HRSA audit findings related to incorrect OPAIS records have increased in the last few audit cycles. In response, HRSA appears to be initiating a new “Integrity Check” to validate the accuracy of OPAIS records for 340B Hospitals subsequent to anticipated Medicare Cost Report filings. Many 340B hospitals with a June fiscal year end received an email from the Office of Pharmacy Affairs stating, “According to data from the 340B Office of Pharmacy Affairs Information System (340B OPAIS) the entity(s) listed below should have filed a new Medicare Cost Report (MCR)” and directs the Authorizing Official and Primary Contact to take the “…following action based on the circumstance that applies to your entity:
- Submit an online termination request for [covered entity ID or IDs] in the 340B OPAIS if the site has fallen below the eligible 340B DSH% threshold.
Or - Submit an online change request for [covered entity ID or IDs] in 340B OPAIS to update the Qualification Information (Cost Reporting Period, Filing Date, and DSH% if applicable). Please attach your MCR to support the updated information to the change request submission.”
Some hospital recipients have expressed concern due to the suggestion of a program termination request in the first bullet. While we agree the phrasing of the email sounds alarming, we recognize this as an effort from HRSA to proactively assist covered entities in maintaining accurate OPAIS Records. HRSA’s primary objective appears to be one of encouraging covered entities to keep their 340B qualification information up to date. We anticipate that these emails will continue to be sent shortly after filing deadlines for applicable hospitals. Medicare Cost Reports are generally due five months after fiscal year end.
Of particular concern is that HRSA is basing the MCR filing deadlines on the fiscal year end found in OPAIS, which while generally accurate, may not represent changes in fiscal year ends or cost report filing extensions that hospitals occasionally experience. The Hospital Integrity Check provides no obvious recognition of special circumstances or enforcement steps for failing to respond to the notification.
OPAIS Records
Covered entities are responsible for ensuring their OPAIS information is correct and up to date. Here are some items to keep in mind when completing recertification:
Hospital Qualification Information
Information used to complete this section during recertification will be found in your hospital’s most recently filedMedicare Cost Report (MCR).
| Filing Date | Worksheet S |
| Cost Reporting Period | Worksheet S |
| Control Type | Worksheet S-2, Part I, Line 21 |
| DSH Percentage | Worksheet E, Part A, Line 33* |
* While updating a CAH’s qualification information today, OPAIS prompted the CAH to upload Worksheet E, Part A, which is not an applicable worksheet for CAH cost reports. The prompt did not prevent the change request from being completed, but we recommend noting in the comments to the OPA Reviewer “Worksheet E, Part A is not applicable to CAH cost reports.”
Managing a 340B Program is complex. You don’t have to go at it alone. If you have questions, contact the Apexus Certified 340B Experts at Draffin Tucker – 340B@Draffin-Tucker.com.