white pills spilling out of orange plastic pill bottle onto hundred dollar bills.

Merck Price Negotiation Lawsuit May Face Same Obstacles as 340B Takings Claims

By Laura Dolbow

Merck recently filed a lawsuit that challenges the constitutionality of the Medicare price negotiation program created by the Inflation Reduction Act. Under this program, HHS will select a small number of single source drugs for price negotiation. Merck alleges that the price negotiation program operates as a price control because it effectively requires manufacturers to accept the maximum fair price as a condition of participation in Medicare and Medicaid. Merck argues that this form of price regulation charts a “radical new course” for Medicare that violates the Takings Clause of the Fifth Amendment.

But the price negotiation program is not the first time that Congress has placed a restriction on the prices that Medicare program participants can charge. And Merck’s lawsuit is not the first suit that has alleged that such price regulations are unconstitutional takings. Drug manufacturers recently made similar claims in litigation involving the 340B Drug Pricing Program. Two district courts rejected those claims, highlighting several obstacles that Merck’s takings claim may face as well.

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Hundred dollar bills rolled up in a pill bottle

Ensuring 340B Discounts Trickle Down to Low-Income Patients

By Sravya Chary

The 340B prescription drug program was created with the original intent of providing discounted drugs to vulnerable patients. However, this program inadvertently created a revenue stream for for-profit retail pharmacies and intermediaries, which is cutting into the benefit received by low-income patients.

In a previous blog post, I discussed the pitfalls of a recent 340B advisory opinion released by the Department of Health and Human Services (HHS). The aim of this opinion was to provide more clarity regarding contract pharmacy use within the 340B program. However, the opinion ultimately did not alleviate the tension between pharmaceutical manufacturers and 340B representatives.

As one facet of a long-term solution to this ongoing issue, I proposed further investigation of 340B savings to analyze whether discounts are truly trickling down to vulnerable, low-income patients.

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Pill pack.

HHS’s 340B Advisory Opinion: Helpful or Harmful?

By Sravya Chary

A recent advisory opinion released by the Department of Health and Human Services (HHS) left many 340B advocates hungry for answers and pharmaceutical manufacturers frustrated.

The 340B program discounts the price of drugs paid by safety net hospitals to pharmaceutical manufacturers. The program is of critical importance to low-income and uninsured patients, especially during the COVID-19 pandemic.

HHS should take timely measures to resolve the concerns raised by the advisory opinion and resume the free flow of 340B discounted drugs to vulnerable patients.

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Pile of colorful pills in blister packs

Duplicate Discounts Threaten the 340B Program During COVID-19

By Sravya Chary

The 340B program, which provides discount drugs to safety-net hospitals, faces an uncertain future due to revenue leakage faced by pharmaceutical manufacturers and increased demand spurred by the COVID-19 pandemic.

Over the last few months, growing demand for 340B drugs and hard-to-monitor billing issues have placed an immense and unforeseen financial burden on pharmaceutical manufacturers. In response, some pharmaceutical manufacturers have threatened to withhold 340B drugs from contract pharmacies, thus limiting access to steeply discounted drugs for eligible patients.

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