340B Compliance Review
| Industry | Health System |
| Problem | The client requested a gap analysis to identify any issues that needed to be addressed in the management controls, processes, and procedures to make sure that the health system was in compliance with 340B Drug Pricing Program regulations. |
| PHSI Solution | A compliance audit was conducted including onsite interviews, review of policies and procedures, and management controls. This review enabled PHSI to recommend operational changes to their policies and procedures along with implementing feedback mechanisms for better management controls of the end-to-end process. |
| Results | PHSI provided recommendations that reduced the audit risk to the health system when HRSA conducts an audit analyzing the health systems compliance with 340B regulations. |
Poll Results
August 2023 Question of the Month
What steps do you take when learning about an electronic prescribing challenge?
Root cause analysis: 0%
Compendia review: 0%
Engage a partner: 0%
All of the above: 50%
None of the above: 50%
July 2023 Question of the Month
Does your organization have a strategy for Humira biosimilar launches?
Yes, well defined: 0%
We have a framework: 50%
Waiting for clarity: 0%
No: 0%
Unaware of need: 50%
June 2023 Question of the Month
How far in advance of NDA/BLA expected approval do (or should) manufacturers begin planning their compendia submission strategy?
During Phase II Trials: 0%
Initiation of Phase III Trials: 66%
6 months prior to approval: 33%
3 months prior to approval: 0%
At time of approval: 0%
After approval: 0%
No strategy: 0%
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