RxStrategies’ Perspective: Proposed Mega Reg Guidance
As you know, the Health Resources and Services Administration (HRSA) released on August 28, the provisions of the 340B Drug Pricing Program Omnibus Guidance (Proposed Guidance). The Proposed Guidance touches on every area of the 340B Program, including, but not limited to:
– Eligibility and registration of hospitals and outpatient facilities;
– Individuals eligible to receive 340B drugs (patient definition);
– Drugs eligible for purchase under the 340B Program;
– Prohibition of duplicate discounts;
– Manufacturer compliance
Read the 340B Drug Pricing Program Omnibus Guidance notice as published in the Federal Register for a complete review and comment submission before October 27, 2015.
RxStrategies’ High-Level Perspective and Suggested Response:
As the industry awaits public comment on the Proposed Guidance (due 10/27), RxStrategies has reviewed the document language and continues to have in-depth discussions with key industry experts regarding its potential impact. There are no unexpected “shockers” from what was originally anticipated. The RxStrategies team shares with our key clients and partners the following view and suggested actions:
- Patient definition expands to a six-part test, with possible changes in current eligibility. Work with RxStrategies to review current data elements used and continue to ensure your electronic medical record (EMR) data is complete and current.
- No reduction in the currently defined number of Contract Pharmacies (CPs) a Covered Entity (CE) can utilize in order to meet patient needs. RxStrategies’ client CP networks are within standards.
- Increased focus on program compliance and audit activity. CEs are encouraged to continue to implement 340B compliance focus (including RxStrategies 340B Compliance Plus Program). It is recommended that CEs establish a 340B team with a designated 340B lead for audit review. That team can work through internal CE program assessment to ensure adequate compliance and self-audit reviews are in place today.
- Introduction of additional HRSA requirements associated with identifying and reporting Medicaid MCO claims. It is important to note that this new process may impose additional contract and reporting requirements with state Medicaid agencies to process certain MCO claims. RxStrategies has historically excluded all Medicaid FFS claims, but processed certain eligible Medicaid MCO claims. RxStrategies’ unique real-time process can address additional Medicaid reporting requirements with markers on RT claims. We can also identify (in report form) similar retro MCO markers via reporting back to the state, to prevent the state’s submission of rebates on 340B related items.
- Continued ability to leverage telemedicine, in certain cases, to support patients via 340B program. RxStrategies is working with clients to reconfirm that current RxStrategies’ telemedicine practice/approach is consistent with draft Mega Reg language.
The RxStrategies’ Next Step Approach:
We are working closely with 340B Health senior leadership, and other industry leaders to help craft responses and alternative solutions for submission to HRSA, well within the comment period. The RxStrategies’ team is currently reaching out to clients to identify key areas of concern and will have collective view on identified issues and proposed CE/CP processes to escalate concerns to HRSA by early October. In the interim, contact us to discuss how RxStrategies can assist your program.
CALENDAR OF EVENTS
Join the RxStrategies’ team at the following upcoming conferences in 2015:
APHCA Annual Conference
September 22 – 24 | Orange Beach, AL
ASHNHA Annual Conference
September 23 – 25 | Girdwood, AK
October 13 – 15 | Jekyll Island, GA
CPCA Annual Conference
October 15 – 16 | Sacramento, CA
ASHP Midyear Clinical Meeting
December 6 – 10 | New Orleans, LA