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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Trump’s Medicare Pricing Policy Could Mean Big Disruptions to Medical Benefits

Posted by Howard Deutsch on Tue, Nov 13, 2018

Gustavo Poblete co-authored this blog post with Howard Deutsch.

The Trump administration rolled out a significant policy proposal aimed at reducing the prices that Medicare pays for prescription drugs covered under the Part B medical benefit. While the policy is positioned as a “pilot” covering half the country, it will, if implemented as proposed, bring substantially greater disruption to drug pricing, contracting and distribution than purportedly envisioned by the government. Manufacturers with drugs covered under the medical benefit will need to fully reevaluate their strategies to adapt.


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Who’s the Real Target of Trump’s Medicare Price Policy?

Posted by Howard Deutsch on Mon, Nov 05, 2018

Bill Coyle, Pratap Khedkar and Gustavo Poblete co-authored this post with Howard Deutsch.

When President Trump announced at the Department of Health and Human Services that the federal government would be taking “revolutionary” action on drug prices, he had harsh words for the “global freeloading” by foreign nations that demand low prices while saddling Americans with the high prices that fund pharmaceutical industry R&D. And he came with a plan: Medicare Part B prices will be lowered by indexing to drug prices in other wealthy nations.


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