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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.

February 2023 Question of the Month

Do you feel like your organization understands the FDA’s Draft Guidance for Industry on Drug Importation?

We have reviewed the guidance and are taking a watch and wait approach: 75%

We have reviewed the guidance and are taking proactive steps to act on it: 25%

We have reviewed the guidance but do not feel like it will impact our organization: 0%

Not familiar/We have not reviewed the guidance: 0%

January 2023 Question of the Month

How will payers manage reimbursement of multiple interchangeable biosimilars?

MAC reimbursement: 10%

Generic non-MAC reimbursement rate: 10%

Brand reimbursement rate: 40%

Specialty drug specific rate: 40%

Average Sales Price (ASP): 0%

Average Manufacturer Price (AMP): 0%

National Average Drug Acquisition Cost (NADAC): 0%

December 2022 Question of the Month

In which area could you or your company most benefit from additional training?

Biosimilars and interchangeability requirements: 46.1%

Dynamics that drive PBM and health plan decisions: 15.4%

Various hurdles a prescription must clear before being dispensed: 15.4%

Changing 340B landscape: 15.4%

Flow of funds and prescriptions through the pharmacy channels: 7.7%

Pharmacy chain initiatives and strategy updates: 0%