March 5, 2014—Details about the Health Resources and Services Administration’s (HRSA) policy priorities for the 340B program this fiscal year and next have emerged in a drug industry newsletter and in a supplement to President Obama’s budget request to Congress.[ms-protect-content id=”2799″]
The Obama administration yesterday asked Congress to provide $17 million for the 340B drug discount program in fiscal 2015, including $10 million in appropriated funds and $7 million from a 0.1 percent user fee on 340B drug purchases.
In a Feb. 4 article, The Pink Sheet reported that HRSA’s Office of Pharmacy Affairs (OPA) plans to use the additional $6 million that Congress gave it in January for fiscal 2014 for:
- Staff to analyze information collected from program oversight efforts
- Staff to conduct more program audits
- Information technology systems “to more effectively track entity and manufacturer compliance, including a new internal system and improvements to our existing eligibility database,” a HRSA spokesperson told the newsletter. “We are reconstituting our pricing database to allow manufacturer price reporting, price validation, and covered entity access to pricing.”
Among other 340B program oversight measures, the Affordable Care Act required HRSA to develop and publish standards for the calculation of 340B ceiling prices; to develop a system to verify the accuracy of such prices; and to give covered entities access to those prices via a secure page on the OPA website.
Last summer, the Senate Appropriations Committee said it “remains strongly committed to OPA’s plans to develop a transparent system to verify the accuracy of the 340B ceiling price” and indicated that it expected HRSA to give top priority to additional 340B funding to creation of the secure website.
When it boosted OPA’s fiscal 2014 funding early this year, congressional appropriators asked the agency to tell them on how they would use the extra money to strengthen program oversight. OPA reportedly briefed the House and Senate appropriations committees late last month.
The Pink Sheet article also quoted OPA Director Cmdr. Krista Pedley as saying during a Feb. 27 drug industry conference that, on a separate track from its forthcoming 340B “mega-reg,” HRSA plans to issue regulations to impose monetary sanctions on manufacturers and covered entities that intentionally violate program rules. HRSA issued an advanced notice of proposed rulemaking on the manufacturer sanctions in September 2010.
Today in its annual budget justification to Congress, HRSA said it would focus OPA’s fiscal 2015 funding on four areas:
Non-compliance with 340B pricing requirements. “Funds from the FY 2015 request will continue to support the 340B pricing system, publication of policies regarding the computation of 340B ceiling prices, implement a systematic quarterly comparison of 340B ceiling prices with the selling prices offered by manufacturers and drug wholesalers, and follow-up efforts to resolve problems wherever they arise in the data supply chain,” HRSA said.
Errors and omissions in the 340B covered entity database. “In FY 2015,” HRSA said, “the continued administration of a systematic verification system will allow annual online verification of all records in the 340B database.”
Program Regulations and Guidance. HRSA said it would use its funding to “continue to support the implementation of program regulations and guidance to provide oversight to maintain the integrity of the 340B Program.”
The OPA Information System (OPAIS). “OPAIS is a multi-function web-based database system that provides information on covered entities, contract pharmacy arrangements, and manufacturers,” HRSA said.
In the portion of the budget justification document regarding the proposed 0.1 percent user fee on 340B drug purchases, HRSA said it would use the additional $7 million in revenues “to address current information deficiencies as well as provide significant resources needed to address both long term goals to improve the program by addressing [HHS Office of Inspector General] requirements and the expanded statutory requirements of Affordable Care Act.”[/ms-protect-content]