On July 11, the U.S. House Appropriations Committee approved the fiscal year (FY) 2022 appropriations bill (the “Bill”) and accompanying report for the Department of Labor, HHS, Education, and Related Agencies. The accompanying report calls for HRSA to report on actions it is taking to (1) safeguard safety-net providers’ access to discounted drugs, including those dispensed at contract pharmacies, and (2) clarify eligibility criteria for patients and providers under the 340B Program.
The Committee emphasizes the importance of the 340B program, explaining that it is a “critical lifeline to safety net providers, including Community Health Centers.” It notes the six letters that HRSA sent to drug companies on May 17, 2021, which notified them that their refusal to honor contract pharmacy arrangements has resulted in overcharges to covered entities and that may result in Civil Monetary Penalties. The Committee “encourages HRSA to continue to use its authority and any available measures, including the imposition of civil penalties, where appropriate, to hold those drug manufacturers in violation of the law directly accountable.”
The Committee also instructs HRSA to complete the remaining two of five recommendations issued in a September 2011 U.S. Government Accountability Office (GAO) report regarding the 340B program. The most significant of those uncompleted recommendations was for HRSA to finalize more specific guidance on the definition of an eligible “patient” under the 340B program. In 2015, HRSA published proposed guidance that narrowed the definition of a patient (the “Mega-guidance”), but this guidance was withdrawn by the Trump administration. Based on HRSA’s numerous admissions that it lacks regulatory authority with respect to the patient definition, 340B community members suspect that HRSA may continue to leave this recommendation incomplete. The other recommendation instructs HRSA to issue more specific guidance on the criteria that private, nonprofit hospitals must meet to register for the 340B program. On July 27, the Bill moved to the House floor for debate and consideration as part of a package which includes six other appropriations bills. The House is expected to complete debate on the over 200 amendments proposed as part of the 7 bill package and vote on the appropriations bill by the end of this week, after which the bill will move to the Senate.