In a Dec. 14 letter to U.S. Health and Human Services (HHS) Secretary Alex Azar and Health Resources and Services Administration (HRSA) Administrator Tom Engels, attorneys general (AGs) from 27 states and the District of Columbia urged the federal government to enforce 340B drug discounts currently being denied by a number of drug manufacturers. Notably, the letter is led by California AG Xavier Becerra, who President-Elect Joe Biden recently announced as his nominee for HHS Secretary.
Wisconsin Attorney General Josh Kaul was among the list of AGs on the letter. The Wisconsin Hospital Association (WHA), along with the Wisconsin Primary Health Care Association and Vivent Health, had the opportunity to brief his staff on this issue in October.
As covered in a
recent The Valued Voice article, the issue stems from drug manufacturers denying discounts to 340B hospitals that utilize community contract pharmacies. Despite warnings from HRSA, drug manufacturers have continued this practice; in fact, Novo Nordisk became the sixth drug maker to announce this month it would follow suit beginning in 2021.
In the
letter, the AGs noted, "HHS has the authority to issue civil monetary penalties, and to issue guidance articulating the statutory responsibilities of drug manufacturers. The illegal actions of drug manufacturers during this time of urgent need compel HHS to utilize its authority to maintain and support the purpose and execution of the 340B Drug Pricing Program."
In related news, HRSA announced last week a long-awaited final rule establishing an administrative dispute resolution process between 340B-covered entities and drug manufacturers. Disappointingly, the process does not directly address this issue. In response, the American Hospital Association, 340B Health and other hospital and pharmacy groups filed a
federal lawsuit requesting HHS enforce these requirements of the 340B statute. WHA continues to advocate on behalf of its members to ensure this issue is resolved expeditiously. Please contact WHA's Vice President of Federal and State Relations
Jon Hoelter with questions.