01/26/2021 | Press release | Distributed by Public on 01/26/2021 08:43
January 26, 2021
(Washington, D.C.) - The Pharmaceutical Care Management Association (PCMA) has filed a motion for summary judgment to vacate the effective date of the Trump Administration's rebate rule.
The motion for summary judgment, filed in the U.S. District Court for the District of Columbia, seeks to vacate the January 1, 2022 effective date for the rebate rule with respect to Part D. The motion is vitally important to ensuring the stability of the Medicare Part D program as the Biden Administration reviews the Trump Administration's 'midnight regulations' and PCMA proceeds with litigation to revoke the rule in its entirety.
Under the Medicare Part D rules, annual drug plan bids must be submitted in early June for the subsequent plan year, and Part D plans currently have largely concluded negotiations with manufacturers and are formulating their benefit designs and bids. Moreover, the Centers for Medicare & Medicaid Services (CMS) has not even begun the months-long Part D rulemaking for the many program changes that would be required to implement the rebate rule. Medicare drug plan bids are used to set beneficiary premiums and other costs.
'The Trump Administration's hastily finalized rebate rule is a clear and present threat to destabilize the Medicare Part D drug benefit,' said PCMA President and CEO JC Scott. 'Not only is the rebate rule itself misguided, but the aggressive timeline is virtually impossible to meet. To be clear, the rebate rule in its entirety should be invalidated, but immediate action must be taken on the effective date. Otherwise, the 47 million Part D beneficiaries could face significant premium increases in 2022.'
To read the filing, click here.
The motion for summary judgment follows the filing of PCMA's lawsuit asking the court to set aside the rebate rule under the Administrative Procedure Act. The PCMA lawsuit also includes a request for a declaration from the court that federal law protects the rebates that the Office of Inspector General, U.S. Department of Health and Human Services (HHS) is seeking to remove from the discount safe harbor regulation.
Here are the Facts on the Rebate Rule:
Click here to see widespread stakeholder opposition to the rebate rule including: AARP, AHIP, the Better Medicare Alliance, academics, and high-ranking lawmakers. Visit the PCMA website for more information.