U.S. House and Senate appropriations committees want federal healthcare officials to brief them by April “on actions taken to safeguard covered entities’ lawful access to discounted drugs” under the 340B program.
The directive to the Health Resources and Services Administration is included in the report that accompanies the $1.7 trillion fiscal year 2023 omnibus appropriations bill that Congress is expected to pass before the end of the week.
The House Appropriations Committee in June marked up a healthcare spending bill with a report that said:
“The Committee is concerned by the fact that the number of pharmaceutical manufacturers that are violating the 340B statute has dramatically increased, threatening the ability of safety-net providers to care for patients in need. The Committee is pleased that HRSA has continued to take steps to enforce the statute and take action against companies that curtail the use of 340B drugs in contract pharmacies, refer violations of the statute by manufacturers to the HHS Office of Inspector General, and appeal litigation in these matters. 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 urges HRSA to continue to take actions to safeguard covered entities’ lawful access to discounted drugs.”
The Senate Appropriations Committee in August released a healthcare spending bill with a report that said:
“The Committee is concerned that manufacturers continue to deny 340B pricing for drugs purchased by covered entities for use in contract pharmacies. The Committee supports HRSA’s continued use of its authorities and any available measures, including the imposition of civil penalties, as appropriate, to hold those drug manufacturers in violation of the law directly accountable. 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.”
The report that accompanies the omnibus appropriations bill says, in lieu of the House language, HRSA is directed “to provide a briefing within 120 days of enactment of this act on actions taken to safeguard covered entities’ lawful access to discounted drugs.”
The bill text, released late yesterday, does not appear to specify how much funding would go to HRSA’s Office of Pharmacy Affairs, the unit that administers the 340B program. Under a recent HRSA reorganization, OPA is now housed in the HRSA administrator’s office. HRSA-wide activities and program support would get $1.7 billion this fiscal year under the bill.
The Biden administration in March asked for $17 million for OPA this fiscal year. The House Appropriations Committee’s bill would have provided $13.2 million. The Senate Appropriations bill called for $12.2 million.