Over the last year, the 340B drug discount program has undergone unprecedented scrutiny by Congress, federal regulators and the pharmaceutical industry. The Health Resources and Services Administration (HRSA) has started auditing 340B covered entities to ensure that discounted drugs are not provided to ineligible patients and that manufacturers are not subjected to duplicate discounts, which occur when a manufacturer gives both a Medicaid rebate and 340B discount on the same drug. Pharmaceutical manufacturers are also preparing to launch their own audits. In addition, the agency recently began requiring annual recertification for all covered entities, a challenging process for all providers from the smallest clinics to large, complex health systems. At the same time, some influential members of Congress continue to closely examine and question the purpose, scope, and growth of the program. There are also questions by some lawmakers whether the program is contributing to drug shortages.
Both critics and supporters of the 340B program have called for more focus on how 340B can be used to benefit the vulnerable patient populations served by covered entities. Faced with numerous financial challenges and pressures, 340B providers are utilizing different approaches to serve the indigent and uninsured while also keeping their organizations financially afloat and their doors open to all patients, regardless of ability to pay.
All of this comes under the backdrop of the U.S. Supreme Court’s recent decision upholding the Affordable Care Act (ACA). In addition to upholding the ACA’s individual mandate, which requires citizens to purchase health insurance, the Court also upheld the ACA-related parts of the 340B program, such as the expansion to rural, children’s and cancer hospitals. The Court also upheld the ACA’s expansion of Medicaid but limited its reach, prohibiting the federal government from denying states all of their Medicaid funding if they decline to expand their programs. It is unclear how this limitation on the Medicaid expansion will impact the 340B community. Republican leaders, including presumptive presidential nominee Mitt Romney, have vowed to repeal the ACA. Therefore, it is also unclear whether certain elements of the ACA, such as the Medicaid and 340B expansions, would remain in place if there is a new President and Congress.
The conference will address how 340B stakeholders are responding to increased program scrutiny and meeting other 340B program challenges. Conference highlights will include sessions devoted to program integrity and audits, key considerations when developing contract pharmacy relationships, how the 340B program helps improve and expand patient care, practical steps and policy solutions to address drug shortages, and how the Supreme Court’s decision will impact health care in general and the 340B program in particular. We will also take a look at key trends in the pharmaceutical sector, including personalized medicine and growth of specialty and orphan drugs. These developments have significant implications for all parties in the 340B supply chain.
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 play a role in shaping the future of the program than to attend the conference. You will learn from all the key players involved in the program, including federal officials, contractors and representatives from 340B advocacy organizations and industry.
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 ensure 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 and respond to this heightened focus on compliance. You will also have an opportunity to network directly with current and prospective customers. There also will be opportunities to participate in small breakout sessions to get the advice you need and to share ideas with others.
The conference will also feature special pre-conference workshops providing an introduction to the 340B program and a half day focused on the nuts and bolts of contract pharmacy compliance and implementation. Click here to view the agenda.