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Home » Drug Pricing » 340B » Marsha Simon Gives Her Thoughts on Recent 340B Policy Developments and the Odds for Passage of 340 Legislation

Marsha Simon Gives Her Thoughts on Recent 340B Policy Developments and the Odds for Passage of 340 Legislation

October 20, 2020

Today, Marsha was quoted for 340B Health for her thoughts about recent 340B policy developments and how she believes the federal government should address this policy issue:

“At base, there needs to be more than talk and no meaningful action to lower drug prices, and that starts by protecting the 340B program. The original U.S. Senate committee report (which Simon helped draft as staffer for Sen. Ted Kennedy, D-Mass.) clearly states that 340B’s purpose is to ensure that clinics receive a discount on drug prices comparable to the Medicaid rebate “with a minimum of administrative costs and burdens.” The health center insulin executive order and the administration’s tacit approval of multiple drug manufacturers unilaterally withholding 340B-priced drugs from contract pharmacies has resulted in completely unacceptable administrative burdens on the clinics.

I hope the next Congress affords the opportunity to reopen the 340B statute and address the lack of a legislative solution to duplicate discounts. If legislation to impose inflation penalties on Medicare Part B physician administered drugs and Medicare Part D drugs also moves—there should be even more impetus.

We need legislation to clearly state whether it is Medicaid or the covered entities that have first dibs on the drug savings. Secondly, we need the legislation to authorize and fund a conflict-of-interest-free contractor to collect the relevant discount and rebate data, vet it, reconcile it, and make both the clinics and the drug companies whole.

All 340B drug out-of-pocket costs should be set on a sliding scale for all patients of the participating safety-net providers as generally required of the Public Health Service Act grantee clinics—health centers and family planning clinics, for example. The issue of how the savings from the 340B program are invested completely misses this critical point.

On the regulatory side, both this and the former administration failed to implement the 340B dispute mechanism mandated in the ACA 10 years ago. Again, to ensure that the mechanism works in a timely manner, HRSA should contract out this function to a conflict-of-interest-free company with experience adjudicating disputes for the government.”

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