Thanks for bringing the 340B drug discount program to the forefront with the article “Federal watchdogs seek better oversight of 340B drug discounts” (ModernHealthcare.com, March 24). Given that the recent 340B hearing was the first congressional review of the program in 10 years, it was interesting to listen to parties on both sides of the aisle agree regarding the vital importance of 340B.
As noted by members of the House Energy and Commerce subcommittee at the hearing, 340B is an essential program for the safety net providers in their districts. This is exactly what Congress intended when the program was enacted in 1992 with bipartisan support. The intent, as quoted by Rep. Gene Green (D-Texas) during the hearing, was “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services” by reducing the amount that qualified entities spend on outpatient drugs. Rep. Kathy Castor (D-Fla.) also noted that Congress intended for eligible providers to use 340B drugs for any patient, regardless of insurance status. Diana Espinosa, deputy administrator of the Health Resources and Services Administration, affirmed that this is true and noted that the law does not state how the savings are to be used or specify the status of patients who may benefit from the program.
During the hearing's Q&A session, Espinosa responded to another common criticism regarding the program. There is a lot of discussion, particularly from the Pharmaceutical Research and Manufacturers of America, regarding an increase in the number of covered entities participating in 340B. However, Espinosa made it clear that the majority of that growth results from the new HRSA requirement for a covered entity to list all their eligible locations—not just the main facility. That answer didn't even delve into the nuance of having to add each specific department of every offsite location, which further adds to the rise in the number of participating entities.
All sides seem to agree that the rules governing the program could be clearer, and HRSA has been working toward that goal, with $6 million in funding to increase 340B program integrity and oversight. HRSA's goal for 2015 is to double the number of audits performed in previous years. In addition, HRSA has sought to clarify program rules with additional guidance for covered entities and drug manufacturers, but these efforts have been delayed by continuing legal battles with the pharmaceutical industry over HRSA's authority.
Let's clear the path for the administrative process to work. As Rep. Green said, “Congress should let HRSA release its guidance and analyze its impact before making changes to the 340B program that would harm safety-net hospitals and our vulnerable patients.”