340B Audit Results
HRSA’s recent 340B program update includes a report on its final results from 51 compliance audits conducted of covered entities, which included a review of 410 covered entity sites.2 The audits were conducted randomly, with a focus on covered entities that posed a higher risk of non-compliance based on several factors, including program type, volume of 340B purchases, complexity of program administration, and use of contract pharmacies, as well as on a targeted basis, such as through responses to specific complaints, self-reports, or whistleblowers. Examples of violations include findings of the diversion of 340B drugs to ineligible patients, inaccurate records in the 340B program database, and the claiming of duplicate discounts.
The final audit findings range from minor problems with covered entities’ 340B database entries, where no sanction was imposed and the corrective action required was simply a database correction. Other audit findings included violations of 340B program requirements, such as the diversion of 340B drugs to non-patients, and resulted in covered entities working with HRSA to develop a corrective action plan to ensure ongoing compliance, as well as sanctions listed by HRSA as repayment to drug manufacturers. HRSA’s report indicates that manufacturers may contact audited entities regarding the listed sanctions once HRSA has approved the entity’s corrective action plan and posted it on the HRSA website.
Forthcoming 340B Actions and Guidance
On January 8, 2014, HRSA provided an update on its upcoming recertification activities for certain covered entities.3 Recertification for Tribal and Urban Indian entities, HRSA grantees, and CDC STD/TB grantees will begin in early February 2014. These entities will need to recertify their compliance with 340B program requirements at this time.
HRSA’s 340B program update also provides notice that HRSA is in the process of drafting regulations that will formalize its existing program guidance. HRSA indicates that the regulations will address the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility criteria, and eligibility of off-site facilities. The proposed regulations are expected to be released for public comment by June 2014.
Additionally, last year the Office of the Inspector General (OIG) within the Department of Health and Human Services (DHHS) undertook a study of 340B contract pharmacy programs. The study was initiated at congressional request and will describe covered entities’ arrangements and their oversight of those arrangements to ensure compliance with 340B program compliance. The OIG report is expected in the near future and may have implications for how HRSA addresses contract pharmacies in its impending regulations.
결론
The recent HRSA update reflects continued intense scrutiny on program integrity issues related to the 340B program. 340B Covered Entities and manufacturers should carefully monitor their participation in the 340B program to ensure compliance with all program requirements, and should carefully track the anticipated guidance from HRSA, which, when finalized, may materially modify those requirements in ways that affect the availability of 340B program drugs.
1 http://www.hrsa.gov/opa/update.html
2 http://www.hrsa.gov/opa/programintegrity/auditresults/results.html
법률 뉴스 알림은 고객과 동료들에게 영향을 미치는 시급한 문제나 업계 동향에 관한 최신 정보를 지속적으로 제공하기 위한 당사의 노력의 일환입니다. 본 알림에 대한 문의사항이 있거나 해당 주제에 대해 추가 논의가 필요하신 경우, 담당 폴리 변호사 또는 아래 연락처로 문의해 주시기 바랍니다:
Elizabeth S. Elson
Los Angeles, California
213.972.4665
[email protected]
Anil Shankar
Los Angeles, California
213.972.4584
[email protected]
