The 340B Drug Pricing Program has become increasingly critical to the ability of our many of our hospital and health system clients to fulfill their missions of providing care to vulnerable patients. Yet, the relative lack of formal agency rules, ever-evolving subregulatory guidance including through feedback during audits, and scrutiny from stakeholders create operational and compliance issues for 340B covered entities. The persistent challenge of high and rising drug costs also keeps the 340B program in the spotlight.
Eyman Associates has unique expertise in assisting clients with issues related to the 340B program. We are integrally involved in federal and state legislative and regulatory policy developments and advise clients on technical compliance with the frequently shifting 340B rules. We leverage our deep involvement in 340B policymaking to advise individual clients in understanding and complying with the complex and ever-evolving rules of 340B, including permissible use of discounted drugs for different patient populations, avoiding Medicaid duplicate discounts, and hospital eligibility issues. We draft and assess 340B policies and procedures, assist with 340B audits and any related corrective actions, and advise clients regarding the impact of changes in service delivery on 340B program participation and compliance. Most recently, we have also been advisors in litigation to protect the program.
The federal District Court of the District of Columbia ruled that OPA’s authority to issue regulations implementing the 340B program is limited to the following areas where the court said the 340B statute gives the agency explicit regulatory authority – civil monetary penalties for manufactures, calculation of the 340B ceiling price, and administrative dispute resolution. These decisions influence the scope of the nature of OPA’s governance of the program, and the
For full program guidance, see the HRSA OPA and Apexus websites
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