340b compliance

Address compliance with HRSA’s duplicate discount prohibition at the covered entity and off-site outpatient facilities for physician administered medications when billing multiple state Medicaid agencies. 650 0 obj <>stream Cloud Hospital, a 489 bed regional medical center. are being released at an unprecedented rate and appear to be a main source for that they need additional authority in order to make any changes to the 340B In In particular, States can require MCOs to exclude 340B drugs from data sent to the state. endstream endobj 614 0 obj <. since 2010? HRSA expects periodic progress reports, as specified, and a final report at the end of the 6 months. HRSA expects CE to review and update written 340B Program policies and procedures for the prevention of duplicate discounts on covered outpatient drugs reimbursed through Medicaid managed care organizations (MCOs). 340B Compliance & Audit. No federal requirements exist for covered entities around the prevention of duplicate discounts for 340B MCO drugs. h�bbd``b`z $g�X+��{�:�`��v b��"�AJ@���\ u��@�# HXf2012}�iC��_� � |U 5 waste), crosswalking of the cost report to child sites (a.k.a., Environment However, amid concerns of excessive pricing, diversion and other abuses of the 340B Program, and at the recommendation of the Government Accountability Office (GAO), the Health Resources and Services Administration (HRSA) has recently increased its regulatory oversight of covered entities. this blog the most important notices as well as other program developments will The 340B Drug Pricing Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. 613 0 obj <> endobj Tulane University School of Medicine. Turnkey newsletter discussion on CAP expectations: July 2018. HRSA auditors are reviewing the submitted documentation as part of the auditing process. These concerns include a lack of assessment 340B stakeholders are ultimately responsible for 340B program compliance and compliance with all other applicable laws and regulations. 340B Compliance For many years, drug manufacturers and covered entities participated in the 340B Program with little oversight. September of 2018) is where additional expectations can be gleaned. If you have up to receive these updates by email. Routinely and periodically audit your claims to confirm compliance with state Medicaid rules. Previous Turnkey newsletter discussions: March 2019 HRSA Update, July 2018, List All Hospital Locations in Contract Pharmacy Agreement. pharmacy oversight, independent audit requirement, inventory control, and strategies HRSA added this requirement to the Data Request List for audits. Not meeting this expectation may subject the covered entity to an HRSA audit. Dr. Hagen had operational responsibility for Infusion Pharmacy Services, the Health System’s four retail pharmacies, and was responsible for 340B compliance at St. Newsletters related to MCO Medicaid: August 2019 Q&A, November 2019 Q&A, August 2018 Q&A), Turnkey newsletter related to out of state Medicaid: June 2019 Q&A, HRSA expects CE to review and update comprehensive written 340B Program policies and procedures – Meaning evidence of policy updates is required, Address compliance with HRSA’s patient eligibility guidelines at the CE specifically addressing confirmation of eligibility of site location of service resulting in the prescription or drug order; eligibility of provider as employed or contracted with the CE, or through a referral process; ownership and maintenance of the medical/patient health record for the service resulting in the prescription or drug order; and patient relationship to CE as an eligible patient including how outpatient to inpatient status change is determined. Given HRSA’s increase in 340B oversight activities, covered entities must demonstrate that their programs have been independently and objectively assessed. of corrective action prior to closing audits. She has served in various pharmacy leadership positions including Director of Ambulatory Pharmacy Services for CentraCare Health for over 5 years. Check back soon for Policies & Procedures, forms and training information. If yes, then you might be interested to learn that HRSA has been posting program updates in the “News” section of the … HRSA expects CE to engage in an independent organization to perform annual audits of its contract pharmacies and to review and update comprehensive written contract pharmacy policies and procedures that include performing independent audits of its contract pharmacies.

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