September 23, 2011—The Senate Appropriations Committee has approved a fiscal 2012 spending bill for the departments of Labor, Health and Human Services, and Education that includes a number of provisions affecting 340B stakeholders.
As first reported in Monitor earlier this week, the committee has approved the first-ever user fee for providers enrolled in 340B. The 0.1 percent levy on drug purchases, which works out to a penny on every $10 dollars in sales, is expected to generate $5 million annually for Office of Pharmacy Affairs (OPA) program integrity efforts, including those recommended today by the Government Accountability Office (GAO) in its long-awaited 340B report. The committee encouraged the Health Resources and Services Administration (HRSA) to use the funding to develop a transparent system to verify the accuracy of 340B ceiling prices. Covered entities and some drug manufacturers have raised concerns for several years over the lack of access to an accurate 340B pricing list that has been blessed by the government.
OPA would receive an additional $4.48 million in operating funds through the appropriations process, roughly the same as it has been receiving in the current fiscal year.
In the report accompanying the bill, the committee raised concerns about a number of matters brought up by 340B covered entities, including a few items that have not been raised before by appropriators.
For example, the committee said it is “troubled” by reports of health care insurers and other third party payers setting reimbursement rates that discriminate against 340B covered entities and supplant the benefit of the 340B discounts. The committee urged HRSA “to clarify to health care insurers and other third party payers that discriminatory reimbursement rates for 340B covered entities is inconsistent with congressional intent.”
The committee also noted that an increasing amount of care is provided on an outpatient basis and that HRSA should keep this in mind as it develops new guidance defining which patients are eligible for 340B discounts. The committee recommended that HRSA focus any guidance that it might issue on preventing vulnerable patients from losing access to affordable drugs.
The committee also for the first time raised concerns over HRSA’s policy that requires hospitals to submit a filed Medicare cost report when adding a new site to the 340B program. The policy has resulted in significant delays in accessing 340B discounts, raising costs for both hospitals and their patients. The committee said it “encourages HRSA to explore other forms of documentation that might be available more quickly upon the opening of a new access point.”
While the bill has been voted out of the full committee, it must pass through both chambers of Congress before becoming law. The House Appropriations Committee has yet to act on its version of the spending measure.