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The Active Ingredient features expert insights and commentary from leaders of ZS Associates' global pharmaceuticals practice.

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A Tale of Two Patients: Who Will the Proposed Safe Harbor Regulation Most Benefit?

Posted by Pranava Goundan on Thu, Apr 11, 2019

Howard Deutsch and Kyle Harpole co-wrote this blog post with Pranava Goundan.

The U.S. Department of Health and Human Services has proposed a new rule for safe harbor protection of drug discounts, effective Jan. 1, 2020. While the rule hasn’t been finalized, it has received more than 25,000 public comments, indicating that the current rebate model likely will be swept out to sea in favor of a model that aims to more directly address beneficiaries’ concerns about rising out-of-pocket costs. The percentage of patients whose out-of-pocket spending exceeds $2,000 nearly doubled between 2011 and 2015. The proposed regulation focuses on curtailing these costs by establishing, among other things, point-of-sale discounts for beneficiaries. We recently wrote about how pharma can prepare for the shifting seas of a new access and reimbursement landscape. In this post, we’ll compare two common Medicare Part D, non-LIS patient populations, diabetes and rheumatoid arthritis, to demonstrate how individual patients’ payment contributions would change under the proposed regulation.

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Topics: regulations, pharma drug pricing, Medicare drug price proposal, drug rebates, safe harbor protection, point of sale discounts

The Rebate Rules Are Changing. Here’s What Pharma Needs to Do to Prepare

Posted by Howard Deutsch on Wed, Mar 20, 2019

Pranava Goundan co-wrote this blog post with Howard Deutsch.

In the classic political film, “The Candidate,” Robert Redford’s character, fresh off his victory, turns to his election strategist and asks, “What do we do now?” And the movie ends right there. The pharmaceutical industry now is facing a similar moment. After years of advocating for more transparent pricing and criticizing the rebate-for-access model for its perverse pricing incentives, pharma is on the cusp of partly getting its wish. But our movie doesn’t end there, so we must answer that question: What do we do now?

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Topics: Howard Deutsch, price transparency, pharma drug pricing, drug rebates, safe harbor protection, HHS proposed rule, point of sale discounts, Pranava Goundan, Medicare Part D, PBMs and payers

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