August 21, 2019
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Keep your finger on the pulse of the most critical issues facing the industry, our Members and Patients with BioNJ's bi-weekly Public Policy Update .

Because Patients Can't Wait ®
STATE
Governor Murphy Signed Innovation District Legislation 
Governor Murphy has signed A-5111 into law. A-5111, sponsored by Assembly Representatives James Kennedy, Nancy Pinkin and Patricia Egan Jones, along with Senators Joseph Cryan and Teresa Ruiz, would create the Innovation District Designation Program within the New Jersey Commission on Science, Innovation and Technology. The Innovation District designation will help facilitate redevelopment in a given area via partnerships between government, higher education and other organizations. BioNJ thanks the legislative sponsors and Governor Murphy for their continued work on behalf of New Jersey’s innovation economy.  
Patient Advocacy Summit Registration Now Open
Registration is now open for BioNJ’s Fourth Annual Patient Advocacy Summit, taking place October 4, at Celgene in Summit, NJ. The Summit will bring together Patients , Patient Advocacy Groups , Caregivers and Industry for a morning of Education , Engagement and Empowerment ! Attendees will gain valuable tools and insights, share best practices and meet key stakeholders within the health care ecosystem. Registration is free to Patient Advocacy Groups and BioNJ Member R&D (Innovation) company Patient advocacy and government affairs professionals. 
FEDERAL
Importation Pathways Unveiled
The U.S. Department of Health and Human Services (HHS) has unveiled a dual track pathway to allow for importation of drugs and biopharmaceuticals into the United States. The first pathway would provide for rulemaking that sets parameters for states, wholesalers and others to safely import prescriptions meant for sale in Canada into the United States. The second pathway would have HHS provide recommendations to manufacturers on ways to import versions of drugs sold in other countries into the United States. BioNJ firmly believes this proposal is the wrong way to lower drug costs for Patients at the pharmacy counter. See August 1 BioNJ Public Policy Alert for more information on the proposal.
CMS Finalizes CAR-T Coverage 
The Centers for Medicare and Medicaid Services (CMS) has announced that Medicare will cover CAR-T cell therapy for beneficiaries. In an August 7 press release, the agency announced that Medicare will pay for CAR-T therapy that is administered in health care facilities enrolled in the U.S. Food and Drug Administration’s risk evaluation and mitigation strategies (REMS) for FDA-approved indications. CMS will also cover CAR-T therapy for off-label uses recommended by compendia approved by CMS. New Jersey has become a hotbed of research and development in cell and gene therapy, and the CMS announcement will have a positive impact on Medicare Patients nationwide.
GAO Report: Rebates Mostly Passed to Plans
The U.S. Government Accountability Office (GAO) has released a report studying Medicare Part D negotiated rebates. Among other findings, the report found that rebates have skyrocketed in recent years – a 66 percent increase from 2014 to 2016. The report also found that nearly all rebates collected by pharmacy benefit managers (PBMs) were passed on to Medicare Part D plan sponsors. Health and Human Services (HHS) recently withdrew a regulation that would have guaranteed negotiated rebates were used to lower Patient costs at the pharmacy counter. BioNJ believes rebate reform is one of the right ways to address drug pricing.  
Thank You To Our Public Policy Support Series Sponsors
Celgene Corporation
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