President Trump Releases Innovation Stifling “Most-Favored Nation” Rule

The Trump Administration released two pre-Thanksgiving regulatory actions on the so-called “Most-Favored Nation” and the Part D rebate rule. Both actions were among the executive orders on drug pricing President Trump had announced earlier this summer. 

The Most-Favored Nation model was unveiled as an interim final rule with a 60-day comment period and would “test” a payment model for certain Part B treatments based on the lowest adjusted price from 22 Organization for Economic Co-Operation and Development (OECD). The model would test 50 sole-source drugs and biologics in care settings accounting for an estimated 88 percent of total Part B spending on the 50 treatments. The seven-year demonstration project would phase in the MFN price over the first four years of the model with years five to seven continuing at 100 percent of the MFN price. The model would also replace the existing ASP+6 model for providers with a flat, per-dose add-on fee. 

BioNJ continues to believe this reckless policy proposal would hurt both innovators and the Patients we serve. And apparently the administration agrees with this assessment, estimating that nearly 20 percent of model savings would come directly from lower Patient utilization of necessary treatments. 

The Trump Administration has also released its rebate rule that was previously withdrawn in July of 2019. The rebate rule would eliminate existing Part D rebate safe harbors while creating new safe harbors for point-of-sale price reductions. BioNJ had previously noted our support of this proposal to help improve Patient access to lifesaving treatments. 

A link to the CMS Innovation Center press release announcing the MFN model that includes a fact sheet and a link to the rule itself is available hereClick here for BioNJ President and CEO Debbie Hart’s statement on this announcement. 

A copy of the rebate rule is available here and a HHS press release is available here
President-Elect Biden Transition Update

As expected, President-Elect Joe Biden announced his intention to nominate several individuals to keyCabinet level posts. Nominations for national security positions include: 
  • Antony Blinken, Secretary of State
  • Alejandro Mayorkas, Secretary of Homeland Security
  • Avril Haines, Director of National Intelligence
  • Linda Thomas-Greenfield, U.S. Ambassador to the United Nations
  • Jake Sullivan, National Security Advisor
  • Former Senator and Secretary of State John Kerry, Special Presidential Envoy for Climate

Click here for more information on President-Elect Biden’s nominations.
Budget Chair Pintor Marin, Former BIO CEO Greenwood Join Virtual BioNJ Finance Briefing

BioNJ was honored to be joined by both New Jersey General Assembly Budget Chair Eliana Pintor Marin and Former Congressman and BIO President and CEO Jim Greenwood for our November 18 Virtual Finance Briefing. Assemblywoman Pintor Marin joined BioNJ President and CEO Debbie Hart for a moderated discussion on the conclusion of fiscal year 2021 budget considerations and near-term expectations for the State budget, tax incentives and other issues. Meanwhile, Hart also hosted Congressman Greenwood for a fireside chat to discuss the outcome of the 2020 election and its impact on health policy and drug pricing discussions.
Legislative Update

Following the passage of the recreational marijuana ballot measure, New Jersey legislators went to work to craft enacting legislation prior to the start of the new year. However, both the NJ Senate and General Assembly canceled November 23 voting sessions with negotiations ongoing on the enacting legislation. Negotiations are expected to continue with a December vote expected to comply with a January 1 deadline. 

Meanwhile, Congress returned post-election for a pre-Thanksgiving gathering to hold party leadership elections for the 117th Congress. House Speaker Nancy Pelosi, Senate Majority Leader Mitch McConnell and all other leadership positions will remain the same in 2021. A COVID relief package still appears most likely in 2021 as significant differences remain in the size of such a package.
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