CHA has issued a members-only summary, prepared by Health Policy Alternatives, Inc., of a proposed rule to implement policies in the Medicaid Drug Rebate Program related to legislative requirements addressing drug misclassification, as well as drug pricing and product data misreporting by manufacturers. The proposed rule also includes several other program integrity and program administration provisions. Comments are due to the Centers of Medicare & Medicaid Services (CMS) by 2 p.m. (PT) on July 25 and can be submitted online.
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- Modifying the definition of covered outpatient drugs
- Designating a time limit on manufacturers initiating audits with states
- Clarifying and establishing requirements for state fee-for-service pharmacy reimbursement
- Codifying conditions relating to states claiming federal Medicaid matching funds for physician-administered drugs
- Clarifying the requirement of accumulating price concessions when determining best price
- Designating drug price verification and transparency through data collection, including a new annual Medicaid Drug Price Verification Survey for verifying prices and publishing non-proprietary information about the prices for certain covered outpatient drugs
Additionally, CMS proposes two new contracting requirements between states and their Medicaid managed care plans and revisions to the third-party liability rules to correct regulation text due to changes authorized under the Bipartisan Budget Act of 2018. Consistent with a 2022 court order, CMS also proposes to rescind regulatory changes made by a Dec. 31, 2020, final rule regarding the determination of best price and average manufacturer price.