On December 30, the Department of Health and Human Services Office of the General Counsel released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program on covered outpatient drugs when community pharmacies are acting as agents of 340B covered entities. Although advisory opinions do not carry the force of law, they set out the agency’s current views on issues. Several major drug manufacturers had adopted practices denying sale of drugs at discounted prices to pharmacies with arrangements with qualified 340B entities. It is unclear what impact the release of the opinion by HHS will have on the practices of the drug manufacturers, unless accompanied by enforcement action.
The American Hospital Association, joined by four other groups representing participants in the 340B program last month filed a federal lawsuit against HHS over the department’s failure to enforce program requirements and halt drug company actions that undermine the program. The AHA and WSHA had also sent several letters to HHS asking it to protect 340B hospitals from these actions by certain drug companies. (Andrew Busz, AndrewB@wsha.org)