Part D, Rebate-Sharing Rules Slated To Be Proposed This Month

Published by Inside Health Policy

Two rules that are expected to include major policies to curb drug prices are scheduled to be released this month, according to the fall regulatory agenda. However, the agenda’s timetable is often wrong. For example, the agenda estimates that the CMS rule requiring the disclosure of drug prices in TV ads would be proposed in December, even though CMS proposed that rule a day before the agenda was published on Tuesday (Oct. 16).

The White House’s budget office is reviewing two rules, a CMS Part D proposed rule and a proposed rule by the HHS Inspector General on anti-kickback safe harbors, that are expected to include policies aimed at lower drug prices, consultants say.

The Part D proposed rule is considered a possible vehicle for changes to plans’ bidding process, the incorporation of pharmacy price concessions into plan bid cost-sharing amounts and the establishment of point-of-sale rebates. According to the title of the anti-kickback proposal, the HHS Inspector General will propose to both remove current safe harbor protections for drug rebates and create new ones. Sources suspect HHS plans to ban, or limit, rebates that are calculated as a percentage of list prices while allowing rebates used in value-based purchasing arrangements.

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