its orphan drug policy and to propose formal regulations on other key program issues such as patient definition, Medicaid billing and contract pharmacies. Meanwhile, disproportionate share, children’s and cancer hospitals are struggling to implement new HRSA guidance on the use of group purchasing organizations which is requiring many of them to overhaul how they purchase and manage their drug inventories. And more manufacturers are expected to submit plans to OPA to audit covered entities for compliance.
These operational and compliance challenges come at a time when the broader purpose and merits of the program are being examined by both policy makers and stakeholders. For instance, the growth in contract pharmacy arrangements has helped improve access and patient adherence to drug regimens but has also raised concerns about program growth and intent. There is also continued debate within the independent pharmacy community about the 340B program, with many community pharmacists expressing their support for the program but others raising concerns about unfair competition. For these reasons, Congressional scrutiny of both HRSA’s oversight efforts and covered entities’ use of the program will continue.
The conference will address these and other program developments and challenges. Conference highlights will include sessions devoted to examining the 20-year history of 340B, exploring the current landscape of the program, and discussing 340B’s future in light of anticipated changes under health care reform. Sessions also will address government and manufacturer audits, the future of multiple contract pharmacies, Medicaid billing and reimbursement policies, inventory management, and annual recertification and registration. The conference will feature several sessions focused on clinical best practices, including how the 340B program has helped to improve patient outcomes and ways that covered entities can use their savings to improve patient’s lives.
Whether you work for a covered entity, pharmacy, pharmaceutical manufacturer, 340B-oriented business, or government agency, there is no better way to stay informed and have a voice in the future of the program than to attend the conference. You will learn from all of the key players involved in the program, including health care providers, industry representatives, government regulators, federal contractors, and representatives from 340B advocacy organizations.
In addition to the emphasis on policy matters, the conference will provide you with many opportunities for hands-on, practical advice to help with program implementation. If you are a health care provider, you will learn how to enhance compliance, improve care, and meet your indigent patients’ needs. If you work for a pharmaceutical company or other pharmacy-related business, you will learn how to prepare for and respond to the heightened focus on compliance and accountability. You will also have an opportunity to network directly with current and prospective customers. Small breakout sessions will provide attendees with an opportunity to solicit advice and to share ideas with others.
The conference will also offer two pre-conference workshops, (1) on making a 340B compliance plan work, including using self-audits to enhance 340B compliance and accountability, and (2) on the basics of creating and maintaining a 340B contract pharmacy arrangement that meets the needs of vulnerable patient populations and follows HRSA’s detailed compliance guidelines. Click here to view the agenda.
We look forward to seeing you in July!