December 16, 2011—Congressional negotiators last night approved a $1 trillion fiscal year 2012 spending agreement for much of the federal government that level-funds the Office of Pharmacy Affairs (OPA) at its current $4.48 million. The measure does not include a proposed user fee that was expected to raise an additional $5 million to finance 340B program integrity initiatives.
Late this afternoon, the Senate had not yet acted on a related bill passed earlier by the House today that would cut all fiscal 2012 base discretionary spending by 1.83 percent across the board except for defense, military construction and Veterans Affairs programs.
Congress is expected complete work on the omnibus spending package soon and send it to the President, who is expected to sign it.
The Obama administration had sought $5.22 million in appropriated funds for OPA plus the additional $5 million from the user fee, which would have been set at 0.1 percent of covered entities total 340B drug purchases. The full Senate Appropriations Committee endorsed the fee in the stand-alone spending bill for the departments of Labor, Health and Human Services, and Education that it passed in September. The full House Appropriations Committee, however, never passed its own version of the bill this year.
In an Oct. 21 letter to three influential members of Congress, OPA had said it would use the $5 million in user-fee revenues to pay for program integrity activities mandated by the Affordable Care Act “in the areas of manufacturer civil monetary penalties; covered entity guidance and/or regulations; pricing changes and transparency; administrative dispute resolution; and the creation of a secure web site to permit covered entities to access 340B ceiling price information.” Several times during the course of the past year, OPA Director Krista Pedley said the office would not implement any of those activities unless it had sufficient funds in hand.
In the same October letter, OPA said that “subject to funding availability,” it would begin selective audits of 340B covered entities in February to deter potential drug diversion and look for evidence of duplicate discounts. An OPA spokesperson declined to answer whether the $4.48 million appropriation would be sufficient to permit the office to move forward with the audits.
Former OPA Director Jimmy Mitchell told the Monitor that while he is “not privy to OPA’s spending plan for 2012,” he believes that “OPA audits and other integrity improvements for the program will be a high priority.”