January 6, 2021

Incentives Package Awaits Governor Murphy Action and includes important measures for life sciences industry Legislation looking to spur economic growth in NJ, including creating new incentive programs to allow innovation to thrive in the Garden State, was passed in late December by both houses of the NJ Legislature. The legislation, for which BioNJ was an active supporting voice, includes the enactment of the New Jersey Innovation Evergreen Fund to help bring more venture funding to the Garden State as well as an increase from $25 to $35 million for the Angel Investor Tax Credit program and an increase from $60 to $75 million in transferable tax credits from the NJEDA’s NOL Program. The legislation’s targeted incentive programs also include the Aspire and Emerge programs to encourage redevelopment and job retention as well as the Ignite program to provide early stage innovative companies with collaborative workspace opportunities.  BioNJ supports this important legislation to maintain New Jersey’s claim as the “State of Innovation.” Click here for a copy of BioNJ President and CEO Debbie Hart’s testimony on A-4/S-3295.

Federal Judge Temporarily Blocks Trump Administration’s MFN Rule The Trump Administration’s “Most-Favored Nation” using foreign reference pricing for Medicare Part B has suffered a temporary setback in federal court. U.S. District Judge Catherine Blake ruled that the administration had not given the public ample opportunity to comment on the regulation and granted a temporary restraining order keeping the Trump administration from implementing the final rule.  BioNJ believes this misguided policy will decimate New Jersey’s innovative biopharmaceutical sector while simultaneously reducing Patient access to new treatments. We are pleased that this policy is temporarily on hold, and we are hopeful the incoming Biden Administration reconsiders its impact on innovators and Patients.   Click here for a copy of Judge Blake’s opinion.

COVID Package Update As you likely know since our last Public Policy Update, President Trump has signed into law a package including COVID-19 relief as well as the remainder of FY2021 federal appropriations. The package had been under negotiations for months following the late spring package of the CARES Act. While issues such as liability protections and additional relief for state and local governments held up the final package, the legislation keeps the government open through the end of the fiscal year and shores up important federal COVID programs, such as the unemployment extensions and small business relief. Meanwhile, the package includes important "extenders," such as the critical four-year rare pediatric disease priority review voucher extension for which we advocated vociferously. BioNJ thanks Senator Menendez, Senator Booker, Energy and Commerce Chairman Pallone and our entire NJ delegation for their continued work on behalf of innovation and Patients.

Congress Reconvenes The United States Congress gaveled in its 117th session on January 3, 2021. Speaker Nancy Pelosi (D-CA) was chosen as Speaker of the House for the fourth time while Senator Mitch McConnell will continue as Senate Majority Leader. New Jersey’s Congressional delegation returns all 14 members from the 116th Congress with Senator Cory Booker and all 12 Members of Congress winning reelection on November 3, 2020. We look forward to working with our delegation during the 117th Congress to support policies that protect both Patient access and robust medical innovation.

Final VBP Rule Among Flurry of Late 2020 HHS Actions The Centers for Medicare and Medicaid Services have finalized a rule related to value-based purchasing for prescription treatments. The final rule codifies a definition of value-based purchasing while allowing manufacturers to report multiple best prices to account for value-based purchasing arrangements. Meanwhile, the final rule significantly scales back the proposed rule’s “line extension” provisions while delaying implementation of these provisions until January 1, 2022. The final rule also pushed back implementation of proposed “co-pay accumulator” provisions through January 1, 2023.  Last summer, BioNJ joined a group of state life sciences associations in expressing significant concerns with the impact of the co-pay accumulator and line extension provisions on biopharmaceutical innovators and the Patients we serve. In particular, the letter expressed concerns that these provisions could result in barriers to Patient access for necessary and lifesaving prescription treatments. BioNJ continues to review this final rule. However, we remain concerned that the co-pay accumulator provisions would make treatments more expensive for Patients.  We thank NJ Congresswoman Bonnie Watson Coleman for her legislation to help address the impact of these provisions on Patients, and we look forward to working with our New Jersey delegation to ensure continued Patient access to innovative therapies.  The U.S. Department of Health and Human Services Office of the General Counsel has also unveiled a December 30 advisory opinion related to 340B covered entities and contract pharmacies. The advisory opinion concludes that manufacturers “in the 340B Program are obligated to deliver their covered outpatient drugs to those contract pharmacies and to charge the covered entity no more than the 340B ceiling price for those drugs.” BioNJ believes the 340B Drug Pricing Program can be an important tool in delivering Patient access to necessary treatments, but reforms may also be necessary to ensure that 340B discounts reach the most vulnerable Patients. We will continue to monitor the impact of this advisory opinion.  A CMS press release announcing the final VBP with links to a fact sheet as well as the final rule text is available here. Click here for a link to the 340B advisory opinion.

We Need Your Help: Support BioNJ Policy and Advocacy Efforts BioNJ is the voice of New Jersey’s life sciences sector in Trenton and Washington. BioNJ’s Public Policy Support Series sponsorship opportunities are available for 2021. Sponsorship opportunities help make sure that our message is delivered in both Trenton and Washington, D.C. Help ensure BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship. Click here for more information.

Thank You to Our Public Policy Sponsors

BioNJ | www.BioNJ.org

‌ ‌ ‌