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September of 2018) is where additional expectations can be gleaned. For many years, drug manufacturers and covered entities participated in the 340B Program with little oversight. This information includes: A description of how the covered entity determined the full scope of non-compliance, A list of all affected manufacturers, a copy of the letter offering repayment to manufacturers, and a list of all settlements with manufacturers, Documentation of continuous monitoring with periodic assessment related to the previous finding(s). 630 0 obj <>/Filter/FlateDecode/ID[<0C459E0BAD6B8345BC9FB8EC24EF70C8>]/Index[613 38]/Info 612 0 R/Length 86/Prev 114485/Root 614 0 R/Size 651/Type/XRef/W[1 2 1]>>stream Key 340B Compliance Elements and Program Updates. are being released at an unprecedented rate and appear to be a main source for %%EOF PYA’s services meet HRSA’s recommendation for independent audit(s).

endstream endobj startxref 650 0 obj <>stream If you are uncertain whether you are in compliance with the 340B Program, contact us about an assessment.
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.

areas for improvement were released regarding new policy expectations (e.g., contract Failure to provide the requested documentation before the registration period closes will result in the registration being rejected and requiring the hospital to re-register during the next quarterly registration period. %PDF-1.5 %���� If a list is used, hospitals must update the contract when changes occur with their locations using the contract pharmacy arrangement per this page on the. If the third audit results in the same non-compliance violation, HRSA may deem the violation as “systemic and egregious as well as knowing and intentional” and remove the covered entity from the 340B program for a “reasonable period of time.”. PYA is well-versed in the complex regulatory environment of the healthcare industry. regulations from HRSA.

It is important to verify whether your state Medicaid agency has policies around Medicaid managed care and 340B and if so, that you can comply with those policies.

HRSA added this requirement to the Data Request List for audits.

the updates, audit data request, audit findings, and as witnessed during Copyright © 2020 Turnkey Rx Solutions  waste), crosswalking of the cost report to child sites (a.k.a., Environment for quite some time. 340B stakeholders are ultimately responsible for 340B program compliance and compliance with all other applicable laws and regulations. @� @�(� Crosswalk or Map of the Environment, ), and specific contract pharmacy contract expectations. for duplicate discounts in Medicaid managed care and that more information is Hospitals that participate in 340B under the category of (a) being owned or operated by a state or local government; or (b) having been granted governmental powers, must submit documentation to support that status. pharmacy oversight, independent audit requirement, inventory control, and strategies Ensure controls for the procurement of 340B drugs including compliance with the GPO prohibition including for replenishment to (stocking of) contract pharmacies at 11-digit to 11-digit NDC match including a process for maintaining auditable records to demonstrate proper accumulation where 11-digit match is not met; 340B OPAIS accuracy, specifically regular review and timely update of 340B records for contract pharmacies. that they need additional authority in order to make any changes to the 340B

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h�bbd``b`z $g�X+��{�:�`��v b��"�AJ@���\ u��@�# HXf2012}�iC��_� � |U 5 existing authority to make changes to the 340B program. Office (GAO) report After the 2018 data request update and as of July is now an AFI: HRSA expects a written contract pharmacy contracts to accurately identify by name and address all contract pharmacy locations participating in the contract pharmacy arrangement and registered in 340B OPAIS.

With over 30 years of experience in advising healthcare clients, PYA has assisted covered entities in multiple areas of 340B compliance. There have been desk audits of contract pharmacy (CP) agreements and we know of one instance of HRSA asking for the agreement between the state and the CE when carving in Medicaid at the CP. You can contact me at 800-270-9629. Additionally, the expansion of the contract pharmacy network for many covered entities is gaining the attention of the Office of Inspector General (OIG) and HRSA. At the conclusion of the assessment, we can advise you on the areas that may need additional attention. In previous newsletters Turnkey has summarized many of these updates. not yet done so, consider signing Office (GAO) report, Working Together – Establishing a 340B Oversight Committee. In If there are no findings, HRSA does not require a written response but expects the covered entity to implement the AFI and states they reserve the right to require additional information related to the implementation of the AFI in the future. Audit 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. A covered entity should maintain policies and procedures which describe the process for ensuring names and addresses in the written contract pharmacy contracts are accurate and an identical match to 340B OPAIS. expectations since there has been no new policy The intent of the program is to allow covered entities to "[s]tretch scarce federal resources as far as possible, reaching more eligible patients and … Previous Turnkey newsletter discussions: March 2019 HRSA Update, July 2018, List All Hospital Locations in Contract Pharmacy Agreement. Routinely and periodically audit your claims to confirm compliance with state Medicaid rules. If you have Only covered entities with audit finding(s) must address noted AFI(s) in the CAP. as they have been recently… HRSA has consistently told congressional committees The updated. You can contact me at 913-232-5145. A second audit finding will trigger a third audit. Previous Turnkey newsletter discussions: March 2019 Tidbit, July 2018.
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Thanks for reaching out. heels of the Government Accountability Beginning April 1, 2018, if HRSA becomes aware during an audit that the covered entity is not following state rules related to duplicate discount prevention for 340B MCO claims, HRSA will note this as an “area for improvement” in the audit report. In particular, just this past July several of corrective action prior to closing audits. 340B University is an interactive full-day educational program offered at locations around the country with a rotating schedule of course topics focusing on compliance cornerstones, practical applications, and perspectives of … Have you been wondering how to keep up with HRSA’s compliance expectations since there has been no new policy released since 2014 and no new compliance related program regulations since 2010? Have you been wondering how to keep up with HRSA’s compliance Turnkey newsletters: Current September 2019 Newsletter and October 2018 Q&A, HRSA updated the “CAP Implementation and Repayment” section of its, HRSA updated the same section of the webpage to say that when the same non- compliance finding occurs in the first and second audits, the covered entity must submit additional documentation, determined by HRSA, supporting the implementation of the CAP and any applicable repayment to manufacturers. Ensure Remedial Action Is Taken for Audit Findings Involving Contract Pharmacies. Congressional leadership has maintained that HRSA should use its HRSA emphasizes in its June 2018 Program Update that it is the covered entities’ responsibility to take remedial action to assure compliance when it discovers diversion or duplicate discount non-compliance relating to prescriptions filled through a contract pharmacy. “The 340B program enables safety net providers not only to mitigate high and rising drug prices, but to be good stewards of finite patient, program, and provider resources with a goal to improve the health of those we are privileged to serve,” wrote Peter Leibold, chief advocacy officer for the 150-hospital Ascension health system. Hospital documentation is being requested as a part of recertification. These concerns include a lack of assessment FQHC 340B Compliance noticed a need for 340B assistance within FQHC’s that was not currently being met. As such, we have a unique understanding of the issues surrounding 340B compliance. Cloud Hospital, a 489 bed regional medical center. posted updates in response to the main concerns.

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