U.S. House appropriators are encouraging HRSA to use fines and "any available measures" to hold drug manufacturers accountable for withholding 340B drug discounts.

Key Congressional Committee Urges HRSA to Fine Drug Makers Over 340B Contract Pharmacy Denials

The U.S. House Appropriations Committee is pleased with the U.S. Health Resources and Services Administration (HRSA) for challenging six drug makers’ denials of 340B pricing when covered entities use contract pharmacies, the committee said in a report released yesterday. It encouraged HRSA in the report to fine drug companies, if warranted, for unlawful charges above 340B ceiling prices.

The report accompanies the full committee’s fiscal year 2022 spending bill for the U.S. Labor, Health and Human Services (HHS), and Education departments. The Labor-HHS-Education appropriations subcommittee marked up and passed its version of the bill on Monday. The full committee mark-up began at 10 a.m. Eastern today.

The Democratic-controlled committee’s report language is a significant expression of support for HHS and HRSA, and of censure for the drug industry, in the 340B contract pharmacy fight.

While 340B provider groups will welcome the congressional support in the contract pharmacy battle, they are likely to feel unease about the committee’s request for an update from HRSA about its plans to clarify the 340B definition of patient and 340B provider eligibility criteria. The U.S. Government Accountability Office recommended that HRSA clarify its guidance on those two matters in a 2011 report on 340B mandated by the Affordable Care Act. (See related story.)

“The committee is pleased that HRSA sent letters to six pharmaceutical companies on May 17, 2021, determining that on-going actions by the companies have resulted in overcharges to 340B covered entities,” the report says. “Furthermore, the committee notes that HRSA articulated that continued failure to provide the 340B price to covered entities utilizing contract pharmacies may result in civil monetary penalties, as described in the final civil monetary penalty rule.”

“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 report continues. “The committee directs HRSA to provide a report no later than 120 days after enactment of this act on actions taken to safeguard covered entities’ lawful access to discounted drugs.”