340B provider groups strongly criticized the Centers for Medicare & Medicaid Services’ draft guidance for Medicare drug price negotiations.

CMS Delays Implementing Rule Allowing Multiple Best Prices for Drugs Until Next July

The Biden administration said yesterday it is delaying by six months the effective date of a Trump administration final rule to let drug manufacturers report multiple best prices on their products if states opt to participate in value-based purchasing (VBP) models.

The rule was to have taken effect on Jan. 1, 2022. The U.S. Centers for Medicare & Medicaid Services (CMS) yesterday pushed the date back to July 1, 2022. “We believed a delay
of 6 months is warranted to assure that stakeholders have the ability to implement the new VBP policy in a manner that assures patient access and quality of care are protected,” CMS said.

CMS said it “plans to provide further operational guidance for states and manufacturers in the near future regarding the implementation of the multiple best price reporting.”

Groups representing 340B covered entities told CMS in comments about the proposal to delay the rule’s effective date that they were concerned that CMS has not analyzed how VBP models and multiple best prices will affect Medicaid rebates and 340B ceiling prices. They said the changes could unintentionally increase 340B providers’ costs.

CMS’s Federal Register notice, released for public inspection yesterday, was silent about the final rule’s impact on the 340B program.

The 340B ceiling price is a drug’s average manufacturer price (AMP) minus the Medicaid unit rebate amount (URA), or AMP minus best price, whichever is lower. URAs are 23.1% for brand drugs, 17.1% for pediatric drugs and clotting factor, and 13% for generic drugs.