340B “Mega-Reg” Update

The White House Office of Management and Budget (OMB) began its review of a proposed 340B Drug Pricing Program “Mega-Reg” in April. (See: RIN 0906-AB04). This proposed rule change is expected to cover the definition of an eligible patient and establish comprehensive 340B Drug Pricing Program requirements for participating covered entities and manufacturers.

During the recent 340B Coalition’s 18th Annual Summer Conference, HRSA announced delay in the release of the proposed “Mega-Reg.” It was also speculated that only modest changes may be seen in issues such as the patient definition. The projected release is now anticipated in summer of 2015.

RxStrategies’ Recommendation for Covered Entities: Ensure compliance with 340B requirements and related regulations. Continue to make all efforts to fully utilize the 340B Drug Pricing Program, which enables safety net providers to expand patient access to health care.